Oral contraceptive effectiveness according to body mass index, weight, age, and other factors.

OBJECTIVE: The purpose of this study was to assess the use-effectiveness of oral contraceptives (OCs) in Europe according to body mass index (BMI), weight, age, and other factors. STUDY DESIGN: In a planned secondary analysis, we used data from the European Active Surveillance Study on Oral Contraceptives, which was a prospective active cohort surveillance study of 59,510 OC users, to assess the effectiveness of OCs overall and by BMI, weight, age, duration of use, ethinylestradiol dose, regimen type, starting/switching status, and parity. Self-reported unplanned pregnancies during OC use were confirmed by interview. RESULTS: An analysis of OC effectiveness (112,659 women-years of exposure and 545 unplanned pregnancies) found little variation in effectiveness by BMI/weight. Failure rates decreased after 30 years of age and with an increasing duration of use. CONCLUSION: OC users in Europe reported high contraceptive effectiveness with "typical use." Failure rates decreased with age and duration of use. BMI and weight had little, if any, influence on effectiveness.

Colon cancer risk and different HRT formulations: a case-control study.

BACKGROUND: Most studies have found no increased risk of colon cancer associated with hormone replacement therapy (HRT), or even a decreased risk. But information about the effects of different HRT preparations is lacking. METHODS: A case-control study was performed within Germany in collaboration with regional cancer registries and tumor centers. Up to 5 controls were matched to each case of colon cancer. Conditional logistic regression analysis was applied to estimate crude and adjusted odds ratios (OR) and 95% confidence intervals (95% CI). Stratified analyses were performed to get an impression of the risk associated with different estrogens and progestins. RESULTS: A total of 354 cases of colon cancer were compared with 1422 matched controls. The adjusted overall risk estimate for colon cancer (ColC) associated with ever-use of HRT was 0.97 (0.71-1.32). No clinically relevant trends for ColC risk were observed with increasing duration of HRT use, or increasing time since first or last HRT use in aggregate. Whereas the overall risk estimates were stable, the numbers in many of the sub-analyses of HRT preparation groups (estrogens and progestins) were too small for conclusions. Nevertheless, if the ColC risk estimates are taken at face value, most seemed to be reduced compared with never-use of HRT, but did not vary much across HRT formulation subgroups. In particular, no substantial difference in ColC risk was observed between HRT-containing conjugated equine estrogens (CEE) or medroxyprogesterone acetate (MPA) and other formulations more common in Europe. CONCLUSION: Ever-use of HRT was not associated with an increased risk of colon cancer. In contrary, most risk estimates pointed non-significantly toward a lower ColC risk in HRT ever user. They did not vary markedly among different HRT formulations (estrogens, progestins). However, the small numbers and the overlapping nature of the subgroups suggest cautious interpretation.

Range of published estimates of venous thromboembolism incidence in young women.

OBJECTIVE: 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. METHODS: 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. RESULTS AND DISCUSSION: 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. CONCLUSION: 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).

The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation.

OBJECTIVES: The study was conducted to compare risks of adverse cardiovascular and other events associated with the use of drospirenone (DRSP)-containing oral contraceptives (OCs) and other OCs. METHODS AND MATERIALS: The European Active Surveillance study (EURAS) was a multinational, prospective, noninterventional cohort study of new users of DRSP, levonorgestrel (LNG) and other progestin-containing OCs. Semiannual follow-up was based on mailed questionnaires, with additional follow-up procedures when needed. RESULTS: Overall, 58,674 women were followed for 142,475 women-years of observation. Loss to follow-up was 2.4%. Serious adverse and fatal events were rare, and rate ratios were close to unity (1.0). Cox regression analysis of cardiovascular outcomes yielded hazard ratios for DRSP-containing vs. LNG-containing and other OCs of 1.0 and 0.8 (upper 95% confidence limits, 1.8 and 1.3) for venous, and 0.3 and 0.3 (upper 95% confidence limits, 1.2 and 1.5) for arterial thromboembolism, respectively. CONCLUSIONS: Risks of adverse cardiovascular and other serious events in users of a DRSP-containing OC are similar to those associated with the use of other OCs.

Use of oral contraceptives containing gestodene and risk of venous thromboembolism: outlook 10 years after the third-generation "pill scare".

BACKGROUND: This study investigated whether gestodene-containing oral contraceptives (OCs) carry a higher risk of venous thromboembolism (VTE) than OCs containing progestins other than desogestrel and gestodene. The study was conducted based on the hypothesis that the biases and confounding factors that were present initially after the introduction of new so-called "third-generation" OCs (i.e., those containing desogestrel and gestodene) in the 1990s, which likely contributed to the alleged increased risk of VTE, may have vanished after 10 years. STUDY DESIGN: This was a matched case-control study using data identified for women (aged 15-49 years) with suspected or diagnosed VTE (deep vein thrombosis or pulmonary embolism) that occurred between January 2002 and February 2006 in Austria. All VTE cases were validated by an attending/relevant physician(s), a detailed review of medical records and patient-completed questionnaires. Data were analyzed using an unconditional logistic regression model with adjustment for relevant confounders. RESULTS: Overall, 451 VTE cases and 1,920 controls without VTE were identified. The adjusted odds ratios for confirmed VTE with OC use versus nonuse were: 3.39 (95% CI 2.36-4.87) for OCs containing gestodene and 3.14 (2.1-4.47) for OCs containing progestins other than desogestrel and gestodene. Adjusted odds ratios for a head-to-head comparison of OCs containing gestodene versus OCs containing progestins other than desogestrel and gestodene were: 0.99 (0.68-1.45) for all cases; 1.01 (0.69-1.47) for confirmed cases and 1.11 (0.73-1.69) for confirmed and idiopathic VTE cases, respectively. CONCLUSION: The risk of VTE is not elevated in users of gestodene-containing OCs relative to users of OCs containing progestins other than desogestrel and gestodene. Our study supports the view that (i) the majority of previous results may be explained by differences in the user populations of so-called "third-generation" OCs (containing desogestrel and gestodene) and "second-generation" OCs (containing progestins other than desogestrel and gestodene) that were present shortly after market introduction of gestodene-containing OCs and that (ii) these differences seem to have disappeared over time.