1.  Peer Reviewed Title: Oral compared with intravenous sedation for first-trimester surgical abortion: a randomized controlled trial. Author: Allen RH; Fitzmaurice G; Lifford KL; Lasic M; Goldberg AB Source: Obstetrics and Gynecology. 2009 Feb;113(2 Pt 1):276-83. Abstract: OBJECTIVE: To test the equivalency of oral sedation and intravenous sedation for pain control in first-trimester surgical abortion. METHODS: Women undergoing suction curettage at less than 13 weeks of gestation were randomly assigned to oral sedation, 10 mg of oxycodone and 1 mg of lorazepam, or intravenous sedation, 100 micrograms fentanyl and 2 mg midazolam. All patients received 800 mg of preoperative ibuprofen and a 20-mL paracervical block with 1% lidocaine. The primary outcome was intraoperative pain as measured on a 21-point verbal rating scale that had a range from 0 to 100 (0=no pain and 100=worst pain ever) with an equivalence margin for the treatment group comparison of +/-10. RESULTS: Of 130 women, 65 were randomly assigned to oral sedation and 65 to intravenous sedation. The groups differed at baseline by age and preoperative ratings of depression, stress, and anxiety; however, when adjusted for these differences, the primary results were unaffected. Mean intraoperative pain scores, controlling for age and preoperative depression, stress, and anxiety, were 61.2 for oral sedation and 36.3 for intravenous sedation (mean difference 24.9, 95% confidence interval 15.9-33.9). Other findings included no difference in postoperative adverse effects and less satisfaction with pain control with oral sedation compared with intravenous sedation. CONCLUSION: Oral sedation, as studied, is not equivalent to intravenous sedation for pain control during first-trimester surgical abortion. CLINICAL TRIAL REGISTRATION:: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00337792 LEVEL OF EVIDENCE: I. Language: English Keywords: MASSACHUSETTS | RESEARCH REPORT | CLINICAL TRIALS | COMPARATIVE STUDIES | EVALUATION INDEXES | KAP SURVEYS | PREGNANT WOMEN | ANESTHESIA | ABORTION | PREGNANCY, FIRST TRIMESTER | CURETTAGE | ADMINISTRATION AND DOSAGE | PAIN | SIDE EFFECTS | SATISFACTION | Developed Countries | United States of America | North America | Americas | Clinical Research | Research Methodology | Studies | Quantitative Evaluation | Evaluation | Surveys | Sampling Studies | Population Characteristics | Demographic Factors | Population | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Fertility Control, Postconception | Family Planning | Pregnancy | Reproduction | Obstetrical Surgery | Surgery | Drugs | Signs and Symptoms | Diseases | Psychological Factors | Behavior Document Number: 330360 Notification |
| 2. Title: Hysteroscopic female sterilization with Essure in an outpatient setting. Author: Andersson S; Eriksson S; Mints M Source: Acta Obstetricia Et Gynecologica Scandinavica. 2009;88(6):743-6. Abstract: The aim of this study is to evaluate the short and long-term results of hysteroscopic sterilization in an outpatient setting. Sixty-one women underwent hysteroscopic sterilization. At follow-up, all of the women were asked to complete a questionnaire concerning possible pregnancy, bleeding patterns, side-effects, or need for further therapy after sterilization. Technical feasibility, complications, patient satisfaction, and tubal occlusion based on X-ray or ultrasound were measured. Fifty-eight (95%) women were sterilized according to this method. Successful bilateral device placement was achieved in 52 women (85%) during the first attempt and in six (9.8%) during the second. A total of 50 (81.9%) women submitted completed outcome questionnaires. The mean follow-up period was 23 (range 7-67) months. No pregnancies were reported. All questionnaire respondents expressed overall satisfaction with the procedure. To conclude, Essure sterilization is a safe effective method for female sterilization thatis feasible in the outpatient setting. Language: English Keywords: SWEDEN | RESEARCH REPORT | CLIENTS | FEMALE STERILIZATION | HYSTEROSCOPY | COMPLICATIONS | SIDE EFFECTS | TUBAL OCCLUSION | SATISFACTION | SAFETY | Developed Countries | Europe, Northern | Europe | Program Activities | Programs | Organization and Administration | Sterilization, Sexual | Family Planning | Endoscopy | Physical Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Diseases | Treatment | Psychological Factors | Behavior | Public Health Document Number: 341444 |
| 3. Peer Reviewed Title: Peripheral neuropathy in HIV-positive patients at an antiretroviral clinic in Lilongwe, Malawi. Author: Beadles WI; Jahn A; Weigel R; Clutterbuck D Source: Tropical Doctor. 2009 Apr;39(2):78-80. Abstract: Peripheral neuropathy (PN) is common in the setting of antiretroviral (ARV) programmes in resource-limited settings and poses significant challenges in assessment and management. A retrospective analysis was undertaken of prevalence and management of PN in a cohort of 3341 patients on highly active antiretroviral therapy. A first line ARV regimen containing stavudine (D4T) is used for clinically eligible patients. Amitriptyline is prescribed for symptom relief and in cases of persistent or escalating symptoms zidovudine (AZT) is substituted for D4T. Leg pain or numbness was reported in 1173 patients (35%). However, only 428 (13%) were given a diagnosis of PN, 228 (7%) were prescribed amitriptyline and 200 (6%) were switched to AZT. A recent pharmokinetic study in this population showed a high Cmax of D4T with the generic combination triomune (D4T 40 mg). This could account for the high prevalence of PN. The optimum time for switch to a non-D4T containing regimen is unknown. Language: English Keywords: MALAWI | RESEARCH REPORT | RETROSPECTIVE STUDIES | CLIENTS | ANTIRETROVIRAL THERAPY | ANTIRETROVIRAL DRUGS | SIDE EFFECTS | NEUROLOGIC EFFECTS | PREVALENCE | SIGNS AND SYMPTOMS | TOXICITY | Africa, Southern | Africa, Sub Saharan | Africa | Developing Countries | Studies | Research Methodology | Program Activities | Programs | Organization and Administration | HIV | HIV Infections | Viral Diseases | Diseases | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Physiology | Biology | Measurement Document Number: 341785 |
| 4. Title: The association of serotonin transporter genotypes and selective serotonin reuptake inhibitor (SSRI)-associated sexual side effects: possible relationship to oral contraceptives. Author: Bishop JR; Ellingrod VL; Akroush M; Moline J Source: Human Psychopharmacology. 2009 Apr;24(3):207-15. Abstract: OBJECTIVE: To study the relationship between functional variants in the serotonin transporter gene (SLC6A4) and selective serotonin reuptake inhibitor (SSRI)-associated sexual dysfunction. METHODS: One hundred fifteen subjects aged 18-40 years and currently being treated with an SSRI for depression were assessed for clinical variables known to affect sexual well-being. SSRI-associated sexual difficulties were assessed with the Changes in Sexual Functioning Questionnaire (CSFQ). Subjects were subsequently genotyped for the SLC6A4 promoter region (5HTTLPR) insertion/deletion variant and a variable number of tandem repeats (VNTR) in the second intron. RESULTS: The 5HTTLPR insertion/deletion variant was associated with sexual dysfunction in this study sample [odds ratio (OR) = 2.7; 95% confidence interval (CI) 1.2, 6.4; p = 0.02]. The relationship between promoter genotypes and sexual well-being differed in males and females and was related to whether females were taking an oral contraceptive (OC) medication. Females with the ll genotype were nearly eight times more likely to be categorized as having sexual dysfunction if they were taking OCs, while no relationship was observed in those not taking OCs. CONCLUSIONS: These results suggest that a functional variant in the serotonin transporter gene is associated with sexual difficulties in persons taking an SSRI for depression. This relationship may differ by sex and be dependent on OC status in females. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | SAMPLING STUDIES | CLIENTS | DEPRESSION | DRUGS | ADMINISTRATION AND DOSAGE | SEROTONIN | SIDE EFFECTS | DECREASED LIBIDO | ORAL CONTRACEPTIVES | GENETICS | Developed Countries | North America | Americas | Studies | Research Methodology | Program Activities | Programs | Organization and Administration | Mental Disorders | Diseases | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Physiology | Biology | Sex Behavior | Behavior | Contraceptive Methods | Contraception | Family Planning Document Number: 341959 |
