Cholesterol Drug Trials Cancelled
Higher Death Rate Cited in Clinical Trial; Drug Never on Market
WebMD News Archive
Dec. 4, 2006 -- The drug company Pfizer has suspended all clinical trials of
its experimental cholesterol drug, torcetrapib, due to possible heart
The drug has never been on the market. It was still being tested in phase
III trials, the last stage of clinical trial required for FDA review.
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
Barter says "the only reason the study was stopped early was due to the
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
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