1.  Peer Reviewed Title: Hormonal contraception, sickle cell trait, and risk for venous thromboembolism among African American women. Author: Austin H; Lally C; Benson JM; Whitsett C; Hooper WC; Key NS Source: American Journal of Obstetrics and Gynecology. 2009 Jun;200:620e1-620e3. Abstract: OBJECTIVE: We evaluated the effect of oral and other hormonal contraceptive (HC) use on venous thromboembolism risk among African American women and investigated whether the association was modified by the sickle cell trait. STUDY DESIGN: We report the findings of a case-control study that included 60 African American women with an idiopathic, first episode of venous thromboembolism and 196 African American controls. RESULTS: The odds of current HC use compared with noncurrent use contrasting cases and controls is 3.8 (95% confidence interval [CI], 1.7-8.1; P < .001). Among subjects with sickle cell trait, the odds ratio is higher (odds ratio [OR], 6.7; 95% CI, 1.0-43) than the odds ratio among subjects without sickle cell trait (OR, 2.6; 95% CI, 1.1-6.2), but the difference is not statistically significant. CONCLUSION: This study provides persuasive evidence that hormonal contraceptive use increases venous thromboembolism risk among African American women and that the increase in risk may be larger among women with sickle cell trait. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CASE STUDIES | BLACKS | WOMEN | CONTRACEPTION | CONTRACEPTIVE AGENTS | THROMBOEMBOLISM | DISEASES | RISK FACTORS | Developed Countries | North America | Americas | Studies | Research Methodology | Ethnic Groups | Cultural Background | Population Characteristics | Demographic Factors | Population | Family Planning | Embolism | Vascular Diseases | Health Document Number: 330853 |
| 2. Title: Limited knowledge on progestogen-only contraception and risk of venous thromboembolism. Author: Bergendal A; Odlind V; Persson I; Kieler H Source: Acta Obstetricia et Gynecologica Scandinavica. 2009;88(3):261-266. Abstract: Objective. To assess the current knowledge concerning progestogen-only contraception (POC) and risks of venous thromboembolism (VTE). Design and setting. Systematic review of the literature on observational and analytical studies reporting risk estimates for VTE in women exposed to POCs. Methods and main outcome measures. We performed a computerized literature search in the Pub Med, Embase, and the Cochrane Library for studies published between 1966 and February 13, 2008. Based on the evaluated studies we calculated an overall risk estimate for VTE in association with POC. Results. Four case-control studies and one cohort study were included. Of the case-control studies, three reported an increased risk and one a decreased risk of VTE. The cohort study found divergent results depending on the type of statistical analysis used. None of the results was statistically significant. The overall odds ratio for POC-associated VTE in the four case-control studies was 1.45 (95% CI=0.92-2.26). Conclusions. The risk of VTE associated with use of POCs is poorly investigated. The slightly elevated overall risk estimate might suggest an association between POC and an increased risk for VTE. The results must, however, be interpreted with caution due to the possibility of residual confounding. Well-designed studies with sufficient statistical power to evaluate risks of VTE with POC are warranted. Language: English Keywords: SWEDEN | RESEARCH REPORT | EPIDEMIOLOGY | CONTRACEPTIVE AGENTS, PROGESTIN | PROGESTERONE | THROMBOEMBOLISM | RISK FACTORS | KNOWLEDGE | Europe, Northern | Europe | Developed Countries | Public Health | Health | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Progestational Hormones | Hormones | Endocrine System | Physiology | Biology | Embolism | Vascular Diseases | Diseases | Sociocultural Factors Document Number: 329655 |
| 3. Peer Reviewed Title: Twenty or thirty microgram ethinyloestradiol in an oral contraceptive: Does it make a difference in the mind and the daily practice of gynaecologists and general practitioners? Author: Bitzer J; Frey B; von Schonau M; Sabler N; Tschudin S Source: European Journal of Contraception and Reproductive Health Care. 2009 Jun 5;:1-10. Abstract: Objectives Currently, evidence-based guidelines concerning the use of oral contraceptives (OCs) containing either 20 or 30 mug ethinyloestradiol (EE) and the same progestogen, are lacking. We wanted to identify whether Swiss gynaecologists and general practitioners (GPs) have specific criteria on which they base their prescribing habit. Methods Two questionnaires were submitted to 158 physicians. The first one contained a list of possible criteria relevant for decision making and a description of specific clinical situations. The second one concerned actual patients who received either a 20 mug (Yasminelle(R)) or a 30 mug (Yasmin(R)) OC containing the same progestogen drospirenone. Results The most relevant criteria for decision making (in hierarchical order) were family history of venous thromboembolic disease (VTE), headache, smoking, age beyond 35, stability of the menstrual cycle, breast tenderness, body mass index, irregular bleeding and acne. The 20 mug dosage was preferred for women older than 35, those smoking more than 15 cigarettes per day, those with a family history of VTE, and those complaining of breast tenderness or headache. The 30 mug dosage was preferred for patients with a history of irregular bleeding, a family history of osteoporosis, expected poor compliance and acne. Conclusion Swiss gynaecologists and GPs do not preferentially prescribe the lowest possible dosage of EE. They use indirect markers they consider relevant for differential prescribing. For some markers, there is inconsistency, indicating that preferences for 20 mug and 30 mug preparations may be influenced by other factors. Language: English Keywords: SWITZERLAND | RESEARCH REPORT | PHYSICIANS | WOMEN | CLIENTS | DECISION MAKING | TOBACCO USE | HEADACHE | ORAL CONTRACEPTIVES | ETHINYL ESTRADIOL | CONTRACEPTIVE AGENTS, SIDE EFFECTS | THROMBOEMBOLISM | AGE FACTORS | ADMINISTRATION AND DOSAGE | Developed Countries | Europe, Central | Europe | Health Personnel | Delivery of Health Care | Health | Demographic Factors | Population | Program Activities | Programs | Organization and Administration | Behavior | Signs and Symptoms | Diseases | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Embolism | Vascular Diseases | Population Characteristics | Drugs | Treatment | Medical Procedures | Medicine | Health Services Document Number: 341601 |
| 4. 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 |