| 5. Title: Venous thromboembolism in women using hormonal contraceptives. Findings from the RIETE Registry. Author: Blanco-Molina A; Trujillo-Santos J; Tirado R; Canas I; Riera A; Valdes M; Monreal M Source: Thrombosis and Haemostasis. 2009;101(3):478-482. Abstract: There is scarce information on the clinical characteristics of contraceptive users who develop venous thromboembolism (VTE). RIETE is an ongoing registry of consecutive patients with symptomatic, objectively confirmed, acute VTE. We analyzed the clinical characteristics and additional risk factors for VTE in all enrolled women aged <50 years who were using or not using contraceptives at presentation with VTE. Of 1,667 women aged <50 years enrolled in RIETE as of December 2007, 593 (36%) were contraceptive users. Of 270 aged <25 years, 190 (70%) were users. Ninety-two contraceptive users (16%) had overweight, 89 (15%) were obese. Of 951 women with no additional risk factors for VTE (i.e. recent surgery, immobility or cancer) 457 (48%) were contraceptive users. Eighty-seven (15%) users had recent immobility for >/=4 days, 44 (7.4%) were postoperative. The most common reason for immobility was lower limb trauma not requiring surgery; 25% of users with recent immobility had received thromboprophylaxis. The most common type of surgery was non-major orthopaedic surgery. Twenty-one (48%) users with postoperative VTE had received prophylaxis. The percentage of users and non-users who tested positive for thrombophilia was similar. Contraceptive use remains the most frequent risk factor for VTE in women at fertile age. Identifying those at increased risk for VTE seems to be difficult. In the meanwhile, a higher use of thromboprophylaxis during immobility or minor surgery should be warranted. Language: English Keywords: SPAIN | RESEARCH REPORT | EPIDEMIOLOGIC METHODS | CLINICAL RESEARCH | WOMEN | PREVALENCE | THROMBOEMBOLISM | RISK FACTORS | CONTRACEPTIVE AGENTS, FEMALE | HORMONES | SIDE EFFECTS | COMPLICATIONS | SURGERY | POSTOPERATIVE PROCEDURES | Developed Countries | Europe, Southwestern | Europe | Research Methodology | Demographic Factors | Population | Measurement | Embolism | Vascular Diseases | Diseases | Health | Contraceptive Agents | Contraception | Family Planning | Endocrine System | Physiology | Biology | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 330607 |
| 6. Title: Contraception for women with epilepsy. Author: Burakgazi E; Harden C; Kelly JJ Source: Reviews in Neurological Diseases. 2009 Spring;6(2):E62-7. Abstract: The choice of a contraceptive drug can be challenging for women with epilepsy due to possible interactions between antiepileptic drugs (AEDs) and hormonal contraception. Enzyme-inducing AEDs can cause hormonal contraception to fail and can increase the risk of teratogenicity. Higher doses of oral contraceptives can overcome pharmacologic failure but may create additional risks. The effects of reproductive hormones on individual AEDs have recently been clarified, providing helpful guidelines for physicians and patients. Studies show that lamotrigine has a significantly increased clearance (> 50%) when used with combined oral contraceptives, which results in an increased seizure frequency in most patients. Useful alternatives to oral contraceptives include depot injections and intrauterine devices. Subdermal implants may increase the risk of pregnancy in women with epilepsy on enzyme-inducing AEDs. Depot medroxyprogesterone acetate is effective but can increase side effects. Intrauterine devices arean alternative to pharmacologic approaches because they lack drug-drug interactions and side effects. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | WOMEN | ORAL CONTRACEPTIVES | IUD | INJECTABLES | NEUROLOGIC EFFECTS | DRUGS | DRUG INTERACTIONS | TREATMENT | SIDE EFFECTS | Developed Countries | North America | Americas | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Physiology | Biology | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 341913 |
| 7. Peer Reviewed Title: Response to zidovudine/didanosine-containing combination antiretroviral therapy among HIV-1 subtype C-infected adults in Botswana: two-year outcomes from a randomized clinical trial. Author: Bussmann H; Wester CW; Thomas A; Novitsky V; Okezie R; Muzenda T; Gaolathe T; Ndwapi N; Mawoko N; Widenfelt E; Moyo S; Musonda R; Mine M; Makhema J; Moffat H; Essex M; Degruttola V; Marlink RG Source: Journal of Acquired Immune Deficiency Syndromes. 2009 May 1;51(1):37-46. Abstract: BACKGROUND: Numerous national antiretroviral (ARV) treatment initiatives offering protease inhibitor-sparing combination antiretroviral therapy (cART) have recently commenced in southern Africa, the first of which began in Botswana in January 2002. Evaluation of the efficacy and tolerability of various protease inhibitor-sparing cART regimens requires intensive study in the region, as does investigation of the development of drug resistance and the optimal means of sustaining adherence. The "Tshepo" Study is the first large-scale, randomized, clinical trial that addresses these important issues among HIV-1 subtype C-infected ARV treatment-naive adults in southern Africa. METHODS: The Tshepo Study is a completed, open-labeled, randomized study that enrolled 650 ARV-naive adults between December 2002 and 2004. The study is a 3 x 2 x 2 factorial design comparing the efficacy and tolerability among factors: (1) 3 combinations of nucleoside reverse transcriptase inhibitors (NRTIs): zidovudine (ZDV) + lamivudine (3TC), ZDV + didanosine (ddI), and stavudine (d4T) + 3TC; (2) 2 different nonnucleoside reverse transcriptase inhibitors (NNRTIs): nevirapine and efavirenz; and (3) 2 different adherence strategies: the current national "standard of care" versus an "intensified adherence strategy" incorporating a "community-based directly observed therapy." Study patients were stratified into 2 balanced CD4 T-cell count groups: less than 201 versus 201-350 cells per cubic millimeter with viral load greater than 55,000 copies per milliliter. Following Data Safety Monitoring Board recommendations in April 2006, ZDV/ddI-containing arms were discontinued due to inferiority in primary end point, namely, virologic failure with resistance. We report both overall data and pooled data from patients receiving ZDV/ddI- versus ZDV/3TC- and d4T/3TC-containing cART through April 1, 2006. RESULTS: Four hundred fifty-one females (69.4%) and 199 males with a median age of 33.3 years were enrolled into the study. The median follow-up as of April 1, 2006, was 104 weeks, and loss to follow-up rate at 2 years was 4.1%. The median baseline CD4 T-cell count was 199 cells per cubic millimeter [interquartile ratio (IQR) 136-252], and the median plasma HIV-1 RNA level was 193,500 copies per milliliter (IQR 69-250, 472-500). The proportion of participants with virologic failure and genotypic resistance mutations was 11% in those receiving ZDV/ddI-based cART versus 2% in those receiving either ZDV/3TC- or d4T/3TC-based cART (P = 0.002). The median CD4 T-cell count increase at 1 year was 137 cells per cubic millimeter (IQR 74-223) and 199 cells per cubic millimeter (IQR 112-322) at 2 years with significantly lower gain in the ZDV/ddI arm. At 1 and 2 years, respectively, 92.0% and 88.8% of patients had an undetectable plasma HIV-1 RNA level (< or = 400 copies/mL). Kaplan-Meier survival estimates at 1 and 2 years were 96.6% and 95.4%. One hundred twenty patients (18.2%) had treatment-modifying toxicities, of which the most common were lipodystrophy, anemia, neutropenia, and Stevens-Johnson syndrome. There was a trend toward difference in time to treatment-modifying toxicity by pooled dual-NRTI combination and no difference in death rates. CONCLUSIONS: The preliminary study results show overall excellent efficacy and tolerability of NNRTI-based cART among HIV-1 subtype C-infected adults. ZDV/ddI-containing cART, however, is inferior to the dual NRTIs d4T/3TC or ZDV/3TC when used with an NNRTI for first-line cART. Language: English Keywords: BOTSWANA | RESEARCH REPORT | CLINICAL TRIALS | COMPARATIVE STUDIES | PERSONS LIVING WITH HIV/AIDS | ADULTS | ANTIRETROVIRAL THERAPY | ANTIRETROVIRAL DRUGS | ADMINISTRATION AND DOSAGE | USER COMPLIANCE | DRUG RESISTANCE | IMMUNOLOGICAL EFFECTS | SIDE EFFECTS | Africa, Southern | Africa, Sub Saharan | Africa | Developing Countries | Clinical Research | Research Methodology | Studies | HIV Infections | Viral Diseases | Diseases | Age Factors | Population Characteristics | Demographic Factors | Population | HIV | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs | Behavior | Immunity | Immune System | Physiology | Biology Document Number: 342371 |
