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New diabetes drug may raise death risk

作者:宦杠    发布时间:2019-03-02 09:04:05    

By Shaoni Bhattacharya A new diabetes medication, currently awaiting the US Food and Drug Administration’s approval, appears to raise the risk of death in patients, a new study suggests. The research, by Steven Nissen and colleagues at the Cleveland Clinic Foundation in Ohio, US, suggests that the new type of diabetes drug called muraglitazar doubles the risk of major cardiovascular events such as heart attack and stroke, and of death. The analysis draws on data from five clinical trials submitted to the FDA in briefing documents prior to its advisory committee meeting on 9 September 2005, and was publicly available through the FDA website. The advisory committee recommended that muraglitazar (trade-name Pargluva) be approved for use on its own, and combined with another drug called metformin. It showed beneficial effects on certain blood lipid levels and in lowering the level of blood glucose. But Nissen’s study of the publicly available data suggests that the new drug may also increase the likelihood of death, heart attack or stroke in diabetes patients by 2.2 times compared with patients given placebo or another drug called pioglitazone. “The FDA has requested additional safety information from ongoing trials or those completed since the safety data from the last formal regulatory submission to address more fully the cardiovascular safety profile of Pargluva,” said manufacturers Bristol-Myers Squibb and Merck in a joint statement on 18 October. “The companies are eager to begin discussion with the FDA to address this issue and to determine what additional information may be necessary.” The study and an accompanying editorial were released early by the Journal of the American Medical Association on Thursday because of “their timeliness and potential importance for public health”. Muraglitazar belongs to a class of drugs called PPARs (peroxisome proliferators-activated receptors) that alter blood lipid and glucose levels in patients with diabetes. But it is the first “dual PPAR” to reach the FDA which combines two families of PPARs – alpha and gamma. Nissen and colleagues found that death, heart attack or stroke occurred in 35 of the 2374 (1.47%) of patients given muraglitazar. This compared with nine of 1351 (0.67%) of patients either on placebo or the established PPAR drug pioglitazone. They say the risk associated with muraglitazar is substantial, “indicating a doubling of irrevocable, major endpoints”. They note that these adverse effects occurred with relatively short-term treatments of between 24 to 104 weeks. A treatment for diabetes is likely to be taken on an ongoing basis. They also point out that patients enrolled in clinical trials are usually younger and healthier than the target population for the condition – “the real world exposure would likely amplify the risk”. The researchers warn that the drug “would constitute an unacceptable patient hazard” if approved by the FDA. They urge that a dedicated trial is first needed to assess the cardiovascular effects of muraglitazar. However, they admit their study has limitations as they did not have access to the original trial databases. James Brophy, at McGill University in Montreal, Canada, highlights that higher cancer rates have been a concern in animal studies involving other PPARs. “Although muraglitazar may yet prove to be a valuable addition to the clinical armamentarium, the meticulous examination of the current evidence by Nissen and colleagues should focus serious attention on the potential cardiovascular risks of this drug,” he writes in the editorial accompanying the paper. Journal reference: Journal of the American Medical Association (DOI:

 

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