Thanks to the internet & trading stocks online, I was able to
get off Vioxx a good six months or more before Merck came
clean about folks using Vioxx dropping dead with heart
attacks. My doctor switched me to Celebrex.
OOF!
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Celebrex Tied to Heart Problems in Cancer Trial
By Amanda Gardner
HealthDay Reporter
FRIDAY, Dec. 17 (HealthDayNews) -- Pfizer Inc. said Friday that a study of its popular pain drug Celebrex in cancer patients had found an apparent increased risk of heart attack and other cardiovascular problems.
But a second, separate cancer trial, however, found no increased risk of heart problems tied to the drug.
The studies, conducted by the National Cancer Institute (news - web sites), uncovered the cardiovascular problems in patients enrolled in the so-called Adenoma Prevention with Celecoxib -- the generic name for Celebrex -- (APC) trial. No problems were found in patients taking part in the Prevention of Spontaneous Adenomatopus Polyps (PreSAP) trial.
In a statement released Friday morning, Pfizer said it was reviewing the data and warned against jumping to conclusions about the use of Celebrex for all types of patients. For instance, those patients enrolled in the two cancer trials were taking twice the dose recommended for people struggling with pain due to osteoarthritis, the company said.
"In placing this new information in context, it is important to understand that the APC trial results differ from both the PreSAP cardiovascular results as well as the large body of data that we and others have accumulated over time, in which an increased risk of serious cardiovascular events in arthritis patients, even at higher-than-recommended doses, had not been seen," said Dr. Joseph Feczko, president of worldwide development for Pfizer.
"These clinical trial results are new," added Hank McKinnell, Pfizer's chairman and chief executive officer. "The cardiovascular findings in one of the studies (APC) are unexpected and not consistent with the reported findings in the second study (PreSAP). Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world."
Celebrex is a COX-2 inhibitor, a cousin of the drug Vioxx, which was pulled form the market by its parent company Merck in September because of increased cardiovascular risks found in patients who were taking it for more than 18 months for pain.
Celebrex is approved in the United States for the treatment of arthritis and pain at recommended doses of 100 to 400 milligrams per day. It is also approved for a rare genetic condition known as familial adenomatous polyposis at doses up to 800 mg. per day. The two cancer trials both used doses above the levels recommended for arthritis and pain: 400 to 800 mg. in the APC trial, and 400 mg. per day in the PreSAP trial.
Patients in the APC trial taking 400 to 800 mg. of Celebrex daily had about a 2.5 higher risk of experiencing major fatal or non-fatal cardiovascular events, compared to those patients taking a placebo, the company said.
The two studies together have enrolled about 3,600 participants, some of whom have been involved in the research for more than four years. Pfizer estimated that about 2,400 participants evaluated in the cardiovascular analysis had completed two years of treatment.
The Data Safety and Monitoring Boards of both trials had conducted a preliminary review of data in September and October and decided to continue with the trials. The safety review boards then convened a panel of cardiovascular experts to conduct additional analysis. Pfizer received preliminary information from those reviews Thursday night. The full analyses have not yet been presented to the company.
A third long-term study is under way to look at Celebrex in patients at high risk for Alzheimer's disease (news - web sites). This study has about 2,000 patients, 750 of whom are on 400 mg. of Celebrex daily. A review by a board of independent safety experts on Dec. 10 did not result in any recommendations to change the study.
Ever since the recall of Vioxx, health experts have been wondering whether the heart problems were unique to that drug or all Cox-2 inhibitors. The new details about Celebrex make it look more like the latter, said Dr. Richard Hayes, a cardiologist and assistant professor of medicine at New York University School of Medicine.
"It sounds like a class-wide effect," he said.
Pfizer said it will continue working with the U.S. Food and Drug Administration (news - web sites) on the company's plans to conduct a clinical trial to further assess Celebrex in individuals with osteoarthritis who are at high risk for cardiovascular disease.
In the meantime, Pfizer urged that all patients "being treated with Celebrex should discuss appropriate treatment options with their health-care professionals."
Other experts, however, are more cautious. "Potentially these medicines can raise blood pressure and cause kidney problems. It's going to be a tough call," Hayes said. It's unfortunate, he added, because COX-2 inhibitors are safer in terms of gastrointestinal effects.
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