| 8. Peer Reviewed Title: Insulin sensitivity and lipid metabolism with oral contraceptives containing chlormadinone acetate or desogestrel: a randomized trial. Author: Cagnacci A; Ferrari S; Tirelli A; Zanin R; Volpe A Source: Contraception. 2009 Feb;79(2):111-6. Abstract: BACKGROUND: Second-generation and third-generation oral contraceptives containing 30 mcg or more of ethinylestradiol (EE) decrease insulin sensitivity (SI). In this study, we investigated whether SI is decreased by contraceptives containing lower doses EE or by progestins with antiandrogenic properties. STUDY DESIGN: Twenty-eight young healthy women were randomly allocated to receive 20 mcg of EE and 150 mcg of desogestrel (DSG) (n=14) or 30 mcg of EE and 2 mg of chlormadinone acetate (CMA) (n=14) for 6 months. SI and glucose utilization independent of insulin (Sg) were investigated by the minimal model method. Lipid modifications were also analyzed. RESULTS: SI decreased with EE/DSG (7.09+/-1.4 vs. 4.30+/-0.91; p=.04; n=12), but not with EE/CMA (5.79+/-0.93 vs. 6.79+/-1.1; p=.48; n=12). SI modifications observed in the two groups were significantly different (-2.79+/-1.15 vs. 1.0+/-1.38; p=.05). Sg did not vary with either treatment. The response of C-peptide to glucose increased, but significantly so only with EE/CMA (p=.01). The C-peptide/insulin response increased with both EE/DSG (p=.05) and EE/CMA (p=.04). High-density lipoprotein (HDL) cholesterol (p=.02) and triglycerides (p=.02 and p=.01) increased in both groups, but HDL/low-density lipoprotein cholesterol (p=.02), apoprotein A1 (Apo-A1) (p=.04) and Apo-A1/apoprotein B (p=.048) increased significantly only with EE/CMA. CONCLUSIONS: The present study confirms that DSG, even when associated with low EE dose, decreases SI. By contrast, EE/CMA does not deteriorate SI and induces a favorable lipid profile. Language: English Keywords: ITALY | RESEARCH REPORT | CLINICAL TRIALS | WOMEN | PROGESTERONE | DESOGESTREL | CONTRACEPTION | ORAL CONTRACEPTIVES | LIPIDS | METABOLIC EFFECTS | SIDE EFFECTS | Developed Countries | Europe, Southern | Europe | Clinical Research | Research Methodology | Demographic Factors | Population | Progestational Hormones | Hormones | Endocrine System | Physiology | Biology | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Family Planning | Contraceptive Methods | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 329611 |
9.  Title: Manual vacuum aspiration for uterine evacuation: pain management. Author: Castleman L; Mann C Source: Chapel Hill, North Carolina, Ipas, 2009. 8 p. Abstract: Reducing the physical pain and anxiety experienced by women undergoing uterine evacuation is an essential part of treatment with MVA. The second edition of this publication addresses the types and origins of discomfort that women may experience, as well as techniques for reducing this discomfort. It includes a table highlighting some common pharmacologic approaches to pain management during MVA. Language: English Keywords: GLOBAL | RECOMMENDATIONS | PROVIDERS WITH CLIENTS | ABORTION | PAIN | PERCEPTION | CERVICAL DILATATION | ANESTHESIA | ANALGESIA | DRUGS | ADMINISTRATION AND DOSAGE | SIDE EFFECTS | POSTOPERATIVE PROCEDURES | Health Services | Delivery of Health Care | Health | Fertility Control, Postconception | Family Planning | Signs and Symptoms | Diseases | Psychological Factors | Behavior | Treatment | Medical Procedures | Medicine | Surgery Document Number: 342497 Notification |
| 10. Peer Reviewed Title: A randomized trial to compare two dosing intervals of misoprostol following mifepristone administration in second trimester medical abortion. Author: Chai J; Tang OS; Hong QQ; Chen QF; Cheng LN; Ng E; Ho PC Source: Human Reproduction. 2009 Feb;24(2):320-4. Abstract: BACKGROUND: The conventional timing of misoprostol administration after mifepristone for second trimester medical abortion is 36-48 h, but simultaneous administration, which may make the regimen more convenient, has not been studied. The objective of this randomized comparison study is to compare two intervals of administration of misoprostol after pretreatment with mifepristone for second trimester medical abortion. METHODS: Eligible women with gestational age between 12 and 20 weeks were randomized to receive mifepristone 200 mg orally followed by 600 microg misoprostol vaginally either immediately or 36-38 h later, followed by 400 microg vaginal misoprostol every 3 h for a maximum of four doses. The primary outcome measure was the success rate at 24 h after the start of misoprostol treatment and the secondary outcome measures were the induction-to-abortion interval and the frequency of side effects. RESULTS: There was a significant difference in the success rate at 24 h (36-38 h: 100%; immediate: 91.5%). The median induction-to-abortion interval was significantly shorter in the 36-38 h regimen (4.9 h) compared with the immediate regimen (10 h). Side effects in terms of febrile episodes and chills/rigors were significantly higher in the immediate administration group. CONCLUSIONS: Simultaneous use of mifepristone and misoprostol for second trimester medical abortion is not as effective as the regimen using a 36-38 h dosing interval. Language: English Keywords: CHINA | HONG KONG | RESEARCH REPORT | CLINICAL RESEARCH | PREGNANT WOMEN | WOMEN IN DEVELOPMENT | ABORTION | ADMINISTRATION AND DOSAGE | MISOPROSTOL | RU-486 | PREGNANCY, SECOND TRIMESTER | TIME FACTORS | SIDE EFFECTS | Asia, Eastern | Asia | Developing Countries | Developed Countries | Research Methodology | Population Characteristics | Demographic Factors | Population | Economic Development | Economic Factors | Fertility Control, Postconception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Prostaglandins, Synthetic | Prostaglandins | Endocrine System | Physiology | Biology | Hormone Antagonists | Hormones | Pregnancy | Reproduction | Population Dynamics Document Number: 331075 Notification |
| 11. Title: Women's health and gender-based clinical trials on etoricoxib: methodological gender bias. Author: Chilet-Rosell E; Ruiz-Cantero MT; Horga JF Source: Journal of Public Health. 2009 Sep;31(3):434-45. Abstract: BACKGROUND: The aim of this study was to determine compliance with published good practice guidelines for gender and clinical trials using etoricoxib. The rationale for choosing etoricoxib was that it is widely used by women and there is evidence of potential interaction with contraceptives and hormone replacement therapy as highlighted in the product characteristics. METHODS: The study reviewed 58 etoricoxib published trials (54 papers) to determine if they met the gender recommendations of the Guidelines of Food and Drug Administration (1993) and the Sex, Gender and Pain Special Interest Group Consensus Working Group Report (2007). RESULTS: Women formed 70% of a total of 49 835 subjects included in the etoricoxib trials, but only 31% of the subjects were in Phase I. About 85.7% of trials did not show sex-stratified data. About 90.6 and 93.3% did not provide efficacy and adverse effects data by sex, respectively. There is scarce information about the influence of issues that specifically affect women. Discussion Women are under-represented in the published etoricoxib trials, specifically, in Phase I. Sex-stratified data on efficacy and adverse effects are scarce in etoricoxib trials. Together with the lack of data on women-specific issues, this suggests that etoricoxib may pose the same potential problems for women as other cyclooxygenase-2 inhibitors. Language: English Keywords: GLOBAL | LITERATURE REVIEW | CLINICAL TRIALS | DRUGS | ADMINISTRATION AND DOSAGE | DRUG INTERACTIONS | CONTRACEPTIVE AGENTS, FEMALE | HORMONE REPLACEMENT THERAPY | SIDE EFFECTS | THROMBOSIS | SEX FACTORS | PREGNANCY | VALIDITY | Clinical Research | Research Methodology | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents | Contraception | Family Planning | Thromboembolism | Embolism | Vascular Diseases | Diseases | Population Characteristics | Demographic Factors | Population | Reproduction | Measurement Document Number: 342950 |
