Treatment of elderly patients with nabumetone or diclofenac - Gastrointestinal safety profile

Goals: To evaluate the efficacy and gastrointestinal safety of nabumetone a nd diclofenac in the treatment of elderly patients with osteoarthritis, par ticipating in a 3-month efficacy trial. Background: Elderly patients have an elevated risk for developing gastroint estinal complications with chronic use of nonsteroidal anti-inflammatory dr ugs. Study: This was a randomized, double-blind, parallel-group, multicenter stu dy with a 3- to 14-day placebo washout period and a 12-week active treatmen t phase. Patients 65 years or older with moderate-to-severe osteoarthritis of the knee or hip were randomized to receive 1,000 to 2,000 mg/d of nabume tone or 100 to 150 mg/d of diclofenac. The primary efficacy parameters were the percent of patients improved using a Patients' and Physicians' Global Assessment at endpoint. Gastrointestinal safety was assessed by the inciden ce of gastrointestinal symptoms and adverse events. Results: Three hundred thirty-five patients (mean age = 72 years) with acti ve osteoarthritis were enrolled. There were no statistically significant di fferences between the two treatment groups in any of the primary efficacy v ariables. However, differences between the groups were apparent in the freq uency of adverse gastrointestinal events. Two patients in the diclofenac gr oup had evidence of gastrointestinal bleeding and/or ulcer compared with no ne in the nabumetone group. In addition, significantly more (p < 0.05) pati ents (4%) receiving diclofenac had alanine transaminase values more than tw ice the upper limit of normal at endpoint compared with patients receiving nabumetone (0%). Conclusions: Nabumetone was as effective as diclofenac in the treatment of elderly patients with moderate-to-severe osteoarthritis. However, the gastr ointestinal safety profile of nabumetone was superior to that of diclofenac with respect to elevation of liver enzymes.