Pfizer on Saturday announced it has ended clinical trials and development of its experimental cholesterol drug torcetrapib after an independent monitoring board said participants in a large trial who took the medication had an increased risk of death, the Washington Post reports (Stein, Washington Post, 12/4). Torcetrapib is a new type of anticholesterol treatment that Pfizer hoped would help replace its blockbuster statin Lipitor when that medication loses patent protection in 2010 or 2011 (Dow Jones, 12/3). The company has spent at least $800 million on developing the drug (Washington Post, 12/4). Late Friday, the independent safety board informed Pfizer researcher Steven Ryder, who was overseeing torcetrapib's development, that its regular monthly review of the drug found that there were 82 deaths among patients taking torcetrapib in a clinical trial, compared with 51 deaths among trial participants who did not take the treatment. Patients taking torcetrapib also were more likely to experience heart failure and other problems than other patients, the board said. Pfizer on Friday evening told its trial investigators to stop administering the drug, and the company on Saturday announced that it was ending torcetrapib development completely. The trial, which began in 2004 and was scheduled to end in 2009, involved about 15,000 participants who were at high risk for heart attack or stroke (Berenson, New York Times, 12/4). Half of the participants took a combination of torcetrapib and Lipitor, and half took Lipitor alone (Washington Post, 12/4). The safety board reviews trial data and submits a monthly torcetrapib progress review to Pfizer officials, who are not permitted to see the data in order to protect the integrity of the studies, the New York Times reports (Berenson, New York Times, 12/4). In October, Pfizer said it had found that a combination of torcetrapib and Lipitor significantly increased HDL, or "good," cholesterol and lowered LDL, or "bad," cholesterol compared with patients taking only Lipitor (Dow Jones, 12/3).
FDA on Sunday in a statement said that it supports Pfizer's decision to halt development and that it will work with Pfizer and other pharmaceutical companies developing drugs targeting HDL cholesterol to ensure that procedures are in place to quickly identify potential safety concerns (Agovino, AP/South Florida Sun-Sentinel, 12/3). Roche, Merck and other companies are developing HDL-raising drugs, some of which are similar to torcetrapib (Wall Street Journal, 12/4). Robert Meyer, director of FDA's office of drug evaluation, said, "If another drug raised HDL but didn't affect blood pressure, that might be suitable. The finding certainly raises concerns and would make everybody appropriately cautious, but it's not enough to say this class is at a dead end." Meyer added, "Research is research. If you knew the answer, you wouldn't be doing it" (Berenson, New York Times, 12/4). Analyst said FDA likely would now require longer outcome trials of three to five years for such drugs. Raymond James analyst Michael Krensavage said, "There's really a genuine interest by drug companies, the patients, the doctors and the medical community abut raising good cholesterol, so one way or another the drug companies will probably find a good way to do that. It just looks like torcetrapib isn't the one. But it isn't over in terms of good cholesterol" (Story/Saul, New York Times, 12/4).
NPR's "Morning Edition" on Monday reported on Pfizer's announcement (Amos, "Morning Edition," NPR, 12/4).
Audio of the segment is available online.
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Publication Date: 2006-12-06 02:00