Efficacy and tolerability profile of etoricoxib in patients with osteoarthritis

A randomized, double-blind, placebo and active-comparator controlled 12-week efficacy trial

Albert T. Leung, Kerstin Malmstrom, Alberto E. Gallacher, Brian Sarembock, G. Poór, Andre Beaulieu, Ricardo Castro, Matilde Sanchez, Lisa M. DeTora, Jennifer Ng

Research output: Contribution to journalArticle

107 Citations (Scopus)

Abstract

Objective: To evaluate the efficacy of 12 weeks of treatment with etoricoxib, a selective COX-2 inhibitor, in patients with osteoarthritis (OA) of the knee or hip. Methods: In the 12-week placebo- and active comparator-controlled period of a randomized, double-blind study, eligible patients were treated with etoricoxib 60 mg once daily (n = 224), naproxen 500 mg twice daily (n = 221), or placebo (n = 56). Western Ontario McMaster's Osteoarthritis Index (WOMAC) pain and physical function subscales and patient's global assessment of disease status were primary end points. Key secondary and other end points were patient's and investigator's global assessment of response to therapy, WOMAC stiffness subscale, investigator's global assessment of disease status, rescue paracetamol use, proportion of patients discontinuing due to lack of efficacy, and study joint tenderness. Results: Etoricoxib 60 mg demonstrated efficacy significantly superior to placebo (p ≤ 0.005) and comparable to naproxen 500 mg twice daily as assessed by the primary efficacy end points. Secondary and other end points confirmed these results. Treatment effects were evident by day 2, maximal by week 2, and sustained over the entire 12 weeks. Etoricoxib was well tolerated for 12 weeks. Conclusions: Etoricoxib showed rapid and durable treatment effects in patients with OA of the knee or hip. Etoricoxib was generally well tolerated.

Original languageEnglish
Pages (from-to)49-58
Number of pages10
JournalCurrent Medical Research and Opinion
Volume18
Issue number2
DOIs
Publication statusPublished - 2002

Fingerprint

etoricoxib
Osteoarthritis
Placebos
Hip Osteoarthritis
Naproxen
Knee Osteoarthritis
Research Personnel
Cyclooxygenase 2 Inhibitors
Ontario
Therapeutics
Acetaminophen
Double-Blind Method
Joints

Keywords

  • Cyclo-oxygenase
  • Etoricoxib
  • Naproxen
  • Non-steroidal anti-inflammatory drugs
  • Osteoarthritis

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Efficacy and tolerability profile of etoricoxib in patients with osteoarthritis : A randomized, double-blind, placebo and active-comparator controlled 12-week efficacy trial. / Leung, Albert T.; Malmstrom, Kerstin; Gallacher, Alberto E.; Sarembock, Brian; Poór, G.; Beaulieu, Andre; Castro, Ricardo; Sanchez, Matilde; DeTora, Lisa M.; Ng, Jennifer.

In: Current Medical Research and Opinion, Vol. 18, No. 2, 2002, p. 49-58.

Research output: Contribution to journalArticle

Leung, Albert T. ; Malmstrom, Kerstin ; Gallacher, Alberto E. ; Sarembock, Brian ; Poór, G. ; Beaulieu, Andre ; Castro, Ricardo ; Sanchez, Matilde ; DeTora, Lisa M. ; Ng, Jennifer. / Efficacy and tolerability profile of etoricoxib in patients with osteoarthritis : A randomized, double-blind, placebo and active-comparator controlled 12-week efficacy trial. In: Current Medical Research and Opinion. 2002 ; Vol. 18, No. 2. pp. 49-58.
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