NOMAC-E2 use was not associated with a higher risk of deep venous thrombosis and pulmonary embolism compared with levonorgestrel-containing oral contraceptives (adjusted HR 0.59; 95% CI 0.25-1.35).
Cohort (n=101,498)
Yes
Does nomegestrol acetate and 17β-oestradiol increase the risk of venous and arterial thromboembolism compared to levonorgestrel-containing combined oral contraceptives in women?
The use of a monophasic oral contraceptive containing nomegestrol acetate and 17β-oestradiol is not associated with a higher risk of venous or arterial thromboembolism compared to levonorgestrel-containing contraceptives.
Effect estimate: HRadj 0.59 (95% CI 0.25-1.35)
Objective To assess and compare the risk of venous thromboembolism (VTE) and arterial thromboembolism (ATE) in NOMAC-E2 users with levonorgestrel-containing combined oral contraceptive (COCLNG) users.Study design This large, prospective, observational active surveillance study used a non-inferiority design. New users of NOMAC-E2 and COCLNG were recruited in 12 countries in Australia, Europe, and Latin America. Women were followed up directly and self-reported outcomes of interest were validated via treating physicians. The main outcome of interest was VTE, specifically deep venous thrombosis of the lower extremities (DVT) and pulmonary embolism (PE). Secondary outcomes included all VTE and ATE. Data on confounders were captured and independent blinded adjudication assessed the classification of events. Incidence rates, crude (HRcrude), and adjusted (HRadj) hazard ratios were calculated.Results A total of 101,498 women (49,598 NOMAC-E2 users and 51,900 COCLNG users) were enrolled and followed for up to 2 years (144,901 WY of observation). NOMAC-E2 users had a higher mean age (31.0 ± 8.63 years) than COCLNG users (29.3 ± 8.53 years) but other baseline characteristics were similar between the cohorts. The main analysis comparing the risk of DVT of the lower extremities and PE in NOMAC-E2 users versus COCLNG users yielded an HRadj of 0.59 (95% CI, 0.25–1.35) (adjusted for age, BMI, family history of VTE, and current duration of use). The risk of all VTE and ATE was not higher in NOMAC-E2 users compared with COCLNG users.Conclusion(s) NOMAC-E2 use was not associated with a higher risk of VTE or ATE compared with COCLNG.
Reed et al. (2021) conducted a cohort in Contraception (n=101,498). NOMAC-E2 (nomegestrol acetate and 17β-oestradiol) vs. Levonorgestrel-containing combined oral contraceptive (COCLNG) was evaluated on Deep venous thrombosis of the lower extremities (DVT) and pulmonary embolism (PE) (HRadj 0.59, 95% CI 0.25-1.35). NOMAC-E2 use was not associated with a higher risk of deep venous thrombosis and pulmonary embolism compared with levonorgestrel-containing oral contraceptives (adjusted HR 0.59; 95% CI 0.25-1.35).