| 5. Title: Massive Pulmonary Embolism Associated With Factor V Leiden, Prothrombin, and Methylenetetrahydrofolate Reductase Gene Mutations in a Young Patient on Oral Contraceptive Pills: A Case Report. Author: Charafeddine KM; Mahfouz R; Ibrahim G; Taher A; Hoballah J; Taha A Source: Clinical and Applied Thrombosis / Hemostasis. 2009 Jun 10; Abstract: Factor V Leiden (Factor V G1691A), prothrombin gene mutation G20210A, and homozygous C677T mutation in the methylenetetrahydrofolate reductase (MTHFR) gene are known to predispose venous thromboembolism (VTE). We present herein a rare case of a young woman heterozygous for these mutations and taking oral contraceptive pills for less than 2 months, diagnosed to have massive deep venous thrombosis and bilateral pulmonary embolism. The patient was managed for 10 days in the hospital and discharged home on oral anticoagulants. This case suggests that screening for these factors in people with family history of thrombosis and in relatives of patients with these mutations is highly recommended to prevent fatal consequences. In addition, a new guideline for treatment and prophylaxis with anticoagulant for these patients and others who are at risk of developing VTE (American College of Chest Physicians [ACCP] guidelines-Chest 2008) has been published recently. Our recommendation is to promote for the internationally published algorithms through their application, where necessary, to prevent any future thrombotic morbidity or mortality incidents. Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | PREVALENCE | PULMONARY EMBOLISM | THROMBOEMBOLISM | MORBIDITY | Developed Countries | North America | Americas | Measurement | Research Methodology | Embolism | Vascular Diseases | Diseases Document Number: 341600 |
| 6. Peer Reviewed Title: Eligibility criteria in venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users. Author: Dore DD; Norman H; Seeger JD Source: Obstetrics and Gynecology. 2009 Jul;114(1):175. Abstract: An erratum printed in Obstetrics & Gynecology in June of 2008 corrected the stated eligibility criterion in a study of venous thromboembolism, myocardial infarction (MI), and stroke in transdermal contraceptive users reported by Cole and colleagues. Originally, it was reported that the authors excluded women with malignancies other than nonmelanoma skin cancer. The actual exclusion implemented was slightly broader: women with a neoplasm other than benign skin disorders. We applied the originally stated exclusion of women to the original study population, so that women with evidence in the claims data of malignancy other than nonmelanoma skin cancer (International Classification of Diseases, 9th revision: 140.xx-208.xx, except 173.xx) were excluded rather than the broader version actually implemented (International Classification of Diseases, 9th revision: 140.xx-239.xx, except 232.xx). There were approximately 423,000 women in the source population before application of exclusions, and 2.4% of them were excluded because of the nonmalignancy neoplasm codes used. In the originally reported case-control analysis comparing use of the transdermal contraceptive to norgestimate- containing oral contraceptives with 35 micrograms of ethinyl estradiol, the odds ratio (OR) for venous thromboembolism was 2.0 (95% confidence interval [CI] 1.0-4.1) overall and 2.4 (95% CI 1.1-5.5) after exclusion of women with high-risk factors and 2.1 (95% CI 0.3-15.5) for MI. No strokes were observed among transdermal contraceptive users. Application of the narrower exclusion criterion (consistent with the originally stated exclusion by Cole and colleagues), yielded six additional cases matched to 24 controls, leading to ORs for venous thromboembolism of 2.0 (95% CI 1.0-4.0) overall and 2.5 (95% CI 1.1-5.5) after exclusion of women with high-risk factors and 2.1 (95% CI 0.3-15.5) for MI. No strokes were observed in transdermal contraceptive users. The broader definition of neoplasm that was used for exclusion in the original analysis did not materially affect the observed association measures. This finding is consistent with the study design principle that the application of broader exclusions will lead to noticeably different estimates than application of narrower exclusions only in settings where the effect (not just the risk) among excluded participants is substantially different from what it is among included participants. (full-text) Language: English Keywords: UNITED STATES OF AMERICA | CRITIQUE | THROMBOEMBOLISM | MYOCARDIAL INFARCTION | CEREBROVASCULAR EFFECTS | CONTRACEPTIVE IMPLANTS | Developed Countries | North America | Americas | Embolism | Vascular Diseases | Diseases | Heart Diseases | Physiology | Biology | Contraceptive Methods | Contraception | Family Planning Document Number: 341716 |
| 7. Peer Reviewed Title: Pill scare: communication conundrum. Author: Edouard L Source: Journal of Family Planning and Reproductive Health Care. 2009 Apr;35(2):121-2. Abstract: Adverse publicity for combined oral contraceptives (COCs) has led to pill scares on numerous occasions such as reproductive cancers in 1983 and venous thromboembolism (VTE) in 1995. Misinformation should be avoided, especially through the correct interpretation of relative risk to avoid confusion and decrease unnecessary anxiety. Reassurance is usually important, as the absolute risk is infinitely small. The popular media are very effective for the prompt dissemination of information, and authoritative statements are useful for improving communications with providers, patients and public. Language: English Keywords: ALGERIA | HISTORICAL REVIEW | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | MISINFORMATION | FEAR | RISK ASSESSMENT | CANCER | THROMBOEMBOLISM | INFORMATION DISTRIBUTION | PUBLIC HEALTH | Africa, North | Africa | Developing Countries | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Health | Communication | Emotions | Psychological Factors | Behavior | Evaluation | Neoplasms | Diseases | Embolism | Vascular Diseases Document Number: 341650 |
| 8. Title: Hormonal contraception and risk of venous thromboembolism: national follow-up study. Author: Lidegaard O; Lokkegaard E; Svendsen AL; Agger C Source: BMJ. 2009;339:b2890. Abstract: OBJECTIVE: To assess the risk of venous thrombosis in current users of different types of hormonal contraception, focusing on regimen, oestrogen dose, type of progestogen, and route of administration. DESIGN: National cohort study. SETTING: Denmark, 1995-2005. PARTICIPANTS: Danish women aged 15-49 with no history of cardiovascular or malignant disease. MAIN OUTCOME MEASURES: Adjusted rate ratios for all first time deep venous thrombosis, portal thrombosis, thrombosis of caval vein, thrombosis of renal vein, unspecified deep vein thrombosis, and pulmonary embolism during the study period. RESULTS: 10.4 million woman years were recorded, 3.3 million woman years in receipt of oral contraceptives. In total, 4213 venous thrombotic events were observed, 2045 in current users of oral contraceptives. The overall absolute risk of venous thrombosis per 10 000 woman years in non-users of oral contraceptives was 3.01 and in current users was 6.29. Compared with non-users of combined oral contraceptives the rate ratio of venous thrombembolism