To the Editor: The study of muraglitazar and adverse events by Dr Nissen and colleagues1 points out why physicians need hard outcomes data obtained in a blinded fashion before prescribing a new therapy for patients. The study, however, raises broader concerns beyond muraglitazar. Mortality data are needed prior to US Food and Drug Administration (FDA) approval for peroxisome proliferator–activated receptor (PPAR) agonists, and current practices that use combined therapy for patients with diabetes who have lipid abnormalities need to be examined.
There is a relative paucity of mortality data for fibric acid derivatives compared with data on statins. One of the 3 large studies examining the use of gemfibrozil in the secondary prevention of cardiovascular disease showed a nonstatistically significant 7% increase in total mortality.2 Another study showed a nonsignificant benefit for gemfibrozil, with a 10% reduction in total mortality.3 Bezafibrate was reported to have a nonsignificant 6% higher mortality.4 These studies were not designed as mortality trials, but there are no published data demonstrating convincing mortality benefit with the use of fibric acid derivatives.
Diabetic dyslipidemia typically refers to patients with a high triglyceride–low high-density lipoprotein (HDL) profile,5 who are the patients most suitable for PPAR-α agents. These patients may receive PPAR-α and PPAR-γ agents as 2 different pills, and the interaction of these was not previously known.
The fibric acid studies were all conducted in different patient populations, and it is not clear how many patients in each group were also taking PPAR-γ agents. However, with limited data supporting a mortality benefit for fibric acids alone, and the apparent increase in mortality seen with muraglitazar, caution should be used in prescribing any fibric acid along with any PPAR-γ agent because this combination may have the same propensity to increased mortality.
Financial Disclosures: None reported.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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