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To the Editor: In the STRADIVARIUS trial, Dr Nissen and colleagues¹ studied the effect of rimonabant on progression of atherosclerosis in patients with abdominal obesity and coronary artery disease. We would like to raise a number of issues about this trial.

From an ethical perspective, new treatments should be tested when possible against an established treatment with proven benefits, rather than against placebo. Medications other than rimonabant have been shown to be superior to placebo for weight reduction in obese patients,^2-3 but in the STRADIVARIUS trial the interventions studied were either rimonabant (20 mg daily) or placebo.

The primary end point used was percent atheroma volume (PAV), determined using intravascular ultrasound. Decrease in body weight is associated with favorable changes in the metabolic profile, which may reduce progression of atherosclerotic disease. The strategy of using a primary end point of PAV rather than weight reduction in this study seems to . . . [Full Text of this Article]

José Miguel Dora, MD
jmdora@gmail.com

Rafael Selbach Scheffel, MD
Endocrine Division
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil

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RELATED ARTICLE

Effect of Rimonabant on Progression of Atherosclerosis in Patients With Abdominal Obesity and Coronary Artery Disease: The STRADIVARIUS Randomized Controlled Trial
Steven E. Nissen, Stephen J. Nicholls, Kathy Wolski, Josep Rodés-Cabau, Christopher P. Cannon, John E. Deanfield, Jean-Pierre Després, John J. P. Kastelein, Steven R. Steinhubl, Samir Kapadia, Muhammad Yasin, Witold Ruzyllo, Christophe Gaudin, Bernard Job, Bo Hu, Deepak L. Bhatt, A. Michael Lincoff, E. Murat Tuzcu, and for the STRADIVARIUS Investigators
JAMA. 2008;299(13):1547-1560.
ABSTRACT | FULL TEXT  

RELATED LETTER

Rimonabant and Progression of Atherosclerosis in Obese Persons—Reply
Steven E. Nissen, Stephen J. Nicholls, and Kathy Wolski
JAMA. 2008;300(3):280-281.
EXTRACT | FULL TEXT