Table 3.
Estimated risk of venous thromboembolism events (VTE) with combined oral contraceptives (COC).
Risk group | Estimated risk of VTE | Reference |
---|---|---|
Non-pregnant non-user | 2/10 000 WY | EMA/739865/2013 (84) |
Pregnant and postpartum women | 20/10 000 WY | 30-year population-based study (85) |
User of COC containing
- EE + LNG - EE + NETA - EE + NGM |
5-7/10 000 WY | EMA/739865/2013 (84) |
User of COC containing
- EE + GSD - EE+ DSG - EE+ DRSP |
9-12/10 000 WY | EMA/739865/2013 (84) |
User of COC containing
- EE + CMA |
Unknown | N/A |
User of COC containing
- EE + DNG |
8-11/10 000 WY (update from the EMA) | EMA |
User of COC containing
- E2V + DNG |
7.0/10 000 WY versus 3.5 in non-user and 9.9 in LNG/EE users | INAS-SCORE study (82) |
User of COC containing
- E2/NOMAC |
2.0/10 000 WY versus 1.8 in non-user and 3.0 in LNG/EE users | PRO-E2 (83) |
User of COC containing
- E4/DRSP |
Pending | PASS required by the EMA and FDA |
CMA, chlormadinone acetate; COC, combined oral contraceptives; DNG, dienogest; DRSP, drospirenone; DSG, desogestrel; EE, ethinylestradiol; EMA, European Medicines Agency; EURAS, European Actie Surveillance Study; E2, 17β-estradiol; E2V, estradiol valerate; E4, estetrol; GSD, gestodene; INAS-CELINA, International Active Surveillance Study: Choice of Estrogen and Long-term Investigation of Nomegestrol Acetate; INAS-SCORE, International Active Surveillance study “Safety of Contraceptives: Role of Estrogens”; LNG, levonorgestrel; NETA, norethisterone acetate; NGM, norgestimate; PASS, post authorization safety study; VTE, venous thromboembolism; WY, women-year. N/A, not applicable.