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news.Archimedes has signed a research pact with the US Food and Drug Administration (FDA) for the development of a computer model of clinical trials evaluating weight loss medications.
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The model will be used to get a better understanding of the benefits of weight loss against the long-term risks of cardiovascular outcomes in patients treated with weight loss drugs.
The computer model will attempt to reproduce the results of the Sibutramine Cardiovascular Outcome Trial (SCOUT), which showed that patients receiving sibutramine were 16% more likely to suffer serious cardiac events than those who received a placebo.
The model is expected to provide insight into the relationship between patient outcomes and cardiovascular risk factors such as blood pressure, heart rate and cholesterol.
The model will then be used to explore outcomes over a 10-year simulated extension of the Scout trial.
Archimedes founder David Eddy said they are excited about the collaborative work they are conducting with the FDA to further understand the effects of weight loss medications in a population of ‘virtual’ patients.