in current users decreased with duration of use (<1 year 4.17, 95% confidence interval 3.73 to 4.66, 1-4 years 2.98, 2.73 to 3.26, and >4 years 2.76, 2.53 to 3.02; P<0.001) and with decreasing dose of oestrogen. Compared with oral contraceptives containing levonorgestrel and with the same dose of oestrogen and length of use, the rate ratio for oral contraceptives with norethisterone was 0.98 (0.71 to 1.37), with norgestimate 1.19 (0.96 to 1.47), with desogestrel 1.82 (1.49 to 2.22), with gestodene 1.86 (1.59 to 2.18), with drospirenone 1.64 (1.27 to 2.10), and with cyproterone 1.88 (1.47 to 2.42). Compared with non-users of oral contraceptives, the rate ratio for venous thromboembolism in users of progestogen only oral contraceptives with levonorgestrel or norethisterone was 0.59 (0.33 to 1.03) or with 75 mug desogestrel was 1.12 (0.36 to 3.49), and for hormone releasing intrauterine devices was 0.90 (0.64 to 1.26). CONCLUSION: The risk of venous thrombosis in current users of combined oral contraceptives decreases with duration of use and decreasing oestrogen dose. For the same dose of oestrogen and the same length of use, oral contraceptives with desogestrel, gestodene, or drospirenone were associated with a significantly higher risk of venous thrombosis than oral contraceptives with levonorgestrel. Progestogen only pills and hormone releasing intrauterine devices were not associated with any increased risk of venous thrombosis. Language: English Keywords: DENMARK | RESEARCH REPORT | COHORT ANALYSIS | WOMEN | ORAL CONTRACEPTIVES, COMBINED | ORAL CONTRACEPTIVES, SIDE EFFECTS | ADMINISTRATION AND DOSAGE | THROMBOEMBOLISM | RISK FACTORS | THROMBOSIS | PULMONARY EMBOLISM | ESTROGENS | PROGESTATIONAL HORMONES | Developed Countries | Europe, Northern | Europe | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Embolism | Vascular Diseases | Diseases | Hormones | Endocrine System | Physiology | Biology Document Number: 342468 |
| 9. Title: Yasmin and venous thromboembolism: new case reports. Author: Lopez M; Vaya A; Martinez Triguero ML; Contreras MT; Todoli J; Ricart A; Laiz B Source: Clinical Hemorheology and Microcirculation. 2009;42(1):65-9. Abstract: It is not yet known whether Yasmin involves a higher thrombotic risk compared with other contraceptives. We present a serie of eight new cases of women who developed thrombotic events early after starting on Yasmin who were sent to our Thrombosis and Hemostasis Unit for a thrombophilia work-up in the last five years. Only two of them were heterozygous carriers of the prothrombin G20210A mutation and three were obese while none of them were smoker. These new cases provide information about the characteristics of the thrombotic events and the concomitant risk factors, indicating that this pill may not be as safe as had been previously thought, and suggest that new studies regarding safety profile of Yasmin are required to explain the association with venous thrombotic events. Language: English Keywords: SPAIN | SUMMARY REPORT | CASE HISTORIES | CLIENTS | THROMBOEMBOLISM | RISK FACTORS | ORAL CONTRACEPTIVES, COMBINED | CONTRACEPTIVE SAFETY | PULMONARY EMBOLISM | GENETICS | OBESITY | Developed Countries | Europe, Southwestern | Europe | Data Collection | Research Methodology | Program Activities | Programs | Organization and Administration | Embolism | Vascular Diseases | Diseases | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Safety | Public Health | Biology | Body Weight | Physiology Document Number: 342317 |
| 10. Title: Intrinsic clotting factors in dependency of age, sex, body mass index, and oral contraceptives: definition and risk of elevated clotting factor levels. Author: Luxembourg B; Schmitt J; Humpich M; Glowatzki M; Seifried E; Lindhoff-Last E Source: Blood Coagulation and Fibrinolysis. 2009 Jul 17; Abstract: Elevated clotting factors have been demonstrated to be a risk factor for venous thromboembolism (VTE). The aim of our study was to investigate the impact of age, sex, body mass index, and oral contraceptives on the clotting factor activities of factors VIII, IX, XI, and XII and their impact on the cutoff definition and risk of VTE associated with elevated clotting factors. Factor VIII, IX, XI, and XII activities were measured in 499 blood donors and 286 patients with VTE. Age and body mass index predicted significantly and independently the clotting factor activities of factors VIII, IX, and XI, whereas use of oral contraceptives predicted factor IX, XI, and XII levels. Percentiles of clotting factor activities, which are often used for the cutoff definition of elevated clotting factors, varied due to the effect of age, body mass index, and oral contraceptives. The adjusted odds ratios for VTE were 10.3 [95% confidence interval (CI) 5.1-20.7], 6.1 (95% CI 3.1-12.0), and 3.3 (95% CI 1.9-5.8) for elevated factors VIII, IX, and XI, respectively. Furthermore, our study demonstrates for the first time that elevated factor XII is associated with an increased risk of VTE (adjusted odds ratio 2.9, 95% CI 1.6-5.3). Language: English Keywords: GERMANY | RESEARCH REPORT | CLIENTS | BLOOD DONORS | AGE FACTORS | BODY WEIGHT | ORAL CONTRACEPTIVES | THROMBOEMBOLISM | RISK FACTORS | Europe, Central | Europe | Developed Countries | Program Activities | Programs | Organization and Administration | Blood Supply | Equipment and Supplies | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Population Characteristics | Demographic Factors | Population | Physiology | Biology | Contraceptive Methods | Contraception | Family Planning | Embolism | Vascular Diseases | Diseases Document Number: 342216 |
| 11. 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 |
| 12. Title: Epidemiology of hormone-related venous thromboembolism. Author: Middeldorp S Source: Thrombosis Research. 2009;123 Suppl 2:S65-9. Abstract: In this short review, I will describe the epidemiology of hormone-related venous thromboembolism (VTE). In particular, the impact of hormones for women who have an increased baseline risk for VTE will be discussed. These include carriers of thrombophilia, women with a positive family history of VTE, and women who have experienced VTE. Furthermore, I will shortly discuss the effects on VTE risk for other hormonal contraceptive and hormone replacement methods. (excerpt) Language: English Keywords: NETHERLANDS | LITERATURE REVIEW | EPIDEMIOLOGIC METHODS | CLINICAL RESEARCH | WOMEN | PREVALENCE | THROMBOEMBOLISM | HORMONE REPLACEMENT THERAPY | EPIDEMIOLOGY | ORAL CONTRACEPTIVES, SIDE EFFECTS | CONTRACEPTIVE AGENTS, ESTROGEN | ETHINYL ESTRADIOL | ADMINISTRATION AND DOSAGE | CONTRACEPTIVE SAFETY | Europe, Western | Europe | Developed Countries | Research Methodology | Demographic Factors | Population | Measurement | Embolism | Vascular Diseases | Diseases | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Public Health | Safety | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Drugs Document Number: 341124 |
