Unintended Pregnancies in Users of Different Combined Oral Contraceptives - Final results from the INAS-SCORE Study
ESC Congress Library. Heinemann K. May 10, 2018; 208247
Disclosure(s): The INAS-SCORE Study is funded by an unconditional grant from Bayer AG (Germany). An independent international Safety Monitoriung and Advisory Council is responsible for all scientific matters.
Dr. Klaas Heinemann
Dr. Klaas Heinemann
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Background: Oral contraceptives are the most popular method of birth control and widely used. The effectiveness is compared between different combined oral contraceptives in Europe.   Objectives: The primary objective of the analysis is to determine the rate of unwanted pregnancies in women using COCs and to compare the contraceptive failure rates between the two user cohorts: Qlaira (Natazia in the US) and established COCs. Methods: The 'International Active Surveillance Study - Safety of Contraceptives: Role of Estrogens' (INAS-SCORE) was requested by the Medicines Evaluation Board. It was a large, prospective, controlled, non-interventional, long-term cohort study with active surveillance of the study participants. It was conducted in Austria, France, Germany, Italy, UK, Poland, Sweden and the United States. Women were enrolled by their prescribing physician. During the follow-up phase, women were contacted every 6 to 12 months for a maximum of 6 years and asked for information about unintended pregnancy as a secondary outcome. Self-reported pregnancies were validated by health care professionals. The last patient follow-up procedures were finalized in January 2017. Absolute numbers, incidence rates (per 10,000 WY), rate ratios, 95% confidence intervals and Pearl Indices were calculated. Inferential statistics were based on Cox proportional hazards models. Crude and adjusted hazard ratios between cohorts were calculated. As requested by the European Medicinal Agency, final analyses are based on the European data only.   Results: The final analysis was based on 68,362 WY (women Years) of OC exposure. Overall, 287 unintended pregnancies were reported, of which 32 occurred under Qlaira use (Pearl Index (PI): 0.2; 95% CI: 0.2-0.3) and 243 under Other COC use (PI: 0.5; 95% CI: 0.4-0.6), including 66 under LNG-COCs (PI: 0.7; 95% CI: 0.5-0.9). Cox regression analysis yielded crude HRs of 0.5 (95% CI, 0.3 - 0.7) and 0.3 (95% CI, 0.2 - 0.5) for DNG/EV versus oCOC and LNG, respectively. Cox regression analysis that included the prognostic factors age, parity, smoking and BMI yielded an adjusted hazard ratio of 0.7 (95% CI, 0.5 - 0.98, p=0.04) and 0.5 (95% CI, 0.3 - 0.8, p 25 - ≤35, >35years) are shown in table 1. Table 1:  Adjusted Hazard ratios comparing the contraceptive failure rate of Qlaira with Other COC and LNG-COCs stratified by age groups Age Group (years) HRadj (95% CI) comparing Qlaira vs Other COC HRadj (95% CI) comparing Qlaira vs LNG-COC ≤25 0.6 (0.4 - 1.1) 0.4 (0.2 - 0.8) >25 - ≤35 1.0 (0.5 - 1.8) 0.8 (0.4 - 1.8) >35 0.1 (0.0 - 0.6) 0.1 (0.0 - 0.6) Conclusions: OCs have a high contraceptive effectiveness. The results do not suggest a higher risk of contraceptive failure in Qlaira users compared to users of other COCs.
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