Skip to main content

Advertisement

SpringerLink
Log in

Valdecoxib for treatment of primary dysmenorrhea

A randomized, double-blind comparison with placebo and naproxen

  • Original Article
  • Published:
Journal of General Internal Medicine Aims and scope Submit manuscript

Abstract

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Dawood MY. Nonsteroidal anti-inflammatory drugs and changing attitudes toward dysmenorrhea. Am J Med. 1988;84(suppl 5A):23–9.

    Article  PubMed  CAS  Google Scholar 

  2. Rosenwaks Z, Seegar-Jones G. Menstrual pain: its origin and pathogenesis. J Reprod Med. 1980;25(4 suppl):207–12.

    PubMed  CAS  Google Scholar 

  3. 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.

    Article  PubMed  CAS  Google Scholar 

  4. 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.

    Google Scholar 

  5. 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.

    Article  PubMed  CAS  Google Scholar 

  6. 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.

    Article  PubMed  CAS  Google Scholar 

  7. 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.

    Article  PubMed  CAS  Google Scholar 

  8. Brooks PM, Day RO. COX-2 inhibitors. N Engl J Med. 1991;324:1716–25.

    Article  PubMed  CAS  Google Scholar 

  9. 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.

    Article  PubMed  CAS  Google Scholar 

  10. 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.

    PubMed  CAS  Google Scholar 

  11. 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.

    Article  Google Scholar 

  12. Leese PT, Talwalker S, Kent JD, Recker DP. Valdecoxib does not impair platelet function. Am J Emerg Med. 2002;20:275–81.

    Article  PubMed  Google Scholar 

  13. 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.

    Article  PubMed  CAS  Google Scholar 

  14. Singh G, Rosen Ramey D. NSAID induced gastrointestinal complications: the ARAMIS perspective—1997. J Rheumatol. 1998;25(suppl 51):8–16.

    Google Scholar 

  15. 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.

    Article  PubMed  CAS  Google Scholar 

  16. 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.

    Article  PubMed  CAS  Google Scholar 

  17. 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.

    Article  PubMed  CAS  Google Scholar 

  18. Ashcroft DM, Chapman SR, Clark WK, Millson DS. Upper gastroduodenal ulceration in arthritis patients treated with celecoxib. Ann Pharmacother. 2001;35:829–34.

    Article  PubMed  CAS  Google Scholar 

  19. 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.

    Article  PubMed  CAS  Google Scholar 

  20. 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.

    Article  PubMed  CAS  Google Scholar 

  21. Kouides PA. Evaluation of abnormal bleeding in women. Curr Hematol Rep. 2002;1:11–8.

    PubMed  Google Scholar 

  22. 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.

    PubMed  CAS  Google Scholar 

  23. 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.

  24. 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.

  25. Samad TA, Sapirstein A, Woolf CJ. Prostanoids and pain: unraveling mechanisms and revealing therapeutic targets. Trends Mol Med. 2002;8:390–6.

    Article  PubMed  CAS  Google Scholar 

  26. Bartfai T. Telling the brain about pain. Nature. 2001;410:425–7.

    Article  PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Scirex Corporation, 3200 Red River, Suite 300, Austin, TX, USA

    Stephen E. Daniels DO & Paul J. Desjardins DMD, PhD

  2. Pfizer Inc., 4901 Searle Parkway, Skokie, IL, USA

    Sarah Torri MPH, RD

Authors
  1. Stephen E. Daniels DO
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Sarah Torri MPH, RD
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Paul J. Desjardins DMD, PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Stephen E. Daniels DO.

Additional information

This study was submitted as an abstract to the 17th World Congress of the International Federation of Gynecology and Obstetrics (FIGO), Santiago, Chile, November 2–7, 2003.

This study was sponsored by Pfizer Incorporated and Pharmacia Corporation.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Daniels, S.E., Torri, S. & Desjardins, P.J. Valdecoxib for treatment of primary dysmenorrhea. J GEN INTERN MED 20, 62–67 (2005). https://doi.org/10.1111/j.1525-1497.2004.30052.x

Download citation

  • Accepted:

  • Issue Date:

  • DOI: https://doi.org/10.1111/j.1525-1497.2004.30052.x

Key Words

Search

Navigation