Long-term treatment of rheumatoid arthritis comparing nabumetone with aspirin.

This report summarizes the results of a 17-investigator multicenter six-month randomized double-blind parallel group study. The safety and efficacy of nabumetone 1,000 mg taken at bedtime was compared with that of aspirin 900 mg four times daily in the treatment of adult patients with active class II or III classical or definite rheumatoid arthritis. Two hundred sixty-four patients were entered into the study. Two hundred fifty-seven (126 nabumetone and 131 aspirin) patients were evaluable for safety. Two hundred thirty-four (113 nabumetone and 121 aspirin) patients were evaluable for efficacy. There was significant improvement in each of six clinical measurements of efficacy in both treatment groups and little difference between groups. The somewhat greater improvement in articular index and duration of morning stiffness in the nabumetone-treated group did not reach statistical significance. There was an equal percentage of patient withdrawal for lack of efficacy in each group. Overall, the rate of patient withdrawal due to adverse experiences was greater (p = 0.01) for aspirin-treated patients. These experiences were usually dispepsia, abdominal pain, and tinnitus. It was concluded that nabumetone was an effective anti-inflammatory drug in the treatment of rheumatoid arthritis with less toxicity than aspirin.

Nabumetone in the treatment of active adult rheumatoid arthritis.

One hundred patients were entered in a six-month, double-blind comparison of 1,000 mg nabumetone once daily and 250 mg naproxen twice daily. Forty-two patients in each arm of the study were evaluable for efficacy; all were evaluable for safety. There was a low incidence of adverse experiences during this study, with no patients withdrawing from the study because of side effects from either drug. Efficacy was equal, with both compounds sharing the same degree and rate of improvement. All of the patients completing the double-blind phase were then switched to open-label treatment with nabumetone. The dosage of nabumetone was gradually increased. At the end of one year, 84 patients remained in the study (52 taking 1,000 mg per day, 23 taking 1,500 mg, and nine taking 2,000 mg). This gradual increase has continued, and, at this time, 61 patients remain in the study (seven taking 1,000 mg per day, 24 taking 1,500 mg, and 30 taking 2,000 mg). There have been very few side effects. From this study, it can be concluded that nabumetone is at least as effective as naproxen and, even at higher doses, had an acceptable safety profile for extended use in patients with rheumatoid arthritis.

Long-term comparison of suprofen and propoxyphene in patients with osteoarthritis.

The analgesic efficacy and safety of suprofen, 200 mg q.i.d., and propoxyphene, 65 mg q.i.d., were compared in 114 patients with chronic pain due to osteoarthritis. Both analgesic agents decreased pain intensity after only 1 week of treatment and considerable pain relief was apparent by week 2 to week 3 of treatment. These beneficial effects persisted with long-term therapy and improvement continued throughout the 24-week treatment period. Overall, the response to suprofen and propoxyphene was good to excellent in most of the patients treated. Long-term administration of suprofen was at least as well tolerated as that of propoxyphene. Only 24% (13 of 55) of suprofen-treated patients and 34% (20 of 59) of propoxyphene-treated patients discontinued therapy, primarily due to gastrointestinal complaints. It was concluded that suprofen, 200 mg q.i.d., is comparable in terms of efficacy to propoxyphene, 65 mg q.i.d., in relieving pain due to osteoarthritis.