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| |  APS: Celebrex Provides Relief From Post-Operative Pain FORT LAUDERDALE, FL. -- October 25, 1999 -- According to the pooled results of two new double-blind, placebo-controlled investigational studies presented at the annual meeting of the American Pain Society, the arthritis medication Celebrex™ (celecoxib capsules) was shown to be as effective as a commonly used narcotic agent for controlling post-surgical pain. Patients taking Celebrex (on average, 400 mg daily, allowable 600 mg daily) for two to five days after outpatient orthopedic surgery reported experiencing less intense pain than patients taking a commonly used dose of the narcotic combination hydrocodone 10 mg/acetaminophen 1000 mg (on average, twice daily, allowable 3 times daily). During the first eight hours following surgery, a single 200 mg dose of Celebrex was as effective as a single dose of hydrocodone 10 mg/acetaminophen 1000 mg at controlling pain when study results were analyzed together. Results from the individual studies showed Celebrex had a comparable onset of action versus the narcotic in one study and statistically slower onset in the other study. However, in both studies, Celebrex showed comparable efficacy to the narcotic over the 8-hour period. Celebrex is not approved for management of acute pain or post-operative pain. Data demonstrate 20 percent of patients receiving the narcotic medication, compared to 12 percent of patients receiving Celebrex, withdrew from the five-day study due to treatment failure. In addition, there were 30 percent fewer adverse events in the Celebrex group than in the narcotic group. The most common complaints in the narcotic-treated patients were nausea, dizziness and drowsiness; in the Celebrex-treated group they were headache, nausea and drowsiness. According to G. Steven Geis, Ph.D., M.D., vice president, arthritis clinical development for Searle, "In treating post-surgical pain, the data from the pooled analysis demonstrate that 200 mg of Celebrex taken twice a day provides pain relief comparable to a commonly used narcotic agent used twice a day, with favorable tolerability." These studies were sponsored by a Searle research group. Celebrex is co-promoted by Searle and Pfizer Inc. Celebrex is indicated for osteoarthritis and adult rheumatoid arthritis. In clinical trials, the most common side effects of Celebrex were dyspepsia, diarrhea and abdominal pain, which were generally mild to moderate. Patients who have a known allergic reaction to celecoxib, certain sulfa drugs called sulfonamides, aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) should not use Celebrex. As with all NSAIDs, serious gastrointestinal toxicity can occur with or without warning symptoms.
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