Valdecoxib, a cyclooxygenase-2-specific inhibitor, is effective in treating primary dysmenorrhea.
OBJECTIVE
To compare the efficacy of the cyclooxygenase (COX)-2-specific inhibitor valdecoxib with naproxen sodium in treating menstrual pain associated with primary dysmenorrhea.


METHODS
This single-center, double-blind, placebo-controlled, randomized, crossover study compared the efficacy and safety of single oral doses of valdecoxib 20 mg and 40 mg with naproxen sodium 550 mg, or placebo, with an option of treatment for up to 3 days, twice daily. Efficacy was assessed by time-weighted sum of total pain relief, sum of pain intensity difference, time-specific pain relief, and pain intensity difference over 12 hours, time to rescue medication or first re-medication, the percentage of patients taking rescue medication, and patient's global evaluation of study medication.


RESULTS
Mean time-weighted sum of total pain relief and sum of pain intensity difference were significantly superior to placebo for the first 8 and 12 hours after the initial dose of valdecoxib 20 mg (P <.01) and 40 mg (P <.001). Valdecoxib 20 mg and 40 mg were comparable to naproxen sodium 550 mg for all efficacy measures. Other differences in efficacy measures favoring the higher dose of valdecoxib did not achieve statistical significance, with the exception of sum of pain intensity difference-12. Both doses of valdecoxib were well tolerated.


CONCLUSIONS
Both valdecoxib 20- and 40-mg doses were effective and well tolerated for the treatment of primary dysmenorrhea. Valdecoxib 20 mg and 40 mg demonstrate analgesic efficacy, based on onset, magnitude, and duration of analgesia that is similar to naproxen sodium, making it a potential choice for treating women with primary dysmenorrhea.
Daniels
Stephen E
SE
From the Scirex Corporation, Austin, Texas, USA.
Talwalker
Sheela
S
Torri
Sarah
S
Snabes
Michael C
MC
Recker
David P
DP
Verburg
Kenneth M
KM
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D018592:Cross-Over Studies; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004412:Dysmenorrhea / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000008:administration & dosage*; D009288:Naproxen / Q000008:administration & dosage*; D010147:Pain Measurement; D011336:Probability; D012016:Reference Values; D013449:Sulfonamides / Q000008:administration & dosage*; D016896:Treatment Outcome; D000096926:Benzenesulfonamides
D016861:Cyclooxygenase Inhibitors; D007555:Isoxazoles; D009288:Naproxen; D013449:Sulfonamides; C406224:valdecoxib; D000096926:Benzenesulfonamides