| 12. Title: Chronic viral hepatitis may diminish the gains of HIV antiretroviral therapy in sub-Saharan Africa. Author: Cooper CL; Mills E; Wabwire BO; Ford N; Olupot-Olupot P Source: International Journal of Infectious Diseases. 2009 May;13(3):302-6. Abstract: There is a heavy burden of HIV-hepatitis B virus (HBV) and HIV-hepatitis C virus (HCV) co-infection in many regions of the developing world. An often unmentioned illness, issues of poverty, socio-economic status, nutrition, access to medical care, and mistrust of Western-style medicine conspire to reduce the opportunity to receive clinical work-up and treatment for chronic viral hepatitis. We discuss key issues specific to the treatment of viral hepatitis and obstacles to success with this endeavor in the context of HIV co-infection in Africa. We predict that provision of viral hepatitis antiviral therapy will become a more pressing issue as more HIV-infected patients receive lifesaving combination antiretroviral therapy only to succumb thereafter from viral hepatitis-induced liver disease. Given the lessons learned from combination antiretroviral rollout in sub-Saharan Africa, establishing expertise and infrastructure for viral hepatitis care and antiviral therapy is relevant. Failure to act now may diminish the milestones and the gains made with antiretroviral therapy in the developing world. Language: English Keywords: AFRICA, SUB SAHARAN | CRITIQUE | ANTIRETROVIRAL THERAPY | ANTIRETROVIRAL DRUGS | SIDE EFFECTS | HEPATIC EFFECTS | TOXICITY | HEPATITIS | ANTIVIRAL DRUGS | OBSTACLES | SCREENING | Africa | Developing Countries | HIV | HIV Infections | Viral Diseases | Diseases | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Physiology | Biology | Drugs | Organization and Administration | Examinations and Diagnoses Document Number: 342111 |
| 13. Peer Reviewed Title: Quinacrine sterilization for human immunodeficiency virus-positive women. Author: de Magalhaes DR; de Carvalho Ferreira CR; Barbosa Magalhaes E; Camargos AF; Lippes J; Carvalho Ferreira D Source: Fertility and Sterility. 2009 Jul;92(1):108-15. Abstract: OBJECTIVE: To evaluate the safety of nonsurgical quinacrine sterilization for HIV-positive (HIV+) women. DESIGN: An open trial of quinacrine sterilization was carried out in women infected with HIV and women who were HIV negative (HIV-). Comparison of the results with the two groups provided an assessment of the safety and effectiveness of quinacrine sterilization for HIV+ women. SETTING: University Medical School outpatient services. PATIENT(S): A total of 258 women who desired sterilization were offered quinacrine sterilization as a means of limiting family size. Sixty-four were HIV+, and 194 were HIV-. Women who were HIV+ had CD4 counts >200 and were otherwise healthy. INTERVENTION(S): A modified Copper T intrauterine device inserter was used to place 252 mg of quinacrine, divided into seven pellets (36 mg each) into the uterine cavity. Three insertions of this formulation were performed, 1 month apart. Viral load and CD8 and CD4 lymphocytes were measured both before and after quinacrine sterilization and at follow-up visits. Pregnancies and adverse events were recorded carefully. A decrement life table was made to statistically analyze results. RESULT(S) AND MAIN OUTCOME MEASURE(S): No serious adverse event occurred in any patient in this study. Adverse effects related to quinacrine sterilization were abdominal cramping, vulvar itching, nausea, and vaginal bleeding. Vaginal bleeding was the only short-term side effect noted to occur more frequently in HIV-infected women after quinacrine sterilization. Among HIV+ women, 35.9% had complaints of increased bleeding, whereas only 8.2% of those who were HIV- had such complaints, which probably were insertion related. Viral load and the CD4+ and CD8+ lymphocyte measures displayed no statistically significant difference after quinacrine sterilization. CONCLUSION(S): Quinacrine sterilization is a safe method for the sterilization of HIV-infected women and has no short-term effect on the pathology of the disease. Language: English Keywords: BRAZIL | RESEARCH REPORT | CLINICAL TRIALS | PERSONS LIVING WITH HIV/AIDS | WOMEN | QUINACRINE STERILIZATION | SAFETY | ANTIRETROVIRAL THERAPY | SIDE EFFECTS | INSERTION | ULTRASONICS | South America, Eastern | South America | Latin America | Americas | Developing Countries | Clinical Research | Research Methodology | HIV Infections | Viral Diseases | Diseases | Demographic Factors | Population | Female Sterilization | Sterilization, Sexual | Family Planning | Public Health | Health | HIV | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 342325 |
| 14. Title: Reduced rate of adverse reactions to the BCG vaccine in children exposed to the vertical transmission of HIV infection and in HIV-infected children from an endemic setting in Brazil. Author: Fernandes RC; de Araujo LC; Medina-Acosta E Source: European Journal of Pediatrics. 2009 Jun;168(6):691-6. Abstract: We report on the adverse reactions to the Bacillus Calmette-Guerin (BCG) vaccine in BCG-vaccinated children. We examined children exposed to the vertical transmission of human immunodeficiency virus (HIV) (n = 141), who participated in a prevention program of vertical transmission, and HIV-infected children (n = 66) in a setting endemic for HIV and tuberculosis (TB) in Brazil from August 2000 to February 2008. No cases of disseminated BCG disease occurred in either group of children. While no cases of regional BCG disease were noted in exposed/uninfected children, the rate of regional BCG disease in HIV-infected children was 4.5% (3/66); the three events occurred in <1-year-old children (3/17; 17.6%). One case was associated with severe immunodepression before highly active antiretroviral therapy (HAART). Two cases were manifestations of immune reconstitution inflammatory syndrome (IRIS). Among the HIV-infected children, the accrued benefits of potentially preventing severe TB outweighed the risks associated with the use of the BCG vaccine. Language: English Keywords: BRAZIL | RESEARCH REPORT | PROSPECTIVE STUDIES | CHILDREN | PERSONS LIVING WITH HIV/AIDS | TUBERCULOSIS | VACCINES | SIDE EFFECTS | MOTHER-TO-CHILD TRANSMISSION | IMMUNOLOGICAL EFFECTS | ANTIRETROVIRAL THERAPY | South America, Eastern | South America | Latin America | Americas | Developing Countries | Studies | Research Methodology | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | HIV Infections | Viral Diseases | Diseases | Infections | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Treatment | Transmission | Immunity | Immune System | Physiology | Biology | HIV Document Number: 342835 |