| 13. Peer Reviewed Title: Venous thrombembolism, thrombophilic defects, combined oral contraception and anticoagulation. Author: Ott J; Promberger R; Kaufmann U; Huber JC; Frigo P Source: Archives of Gynecology and Obstetrics. 2009 Feb 26; Abstract: BACKGROUND: Several genetic polymorphisms increase the risk for venous thrombembolism (VTE). In particular, combined oral contraceptives (COCs) are known to enhance the risk for VTE and are therefore contraindicated. CASE: We present here the case of a patient with protein S deficiency, who has used COCs together with anticoagulatory therapy (Phenprocoumon) after suffering from deep venous thromboses for 4 years. At the time of her first consultation at our clinic, the ultrasound examination showed a complete involution of her venous thrombosis. CONCLUSION: COCs can be used in patients with thrombogenic mutations and anticoagulatory therapy in individual cases. Language: English Keywords: AUSTRIA | RESEARCH REPORT | CLINICAL RESEARCH | CASE STUDIES | WOMEN | THROMBOEMBOLISM | ORAL CONTRACEPTIVES, COMBINED | BLOOD COAGULATION EFFECTS | ORAL CONTRACEPTIVES, SIDE EFFECTS | CHROMOSOME ABNORMALITIES | DEFICIENCY DISEASES | PROTEINS | ULTRASONICS | Developed Countries | Europe, Central | Europe | Research Methodology | Studies | Demographic Factors | Population | Embolism | Vascular Diseases | Diseases | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Hematological Effects | Hemic System | Physiology | Biology | Contraceptive Safety | Safety | Public Health | Health | Neonatal Diseases and Abnormalities | Nutrition Disorders | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 330418 |
| 14. Title: Contraception and thrombophilia. Author: Rott H; Krumpel A; Kappert G; Nowak-Gottl U; Halimeh S Source: Hamostaseologie. 2009 May;29(2):193-6. Abstract: The risk of thromboembolic events (TE) is increased by acquired or inherited thrombophilias (IT). We know that some hormonal contraceptives also increase the risk of thrombosis, thus, the use of such contraceptives are discussed as contraindications in women with IT. TEs are infrequent events in children and adolescents and in the majority of cases are associated with secondary complications from underlying chronic illness. Although adolescents are not typically considered to be at high-risk for TE, this cohort is frequently using hormonal contraception, leading to an increased risk in cases with unknown IT. The risk of TE with pregnancy alone is higher than associated with combined hormonal contraception. Progestin-only methods have not been found to increase the risk of TE with only moderate changes of coagulation proteins compared to normal reference values . Conclusion: Thrombophilic women are good candidates for progestin-only contraceptive methods. Language: English Keywords: FEDERAL REPUBLIC OF GERMANY | LITERATURE REVIEW | CLINICAL RESEARCH | WOMEN | ADOLESCENTS, FEMALE | THROMBOEMBOLISM | CONTRACEPTIVE SAFETY | CONTRACEPTIVE AGENTS, SIDE EFFECTS | CONTRAINDICATIONS | CONTRACEPTIVE AGENTS, PROGESTIN | PREGNANCY COMPLICATIONS | Developed Countries | Europe, Central | Europe | Research Methodology | Demographic Factors | Population | Adolescents | Youth | Age Factors | Population Characteristics | Embolism | Vascular Diseases | Diseases | Safety | Public Health | Health | Contraceptive Agents | Contraception | Family Planning | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Contraceptive Agents, Female Document Number: 331280 |
| 15. Title: Mechanisms of thrombosis related to hormone therapy. Author: Sandset PM; Hoibraaten E; Eilertsen AL; Dahm A Source: Thrombosis Research. 2009;123 Suppl 2:S70-3. Abstract: Combined oral contraceptives and combined oral postmenopausal hormone therapy are associated with a weak, but clinically significant risk of arterial and venous thrombosis (VT). The effects are related to dose of estrogen and type of progestin. The main effects are increase in markers of activated coagulation, reduction in coagulation inhibitors, and acquired activated protein C resistance. Reduction in tissue factor pathway inhibitor (TFPI) is probably an important mechanism, which predicts activation of coagulation and acquired resistance to activated protein C. Coagulation markers should be used as intermediate or surrogate markers in early pharmacodynamic studies to evaluate the risk associated with new formulations. Language: English Keywords: NORWAY | LITERATURE REVIEW | CLINICAL RESEARCH | WOMEN | ORAL CONTRACEPTIVES, COMBINED | THROMBOSIS | HORMONE REPLACEMENT THERAPY | THROMBOEMBOLISM | CONTRACEPTIVE AGENTS, ESTROGEN | CONTRACEPTIVE AGENTS, PROGESTIN | PROTEINS | ORAL CONTRACEPTIVES, SIDE EFFECTS | SIDE EFFECTS | BLOOD COAGULATION EFFECTS | Developed Countries | Europe, Northern | Europe | Research Methodology | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Embolism | Vascular Diseases | Diseases | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Contraceptive Agents, Female | Contraceptive Agents | Physiology | Biology | Contraceptive Safety | Safety | Public Health | Hematological Effects | Hemic System Document Number: 341123 |
| 16. Peer Reviewed Title: Sex hormone-binding globulin: an adequate surrogate marker for venous thromboembolism in women using new hormonal contraceptives [letter] Author: van Vliet HA; Rosendaal FR; Rosing J; Helmerhorst FM Source: Contraception. 2009 Apr;79(4):328-9; author reply 329-30. Abstract: Language: English Keywords: EUROPE | CRITIQUE | WOMEN | THROMBOEMBOLISM | ORAL CONTRACEPTIVES | LEVONORGESTREL | RISK FACTORS | Developed Countries | Demographic Factors | Population | Embolism | Vascular Diseases | Diseases | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Health Document Number: 330554 |
| 17. Title: [Oral contraceptives use increases venous thromboembolic risk even for minor surgical procedure - a case report] Stosowanie doustnych srodkow antykoncepcyjnych zwieksza ryzyko powiklan Author: Elikowski W; Malek M; Wojtasinska E; Duszynska M; Kawczynski S; Zawilska K Source: Kardiologia Polska. 2008 Oct;66(10):1091-4; discussion 1095. Abstract: A case of a 25-year-old woman with life-threatening pulmonary embolism, which occurred on fourth day after appendectomy and was safely treated with alteplase infusion. Before surgery, oral contraceptive use history, as a sole venous thromboembolic risk factor has been missed and the patient did not receive perioperative, pharmacologic antithrombotic prophylaxis. Further screening for thrombophilia was negative. This case proves that contraceptives use may create, irrespectively of the woman age, a possibility of perioperative thromboembolic complications, even for such minor procedure as appendectomy. Language: Polish Keywords: SUMMARY REPORT | CASE STUDIES | WOMEN | ORAL CONTRACEPTIVES | PULMONARY EMBOLISM | THROMBOEMBOLISM | SURGERY | RISK FACTORS | COMPLICATIONS | Studies | Research Methodology | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Embolism | Vascular Diseases | Diseases | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Biology Document Number: 330143 |
