October 01, 2018
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Association between extended oral contraceptive use, increased VTE risk may not be clinically significant

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Extended and continuous combined oral contraceptive use was associated with a slightly elevated, but potentially clinically insignificant risk for venous thromboembolism compared with traditional cyclic use, according to research published in JAMA Internal Medicine.

“Continuous/extended cyclic estrogen use (84/7 or 365/0 days cycles) in combined oral contraceptives could potentially expose women to an increased cumulative dose of estrogen, compared with traditional cyclic regimens (21/7 days cycle), and may increase the risk for venous thromboembolism (VTE),” Jie Li, PhD, from the Center for Drug Evaluation and Research at the FDA, and colleagues wrote.

To determine whether the use of extended cyclic and continuous combined oral contraceptives is associated with a higher risk for VTE when holding the progestogen type (levonorgestrel) constant compared with cyclic combined oral contraceptives, Li and colleagues performed a retrospective cohort study of women aged between 18 and 50 years who initiated a combined oral contraceptive containing ethinyl estradiol or levonorgestrel of any dose between May 2007 and September 2015.

The researchers identified 210,691 women taking continuous/extended combined oral contraceptives (mean age, 30.4 years) and 522,316 women taking cyclic combined oral contraceptives (mean age, 28.8 years).

At baseline, continuous/extended cyclic combined oral contraceptives users were slightly more likely to have cardiovascular and metabolic conditions (7.2% vs. 4.7%), gynecological conditions (39.7% vs. 32.3%) and health services utilization than cyclic combined oral contraceptive users.

When the researchers analyzed the data using a propensity score matching approach, HR estimates declined from 1.84 (95% CI, 1.53-2.21) to 1.32 (95% CI, 1.07-1.64) for continuous/extended use compared with cyclic use. The two propensity score–matched cohorts had low absolute risk differences (0.27 per 1,000 persons) and incidence rate differences (0.35 cases per 1,000 person-years).

“Because of the small absolute risk difference and potential residual confounding, these findings did not show strong evidence supporting a VTE risk difference between noncyclic and cyclic estrogen use,” Li and colleagues concluded. “Accordingly, we do not recommend selective prescribing of combined oral contraceptives based on the cyclic and continuous/extended type. Clinicians should prescribe combined oral contraceptives based on patients’ individual risk factors and preferences.” – by Alaina Tedesco

Disclosure: The authors report no relevant financial disclosures.