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New Diabetes Drug Discontinued Due to Safety Concerns

According to a recent report, Roche, a Swiss pharmaceutical company, announced that it is abandoning development of a diabetes drug known as aleglitazar. The announcement came after a safety monitoring committee recommended stopping a late-stage clinical trial of the drug due to “safety signals and lack of efficacy.” Roche ultimately decided to halt the study and all others involving aleglitazar, a move that could spur new safety concerns about the entire category of drugs.

Aleglitazar, a dual PPAR agonist, works by activating two receptors in the body, known as PPAR alpha and PPAR gamma. By activating both of these receptors equally, Roche hoped the drug would improve both blood lipids and blood sugar, and thereby lower the additional cardiovascular risks that diabetics face. For this reason, the aleglitazar trial not only tested the drug for its capacity to lower blood sugar, but also assessed whether the drug could prevent the risk of heart attack and stroke in individuals with Type 2 diabetes. However, the trial indicated that aleglitazar use was associated with an increase in fractures, kidney problems, and heart failure.

The failure of aleglitazar could conceivably factor into the FDA’s deliberations regarding Avandia ®, which has a somewhat similar mechanism of action. Avandia’s ® use was severely restricted in the United States and banned in Europe entirely in 2010 due to concerns that the drug increased the risk of heart attack and stroke. However, an FDA Advisory Committee recommended in June that the restrictions should be eased. The agency as a whole has yet to make a decision.


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