| 18. Title: Possible association of venous thromboembolism and hyperthyroidism: 4 case reports and literature review [letter] Author: Kim DD; Young S; Chunilal S; Cutfield R Source: New Zealand Medical Journal. 2008 Aug 22;121(1280):53-7. Abstract: Hyperthyroidism is not a widely recognised association with venous thromboembolism (VTE). However, various changes in the coagulation pathway and platelet function that might predispose to VTE have been described in patients with hyperthyroidism. We present four cases of VTE occurring in the setting of acute hyperthyroidism at North Shore and Waitakere Hospitals, New Zealand. (excerpt) Language: English Keywords: NEW ZEALAND | LITERATURE REVIEW | CASE STUDIES | THROMBOEMBOLISM | THYROID EFFECTS | ENDOCRINE EFFECTS | SCREENING | ORAL CONTRACEPTIVES, COMBINED | TREATMENT | Developed Countries | Oceania | Studies | Research Methodology | Embolism | Vascular Diseases | Diseases | Endocrine System | Physiology | Biology | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning Document Number: 328682 |
| 19. Peer Reviewed Title: Contraception in the cosmos: The combined oral contraceptive pill in space. Author: Murad A Source: Journal of Family Planning and Reproductive Health Care. 2008;34(1):55-59. Abstract: The combined oral contraceptive pill (COC) is one medication that could be used to prevent health problems in space. Whilst there is no official requirement for them to do so, the vast majority of the National Aeronautics and Space Administration's (NASA) female astronauts choose to use the COC whilst in space (P Stepaniak, NASA Flight Surgeon, personal communication, 23 October 2006). Whilst much is known about the physiological effects of the COC on Earth, there has been no discussion of the potential benefits and disadvantages of its use in space. Such a discussion must take into account the effects of spaceflight on human physiology and the fact that modern female astronauts are a highly selected, motivated and, in general, healthy group of individuals. This article aims to review the potential benefits and disadvantages of using the COC during long-duration stays in space. It begins with a discussion of the gynaecological effects of the COC. It then examines how the COC might influence the effects of spaceflight on the human musculoskeletal system. Finally, it explores ways in which the COC could affect other systems of the body in ways that are relevant to spaceflight. (excerpt) Language: English Keywords: RESEARCH REPORT | RESEARCH AND DEVELOPMENT | ORAL CONTRACEPTIVES | CONTRACEPTIVE AGENTS, SIDE EFFECTS | MENSTRUATION DISORDERS | SKELETAL EFFECTS | BREAST CANCER | THROMBOEMBOLISM | SIGNS AND SYMPTOMS | PHYSIOLOGY | Technology | Economic Factors | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents | Diseases | Biology | Cancer | Neoplasms | Embolism | Vascular Diseases Document Number: 323394 |
20.  Title: Controversies in contraception. Author: Pitts SA; Emans SJ Source: Current Opinion in Pediatrics. 2008;20:383-389. Abstract: New research is constantly being published regarding hormonal contraceptives and bone health, migraine headaches, thrombosis risk, hypertension, weight gain, and obesity, as well as emergency contraception. At times, these studies can be clarifying, but they can also raise new controversies and questions. It is important for providers to be aware of the emerging issues regarding contraceptive care for adolescent patients. Research suggests that Depo-Provera (depot medroxyprogesterone acetate; Pfizer, New York City, New York, USA) and, perhaps, low-dose oral contraceptive pills can have adverse effects on adolescent bone health, although the data demonstrating reversibility of bone loss after discontinuation of these contraceptives are reassuring. Additionally, estrogen-containing contraceptives pose risks for patients, including the onset of or exacerbation of migraine headaches, venous thromboembolism, and hypertension. Depo-Provera has been implicated in weight gain, especially in girls who are already overweight. Obesity may decrease the efficacy of some hormonal contraceptives. Finally, the mechanism of action of emergency contraception is still unknown, although studies continue to suggest that it has primarily preovulatory, not postovulatory, effects. Adolescent health providers need to be aware of the new research and controversies in contraceptive care in order to counsel and care for patients effectively. (author's) Language: English Keywords: GLOBAL | LITERATURE REVIEW | ADOLESCENTS | CONTRACEPTION | ADOLESCENT HEALTH | SKELETAL EFFECTS | MIGRAINE | THROMBOEMBOLISM | HYPERTENSION | BODY WEIGHT | OBESITY | CONTRACEPTIVE AGENTS, SIDE EFFECTS | EMERGENCY CONTRACEPTION | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Family Planning | Health | Physiology | Biology | Vascular Diseases | Diseases | Embolism | Contraceptive Agents Document Number: 328122 |
| 21. Peer Reviewed Title: Sex hormone-binding globulin: not a surrogate marker for venous thromboembolism in women using oral contraceptives. Author: Stanczyk FZ; Grimes DA Source: Contraception. 2008 Sep;78(3):201-203. Abstract: Several recent reports have suggested that sex hormone-binding globulin (SHBG) might be a surrogate marker for venous thromboembolism (VTE) during combined oral contraceptive (COC) use. Uncritical acceptance of invalid surrogate markers threatens patient health and has caused thousands of preventable deaths in recent decades. Hence, clinicians have an ethical obligation to validate any proposed surrogate end point. The author's examine the hypothesis that this globulin is a surrogate marker for VTE in oral contraceptive users, considering both laboratory medicine and epidemiology. The author's conclude no valid surrogate marker for VTE exists for women using COCs. The best available evidence suggests that all contemporary COCs in Europe are associated with a similar risk of VTE. Hence, putative surrogate markers for VTE cannot distinguish between different types of COCs. Language: English Keywords: CRITIQUE | THROMBOEMBOLISM | ORAL CONTRACEPTIVES, COMBINED | HEMATOLOGICAL EFFECTS | HORMONE RECEPTORS | LABORATORY PROCEDURES | Embolism | Vascular Diseases | Diseases | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Hemic System | Physiology | Biology | Membrane Proteins | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 328333 |
