The FDA has tapped Archimedes to build a computer model of clinical trials evaluating weight-loss medications. The agency will use the model to contrast the benefits of weight loss against cardiovascular outcomes (blood pressure, heart rate and cholesterol).
To build the model, Archimedes will use records from the Sibutramine Cardiovascular Outcome Trial (SCOUT). The trial compared Abbott Labs' Meridia with placebo and found increased risk of CV problems among its 10,000 subjects. SCOUT results led to Abbott's voluntary withdrawal of the drug from the U.S. and European markets.
Abbott noted last September that the trial didn't directly assess the risk/benefit profile of the medication in its target population--those having no history of cardiovascular disease--and that SCOUT results can't be "readily extrapolated to that population," according to a statement.
- see the Archimedes release
- here's Abbott's September statement