Valdecoxib for treatment of primary dysmenorrhea
Rent the article at a discountRent now
* Final gross prices may vary according to local VAT.Get Access
OBJECTIVE: To compare the analgesic efficacy of valdecoxib with placebo and naproxen sodium for relieving menstrual cramping and pain due to primary dysmenorrhea.
DESIGN: Single-center, double-blind study with a 4-period, 4-sequence crossover design. Patients assessed pain intensity and pain relief at regular intervals up to 12 hours following the initial dose.
SETTING: Privately owned outpatient clinic.
PATIENTS/PARTICIPANTS: One hundred twenty patient with moderate to severe menstrual cramping were randomized. Eighty-seven patients completed all treatment cycles.
INTERVENTIONS: Valdecoxib 20 mg or 40 mg, naproxen sodium 550 mg, or placebo twice a day as required for ≤ 3 days in a single menstrual cycle.
MEASUREMENTS AND MAIN RESULTS: Both doses of valdecoxib (20 and 40 mg) were comparable to naproxen sodium and superior to placebo at all time points assessed for each of the primary end points. Valdecoxib and naproxen sodium had comparable onset and duration of action. Although the study design allowed patients 2 doses per day, only 15% and 20% of patients in the valdecoxib 20 mg and valdecoxib 40 mg groups, respectively, required remedication within the first 12 hours. The incidence of adverse events was similar between active and placebo groups.
CONCLUSION: Valdecoxib provided a fast onset of analgesic action, a level of efficacy similar to naproxen sodium, and a high level of patient satisfaction in the relief of menstrual pain due to primary dysmenorrhea. Valdecoxib was effective and well tolerated and thus appears to be a viable treatment for menstrual pain due to primary dysmenorrhea.
- Dawood MY. Nonsteroidal anti-inflammatory drugs and changing attitudes toward dysmenorrhea. Am J Med. 1988;84(suppl 5A):23–9. CrossRef
- Rosenwaks Z, Seegar-Jones G. Menstrual pain: its origin and pathogenesis. J Reprod Med. 1980;25(4 suppl):207–12.
- Masferrer JL, Zweifel BS, Manning PT, et al. Selective inhibition of inducible cyclooxygenase 2 in vivo is antiinflammatory and nonuclerogenic. Proc Natl Acad Sci USA. 1994;91:3228–32. CrossRef
- García Rodríguez LA, Jick H. Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs. 1994;343:769–72. Erratum in Lancet. 1994;343:1048.
- Copeland RA, Williams JM, Giannaras J, et al. Mechanism of selective inhibition of the inducible isoform of prostaglandin G/H synthase. Proc Natl Acad Sci USA. 1994;91:11202–6. CrossRef
- Gierse JK, McDonald JJ, Hauser SD, Rangwala SH, Koboldt CM, Seibert K. A single amino acid difference between cyclooxygenase-1 (COX-1) and-2 (COX-2) reverses the selectivity of COX-2 specific inhibitors. J Biol Chem. 1996;271:15810–4. CrossRef
- Morrison BW, Daniels SE, Kotey P, Cantu N, Seidenberg B. Rofecoxib, a specific cyclooxygenase-2 inhibitor, in primary dysmenorrhea: a randomized controlled trial. Obstet Gynecol. 1999;94:504–8. CrossRef
- Brooks PM, Day RO. COX-2 inhibitors. N Engl J Med. 1991;324:1716–25. CrossRef
- Talley JJ, Brown DL, Carter JS, et al. 4-[5-methyl-3-phenylisoxazol-4-yl]-benzenesulfonamide, valdecoxib: a potent and selective inhibitor of COX-2. J Med Chem. 2000;43:775–7. CrossRef
- Daniels SE, Desjardins PJ, Talwalker S, Recker DP, Verburg KM. The analgesic efficacy of valdecoxib vs. oxycodone/acetaminophen after oral surgery. J Am Dent Assoc. 2002;133:611–21.