| 15. Peer Reviewed Title: Rationing antiretroviral therapy in Africa--treating too few, too late. Author: Ford N; Mills E; Calmy A Source: New England Journal of Medicine. 2009 Apr 30;360(18):1808-10. Abstract: The past 6 years have seen striking advances in access to antiretroviral therapy in Africa. From 2002 onward, the international drive to scale up antiretroviral treatment gained considerable momentum, most notably with the establishment of the Global Fund to Fight AIDS, Tuberculosis, and Malaria, the "3 by 5" Initiative of the World Health Organization (WHO), and the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). The momentum has now begun to wane, with various groups arguing that the focus on AIDS has had its day and that health care funding should now be redirected to other areas, such as maternal and child health and primary care. But before the international community gives up on prioritizing care for patients with HIV infection, we believe that on-the-ground discussions must address not only whether enough has been done to scale up treatment but also whether the treatment that patients are receiving is good enough. The standard approach to HIV treatment in Africa is to wait until people are visibly sick, treat them with effective but poorly tolerated drugs, and then wait until they are sick again before switching regimens. There are several problems with this approach. The first is that too few people are receiving treatment. Second, we are waiting until people are symptomatic before they are treated. Another concern is that in most developing countries, patients are receiving drugs with major tolerability issues. Furthermore, not only should initial treatment begin earlier in developing countries, but when the first-line regimen fails, patients should also be switched earlier to another regimen. The drive to scale up antiretroviral treatment in Africa has encouraged a public health approach that promotes reaching the greatest number of patients with the simplest, most affordable regimens. We would argue that treating people when they are less sick with drugs that are less toxic and providing a simple tool for monitoring adherence and detecting treatment failure would be entirely consistent with this approach and would improve access to care by facilitating the decentralization of services from the hospital level to the clinic. (excerpt) Language: English Keywords: AFRICA | DEVELOPING COUNTRIES | SUMMARY REPORT | HIV INFECTIONS | ANTIRETROVIRAL THERAPY | TREATMENT | TIME FACTORS | SIGNS AND SYMPTOMS | DRUG RESISTANCE | ANTIRETROVIRAL DRUGS | SIDE EFFECTS | HIV TRANSMISSION | HEALTH POLICY | NEEDS ASSESSMENT | Viral Diseases | Diseases | HIV | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Population Dynamics | Demographic Factors | Population | Policy | Political Factors | Sociocultural Factors | Evaluation Document Number: 341021 |
| 16. Title: Hematologic changes associated with zidovudine following single-drug substitution from stavudine in a home-based AIDS care program in rural Uganda. Author: Forna F; Moore D; Mermin J; Brooks JT; Were W Source: Journal of the International Association of Physicians in AIDS Care. 2009 Mar-Apr;8(2):128-138. Abstract: Background. The authors evaluated hematologic changes associated with zidovudine (ZDV) following single-drug substitution from stavudine (D4T) in HIV-infected persons in Uganda. Methods. From May 2003 through February 2007, the authors evaluated incidence rates (IR) of hematologic abnormalities from quarterly blood draws among adults prescribed highly active antiretroviral therapy (HAART) before and after single-drug substitution of D4T to ZDV. Results. A total of 1089 adults received D4T-containing HAART (median observation time 35.9 months), and 290 (27%) had ZDV substituted for D4T. While taking D4T, IR for anemia was 0.35/100 person-months (PMs), leukopenia was 0.29/100PM, and thrombocytopenia was 0.32/100 PM. While taking ZDV, IR for anemia was 0.44/100 PM, leukopenia was 1.05/100 PM, and thrombocytopenia was 0.30/100 PM. Conclusions. Patients had a higher incidence of anemia and leukopenia after substitution from D4T to ZDV, but hematologic toxicity was not a major complication in this population. Patients on ZDV-containing HAART regimens are still at risk for anemia and need close monitoring. Language: English Keywords: UGANDA | RESEARCH REPORT | CLINICAL RESEARCH | EPIDEMIOLOGIC METHODS | PERSONS LIVING WITH HIV/AIDS | ADULTS | RURAL POPULATION | HIV INFECTIONS | PREVALENCE | HOME CARE | ANTIRETROVIRAL THERAPY | HEMIC SYSTEM | SIDE EFFECTS | THROMBOSIS | ANEMIA | Africa, Eastern | Africa, Sub Saharan | Africa | Developing Countries | Research Methodology | Viral Diseases | Diseases | Age Factors | Population Characteristics | Demographic Factors | Population | Measurement | Care and Support | Health Services | Delivery of Health Care | Health | HIV | Physiology | Biology | Treatment | Medical Procedures | Medicine | Thromboembolism | Embolism | Vascular Diseases Document Number: 331335 |
| 17. Title: A prospective study evaluating clinical outcomes and costs of three NNRTI-based HAART regimens in Kerala, India. Author: George C; Yesoda A; Jayakumar B; Lal L Source: Journal of Clinical Pharmacy and therapeutics. 2009 Feb;34(1):33-40. Abstract: OBJECTIVE: This prospective, observational, study evaluates the clinical outcomes, drug utilization patterns, and adherence to treatment of patients on highly active anti retroviral therapy (HAART) at a government institution in Kerala, India. METHODS: Patients who met criteria for treatment of HIV/AIDS were enrolled into the study, given free NNRTI-based combination therapy, and were followed for a period of 6 months. Data regarding demographics, clinical outcome, laboratory results, drug utilization, adherence and adverse effects were collected. Analysis was conducted utilizing descriptive statistics, anova, Fisher-exact, andt-test. RESULTS: One hundred and forty-two patients with HIV-1 were enrolled in the study into three treatment groups. The mean age was 37.88 years, 64% of the patients were male, and 92% were married. Group 1 was given zidovudine, lamivudine, and nevirapine [n = 52 (37%)], group 2 was given lamivudine, stavudine, and nevirapine [n = 51 (36%)], and group 3 was given lamivudine, stavudine, and efavirenz [n = 39 (27%)]. The increase in CD4 was 107.46 (SD: 106.25). Mean medication adherence for the 104 patients who completed the study, was 90.7%; for group 1: 92.06%, group 2: 93.37%1, and group 3: 85.71% (P > 0.05). Forty (38%) patients have at least one adverse event to HARRT, with headache being the most common side effect (11.5%). Mortality rate was 3.5% during the course of the study. CONCLUSION: Provision of free NNRTI-based combination therapy to patients in Kerala, India, resulted in greater than 90% adherence leading to better clinical outcomes in terms of increasing CD4 counts and low mortality, for patients consistently attending a treatment clinic. Language: English Keywords: INDIA | RESEARCH REPORT | CLINICAL RESEARCH | PROSPECTIVE STUDIES | COST BENEFIT ANALYSIS | COMPARATIVE STUDIES | PERSONS LIVING WITH HIV/AIDS | COST EFFECTIVENESS | HIV INFECTIONS | ANTIRETROVIRAL THERAPY | USER COMPLIANCE | HEADACHE | SIDE EFFECTS | DEATH RATE | Developing Countries | Asia, Southern | Asia | Research Methodology | Studies | Quantitative Evaluation | Evaluation | Persons Living With HIV/AIDS | Viral Diseases | Diseases | Evaluation Indexes | HIV | Behavior | Signs and Symptoms | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Mortality | Population Dynamics | Demographic Factors | Population Document Number: 330372 |
| 18. Peer Reviewed Title: The use of depot-medroxyprogesterone acetate in contraception and its potential impact on skeletal health. Author: Guilbert ER; Brown JP; Kaunitz AM; Wagner MS; Berube J; Charbonneau L; Francoeur D; Gilbert A; Gilbert F; Roy G; Senikas V; Jacob R; Morin R Source: Contraception. 