Higher Death Rate Cited in Clinical Trial; Drug Never on Market
By Miranda Hitti
WebMD Health News
Latest MedicineNet News
Reviewed By Louise Chang, MD
on Monday, December 04, 2006
Torcetrapib was intended to raise HDL "good" cholesterol.
Pfizer's decision to halt clinical trials was due to an increased death rate in patients taking a combination of torcetrapib and Lipitor, compared to those taking Lipitor alone, in a clinical trial, according to the FDA.
"This new information was totally unexpected and disappointing, given the potential benefits of this drug," says Philip Barter, MD, PhD, in a Pfizer news release dated Dec. 2.
Barter directs the Heart Research Institute in Australia and chairs the steering committee overseeing the clinical trial upon which Pfizer's decision was based.
Barter says "the only reason the study was stopped early was due to the torcetrapib data."
The steering committee "wants to reassure physicians and patients that nothing in today's information has any impact on the safety or efficacy of Lipitor whatsoever," he says.
The FDA supports Pfizer's decision, the administration says in a news release.
FDA says it will work with Pfizer and other companies developing drugs in the class that includes torcetrapib to "ensure that appropriate protections are in place to identify any safety signals as early in the development process as possible."
SOURCES: News release, Pfizer. News release, FDA.
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