Effect of rimonabant on progression of atherosclerosis in patients with abdominal obesity and coronary artery disease - The STRADIVARIUS randomized controlled trial
| Autor: | 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, for the STRADIVARIUS Investigators |
|---|---|
| Přispěvatelé: | ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine |
| Jazyk: | angličtina |
| Rok vydání: | 2008 |
| Předmět: |
Male
medicine.medical_specialty Diet Reducing METIS-254324 Context (language use) Coronary Artery Disease Placebo Gastroenterology Coronary artery disease chemistry.chemical_compound Double-Blind Method Piperidines Receptor Cannabinoid CB1 Rimonabant Weight loss Internal medicine medicine Humans Obesity Prospective Studies Ultrasonography Interventional Abdominal obesity Aged Metabolic Syndrome business.industry General Medicine Middle Aged Atherosclerosis medicine.disease Coronary Vessels Surgery chemistry Disease Progression Pyrazoles Female Glycated hemoglobin medicine.symptom Metabolic syndrome business medicine.drug |
| Zdroj: | JAMA, 299(13), 1547-1560. American Medical Association JAMA-Journal of the American Medical Association, 299(13), 1547-1560. American Medical Association |
| ISSN: | 0098-7484 |
| Popis: | Context Abdominal obesity is associated with metabolic abnormalities and increased risk of atherosclerotic cardiovascular disease. However, no obesity management strategy has demonstrated the ability to slow progression of coronary disease. Objective To determine whether weight loss and metabolic effects of the selective cannabinoid type 1 receptor antagonist rimonabant reduces progression of coronary disease in patients with abdominal obesity and the metabolic syndrome. Design, Setting, and Patients Randomized, double- blinded, placebo- controlled, 2- group, parallel- group trial ( enrollment December 2004- December 2005) comparing rimonabant with placebo in 839 patients at 112 centers in North America, Europe, and Australia. Interventions Patients received dietary counseling, were randomized to receive rimonabant ( 20 mg daily) or matching placebo, and underwent coronary intravascular ultrasonography at baseline ( n= 839) and study completion ( n= 676). Main Outcome Measures The primary efficacy parameter was change in percent atheroma volume ( PAV); the secondary efficacy parameter was change in normalized total atheroma volume ( TAV). Results In the rimonabant vs placebo groups, PAV ( 95% confidence interval [ CI]) increased 0.25% (- 0.04% to 0.54%) vs 0.51% ( 0.22% to 0.80%) ( P=. 22), respectively, and TAV decreased 2.2 mm(3) (- 4.09 to - 0.24) vs an increase of 0.88 mm(3) (- 1.03 to 2.79) ( P=. 03). In the rimonabant vs placebo groups, imputingresultsbasedonbaselinecharacteristics for patients not completing the trial, PAV increased 0.25% (- 0.04% to 0.55%) vs 0.57% ( 0.29% to 0.84%) ( P=. 13), and TAV decreased 1.95 mm(3) (- 3.8 to - 0.10) vs an increase of 1.19 mm(3) (- 0.73 to 3.12) ( P=. 02). Rimonabant- treated patients had a larger reduction in body weight ( 4.3 kg [- 5.1 to - 3.5] vs 0.5 kg [- 1.3 to 0.3]) and greater decrease in waist circumference ( 4.5 cm [- 5.4 to - 3.7] vs 1.0 cm [- 1.9 to - 0.2]) ( P |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|