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Bextra (Valdecoxib) Offers Effective, Morphine-Sparing Pain Relief After Knee Surgery: Presented at AAOS

DALLAS, TX -- February 13, 2002 -- BextraŽ (valdecoxib), a new COX-2 specific inhibitor, demonstrated effective post-operative pain relief and significantly reduced patient consumption of the opioid analgesic morphine, when administered post-operatively to patients undergoing knee replacement surgery, according to an investigational study presented this week at the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS).

Valdecoxib was recently approved by the U.S. Food and Drug Administration for the treatment of osteoarthritis, adult rheumatoid arthritis, and primary dysmenorrhea (menstrual cramps).

"Avoiding post-operative pain is a major priority, and a significant source of anxiety, for patients undergoing surgery," said principal investigator Lowell Reynolds, MD, Medical Director, Loma Linda University, Loma Linda, California. "We are encouraged by the results of this study as they suggest valdecoxib may be a viable alternative for treating post-surgical pain."

In this multicenter, randomised, double-blind study, 209 patients were randomised to receive valdecoxib (20 mg or 40 mg) or placebo as soon as they could tolerate oral medication following surgery, and subsequent doses at 12, 24, and 36 hours after the first dose or until discontinuation of morphine. Morphine administration by a patient-controlled analgesia (PCA) pump began following administration of study medication. Efficacy was assessed by measuring the total amount of morphine consumed over the first 24 and 48 hours following the first dose of valdecoxib.

Mean consumption of morphine in the morphine plus placebo group was 69.5 mg on day one and 27.1 mg on day two. Patients who received valdecoxib 40 mg every 12 hours consumed 56.5 mg and 16.7 mg morphine on day one and day two, respectively. These figures represent significant reductions of 19 percent and 38 percent versus placebo on day one and two, respectively (p<0.05). Patients receiving valdecoxib 20 mg every 12 hours also consumed a lower total mean amount of morphine versus placebo. Although morphine consumption in the valdecoxib group was comparable to placebo on day one (61.2 mg versus 69.5 mg, respectively), patients in the valdecoxib group consumed significantly less morphine (27 percent or 19.7 mg, p<0.05) on day two than those in the placebo group.

Overall, during the 48 hours post surgery, morphine consumption by patients receiving valdecoxib 20 mg or 40 mg every 12 hours was reduced by 16.3 percent and 24.2 percent, respectively, compared with those patients receiving morphine plus placebo.

Additionally, a higher percentage of patients treated with valdecoxib 20 mg and 40 mg plus morphine (79 percent and 84 percent, respectively) described their study medication as "good" or "excellent," compared with 70 percent of patients receiving morphine plus placebo. In addition, patients receiving valdecoxib 40 mg BID plus morphine reported greater reductions in pain intensity than those receiving placebo, even though those patients consumed more morphine.

Patients were included in the study if they were 18 years of age or older, requiring uncomplicated, unilateral total knee replacement or revision to a total knee replacement. Patients were excluded if they had a surgical procedure time greater than six hours, were undergoing emergency knee replacement surgery, or were within six weeks of a previous knee replacement surgery.

There were no significant differences in the incidence of most adverse events between treatment groups, but the incidence of fever was significantly higher among patients receiving morphine alone versus either group of patients receiving morphine plus valdecoxib.

Bextra is indicated for treating the signs and symptoms of osteoarthritis (OA) and adult rheumatoid arthritis (RA), and the pain of menstrual cramping. The recommended dose for arthritis is 10 mg once daily. For menstrual pain, the recommended dose is 20 mg, administered twice daily as needed.

Bextra is contraindicated in patients with known hypersensitivity to valdecoxib. Bextra should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or non-steroidal anti-inflammatories (NSAIDs), or who are in their third trimester of pregnancy. As with all NSAIDs, serious gastrointestinal (GI) toxicity can occur with or without warning. Physicians and patients should remain alert to the signs and symptoms of GI bleeding.

Bextra does not affect platelet function and therefore should not be used for cardiovascular prophylaxis. Rare cases of severe renal and hepatic reactions have been reported with NSAIDs.

As with all NSAIDs, Bextra should be used with caution in patients with fluid retention, hypertension, or heart failure. In clinical studies, the most common side effects were headache, abdominal pain, dyspepsia, upper respiratory tract infection, nausea, and diarrhea. Anticoagulant therapy should be monitored, particularly during the first few weeks, after initiating therapy with Bextra in patients receiving warfarin or similar agents.

The drug is co-marketed by Pharmacia Corporation and Pfizer Inc.

SOURCE: Pharmacia Corporation

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