Everyone remembers rosiglitazone (Avandia, GlaxoSmithKline), a diabetes drug finally withdrawn in Europe and severely restricted in the United States in 2010 after it emerged that it could increase the risk for heart attack and cardiovascular death.
Debate about rosiglitazone had rumbled on for years, and prior to its demise, the US Food and Drug Administration (FDA) had already decreed in 2008 that, going forward, new type 2 diabetes drugs should be subject to more stringent clinical trials, to rule out cardiovascular toxicity rather than being approved on the basis of studies that simply showed than an agent lowered blood sugar. Last year, the European Medicines Agency (EMA) followed suit.
Given that cardiovascular disease (CVD) is the biggest cause of morbidity and mortality among those with diabetes, most diabetologists seem to agree that this decision is a "no brainer." But some had concerns that these regulatory requirements might have drawbacks. These included curtailment of drug development — deterring all but the biggest pharmaceutical companies from investing in diabetes programs — increasing cost of medicines to patients and the concern that focusing overly on cardiovascular risk might detract from other outcomes of interest in patients with diabetes.
Last month, at the Excellence in Diabetes meeting in Istanbul, doctors discussed what has happened in the 5 years since the FDA introduced this new requirement, and what they think the impact has been on diabetes drug development. Medscape Medical News also polled other key opinion leaders to see how they think this whole issue is panning out.
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Cite this: Lisa Nainggolan. Heart-Smart Diabetes Drugs: Pipe Dream or Possibility? - Medscape - Mar 27, 2013.
