Ulipristal acetate for emergency contraception?

Abstract

Anna Glasier and colleagues1Glasier AF Cameron ST Fine PM et al.Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis.Lancet. 2010; 375: 555-562Summary Full Text Full Text PDF PubMed Scopus (428) Google Scholar report on a randomised non-inferiority trial to compare the efficacy and safety of ulipristal acetate with levonorgestrel for emergency contraception. They conclude that ulipristal acetate provides women and health-care providers with an effective alternative for emergency contraception that can be used up to 5 days after unprotected sexual intercourse.As Giuseppe Benagiano and Helena von Hertzen suggest in their associated Comment,2Benagiano G von Hertzen H Towards more effective emergency contraception?.Lancet. 2010; 375: 527-528Summary Full Text Full Text PDF PubMed Scopus (12) Google Scholar this conclusion is at least premature and in fact misleading. The design of Glasier and colleagues' trial (drafted and funded by the manufacturer of ulipristal) lacks the attributes to prove the efficacy of ulipristal in preventing pregnancy up to 5 days after unprotected intercourse.First, the sample size is too small to permit comparisons between ulipristal and levonorgestrel administered 73–120 h after unprotected intercourse from reaching significance.Second, a superiority trial is needed to provide evidence that ulipristal should be implemented in current care, since this product is less accessible (need for prescription), more costly (three times the price of levonorgestrel in Belgium), and does not yet have the same safety data as levonorgestrel. This industry-driven publication fails to support a change in current practice, where levonorgestrel is the first choice for emergency contraception if administered within 72 h of sexual intercourse and (if feasible) emergency insertion of a copper intrauterine device can be considered after 72 h. Further evidence is needed before a change in practice should be entertained.We declare that we have no conflicts of interest. Anna Glasier and colleagues1Glasier AF Cameron ST Fine PM et al.Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis.Lancet. 2010; 375: 555-562Summary Full Text Full Text PDF PubMed Scopus (428) Google Scholar report on a randomised non-inferiority trial to compare the efficacy and safety of ulipristal acetate with levonorgestrel for emergency contraception. They conclude that ulipristal acetate provides women and health-care providers with an effective alternative for emergency contraception that can be used up to 5 days after unprotected sexual intercourse. As Giuseppe Benagiano and Helena von Hertzen suggest in their associated Comment,2Benagiano G von Hertzen H Towards more effective emergency contraception?.Lancet. 2010; 375: 527-528Summary Full Text Full Text PDF PubMed Scopus (12) Google Scholar this conclusion is at least premature and in fact misleading. The design of Glasier and colleagues' trial (drafted and funded by the manufacturer of ulipristal) lacks the attributes to prove the efficacy of ulipristal in preventing pregnancy up to 5 days after unprotected intercourse. First, the sample size is too small to permit comparisons between ulipristal and levonorgestrel administered 73–120 h after unprotected intercourse from reaching significance. Second, a superiority trial is needed to provide evidence that ulipristal should be implemented in current care, since this product is less accessible (need for prescription), more costly (three times the price of levonorgestrel in Belgium), and does not yet have the same safety data as levonorgestrel. This industry-driven publication fails to support a change in current practice, where levonorgestrel is the first choice for emergency contraception if administered within 72 h of sexual intercourse and (if feasible) emergency insertion of a copper intrauterine device can be considered after 72 h. Further evidence is needed before a change in practice should be entertained. We declare that we have no conflicts of interest. Ulipristal acetate for emergency contraception? – Authors' replyGilda Piaggio, Helena von Hertzen, Geert Herman Page, and Veerle Verhaeghe are unhappy with the methods or statistical analyses used in our published trial to compare levonorgestrel and ulipristal acetate for emergency contraception. The study was designed to provide a rigorous evaluation of efficacy in line with regulatory requirements for the approval of a new drug. As a registration trial, the protocol and statistical methods were reviewed by the US Food and Drug Administration before the start of the study, and the procedures, data collection, and analysis were subject to routine audit by independent quality assurance teams. Full-Text PDF