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PAIN MEDICINE

Etoricoxib Provides Analgesic Efficacy to Patients After Knee or Hip Replacement Surgery: A Randomized, Double-Blind, Placebo-Controlled Study

G. Lynn Rasmussen, MD^*, Kerstin Malmstrom, PhD, Michael H. Bourne, MD^,, Maurice Jove, MD, Steven M. Rhondeau, MD^¶, Paul Kotey, PhD, Jennifer Ang, MPH, Michelle Aversano, BS, Alise S. Reicin, MD for the Etoricoxib Postorthopedic Study Group

*Orthopedic Specialty Hospital, Murray, Utah; Merck Research Laboratories, Rahway, New Jersey; Salt Lake Orthopedic Clinic, St. Mark’s Hospital, Salt Lake City, Utah; Atlanta Knee and Sports Medicine, Decatur, Georgia; ¶LDS Hospital, Salt Lake City, Utah

Address correspondence and reprint requests to Alise Reicin, MD, Clinical Immunology & Analgesia, RY34B-264, Merck Research Laboratories, PO Box 2000, Rahway, NJ 07065 USA. Address e-mail to alise_reicin{at}merck.com.

In this randomized, double-blind, placebo-controlled, multicenter study we assessed the analgesic effect of etoricoxib (a new cyclooxygenase-2 inhibitor) in patients having had knee or hip replacement surgery. A total of 228 patients with moderate or severe pain were randomly allocated within 72 h after surgery to receive etoricoxib 120 mg, controlled-release naproxen sodium 1100 mg, or placebo (1:1:1) on day 1 followed by etoricoxib and placebo (1:2) on days 2 to 7. Patients reported pain scores, rescue (opioid-combination) medication use, and the response to study drug. On day 1, etoricoxib provided an analgesic effect superior to placebo and similar to controlled-release naproxen sodium as demonstrated by the total pain relief score over 8 h, the primary end-point; least-squares mean scores were 11.0, 11.5, and 5.6, respectively (P < 0.001 versus placebo). Similarly, a larger percentage of patients receiving etoricoxib and naproxen sodium than those receiv-ing placebo reported good to excellent responses to study drug: 53%, 60%, and 26% respectively. On days 2-7, etoricoxib demonstrated a significant reduction of rescue medication use, 35% (P < 0.001 versus placebo). The clinical relevance of the decrease was confirmed by Patient’s Global Evaluation (P < 0.05 versus placebo). Patients receiving etoricoxib also experienced significantly less "worst" and "average" pain than did those on placebo. Etoricoxib was generally well tolerated in this study; the incidence of adverse experiences was infrequent and similar across treatment groups. In summary, etoricoxib provided analgesia that was similar to controlled-release naproxen sodium on day 1 and superior to placebo with reduced supplemental opioid use over 7 days.

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