Withdrawal of sibutramine. Editorial is judgment in advance of the facts.
نویسنده
چکیده
editorial is judgment in advance of the facts Williams’s negative, even nihilistic, approach to obesity treatment and to sibutramine in particular is ill judged and inaccurate. His editorial seems to be based mainly on the limited data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT) released by the European Medicines Agency, and perhaps data not in the public domain. It would have been better to await full details of the trial findings before writing an editorial. To say that the trial has left a “mess of data that are impossible to interpret” is wrong. We, the Executive Steering Committee, delayed the final closure of the database expressly to ensure that the data collection is as robust as that of other cardiovascular trials. We are now analysing for publication unique data on the impact of therapeutic weight loss in obese people. The cardiovascular effects of sibutramine are complex: for most patients in SCOUT it reduced blood pressure during a six week active run-in, as well as increasing HDL cholesterol. SCOUT was not “an act of faith” but required by the European regulatory authorities when sibutramine received its product licence. To say that no other manufacturer signed up for such a long study is also not true: Sanofi-aventis did just this for rimonabant until its withdrawal (CRESCENDO trial). Williams is dismissive of small percentages of weight loss: the newly published SIGN guidelines, among others, contradict him. He seems twice to endorse the concept of a magic bullet for obesity, which few in the discipline subscribe to because of the well known complexities of neural defences against body weight loss. Most involved doctors hope for progressive advances in treatment strategies, perhaps akin to hypertension treatment. Sibutramine withdrawal needs to be considered carefully once all the data are formally published. Given the need for better obesity treatments, a more appropriate editorial would have been in order.
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عنوان ژورنال:
- BMJ
دوره 340 شماره
صفحات -
تاریخ انتشار 2010