| 22. Title: A comprehensive screening analysis of antiphospholipid antibodies in Indian women with fetal loss. Author: Vora S; Shetty S; Salvi V; Satoskar P; Ghosh K Source: European Journal of Obstetrics, Gynecology and Reproductive Biology. 2008 Apr;137(2):136-140. Abstract: The present study was aimed at a comprehensive analysis of acquired thrombophilia in a large series of Indian women with fetal loss. Four hundred and thirty women (median age 26 years, range 18-39 years) with unexplained fetal loss (median number of abortions 3, range 1-13) were screened for the presence of antiphospholipid antibodies (APA), i.e. lupus anticoagulant (LA), IgG/M antibodies for cardiolipin (ACA), beta2 glycoprotein 1 (beta2 GP1) and annexin V. We also studied 100 normal healthy women (median age 24 years, range 18-30 years) who had at least one healthy child and did not have any miscarriage or other obstetric complications. The prevalence of persistently positive LA was 8.1% and 1% in the patients and controls, respectively (OR 8.7; 95% CI, 1.4-51; P less than 0.05). The overall prevalence of IgG and/or IgM antibodies for cardiolipin, beta2 GP1 and annexin V were as follows-ACA 27.9% (OR 18.9; 95% CI, 5-70; P less than 0.05), beta2 GP1 12.2% (OR 6.8; 95% CI, 1.8-25; P less than 0.05) and annexin V 14.6% (OR 17; 95% CI, 2.9-98; P less than 0.05). The conventional LA and ACA tests were positive 23.2% of the cases as against 1% in the controls (OR 14.8; 95% CI, 3.9-55; P less than 0.05). The prevalence of LA, ACA, beta2 GP1 and annexin Vantibodies as independent risk factors were observed in 0.5%, 16.5%, 5.4% and 7.8% in the patients as against 1% each in the controls. The overall positivity for any one of the APA studied was 42.6% (OR 10.2; 95% CI, 4.5-23; P less than 0.05). The present study thus indicates the importance of APA in women experiencing fetal loss where all the conventional causes of miscarriages have been ruled out. It also suggests that conventional APA assays (LA and ACA) are effective in the detection of a majority of APA positive cases and by the addition of other cofactor-dependent (beta2 GP1 and annexin V) APA assays, there is a considerable increase in the diagnostic efficiency in the detection of APA. (author's) Language: English Keywords: INDIA | RESEARCH REPORT | CLINICAL RESEARCH | WOMEN | FETAL DEATH | THROMBOEMBOLISM | ANTIBODIES | ANTIBODY FORMATION | SCREENING | Developing Countries | Asia, Southern | Asia | Research Methodology | Demographic Factors | Population | Mortality | Population Dynamics | Embolism | Vascular Diseases | Diseases | Immunologic Factors | Immunity | Immune System | Physiology | Biology | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health Document Number: 325772 |
| 23. Peer Reviewed Title: Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users. Author: Cole JA; Norman H; Doherty M; Walker AM Source: Obstetrics and Gynecology. 2007 Feb 1;109(2):339-346. Abstract: The objective was to estimate the incidence of venous thromboembolism, acute myocardial infarction, and ischemic stroke among transdermal contraceptive system users compared with users of norgestimate-containing oral contraceptives with 35 mcg ethinyl estradiol. We began with insurance claims data from UnitedHealthcare. We identified women exposed to the transdermal contraceptive system or norgestimate-containing oral contraceptives from April 2002 through December 2004. Outcomes were confirmed from medical records. We calculated incidence rates and age-adjusted incidence rate ratios. In a nested case-control analysis, we investigated and controlled for confounding. There were 49,048 woman-years of transdermal contraceptive system exposure and 202,344 woman-years of norgestimate-containing oral contraceptives exposure. There was a more than two-fold increase in the venous thromboembolism rate (incidence rate ratio 2.2, 95% confidence interval [CI] 1.3-3.8) among transdermal contraceptive system users (20 cases, 40.8 per 100,000 woman-years) compared with norgestimate-containing oral contraceptives users (37 cases, 18.3 per 100,000 woman-years). Acute myocardial infarction occurred in three transdermal contraceptive system users compared with seven among norgestimate-containing oral contraceptives users (incidence rate ratio 1.8, 95% CI 0.5- 6.8). No strokes occurred among transdermal contraceptive system users, whereas 10 occurred among norgestimate-containing oral contraceptives users. In the nested case-control analysis, after exclusions for high-risk factors, the odds ratio for venous thromboembolism was 2.4 (95% CI 1.1-5.5). There was a more than two-fold increase in the risk of venous thromboembolism associated with use of the transdermal contraceptive system. Acute myocardial infarction and stroke occurred too rarely to ascertain precise risk estimates. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | EPIDEMIOLOGIC METHODS | COMPARATIVE STUDIES | WOMEN | THROMBOEMBOLISM | MYOCARDIAL INFARCTION | CEREBROVASCULAR EFFECTS | INCIDENCE | ORAL CONTRACEPTIVES | NORGESTIMATE | ETHINYL ESTRADIOL | HEALTH INSURANCE | ORAL CONTRACEPTIVES, SIDE EFFECTS | CONTRACEPTIVE AGENTS, SIDE EFFECTS | North America | Americas | Developed Countries | Research Methodology | Studies | Demographic Factors | Population | Embolism | Vascular Diseases | Diseases | Heart Diseases | Physiology | Biology | Measurement | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Progestin | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Financial Activities | Economic Factors | Contraceptive Safety | Safety | Public Health | Health Document Number: 312126 |
| 24. Title: Effect of a low-dose oral contraceptive on venous endothelial function in healthy young women: Preliminary results. Author: Giribela CR; Rubira MC; de Melo NR; Plentz RD; de Angelis K Source: Clinics. 2007;62(2):151-158. Abstract: A possible increase in the incidence of venous thromboembolic events has been reported among users of third generation oral contraceptives. The objective of this study was to evaluate the effect of a low dose oral contraceptive (15 µg ethinyl estradiol/60 µg gestodene) on the venous endothelial function of healthy young women. Prospective case control study using the dorsal hand vein technique. Venous endothelial function was evaluated at baseline and after 4 months in the oral contraceptive users group (11 women) and in a control group (9 women). After preconstriction of the vein with phenylephrine, dose-response curves for acetylcholine and sodium nitroprusside were constructed. In the contraceptive users group, a reduction occurred in the maximum venodilation response to acetylcholine and sodium nitroprusside after 4 months of oral contraceptive use, but this difference was not statistically significant (P > 0.05). No significant changes were detected in maximum venodilation responses to acetylcholine and sodium nitroprusside at the 4-month time point in the control group. This study found no significant impairment of endothelium-dependent or independent venodilation in healthy young women following oral contraceptive use. Further studies are necessary using the same methodology in a larger sample over a longer follow-up period. (author's) Language: English Keywords: BRAZIL | RESEARCH REPORT | CASE CONTROL STUDIES | WOMEN | YOUTH | ORAL CONTRACEPTIVES, LOW-DOSE | ORAL CONTRACEPTIVES, SIDE EFFECTS | HEMATOLOGICAL EFFECTS | THROMBOEMBOLISM | South America, Eastern | South America | Latin America | Americas | Developing Countries | Studies | Research Methodology | Demographic Factors | Population | Age Factors | Population Characteristics | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Contraceptive Safety | Safety | Public Health | Health | Hemic System | Physiology | Biology | Embolism | Vascular Diseases | Diseases Document Number: 320496 |
