Source: DGNews  |  Posted 9 years ago

By Roberta Friedman, PhD

BALTIMORE, MD -- May 16, 2003 -- Patients with osteoarthritis who continue to use rofecoxib or diclofenac for 2 years achieve sustained control of their pain, according to findings reported here May 15th at the 2003 Annual Scientific Meeting of the American Geriatrics Society.

A extension trial followed patients taking the COX-2 blocker rofecoxib and the nonsteroidal anti-inflammatory diclofenac for 2 years, noted Janet van Adelsberg, MD, of Merck & Co. of Rahway, New Jersey, U.S.A.. "The good news is, it continues to work [on rated pain and disability]" said Dr. van Adelsberg.

Of the 1,158 patients who entered the first year of treatment, 616 entered the second year of treatment -- 210 received rofecoxib 12.5 mg/d, 205 received rofecoxib 25 mg/d; and 201 received diclofenac 150 mg. A total of 441 patients (72%) completed the full 2 years of treatment.

Improvement in pain was evaluated every 10 to 12 weeks using the visual analog score (VAS) to determine levels of pain on walking on a flat surface, patient-scored 100 mm VAS, and investigator-scored 5-point Likert scale to determine patient disease status.

Both rofecoxib and diclofenac controlled walking pain and improved disease activity throughout the second year of treatment.

At the end of Year 2, the mean changes from baseline in patient-rated VAS for walking pain were 44 to 47 mm for the first year and 40 to 43 mm for the second year. Likert scale scores ranged from 1.8 to 2.0 in the first year and from 1.6 to 1.9 in the second year.

Both rofecoxib and diclofenac resulted in very low rates of gastrointestinal (GI) complications, which were consistent with what has been seen in outcome studies, noted Dr. van Adelsberg. Three patients taking rofecoxib and four taking diclofenac sustained either perforations, ulcers or GI bleeds.

Two serious adverse GI events occurred, both in patients taking diclofenac, "which is consistent with the GI safety advantage of COX-2 inhibitors," said Dr. van Adelsberg.

Efficacy was similar in the three treatment groups, said Dr. van Adelsberg. But she added that this long-term study was not the best measure of any difference between the two drugs -- either for efficacy or as a rating of side effects -- as it followed only patients who tolerated the drugs well for the first year of treatment.

This study was supported by Merck & Co., Inc.

[Study title: Two-Year Efficacy of Rofecoxib and Diclofenac in Treatment of Knee and Hip Osteoarthritis. Abstract P169]