Journal
DIABETES OBESITY & METABOLISM
Volume 14, Issue 6, Pages 523-530Publisher
WILEY
DOI: 10.1111/j.1463-1326.2011.01554.x
Keywords
cardiovascular outcomes; sibutramine; weight loss
Categories
Funding
- Abbott Laboratories, Abbott Park, IL, USA
- Abbott Laboratories
- Wiley-Blackwell
- Sanofi-Aventis
- Pfizer (Australia)
- Weight Watchers(R)
- Allergan
- Korean Ministry of Agriculture
- Abbott
- British Pharmaceutical Society
- GlaxoSmithKline
- Ache Laboratorios Farmaceuticos SA
- Roche
- Novo Nordisk
- Eli Lilly
- Astra Zeneca
- Merck
- Covidian
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Aim: The Sibutramine Cardiovascular OUTcomes trial showed that sibutramine produced greater mean weight loss than placebo but increased cardiovascular morbidity but not mortality. The relationship between 12-month weight loss and subsequent cardiovascular outcomes is explored. Methods: Overweight/ obese subjects (N = 10 744), = 55 years with cardiovascular disease and/ or type 2 diabetes mellitus, received sibutramine plus weight management during a 6-week Lead-in Period before randomization to continue sibutramine (N = 4906) or to receive placebo (N = 4898). The primary endpoint was the time from randomization to first occurrence of a primary outcome event (non-fatal myocardial infarction, non-fatal stroke, resuscitated cardiac arrest or cardiovascular death). Results: For the total population, mean weight change during Lead-in Period (sibutramine) was -2.54 kg. Post-randomization, mean total weight change to Month 12 was -4.18 kg (sibutramine) or -1.87 kg (placebo). Degree of weight loss during Lead-in Period or through Month 12 was associated with a progressive reduction in risk for the total population in primary outcome events and cardiovascular mortality over the 5-year assessment. Although more events occurred in the randomized sibutramine group, on an average, a modest weight loss of approximately 3 kg achieved in the Lead-in Period appeared to offset this increased event rate. Moderate weight loss (3-10 kg) reduced cardiovascular deaths in those with severe, moderate or mild cardiovascular disease. Conclusions: Modest weight loss over short-term (6 weeks) and longer-term (6-12 months) periods is associated with reduction in subsequent cardiovascular mortality for the following 4-5 years even in those with pre-existing cardiovascular disease. While the sibutramine group experienced more primary outcome events than the placebo group, greater weight loss reduced overall risk of these occurring in both groups.
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