2009 Mar;79(3):167-77. Abstract: BACKGROUND: In the fall of 2007, the controversy about the contraceptive use of depot-medroxyprogesterone acetate (DMPA) and its potential impact on skeletal health reached the media in the province of Quebec, Canada, thereby becoming a matter of concern for the lay public and physicians. In order to discuss this subject openly, the National Institute of Public Health of Quebec (INSPQ) organized a scientific meeting on February 15, 2008, with targeted physicians delegated by their medical associations in the fields of general practice, obstetrics and gynaecology, rheumatology, orthopaedic surgery, physiatry and endocrinology. STUDY DESIGN: Participants reviewed the scientific literature using the study classification method according to the level of evidence, reviewed published guidelines of medical societies and organizations on the subject and reached a consensus position. This manuscript presents a review of the literature and describes the consensus position of the targeted medical associations. RESULTS: The consensus position adopted by all the targeted medical associations determined that DMPA was a cost-effective contraceptive option that must be considered in the light of the clinical situation and preference of each woman. Candidates for injectable contraception should be informed that the use of DMPA is associated with a slight decrease in bone mineral density (BMD), which is largely, if not completely, reversible. There should not be an absolute limit to the length of time that the DMPA contraceptive is used, regardless of the woman's age. Monitoring BMD is not recommended among users of DMPA for contraceptive purposes. Finally, the consensus statement declared that, although supplements of calcium and vitamin D are beneficial for skeletal health for women in general, such supplementation should not be recommended solely based on a woman's use of DMPA. CONCLUSION: Given the scientific evidences, DMPA use remains a valid contraceptive option for women. Its potential impact on BMD must be balanced against the significant individual, familial and social consequences of unintended pregnancy. Language: English Keywords: CANADA | CONFERENCES AND CONGRESSES | LITERATURE REVIEW | CLINICAL RESEARCH | CLASSIFICATION | PHYSICIANS | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | SKELETAL EFFECTS | SIDE EFFECTS | PANEL DISCUSSION | CONTRACEPTIVE SAFETY | TIME FACTORS | AGE FACTORS | CONTRAINDICATIONS | North America, Northern | Americas | Developed Countries | Research Methodology | Health Personnel | Delivery of Health Care | Health | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Physiology | Biology | Treatment | Medical Procedures | Medicine | Health Services | Group Meeting | Communication | Safety | Public Health | Population Dynamics | Demographic Factors | Population | Population Characteristics Document Number: 330061 |
| 19. Title: ECP handbook: introducing and mainstreaming the provision of emergency contraceptive pills in developing countries. Author: Hossain SM; Khan ME; Vernon R; Keesbury J; Askew I Source: Washington, DC, Population Council, 2009. v, 25 p. (USAID Contract No. HRN A-00-98-00012-00William and Flora Hewlett Foundation Project No. 2007-1124) Abstract: The intended audience for this handbook includes reproductive health (RH) program managers and government and NGO policy makers. It can be used in countries where ECPs are not currently available, as well as in contexts where the intention is to expand or mainstream access to existing ECP services. The handbook: Recognizes the different needs of diverse segments of the population, and places additional emphasis on targeting ECP services to "special groups," which include rape survivors and adolescents; Seeks to present an overall process that can be adapted to specific contexts and that is based on documented successful experiences in a range of contexts; Guides policymakers and program managers through the continuum of ECP programming: from needs assessments and operations research, to registration, to training, logistics, and ultimately mainstreaming through nationwide scaling-up. The handbook contains four sections: Introduction and Background describes the existing situation of ECP programmingaround the globe: Addressing the Needs of Specific Populations describes programming approaches designed for specific populations; Introducing and Mainstreaming ECPs describes five chronological steps for making ECP programming an integral component of a national RH program; The Bibliography lists useful resources for ECP programming. Language: English Keywords: DEVELOPING COUNTRIES | SUMMARY REPORT | YOUTH | WOMEN | EMERGENCY CONTRACEPTION | RAPE | SIDE EFFECTS | CONTRACEPTIVE USE-EFFECTIVENESS | CONTRACEPTIVE AGENTS, PROGESTIN | PROGRAM ACCESSIBILITY | Age Factors | Population Characteristics | Demographic Factors | Population | Contraception | Family Planning | Crime | Social Problems | Sociocultural Factors | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Effectiveness | Contraceptive Agents, Female | Contraceptive Agents | Program Evaluation | Programs | Organization and Administration Document Number: 315212 |
| 20. Title: Lack of effect of tenofovir disoproxil fumarate on pharmacokinetics of hormonal contraceptives. Author: Kearney BP; Mathias A Source: Pharmacotherapy. 2009 Aug;29(8):924-9. Abstract: STUDY OBJECTIVE: To assess the potential for a drug-drug interaction between a representative hormonal contraceptive (norgestimate-ethinyl estradiol) and tenofovir disoproxil fumarate (tenofovir DF), a prodrug of tenofovir, when coadministered. DESIGN: Thirty-day, open-label, fixed-sequence, pharmacokinetic drug-drug interaction study. SETTING: Single clinical phase I center. PARTICIPANTS: Twenty nonpregnant and nonlactating women aged 19-45 years who were taking a norgestimate-ethinyl estradiol oral contraceptive. INTERVENTION: Each woman received norgestimate-ethinyl estradiol alone on study days 1-22, followed by norgestimate-ethinyl estradiol plus tenofovir DF 300 mg once/day for 7 days during two consecutive 28-day contraceptive cycles. MEASUREMENTS AND MAIN RESULTS: Pharmacokinetic assessments were performed over 24 hours on study days 1 and 29 (corresponding to matching days [day 21] of the two contraceptive cycles). Serum or plasma concentrations of tenofovir, norgestimate and its active metabolite deacetyl norgestimate, and ethinyl estradiol were measured by high-performance liquid chromatography-tandem mass spectrometry assays. Geometric mean ratios (90% confidence intervals) for the pharmacokinetic parameters for deacetyl norgestimate and ethinyl estradiol were estimated by using analysis of variance and compared with the no-effect criterion for bioequivalence. The tenofovir pharmacokinetic parameters were compared with historical controls. Pharmacokinetic parameters for deacetyl norgestimate and ethinyl estradiol were unaltered by coadministration of tenofovir DF. The tenofovir pharmacokinetic parameters in subjects receiving norgestimate-ethinyl estradiol were consistent with historical control data for tenofovir. CONCLUSION: Tenofovir DF and norgestimate-ethinyl estradiol are not involved in a clinically significant drug-drug interaction; tenofovir DF did not affect the steady-state pharmacokinetics of norgestimate or ethinyl estradiol, including the concentration at the end of the dosing interval. Both drugs were well tolerated when coadministered. Tenofovir DF is unlikely to affect the pharmacokinetics of hormonal oral contraceptives. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CLINICAL TRIALS | WOMEN | ORAL CONTRACEPTIVES, COMBINED | NORGESTIMATE | ETHINYL ESTRADIOL | ANTIRETROVIRAL DRUGS | ADMINISTRATION AND DOSAGE | DRUG INTERACTIONS | SIDE EFFECTS | Developed Countries | North America | Americas | Clinical Research | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Drugs Document Number: 342300 |
| 21. Title: Immune reconstitution inflammatory syndrome in a resource-poor setting. Author: Klotz SA; Mohammed AA; Woldemichael MG; Mitku MW; Handrich M Source: Journal of the International Association of Physicians in AIDS Care. 2009 Mar-Apr;8(2):122-127. Abstract: The immune reconstitution inflammatory syndrome (IRIS) associated with highly active antiretroviral therapy (HAART) was studied in rural Ethiopian HIV-infected patients. Review of 1002 charts in an outpatient clinic was conducted. The median CD4 count was 89 cells/mm3. Nighty-eight patients were hospitalized after initiation of HAART, of whom 74 were hospitalized for manifestations of IRIS (ie, 7% of patients on HAART). Of the 74 patients hospitalized with IRIS, 27 patients had tuberculosis; 12 patients, cryptococcal meningitis; 7 patients, toxoplasmosis; 6 patients, pneumonia and/or effusion; and 5 patients, Pneumocystis jiroveci pneumonia (PCP). Ten adult patients were admitted with gastroenteritis, heretofore not recognized as a manifestation of IRIS. Eighty-one percent of IRIS patients were hospitalized within 3 months of beginning HAART and 99% by 6 months. Of those hospitalized with IRIS, 4 patients (5%) died while in the hospital (3 with cryptococcal meningitis). Thirty-seven or 50% of those hospitalized with IRS were lost to medical follow up, thus the mortality rate is likely a gross underestimate of the severity of IRIS. In resource-poor settings where the primary goal is to initiate HAART, IRIS may go unrecognized and have fatal consequences. Language: English Keywords: ETHIOPIA | RESEARCH REPORT | EPIDEMIOLOGIC METHODS | CLINICAL RESEARCH | PERSONS LIVING WITH HIV/AIDS | PREVALENCE | ANTIRETROVIRAL THERAPY | SIDE EFFECTS | HIV INFECTIONS | IMMUNOLOGICAL EFFECTS | TUBERCULOSIS | COMPLICATIONS | TOXICITY | PNEUMONIA | GASTROINTESTINAL EFFECTS | Africa, Eastern | Africa, Sub Saharan | Africa | Developing Countries | Research Methodology | Viral Diseases | Diseases | Measurement | HIV | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Immunity | Immune System | Physiology | Biology | Infections | Pulmonary Effects Document Number: 331334 |
