No Evidence of Cardiovascular Safety Signal for Pfizer's Celebrex in Long-Term Clinical Trials of More Than 6,000 Patien

10/11/04 - PRNewswire

No Evidence of Cardiovascular Safety Signal for Pfizer's Celebrex in Long-Term Clinical Trials of More Than 6,000 Patients PRNewswire NEW YORK October 1

NEW YORK, October 1 /PRNewswire/ --

- 'Data demonstrate that Celebrex does not increase the risk of heart attack or stroke in patients with arthritis and pain, even at higher-than-recommended doses'

Pfizer Inc said today that three large long-term Celebrex (celecoxib capsules) studies involving more than 6,000 patients have not shown any significant safety issues and are expected to continue to completion.

The ongoing studies, which are assessing Celebrex as a potential preventative treatment in both Alzheimer's disease and colorectal cancer, have been under way at multiple medical centers worldwide for several years. The studies are being conducted by the National Cancer Institute, the National Institutes of Health and Pfizer.

The evidence distinguishing the cardiovascular safety of Celebrex has accumulated over years in multiple completed studies, none of which has shown any increased cardiovascular risk for Celebrex, the world's most prescribed arthritis and pain relief brand.

"Each Cox-2 inhibitor has a distinct chemical structure and we would not expect them to have the same side effect profile," said Dr. Joe Feczko, Pfizer's president of worldwide development. "The data we've accumulated over time demonstrate that Celebrex does not increase the risk of serious cardiovascular events in patients with arthritis and pain, even at higher-than-recommended doses."

Two of the large placebo-controlled studies under way -- one sponsored by the National Cancer Institute and the other by Pfizer -- are designed to determine whether Celebrex reduces the recurrence of pre-cancerous polyps in patients who have previously had polyps removed. Both studies, which are following patients over a five-year period, have enrolled roughly 4,000 patients, some who have participated for more than four years.

A third placebo-controlled study examining Celebrex's potential to prevent or slow the progression of Alzheimer's disease, is sponsored by the National Institutes of Health and has enrolled about 2,400 patients to date over the past three years.

"It is important to note that Alzheimer's patients are typically elderly and therefore at higher risk for cardiovascular events," said Dr. John Breitner of the Seattle VA and the University of Washington and Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) study chair. "To date we have seen no evidence that there is any increased cardiovascular safety risk among study patients."

All three studies are monitored by independent safety experts who meet regularly to assess adverse events. To date no significant safety concerns have been raised that could potentially put patients at risk.

The cardiovascular safety of Celebrex is well documented. Key study data include:

-- A long-term prospective outcomes study showing that Celebrex -- at two to four times the approved doses for arthritis and pain -- was not associated with an increased risk for serious cardiovascular events compared to non-specific non-steroidal anti-inflammatory (NSAID) medicines. -- A retrospective study of more than 54,000 elderly patients published in the journal Circulation showed that Celebrex was not associated with an increased risk for heart attack compared to other medications studied. -- In a recent FDA-sponsored study of 1.4 million patients, those who received Celebrex demonstrated no increased risk of cardiac events. Further, patients who took Celebrex were significantly less likely to have cardiovascular events -- including heart attacks and sudden death -- compared to those who took Vioxx (greater than 25 mg).

"In addition to its established cardiovascular safety, Celebrex provides necessary pain relief to millions of patients each day with a low risk of gastrointestinal bleeding compared to traditional anti-inflammatory pain relievers," Dr. Feczko said.

Celebrex was the first Cox-2 introduced in 1998. Since then, data show that the rate of hospitalizations from adverse gastrointestinal events associated with long-term NSAID use has declined markedly.

Celebrex was preferred by patients over acetaminophen/paracetamol (Tylenol), the most widely used pain medication worldwide, according to recent osteoarthritis studies. In a separate study, Celebrex has shown efficacy comparable to an opioid combination in patients experiencing post-surgical pain.

In arthritis, Celebrex has demonstrated proven efficacy compared to the NSAID medicines ibuprofen and naproxen in treating osteoarthritis a chronic and debilitating condition that affects more than 70 million Americans.Following Thursday's announcement of Merck & Co.'s worldwide withdrawal of its COX-2 medicine Vioxx, Pfizer has begun communicating with business partners including wholesalers, pharmacy chains, pharmacy benefit managers and other managed care organizations to assure them of the availability of Celebrex to meet potential patient need.

Information for Celebrex patients and physicians is available at http://www.celebrex.com. Patients who have questions can call our toll-free consumer information center at +1-888-678-2692.

Additional Information

Celebrex should not be taken by patients who have aspirin-sensitive asthma, or allergic reactions to aspirin or other arthritis medicines or certain sulfa drugs called sulfonamides, or who are in their third trimester of pregnancy. As with all NSAIDs, serious gastrointestinal tract ulcerations can occur without warning symptoms. Physicians and patients should remain alert to the signs and symptoms of GI bleeding. Celebrex does not affect platelet function and therefore should not be used for cardiovascular prophylaxis. As with all NSAIDs, Celebrex should be used with caution in patients with fluid retention, hypertension, or heart failure. In overall clinical studies the most common side effects of Celebrex were dyspepsia, diarrhea and abdominal pain, which were generally mild to moderate.

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