From the Journals

Mifepristone, then misoprostol is best in early pregnancy loss

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‘Standard of care’ has unnecessary FDA restriction

The results of this study provide strong evidence that the sequential regimen of mifepristone followed by misoprostol is safe and superior to misoprostol alone in achieving treatment success and avoiding an aspiration procedure, wrote Carolyn L. Westhoff, MD, in an editorial accompanying the article.

In addition to its greater efficacy, the mifepristone treatment is quicker, which is more desirable for patients and reduces costs, inconvenience, and patient anxiety. Some women still will need prompt access to aspiration.

The mifepristone-pretreatment regimen should be the standard of care, Dr. Westhoff writes, but access to mifepristone is limited by the FDA’s Risk Evaluation and Mitigation Strategy restriction, which requires that the oral drug be taken in the doctor’s office rather than obtained at a retail pharmacy. “Extensive clinical experience with mifepristone indicates that there is no need for such restrictions,” she wrote.

Carolyn L. Westhoff, MD, is a professor of epidemiology and population and family health at Columbia University in New York. Her remarks are adapted from an accompanying editorial (N Engl J Med. 2018;378:2232-3). She reported personal fees from Planned Parenthood, Bayer, Agile Therapeutics, Cooper Surgical, Allergan, Elsevier, and personal fees and nonfinancial support from Merck.


 

FROM THE NEW ENGLAND JOURNAL OF MEDICINE


Serious adverse events were rare in both groups, and both groups had matching mean scores for bleeding intensity and pain.

“Pretreatment with mifepristone followed by treatment with misoprostol resulted in a significantly higher rate of complete gestational sac expulsion by approximately 2 days after treatment ... [and] a significantly lower rate of uterine aspiration than misoprostol use alone,” wrote Dr. Schreiber and her coauthors. Patient satisfaction was similar between the two groups (89.4% vs. 87.4%, respectively, described their experience overall as either “good” or “neutral”).

The trial was funded by the National Institute of Child Health and Human Development. Two coauthors reported grants from the National Institutes of Health during the study and another reported personal fees from Danco Laboratories, which markets mifepristone, outside the submitted work.

SOURCE: Schreiber CA et al. N Engl J Med. 2018;378:2161-70.

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