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Authors’ Response: Troglitazone Use in Polycystic Ovary Syndrome

Departments of Obstetrics and Gynecology and Medicine (R.A.), The University of Alabama at Birmingham, Birmingham, Alabama; Department of Medicine (D.E.), The University of Chicago Medical Center, Chicago, Illinois; Department of Obstetrics and Gynecology (R.S.L.), The Pennsylvania State University, Hershey, Pennsylvania; St. Joseph Mercy Hospital (R.W.), Ann Arbor, Michigan; and Pfizer Global Research and Development (R.H., A.G.F., M.O., M.N.G.), Ann Arbor, Michigan

To the editor:

We appreciate the interest of Drs. Landman and Jacobs in our study and their queries. Firstly, the correspondents would like to know how many patients were terminated due the withdrawal of troglitazone from the market in March 2000 vs. those withdrawn for adverse outcomes. On page 1628, top paragraph, right column of the published article we note that "The principal reasons for patients not completing the study were early termination of the study by the Sponsor (range: 11.5% to 19.8%) and lack of compliance (range: 5.0% to 13.6%). The percentage of patients withdrawing from the study due to adverse events ranged from 4% to 7%, not different between treatment arms." Table 1 provides greater detail.

Drs. Landman and Jacobs also question whether an unwanted pregnancy should be considered an adverse outcome in this study. In fact, pregnancies were considered as adverse events, although they were reported separately in the Results section of our manuscript. We should note that the study inclusion and exclusion criteria stipulated that subjects must either have had a tubal ligation or use barrier contraceptive. In general, all studies performed in reproductive-aged women should be considered to carry the potential risk of unplanned (at least for the investigator) pregnancy. If the teratogenic risk of a drug is significant then investigators should include only patients with permanent forms of contraception (e.g., tubal ligation). However, since the FDA had classified troglitazone as pregnancy class B, we did not feel that this was a necessary exclusion.

Finally, the correspondents would like to know what the outcome of the pregnancies occurring in the study was. As noted in the report, 12 of the 17 pregnancies resulted in live births. Of these 10 were reported normal. One child whose mother received placebo was reported to have cerebral palsy, and another child whose mother received troglitazone 300 mg/d had normal cognitive function but mild growth retardation and was being followed for possible cerebral palsy. In all cases, the investigators did not feel that the pregnancies outcomes were related to the use of drug.

We appreciate the interest in this study and look forward to other investigations in this important and clinically challenging field.

Received June 21, 2001.

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