| 22. Peer Reviewed Title: Safety, tolerability and effectiveness of generic HAART in HIV-infected children in South India. Author: Kumarasamy N; Venkatesh KK; Devaleenol B; Poongulali S; Mothi SN; Solomon S Source: Journal of Tropical Pediatrics. 2009 Jun;55(3):155-9. Abstract: HIV-infected children in resource-limited settings are increasingly gaining greater access to highly active antiretroviral therapy (HAART) but documented longitudinal data remains limited. We aimed to study the clinical and immunological outcomes among 67 South Indian HIV-infected children with >18 months of follow-up on HAART at a tertiary HIV care program. The median CD4 cell count at enrolment was 290 cells microl(-1) and at treatment initiation was 225 cells microl(-1). Patients demonstrated a significant rise in their CD4 cell counts between treatment initiation and after 6 months (701 cells microll(-1); p = 0.007), 12 months (741 cells microl(-1); p = 0.037), and 18 months of therapy (718 cells microl(-1); p = 0.005). The most common adverse events to therapy were nausea (20.9%) and rash (25.4%). Over one-fifth of patients (25.4%) substituted therapy due to toxicities and 19.4% of patients switched to second-line protease inhibitor-containing regimens. In this South Indian pediatric cohort, generic HAART was safe, effective and relatively well tolerated. Language: English Keywords: INDIA | RESEARCH REPORT | COHORT ANALYSIS | CHILDREN | PERSONS LIVING WITH HIV/AIDS | CLIENTS | ANTIRETROVIRAL THERAPY | IMMUNOLOGICAL EFFECTS | SIDE EFFECTS | SAFETY | Asia, Southern | Asia | Developing Countries | Research Methodology | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | HIV Infections | Viral Diseases | Diseases | Program Activities | Programs | Organization and Administration | HIV | Immunity | Immune System | Physiology | Biology | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Public Health Document Number: 341971 |
| 23. Peer Reviewed Title: Both a combined oral contraceptive and depot medroxyprogesterone acetate impair endothelial function in young women. Author: Lizarelli PM; Martins WP; Vieira CS; Soares GM; Franceschini SA; Ferriani RA; Patta MC Source: Contraception. 2009 Jan;79(1):35-40. Abstract: BACKGROUND: The study was conducted to determine whether the use of a combined oral contraceptive (COC) or depot medroxyprogesterone acetate (DMPA) interferes with endothelial function. STUDY DESIGN: The study was conducted on 100 women between the ages of 18 and 30 years. Fifty women had not used hormonal contraception (control group) for at least 12 months, 25 were current users of a COC (ethinylestradiol 30 mcg+levonorgestrel 150 mcg) and 25 were current users of DMPA (150 mg) for at least a 6-month period. All women were evaluated for brachial flow-mediated dilation (FMD), intima-media thickness, carotid distensibility and stiffness index, arterial pressure, body mass index, waist circumference, heart rate and lipid profile. RESULTS: A significant difference in FMD was observed between the COC and control groups (6.4+/-2.2% vs. 8.7+/-3.4%, p<.01) and between the DMPA and control groups (6.2+/-2.1% vs. 8.7+/-3.4%, p<.01). The DMPA group had lower values of total cholesterol (TC) and low-densitylipoprotein (LDL-C) than COC users and the control group (TC: DMPA=139.9+/-21.5 mg/dL vs. controls=167.1+/-29.2 mg/dL vs. COC=168.2+/-37.5, p=.001; LDL-C: DMPA=85.3+/-20.1 mg/dL vs. controls=102+/-24.5 mg/dL vs. COC=106.7+/-33.3 mg/dL, p=.01). The control group had higher levels of high-density lipoprotein (HDL-C) than the DMPA and COC groups (controls=52.4+/-14.1 mg/dL vs. DMPA=42.2+/-7.2 mg/dL vs. COC=45.4+/-9.1 mg/dL, p=.001). No significant differences were observed regarding the other variables. CONCLUSIONS: FMD was lower among COC and DMPA users, suggesting that these hormonal contraceptives may promote endothelial dysfunction. Language: English Keywords: BRAZIL | RESEARCH REPORT | CLINICAL RESEARCH | CASE CONTROL STUDIES | EVALUATION INDEXES | WOMEN IN DEVELOPMENT | ORAL CONTRACEPTIVES, COMBINED | DEPO-PROVERA | SIDE EFFECTS | HEALTH STATUS INDEXES | CHOLESTEROL | ADMINISTRATION AND DOSAGE | BLOOD PRESSURE | South America, Eastern | South America | Latin America | Americas | Developing Countries | Research Methodology | Studies | Quantitative Evaluation | Evaluation | Economic Development | Economic Factors | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Medroxyprogesterone Acetate | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Lipids | Physiology | Biology | Drugs | Hemic System Document Number: 330537 |
| 24. Peer Reviewed Title: Pregnancy outcome in women infected with HIV-1 receiving combination antiretroviral therapy before versus after conception. Author: Machado ES; Hofer CB; Costa TT; Nogueira SA; Oliveira RH; Abreu TF; Evangelista LA; Farias IF; Mercadante RT; Garcia MF; Neves RC; Costa VM; Lambert JS Source: Sexually Transmitted Infections. 2009 Apr;85(2):82-7. Abstract: OBJECTIVE: The potential adverse effects of antiretroviral drugs during pregnancy are discrepant and few studies, mostly from Europe, have provided information about pregnancy outcomes of those already on treatment at conception. The aim of this study was to investigate the impact of antiretrovirals (ARVs) on pregnancy outcome according to the timing of treatment initiation in a cohort of pregnant women from Brazil infected with HIV. METHODS: A prospective cohort of 696 pregnant women followed up in one single centre between 1996 and 2006 was studied. Patients who had ARV treatment before pregnancy were compared with those treated after the first trimester. The outcomes evaluated were preterm delivery (PTD) (<37 weeks), severe PTD (<34 weeks), low birth weight (LBW) (<2500 g) and very LBW (<1500 g). RESULTS: Patients who were using ARVs pre-conception had higher rates of LBW (33.3% vs 16.5%; p<0.001) and a similar trend for PTD (26.3% vs 17.7%; p = 0.09). Stratification by type of therapy (dual vs highly active antiretroviral therapy (HAART)) according to timing of initiation of ARVs showed that patients who use HAART pre-conception have a higher rate of PTD (20.2% vs 10.2%; p = 0.03) and LBW (24.2% vs 10.2%; p = 0.002). After adjusting for several factors, HAART used pre-conception was associated with an increased risk for PTD (AOR 5.0; 95% CI 1.5 to 17.0; p = 0.009) and LBW (OR 3.6; 95% CI 1.7 to 7.7; p = 0.001). CONCLUSIONS: We identified an increased risk for LBW and PTD in patients who had HAART prior to pregnancy. Language: English Keywords: BRAZIL | RESEARCH REPORT | PROSPECTIVE STUDIES | PREGNANT WOMEN | PERSONS LIVING WITH HIV/AIDS | ANTIRETROVIRAL THERAPY | SIDE EFFECTS | PREGNANCY OUTCOMES | TIME FACTORS | PREMATURE BIRTH | LOW BIRTH WEIGHT | South America, Eastern | South America | Latin America | Americas | Developing Countries | Studies | Research Methodology | Population Characteristics | Demographic Factors | Population | HIV Infections | Viral Diseases | Diseases | HIV | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Pregnancy | Reproduction | Population Dynamics | Birth Weight | Body Weight | Physiology | Biology Document Number: 341851 |