| 25. Peer Reviewed Title: Adolescents: Is there an association between knowledge of oral contraceptives and profession of provider? Author: Hansen T; Skjeldestad FE Source: European Journal of Contraception and Reproductive Health Care. 2007 Dec;12(4):303-308. Abstract: Knowledge about oral contraceptives (OCs) was investigated among young users of OCs by profession of provider, namely, physician or public health nurse. A 44-item questionnaire designed to assess communication about contraception and knowledge of OCs was distributed to students in 11 of 13 high schools in Trondheim, Norway. Data from 688 OC users were eligible for analyses. Knowledge about OCs was measured by means of 15 questions, from which scores on three separate indices and a total index were determined. Separate indices included knowledge about physical changes during OC use (index I), knowledge about the pill's relative efficacy (index II) and knowledge about risks of cancer/thromboembolism (index III). Logistic regression analyses showed that high scores with regard to knowledge indices were predicted by sexual activity and communication about contraception with peers and/or parents. Profession of provider was not associated with high knowledge scores. Information given during brief and annual discussions with health professionals appears to have an insignificant impact as compared with information from other sources. Our results plead for an over-the-counter practice. (author's) Language: English Keywords: NORWAY | RESEARCH REPORT | QUESTIONNAIRES | ADOLESCENTS | PROVIDERS WITH CLIENTS | KNOWLEDGE | ORAL CONTRACEPTIVES | RISK FACTORS | CANCER | THROMBOEMBOLISM | PUBLIC HEALTH | COMMUNICATION | Europe, Northern | Europe | Developed Countries | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Health Services | Delivery of Health Care | Health | Sociocultural Factors | Contraceptive Methods | Contraception | Family Planning | Biology | Neoplasms | Diseases | Embolism | Vascular Diseases Document Number: 322473 |
| 26. Peer Reviewed Title: Range of published estimates of venous thromboembolism incidence in young women. Author: Heinemann LA; Dinger JC Source: Contraception. 2007 May;75(5):328-336. Abstract: This review was conducted to show the full range of incidence estimates published for venous thromboembolism (VTE) in women depending on study design and to suggest a more reliable estimate for women of reproductive age. A literature search was performed to identify studies on the incidence of VTE in women. Incidence rates were compiled from studies with different methodologies and varying methodological quality. Algorithms were used to estimate VTE incidence from more reliable studies in young women. The literature shows two levels of VTE incidence rates: community/cohort studies and database studies. The estimated VTE incidence for women of reproductive age was 5.5-13.5 and 3.8-12.2 in community and cohort studies, respectively, but only 0.7-3.8 per 10,000 women-years (WY) in database studies. This difference is probably attributable to methodological problems associated with some database studies. The VTE incidence in women of reproductive age is likely to be in the range of 5-10 per 10,000 WY.These rates for the background incidence are clearly higher than the reference figures that are often utilized in the comparison with users of hormonal contraception (0.5-1 VTE per 10,000 WY). (author's) Language: English Keywords: GLOBAL | LITERATURE REVIEW | METHODOLOGICAL STUDIES | ESTIMATION TECHNIQUES | STUDY DESIGN | EPIDEMIOLOGIC METHODS | COHORT ANALYSIS | WOMEN | THROMBOEMBOLISM | PREVALENCE | CONTRACEPTIVE METHOD ACCEPTABILITY | DATA STORAGE AND RETRIEVAL | PULMONARY EMBOLISM | THROMBOSIS | Research Methodology | Demographic Factors | Population | Embolism | Vascular Diseases | Diseases | Measurement | Contraceptive Usage | Contraception | Family Planning | Information Processing | Information Document Number: 315382 |
| 27. Peer Reviewed Title: Further results on the risk of nonfatal venous thromboembolism in users of the contraceptive transdermal patch compared to users of oral contraceptives containing norgestimate and 35 micrograms of ethinyl estradiol. Author: Jick S; Kaye JA; Li L; Jick H Source: Contraception. 2007 Jul;76(1):4-7. Abstract: In 2006, we published a study that indicated that the new transdermal contraceptive patch containing ethinyl estradiol (EE) and the progestin norelgestromin did not increase the risk for venous thromboembolism (VTE) compared to oral contraceptive containing norgestimate and 35 µg of EE. This report updates information on the risk of nonfatal VTE in women using the contraceptive patch in comparison to women using oral contraceptives containing norgestimate (either monophasic or triphasic) and 35 µg of EE (norgestimate-35) using an additional 17 months of data. Nested case-control design based on information from PharMetrics, a US-based company that collects and organizes information on claims paid by managed care plans. The study was nested among all women, aged 15 to 44 years, who started either the contraceptive patch or norgestimate-35 after April 1, 2002. Cases were women with current use of one of these two study drugs and a documented diagnosis of VTE in the absence of identifiable clinical risk factors (idiopathic VTE) who were not in the earlier study. Up to four controls were matched to each case by age and calendar time. Odds ratios (ORs) comparing the risk of nonfatal VTE in new users of the two contraceptives. We identified 56 new cases of newly diagnosed, idiopathic VTE in the updated study population. The OR comparing the contraceptive patch to norgestimate-35 was 1.1 (95% CI 0.6-2.1). After evaluating an additional 17 months of data, the results indicate that the risk of nonfatal VTE for the contraceptive patch is closely similar to the risk for oral contraceptives containing 35 µg of EE and norgestimate. (author's) Language: English Keywords: UNITED STATES OF AMERICA | RESEARCH REPORT | CASE CONTROL STUDIES | WOMEN | ORAL CONTRACEPTIVES | NORGESTIMATE | ETHINYL ESTRADIOL | CONTRACEPTIVE AGENTS, PROGESTIN | ADMINISTRATION AND DOSAGE | RISK FACTORS | THROMBOEMBOLISM | Developed Countries | North America | Americas | Studies | Research Methodology | Demographic Factors | Population | Contraceptive Methods | Contraception | Family Planning | Contraceptive Agents, Female | Contraceptive Agents | Contraceptive Agents, Estrogen | Drugs | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Biology | Embolism | Vascular Diseases | Diseases Document Number: 317952 |
