Similarly, for the CV deaths, the rates were 3/1,000 patient-years for placebo, compared with 2.6/1,000 with muraglitazar. “By taking into account the difference in patient exposure, the apparent imbalance in cardiovascular death is reversed,” Dr. Belder said.
But that analysis was challenged by James M. Brophy, M.D. in an editorial accompanying the Dr. Nissen's report. He pointed out that the company's analysis included 495 patients who had received subtherapeutic doses of 2.5 mg or less in whom there were no CV events, thereby diluting the risk estimate. When the rates were recalculated to include only those patients receiving the proposed marketed doses of 2.5 or 5 mg, the muraglitazar group shows a 20% increase in events, compared with placebo, and a 67% increase, compared with the combined pioglitazone/placebo control group, said Dr. Brophy, of McGill University, Montreal, who also listed several other flaws in the analysis.