| 25. Peer Reviewed Title: Adverse events to antituberculosis therapy: influence of HIV and antiretroviral drugs. Author: Marks DJ; Dheda K; Dawson R; Ainslie G; Miller RF Source: International Journal of STD and AIDS. 2009 May;20(5):339-45. Abstract: This study investigated whether serious adverse events (SAEs) during antituberculosis therapy occur more frequently in HIV co-infected patients in a South African population. A retrospective analysis examined incidences of hepatotoxicity, peripheral neuropathy, severe arthralgia, persistent vomiting and severe rash in 400 patients treated for tuberculosis in a community clinic. A total of 141 patients were co-infected with HIV, among whom only 16.3% were receiving antiretrovirals. Details of SAEs were ascertainable in 331/400 patients, and occurred in 26.7% of HIV-infected and 13.3% of HIV-uninfected individuals (P = 0.003). The excess was attributable to increased peripheral neuropathy (8.3% and 1.9%, respectively, P = 0.009) and persistent vomiting (13.3% and 3.3%, P = 0.001). SAE occurrence was not related to antiretroviral use, although median CD4 counts were lower in those experiencing side-effects (130 and 259 cells/microL, P = 0.008). The treatment completion did not differ significantly between the two groups (76.6% and 84.2%, P = 0.08). Language: English Keywords: SOUTH AFRICA | RESEARCH REPORT | RETROSPECTIVE STUDIES | CLIENTS | PERSONS LIVING WITH HIV/AIDS | TUBERCULOSIS | DRUGS | ADMINISTRATION AND DOSAGE | ANTIRETROVIRAL DRUGS | SIDE EFFECTS | NEUROLOGIC EFFECTS | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Studies | Research Methodology | Program Activities | Programs | Organization and Administration | HIV Infections | Viral Diseases | Diseases | Infections | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Physiology | Biology Document Number: 341815 |
| 26. Title: Counselling women about hormonal therapy. Author: Martinelli I Source: Thrombosis Research. 2009;123 Suppl 2:S74-8. Abstract: Effective communication and counselling are critical for the successful use of oral contraceptives (OCs) and hormone replacement therapy (HRT). Effective communication requires listening and responding to patient concerns and then educating patients through personal interaction and materials that explain the risks and benefits of OC and HRT use. Where possible, actual data should be provided in terms that are easily understood by patients. The discussion of whether or not a woman should be tested for thrombophilia before using hormonal therapy should include the implications of thrombophilia testing for symptomatic and asymptomatic individuals. Pre-test counselling should include the potential advantages and disadvantages of hormone therapies and of thrombophilia testing, including the psychosocial aspects and implications for medical management. Clinicians should also clarify that thrombophilia testing is a matter of testing for a susceptibility gene rather than a disease state. Post-test counselling is equally as important for women who test both positive and negative. The goal of post-test counselling should be to help make decisions about hormone therapies. (excerpt) Language: English Keywords: ITALY | CRITIQUE | CLINICAL RESEARCH | EPIDEMIOLOGIC METHODS | WOMEN | COUNSELING | HORMONE REPLACEMENT THERAPY | THROMBOEMBOLISM | MENOPAUSE | CONTRACEPTIVE SAFETY | ORAL CONTRACEPTIVES, SIDE EFFECTS | SIDE EFFECTS | PREVALENCE | AGE FACTORS | RISK FACTORS | Developed Countries | Europe, Southern | Europe | Research Methodology | Demographic Factors | Population | Clinic Activities | Program Activities | Programs | Organization and Administration | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Embolism | Vascular Diseases | Diseases | Reproduction | Safety | Public Health | Measurement | Population Characteristics Document Number: 341122 |
| 27. Title: Study of awareness among pregnant women of the effects of drugs on the fetus and mother in Iran. Author: Mashayekhi SO; Dilmaghanizadeh M; Fardiazar Z; Bamdad-Moghadam R; Ghandforoush-Sattari F Source: Health Policy. 2009 Jun;91(1):89-93. Abstract: OBJECTIVE: The aim of the study was to examine the awareness of Iranian pregnant women about the effects of drugs in pregnancy. METHODS: Awareness of 400 women in postnatal and prenatal wards was assessed using self-completion questionnaire, which included demographic information, medication use, and the level of information regarding the safety of drugs during pregnancy and the most susceptible periods in pregnancy. RESULTS: Out of 400 participants from prenatal and postnatal wards of two hospitals, 19.0% used medications other than vitamins and minerals supplements during pregnancy, and 7% believed in the safety of medications for mother and/or fetus during pregnancy. The first and second trimesters were believed to be the most and the least susceptible periods of pregnancy, respectively. Most information on drugs safety in pregnancy was obtained from physicians and health centers. CONCLUSIONS: Present study indicates weaknesses in the awareness of this population and weak role of pharmacists in informing this vulnerable population. This study shows the requirement of training of this group of people in order to enhance the health of our community. Language: English Keywords: IRAN | RESEARCH REPORT | PREGNANT WOMEN | FETUS | DRUGS | SIDE EFFECTS | SAFETY | AWARENESS | QUESTIONNAIRES | INFORMATION SOURCES | EDUCATIONAL STATUS | Middle East | Developing Countries | Population Characteristics | Demographic Factors | Population | Pregnancy | Reproduction | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Public Health | Knowledge | Sociocultural Factors | Information | Socioeconomic Status | Socioeconomic Factors | Economic Factors Document Number: 342378 |
| 28. Peer Reviewed Title: Novel relationship between tuberculosis immune reconstitution inflammatory syndrome and antitubercular drug resistance. Author: Meintjes G; Rangaka MX; Maartens G; Rebe K; Morroni C; Pepper DJ; Wilkinson KA; Wilkinson RJ Source: Clinical Infectious Diseases. 2009 Mar 1;48(5):667-76. Abstract: BACKGROUND: Tuberculosis (TB) immune reconstitution inflammatory syndrome (IRIS) is emerging as an important early complication of combination antiretroviral therapy in patients with TB in developing countries. The differential diagnosis of TB IRIS includes deterioration caused by other human immunodeficiency virus-related morbidities and drug-resistant TB. METHODS: We prospectively evaluated consecutive patients with suspected TB IRIS from February 2005 through July 2006 at a community-based secondary hospital in Cape Town, South Africa, by means of clinical case definitions for TB IRIS. Specimens were sent for TB culture and susceptibility testing, and a rapid test (FASTplaque-Response) was performed to expedite determination of rifampin susceptibility. RESULTS: One hundred patients with suspected TB IRIS were evaluated, 26 of whom were being retreated for TB. IRIS symptoms developed a median of 14 days (interquartile range, 7-25 days) after the initiation of combination antiretroviral therapy. In 7 patients, an alternative opportunistic disease was diagnosed. Rifampin-resistant TB was present in 13 patients, 9 of whom received a diagnosis after study entry (7 of 9 had multidrug-resistant TB). Undiagnosed rifampin-resistant TB was thus present in 10.1% of patients (95% confidence interval, 3.9%-16.4%) who presented with TB IRIS, once those with alternative diagnoses and TB with known rifampin resistance were excluded. In the remaining 80 patients, TB IRIS without rifampin resistance was the final diagnosis. CONCLUSIONS: TB IRIS that is clinically indistinguishable from TB IRIS that occurs in the context of drug-susceptible disease may occur in patients with undiagnosed multidrug-resistant TB. Antitubercular drug resistance should be excluded in all cases of suspected TB IRIS, and corticosteroids should be used with caution for patients with presumed TB IRIS until the result of drug-susceptibility testing is known. Language: English Keywords: SOUTH AFRICA | RESEARCH REPORT | CLINICAL RESEARCH | PROSPECTIVE STUDIES | EPIDEMIOLOGIC METHODS | PERSONS LIVING WITH HIV/AIDS | DRUG RESISTANCE | TUBERCULOSIS | ANTIRETROVIRAL THERAPY | SIDE EFFECTS | COMPLICATIONS | IMMUNOLOGICAL EFFECTS | PREVALENCE | Africa, Southern | Africa, Sub Saharan | Africa | Developing Countries | Research Methodology | Studies | Persons Living With HIV/AIDS | HIV Infections | Viral Diseases | Diseases | Treatment | Medical Procedures | |