Abstract |
Uncertainties about the cardiovascular safety of sibutramine led to the SCOUT trial that is investigating sibutramine plus weight management in high-risk, overweight/obese patients. A 6-week lead-in period during which all patients received sibutramine permitted an initial assessment of tolerability. A total of 10,742 patients received sibutramine and 3.1% of these discontinued due to an adverse event; issues affecting more than 10 patients were drug intolerance, headache, insomnia, nausea, dry mouth, and constipation-, tachycardia-, and hypertension-related events. Serious adverse events, most commonly associated with the System Organ Class, Cardiac disorders, were reported by 2.7% of patients; however, the majority was not considered sibutramine-related. Adverse events relating to high blood pressure and/or pulse rate, whether reported as adverse events leading to discontinuation, or serious adverse events were reported by less than 0.2% of patients. No serious or individual events leading to discontinuation occurred in more than 25 patients. There were 15 (0.1%) deaths; 10 were attributed to a cardiovascular cause. Discontinuations for adverse events were lower than anticipated. Serious adverse events generally reflected sibutramine's known pharmacology or were related to cardiac disorders already present in this high-risk population. When compared with epidemiological data, overall mortality rate was low and sibutramine was well tolerated in this mainly off-label population. No new safety issues were detected.
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Authors | Aldo P Maggioni, Ian Caterson, Walmir Coutinho, Nick Finer, Luc Van Gaal, Arya M Sharma, Christian Torp-Pedersen, Peter Bacher, Gillian Shepherd, Rui Sun, Philip James, SCOUT Investigators |
Journal | Journal of cardiovascular pharmacology
(J Cardiovasc Pharmacol)
Vol. 52
Issue 5
Pg. 393-402
(Nov 2008)
ISSN: 1533-4023 [Electronic] United States |
PMID | 19033818
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Appetite Depressants
- Cyclobutanes
- sibutramine
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Topics |
- Appetite Depressants
(administration & dosage, adverse effects, therapeutic use)
- Blood Pressure
(drug effects)
- Body Mass Index
- Cardiovascular Diseases
(complications, diagnosis, physiopathology)
- Cyclobutanes
(administration & dosage, adverse effects, therapeutic use)
- Diabetes Mellitus, Type 2
(complications, physiopathology)
- Drug Administration Schedule
- Female
- Humans
- Male
- Middle Aged
- Obesity
(complications, drug therapy, physiopathology)
- Single-Blind Method
- Treatment Outcome
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