To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: COX-2 Specific Inhibitor Bextra (Valdecoxib) Effective And Well-Tolerated Treatment For Painful Menstrual Cramping URL: http://www.pslgroup.com/dg/21A266.htm Doctor's Guide August 1, 2002
- Study Results Published in Obstetrics and Gynecology - PEAPACK, NJ -- August 1, 2002 -- Study results published today in the journal Obstetrics and Gynecology showed that the COX-2 specific inhibitor Bextra® (valdecoxib tablets) is as effective as the non-specific non-steroidal anti-inflammatory drug (NSAID) naproxen sodium, the active ingredient in Anaprox®, for treating the pain of primary dysmenorrhea (painful menstrual cramping). "Our study showed that Bextra provided a level of relief from menstrual pain that is comparable to the widely-used naproxen sodium," said author and principal investigator Stephen E. Daniels, DO, of SCIREX Clinical Research Center in San Marcos, Texas. "Bextra is a valuable treatment option for women suffering from the monthly pain of menstrual cramping." Efficacy Conclusions The investigators evaluated two Bextra dosing regimens: 20 mg twice daily as needed (BID PRN) and 40 mg BID PRN. Both regimens were comparable to naproxen sodium 550 mg BID PRN with regard to onset, magnitude, and duration of analgesia in treating primary dysmenorrhea. "Dysmenorrhea occurs when prostaglandins are released within the uterine lining during menstruation and stimulate the uterus to contract forcefully, causing pain and cramping," noted Dr. Daniels. "Bextra acts by blocking the production of prostaglandins through the inhibition of the cyclooxygenase (COX-2) enzyme. By inhibiting COX-2, and consequently prostaglandin production, pain and inflammation can be reduced." Characterized by abdominal pain during menstruation that is not attributable to any other underlying cause, primary dysmenorrhea can be severe enough to interfere with everyday activities. It is estimated that 600 million work hours are lost each year due to incapacitating pain of dysmenorrhea. Dysmenorrhea may affect more than 50 percent of menstruating women, with about 5 to 15 percent experiencing severe symptoms. Study Design The double-blind, placebo-controlled, randomized, crossover study was conducted at SCIREX Clinical Research Center in Austin, Texas and included 118 women. The study compared the efficacy and tolerability of Bextra 20 mg BID PRN and Bextra 40 mg BID PRN with placebo or naproxen sodium 550 mg BID PRN. All patients received each of the four treatments in a random sequence. The initial dose was taken at the onset of moderate to severe menstrual cramping pain but could be followed by a second dose 8 to 12 hours later if required and continued for up to three days if needed. Primary efficacy endpoints were assessed by standard measures including Time-Weighted Sum of Total Pain Relief (TOTPAR) and Sum of Pain Intensity Difference (SPID). Efficacy was also assessed by time-specific Pain Relief (PR) and Pain Intensity Difference (PID) over 12 hours, Patient's Global Evaluation of Study Medication, time to rescue medication or first remedication, and the percentage of patients taking rescue medication. The incidence of adverse events reported by the Bextra treatment groups was similar to that of placebo and naproxen sodium. Additional Information Bextra (valdecoxib tablets) is indicated for treating the signs and symptoms of osteoarthritis (OA) and adult rheumatoid arthritis (RA), and primary dysmenorrhea (painful menstrual cramping). The recommended dose for OA and adult RA 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 aspirin-sensitive asthma, urticaria, or allergic-type reactions after taking aspirin or NSAIDs, or who are in their third trimester of pregnancy. As with all NSAIDs, serious 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. Bextra should be used with caution in patients with fluid retention, hypertension, or heart failure. Patients should tell their doctor if they have liver or kidney problems. In arthritis and primary dysmenorrhea 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. Pharmacia Corporation is a top-tier global pharmaceutical company with a leading agricultural subsidiary. Pharmacia's innovative medicines and other products save lives and enhance health and wellness. Pharmacia's 59,000 people work together with many diverse stakeholders to bring these benefits to people around the world, and to create new health solutions for the future. Pfizer Inc (NYSE: PFE) discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best-known consumer products. Bextra® is a registered trademark of Pharmacia Corporation. Anaprox® is a registered trademark of Roche Laboratories Inc. For complete prescribing information on Bextra, access http://www.Bextra.com or call toll-free 888-4-Bextra. This press release contains forward-looking or anticipatory statements about the companies' business and financial performance plans which are based on the information currently available and the expectations currently deemed reasonable by the companies. However, because these forward-looking statements are subject to many risks, uncertainties and changes over time, including those referenced in the companies' filings with the U.S. Securities and Exchange Commission, actual results may differ materially from those expressed or implied by these forward-looking statements. The companies undertake no obligation to update any forward-looking statements as a result of new information or future developments. SOURCE: Pharmacia Corporation --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. 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