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January 23/30, 2002

Measuring the Effect of Sibutramine for Weight Loss

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthor


Copyright 2002 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2002

JAMA. 2002;287(4):449-450. doi:10.1001/jama.287.4.447

To the Editor: Dr Wirth and Ms Krause1 reported that sibutramine resulted in similar amounts of weight loss among obese patients whether given as an intermittent therapy (IT) or as continuous therapy (CT), compared with placebo. We have 4 concerns with the study and its conclusions.

First, the authors make statistical comparisons starting at 4 weeks in all 3 groups. Although both the IT and CT groups had had a 4-week run-in, there was no difference in treatment between the IT and CT groups until week 12. In effect, the IT group had a 12-week run-in. This makes comparison using 4-week values as a starting point invalid. Either there should not have been a sibutramine run-in period at all, given that only 23 of 1102 patients were excluded due to being nonresponders during this period, or the placebo group should have stayed on sibutramine for 12 weeks as well to ensure an equivalent baseline for all 3 groups. Alternatively, the authors could have included a washout period for all groups after having had identified nonresponders with a trial of sibutramine. The importance of this is most evident in Figure 2A of the article by Wirth and Krause, which shows weight trends of men during the study. Using week 12 as the true starting point for comparison, there was apparently a significant weight gain in the IT group.

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