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Pfizer Will Sponsor Major Celecoxib Clinical Trial
This study is part of a larger CV exploration program with Celebrex that started over 18 months ago. This newly announced clinical trial, which will be conducted at major universities and hospitals around the world, is expected to start early in 2005. Due to recent questions raised about the cardiovascular safety of the COX-2 specific inhibitors, Pfizer will be discussing the study design with the FDA and other regulatory agencies prior to finalizing its details and start date.
"Our strong confidence in the CV safety of Celebrex is based on the substantial body of experience that has accumulated over several years in multiple completed studies and ongoing trials,” said Dr. Joseph Feczko, MD, president of worldwide development at Pfizer . “In fact, small mechanistic studies suggest that Celebrex’s anti-inflammatory properties as well as additional unique Celebrex-specific characteristics may improve vascular function in patients with established coronary artery disease. That is why we feel it is important at this time to announce our plans to conduct the first large-scale clinical study involving the use of a COX-2 specific inhibitor to look at inflammation and CV events in osteoarthritis patients at high risk for cardiovascular disease.”
The study will enroll more than 4,000 patients around the world who have had a recent heart attack and who also have a history of osteoarthritis. The study will assess the effects of Celebrex on inflammation and cardiovascular (CV) events. The multi-center, randomized, placebo-controlled study will be conducted over a period of at least two years and will include rigorous monitoring of cardiovascular safety by an independent data safety monitoring committee.
Inflammation occurs in blood vessels as a response to injury or infection, and causes atherosclerotic plaques to become more prone to rupture, with devastating consequences. Epidemiology and clinical studies have demonstrated the relationship between markers of inflammation such as C-reactive protein (CRP) and risk of future cardiovascular events.
The COX-2 specific inhibitors were designed to relieve pain and reduce the serious gastrointestinal side effects associated with the older and over the counter non-steroidal anti-inflammatory medicines. Based on the results of Pfizer ’s extensive clinical program, Celebrex has demonstrated a favorable gastrointestinal safety profile when compared to this older class of pain relievers. Celebrex has a strong long-term safety profile and broad indication base including osteoarthritis, rheumatoid arthritis and acute pain, backed up by observational data and ongoing trials.
Pfizer remains confident in the long-term cardiovascular safety of Celebrex. The CV safety profile of Celebrex is supported by extensive clinical and widespread post-marketing experience. More than 27 million patients in the US have been prescribed Celebrex, which was approved by the U.S. Food and Drug Administration in 1998—even more patients have used Celebrex in over 60 countries worldwide. Patients treated in clinical studies of up to 4 years show no increased CV safety concerns.
Add9tional Information on Celebrex
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 should not take Celebrex. 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.