A longterm endoscopic evaluation of patients with arthritis treated with nabumetone vs naproxen.
OBJECTIVE
To compare the gastrointestinal safety, ulcerogenic potential, and clinical efficacy over 5 years of nabumetone and naproxen therapy, in patients with rheumatoid arthritis (RA) or osteoarthritis (OA).


METHODS
Fifty-two patients entered a randomized, double blind study. Patients were randomized to 3 months treatment with either nabumetone, 1000 mg nightly, or naproxen, 250 mg twice daily, followed by an endoscopist-blind 5-year followup study. After the double blind phase, 15 patients in the nabumetone group and 12 in the naproxen group continued in the longterm endoscopist-blind phase. Endoscopic evaluations for gastroduodenal damage and global assessments of arthritis activity and degree of pain for efficacy were measured.


RESULTS
Over the 5-year period, endoscopically visible gastroduodenal ulceration was found in 8 of the naproxen treated patients compared with one of the nabumetone treated patients (p = 0.02). There was a significant difference in the time to develop an ulcer, with a greater risk of developing an ulcer sooner while taking naproxen (p < 0.01). Patients in both groups reported significant improvements in arthritis symptoms (p < 0.01).


CONCLUSIONS
Nabumetone appears to have a significantly lower ulcerogenic potential than naproxen over a 5-year period, and there is a trend toward better tolerability as measured by withdrawals for adverse experiences.
Roth
S H
SH
Arthritis Center, Ltd., Phoenix, AZ 85012.
Bennett
R
R
Caldron
P
P
Mitchell
C
C
Swenson
C
C
Koepp
R
R
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D002074:Butanones / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005773:Gastroscopy; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077430:Nabumetone; D009288:Naproxen / Q000009:adverse effects* / Q000627:therapeutic use; D010003:Osteoarthritis / Q000188:drug therapy*; D010437:Peptic Ulcer / Q000139:chemically induced; D011446:Prospective Studies; D013997:Time Factors
D000894:Anti-Inflammatory Agents, Non-Steroidal; D002074:Butanones; D009288:Naproxen; D000077430:Nabumetone