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January 23/30, 2002

Measuring the Effect of Sibutramine for Weight Loss—Reply

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthor

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

In Reply: Drs Ransom and Ur doubt the suitability of data from week 4 (after a 4-week run-in period) as a valid baseline. Extending the run-in period for placebo to 12 weeks just to obtain a comparable baseline situation at that time point would not be sensible, as the aim of the study was not to demonstrate the efficacy of sibutramine in comparison to placebo (which has been demonstrated in a number of earlier studies). Instead, we were interested in the effect of possible interruptions in the therapy, which are quite common during long-term treatment. The study design suggested by Ransom and Ur would be appropriate for a weight-maintenance trial, which has been addressed elsewhere. Nevertheless, taking week 12 as baseline did not result in statistically significant or clinically relevant differences between IT and CT, either for men or for women.