| 28. Peer Reviewed Title: Combined hormonal contraception and venous thromboembolism. Author: Martinez F; Avecilla A Source: European Journal of Contraception and Reproductive Health Care. 2007 Jun;12(2):97-106. Abstract: This review provides an update of knowledge regarding venous thromboembolism (VTE) and combined hormonal contraceptives (CHCs) in the light of new progestins and new administration routes for CHCs. Practical recommendations are also offered. The association between the use of combined oral contraceptives (COCs) and an increased risk of VTE has been known about for many years, it being related mainly to the dose of oestrogen; however, recent research has also shown the influence of the type of progestin. When compared to COCs containing levonorgestrel or norethisterone, those containing desogestrel or gestodene present a two-fold greater risk of VTE; for COCs containing cyproterone acetate, the risk is four-fold greater, while there are no or insufficient data for those containing norgestimate, chlormadinone acetate or drospirenone. With regard to the contraceptive patch, the available data suggest that the risk of VTE is similar to that observed with COCs. There are no data concerning vaginal rings. The greatest risk of COC-associated VTE occurs during the first year of use, thus suggesting the existence of a predisposing condition, such as being a carrier of a thrombogenic mutation with which the COCs would exert a synergistic effect. Routine screening for such conditions is not justified. Changes in haemostatic variables produced by COCs, for example, acquired resistance to protein C, could be linked to VTE, although it has yet to be demonstrated that such alterations are related to a clinical risk of VTE among COC users. At present there are no laboratory tests able to detect an increased risk of VTE in asymptomatic women. The key procedures in terms of ensuring the safe use of this contraceptive method are a full clinical, personal and family history, in order to evaluate risk factors for VTE and cardiovascular disease, along with the recording of blood pressure and body mass index prior to the prescription of COCs. (author's) Language: English Keywords: SPAIN | LITERATURE REVIEW | WOMEN | ORAL CONTRACEPTIVES, COMBINED | BIODEGRADABLE DELIVERY SYSTEMS | VAGINAL RING | THROMBOEMBOLISM | RISK FACTORS | CONTRACEPTIVE SAFETY | CONTRAINDICATIONS | Europe, Southwestern | Europe | Developed Countries | Demographic Factors | Population | Oral Contraceptives | Contraceptive Methods | Contraception | Family Planning | Embolism | Vascular Diseases | Diseases | Biology | Safety | Public Health | Health | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care Document Number: 317561 |
| 29. Peer Reviewed Title: The transdermal contraceptive patch: An updated review of the literature. Author: O'Connell K; Burkman RT Source: Clinical Obstetrics and Gynecology. 2007 Dec;50(4):918-926. Abstract: The transdermal contraceptive patch which contains ethinyl estradiol and norelgestromin has an efficacy similar to current oral contraceptives (OCs). The major advantages include transdermal application and maintenance of adequate hormonal levels for at least 7 days. Side effects are similar to OC except for breast tenderness in the first 2 months of use and skin irritation at the application site. Although concern has been raised about a possible increased risk of venous thromboembolism, current available data comparing the patch to a norgestimate-containing OC ranges from no increase in risk to a 2.4-fold increase. (author's) Language: English Keywords: UNITED STATES OF AMERICA | LITERATURE REVIEW | CLINICAL RESEARCH | WOMEN | ETHINYL ESTRADIOL | CONTRACEPTIVE MODE OF ACTION | CONTRACEPTIVE AGENTS, SIDE EFFECTS | DERMATOLOGICAL EFFECTS | THROMBOEMBOLISM | ORAL CONTRACEPTIVES, COMBINED | CONTRACEPTIVE EFFECTIVENESS | BODY WEIGHT | CONTRACEPTIVE SAFETY | CARDIOVASCULAR EFFECTS | USER COMPLIANCE | Developed Countries | North America | Americas | Research Methodology | Demographic Factors | Population | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Physiology | Biology | Embolism | Vascular Diseases | Diseases | Oral Contraceptives | Contraceptive Methods | Safety | Public Health | Health | Behavior Document Number: 322251 |
| 30. Peer Reviewed Title: Risk of thromboembolism in women taking ethinylestradiol / drospirenone and other oral contraceptives. Author: Seeger JD; Loughlin J; Eng PM; Clifford CR; Cutone J Source: Obstetrics and Gynecology. 2007 Sep;110(3):587-593. Abstract: The oral contraceptive ethinylestradiol 0.03 mg/drospirenone 3 mg contains a progestin component that differs from other oral contraceptives. Case reports and prescription event monitoring suggested that ethinylestradiol/ drospirenone might be associated with an elevated risk of thromboembolism. We sought to estimate the association between ethinylestradiol/drospirenone and risk of thromboembolism relative to the association among other oral contraceptives. We identified ethinylestradiol/drospirenone initiators and a twofold larger group of other oral contraceptive initiators between June 2001 and June 2004 within a U.S. health insurer database. The comparison group was selected to have demographic and health care characteristics preceding oral contraceptive initiation that were similar to ethinylestradiol/drospirenone initiators. Thromboembolism during the follow-up of the cohorts was identified through claims for medical services, and only medical record-confirmed cases were included in analyses. The primary (as-matched) analysis used proportional hazards regression, whereas a secondary (as-treated) analysis accounted for changes in oral contraceptives during follow-up using Poisson regression. The 22,429 ethinylestradiol/drospirenone initiators and 44,858 other oral contraceptive initiators were followed for an average of 7.6 months, and there were 18 cases of thromboembolism in ethinylestradiol/drospirenone initiators and 39 in the comparators (rate ratio 0.9, 95% confidence interval 0.5-1.6). More than 9,000 women would need to be prescribed oral contraceptives to observe a difference of one case of thromboembolism. Results of the as-treated analysis were similar to those of the as-matched analysis. Ethinylestradiol/drospirenone initiators and initiators of other oral contraceptives are similarly likely to experience thromboembolism. (author's) Language: English Keywords: GLOBAL | RESEARCH REPORT | COHORT ANALYSIS | WOMEN | ETHINYL ESTRADIOL | ORAL CONTRACEPTIVES | THROMBOEMBOLISM | Research Methodology | Demographic Factors | Population | Contraceptive Agents, Estrogen | Contraceptive Agents, Female | Contraceptive Agents | Contraception | Family Planning | Contraceptive Methods | Embolism | Vascular Diseases | Diseases Document Number: 313851 |
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