A 60-year-old man with type 2 diabetes and a history of myocardial infarction is being considered for a thiazolidinedione. Rosiglitazone was restricted by the FDA in 2010 due to cardiovascular safety concerns. Which finding from the RECORD trial ultimately led to the lifting of these restrictions?
- A Rosiglitazone showed no increase in myocardial infarction or cardiovascular death compared to metformin plus sulfonylurea ✓
- B Rosiglitazone reduced non-fatal heart failure hospitalizations
- C Rosiglitazone demonstrated a mortality benefit in patients with prior stroke
- D Rosiglitazone was shown to reduce progression of diabetic retinopathy
Correct answer: A. Rosiglitazone showed no increase in myocardial infarction or cardiovascular death compared to metformin plus sulfonylurea
Explanation
The RECORD trial, reviewed by the FDA in 2013, found no statistically significant increase in myocardial infarction or cardiovascular death with rosiglitazone compared to active comparators, leading to removal of the restricted access program. The earlier 2007 Nissen meta-analysis had suggested increased MI risk, which triggered the initial restrictions.
Reference: Goodman and Gilman's The Pharmacological Basis of Therapeutics, 14th ed.
High-yield for: NEET PGINI-CETNExTFMGEUSMLEPLABMRCP
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