Stephen J.LurieMD, PhD, Senior EditorIndividualAuthor
Copyright 2002 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.2002
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.
Wirth A. Measuring the Effect of Sibutramine for Weight Loss—Reply. JAMA. 2002;287(4):449-450. doi:10.1001/jama.287.4.447