Meridia sibutramine: Phase III data

The double-blind, U.S. Phase III SCOUT trial in 10,744 overweight or obese patients >=55 years old with pre-existing cardiovascular disease and/or Type II diabetes showed that Meridia led to a significantly higher rate of primary outcome events, which included non-fatal MI, non-fatal stroke, resuscitation after cardiac arrest or CV death vs. placebo after a mean treatment duration of 3.4 years (11.4% vs. 10%, p=0.02). Furthermore, rates of non-fatal MI (4.1% vs. 3.2%, p=0.02) and non-fatal stroke (2.6% vs. 1.9%, p=0.03) were significantly higher in Meridia-treated patients vs. placebo. There was no significant difference in the rates of CV death (p=0.9) or death from any cause (p=0.54) between treatment groups. Rates of serious adverse events were 42.1% for Meridia and 40.5% for placebo, and the most common adverse event in both groups was MI. Data were published in the New England Journal of Medicine. ...