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Abstract
The comparative safety of nabumetone (1,000–2,000 mg/day) versus diclofenac (100–200
mg/day), naproxen (500–1,500 mg/day), piroxicam (10–20 mg/day), and ibuprofen (1,200–3,200
mg/day) was evaluated in a 12-week, randomized, open-label, multicenter study. Patients
with osteoarthritis (OA) or rheumatoid arthritis (RA) were enrolled in a 3:1 ratio
(nabumetone:one of the four comparator NSAIDs). The incidence of ≥1 adverse event
considered by the investigator to be related or probably related to therapy was similar
in all groups. However, significantly (p <0.02) more diclofenac-treated patients experienced
abdominal pain and/or gastritis than nabumetone-treated patients. Naproxen-treated
patients experienced significantly (p <0.002) more dyspepsia as compared with patients
treated with nabumetone or ibuprofen and significantly (p ≤0.001) more nabumetone-treated
patients experienced diarrhea than patients treated with naproxen, ibuprofen, or piroxicam.
Ulcers occurred in one (0.03%) nabumetone-treated patient versus six (0.5%) patients
treated with one of the comparator NSAIDs (p = 0.001). A decrease in hemoglobin ≥1.5
g/dL occurred in fewer nabumetone-treated patients than in patients treated with diclofenac
(p <0.04), ibuprofen (p ≤0.04), or piroxicam (p = 0.055). Finally, a similar percentage
of patients in all treatment groups withdrew from the study because of adverse events
related or probably related to treatment. More (p <0.001) diclofenac-treated patients
withdrew because of elevated hepatic transaminases than patients treated with the
other agents. Withdrawal because of gastritis was also noted for more diclofenac-treated
patients than nabumetone-treated patients (p <0.04). In conclusion, nabumetone was
demonstrated to be at least as safe as diclofenac, piroxicam, ibuprofen, and naproxen
as related to subjective complaints, such as dyspepsia or gastritis. However, more
serious events, such as ulcers or meaningful decreases in hemoglobin, seem to occur
less often with nabumetone.
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Article info
Footnotes
☆This work was supported by SmithKline Beecham Pharmaceuticals.
Identification
Copyright
© 1993 Published by Elsevier Inc.