- Sikes DH, Agrawal NM, Zhao WW, Kent JD, Recker DP, Verburg KM. Incidence of gastroduodenal ulcers associated with valdecoxib compared with that of ibuprofen and diclofenac in patients with osteoarthritis. Eur J Gastroenterol Hepatol. 2002;14:1011–11. CrossRef
- Leese PT, Talwalker S, Kent JD, Recker DP. Valdecoxib does not impair platelet function. Am J Emerg Med. 2002;20:275–81. CrossRef
- Daniels SE, Talwalker S, Torri S, Snabes MC, Recker DP, Verburg KM. Valdecoxib, a cyclooxygenase-2-specific inhibitor, is effective in treating primary dysmenorrhea. Obstet Gynecol. 2002;100:350–8. CrossRef
- Singh G, Rosen Ramey D. NSAID induced gastrointestinal complications: the ARAMIS perspective—1997. J Rheumatol. 1998;25(suppl 51):8–16.
- Strom BL, Berlin JA, Kinman JL, et al. Parenteral ketorolac and risk of gastrointestinal and operative site bleeding. A postmarketing surveillance study. JAMA. 1996;275:376–82. CrossRef
- Goldstein JL, Kivitz AJ, Verburg KM, Recker DP, Palmer RC, Kent JD. A comparison of the upper gastrointestinal mucosal effects of valdecoxib, naproxen and placebo in healthy elderly subjects. Aliment Pharmacol Ther. 2003;18:125–32. CrossRef
- Hawkey CJ, Jackson L, Harper SE, Simon TJ, Mortensen E, Lines CR. Review article: the gastrointestinal safety profile of rofecoxib, a highly selective inhibitor of cyclooxygenase-2, in humans. Aliment Pharmacol Ther. 2001;15:1–9. CrossRef
- Ashcroft DM, Chapman SR, Clark WK, Millson DS. Upper gastroduodenal ulceration in arthritis patients treated with celecoxib. Ann Pharmacother. 2001;35:829–34. CrossRef
- Milsom I, Minic M, Dawood MY, et al. Comparison of the efficacy and safety of nonprescription doses of a naproxen and naproxen sodium with ibuprofen, acetaminophen, and placebo in the treatment of primary dysmenorrhea: a pooled analysis of five studies. Clin Ther. 2002;24:1384–400. CrossRef
- Singh G, Rosen Ramey D, Morfeld D, Shi H, Hatoum HT, Fries JF. Gastrointestinal tract complications of nonsteroidal anti-inflammatory drug treatment in rheumatoid arthritis. Arch Intern Med. 1996;156:1530–6. CrossRef
- Kouides PA. Evaluation of abnormal bleeding in women. Curr Hematol Rep. 2002;1:11–8.
- Leese PT, Recker DP, Kent JD. The COX-2 selective inhibitor, valdecoxib, does not impair platelet function in the elderly: results of a randomized controlled trial. J Clin Pharmacol. 2003;43:504–13.
- Zhang Y, Isakson P, Rathmell J, Panchal S, Seibert K. Distribution of the COX-2 specific inhibitor valdecoxib into cerebrospinal fluid following oral administration. J Pain. 2003;4(suppl 1):A765. Abstract.
- Zhang Y, Isakson P, Rathmell J, Panchal S, Seibert K. Reduction of hyperalgesia, PGE2 in paw exudates, and PGE2 in CSF after oral administration of valdecoxib or ketorolac. J Pain. 2003;4(suppl 1):A794. Abstract.
- Samad TA, Sapirstein A, Woolf CJ. Prostanoids and pain: unraveling mechanisms and revealing therapeutic targets. Trends Mol Med. 2002;8:390–6. CrossRef
- Bartfai T. Telling the brain about pain. Nature. 2001;410:425–7. CrossRef
- Valdecoxib for treatment of primary dysmenorrhea
Journal of General Internal Medicine
Volume 20, Issue 1 , pp 62-67
- Cover Date
- Print ISSN
- Online ISSN
- Additional Links
- naproxen sodium
- primary dysmenorrhea
- menstrual pain
- Industry Sectors