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The FDA recently issued an approvable letter for muraglitazar (Pargluva), a peroxisome proliferator–activated receptor (PPAR) agonist with both PPAR-γ and PPAR-α effects, for the management of type 2 diabetes. PPAR-α agonists lower triglyceride levels and increase HDL levels, and PPAR-γ agonists increase insulin sensitivity. (An approvable letter from the FDA indicates that the agency is leaning toward approval but that the decision is not yet final.)
Prompted by concerns about potential harms from dual-PPAR agonists, researchers reviewed data from five clinical trials of muraglitazar that the FDA had published on its website. The subjects were 3725 adults with type 2 diabetes (age ≤70; body-mass index <41; hemoglobin A1c level, 7%–10%) who …