The FDA was notified on Dec. 2 that Pfizer will suspend a large, Phase 3 trial evaluating the investigational cardiovascular therapy torceptrapib/atorvastatin (T/A) due to an increased rate of mortality (death) in patients receiving the combination compared to those receiving atorvastatin alone. The agency says it fully supports Pfizer’s decision.
With the T/A development program, as it does with all such development programs, the FDA assured that Pfizer had the appropriate protections in place for patients participating in the drug’s development, including informed consent, a Data Safety Monitoring Board (DSMB) for its outcome study, and that the development program was done in a careful, stepwise manner.
For this trial, the DSMB was conducting a monthly analysis of mortality data and a quarterly analysis of a number of outcomes including stroke, heart attack, and revascularizations (e.g., coronary stents or bypass surgery) to ensure the ongoing safety of patients in this trial. This independent board notified Pfizer of the mortality finding early the morning of December 2, 2006 and FDA was notified at 4:00 PM EST that evening that Pfizer planned to halt this trial and the development program overall.