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2002 SEP 12 - (NewsRx.com & NewsRx.net) -- Study results published in the journal Obstetrics and Gynecology showed that the COX-2 specific inhibitor Bextra (valdecoxib tablets) is as effective as the nonspecific 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."
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 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% of menstruating women, with about 5 to 15% experiencing severe symptoms.
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 ...