This paper is only available as a PDF. To read, Please Download here.
Abstract
Objective
The purpose of this study was to compare the tolerability and efficacy of nabumetone
and naproxen in the treatment of patients with rheumatoid arthritis (RA). The occurrence
of gastrointestinal (GI) adverse events was compared.
Background
Nonsteroidal anti-inflammafory drugs (NSAIDs) have similar efficacy at equipotent
doses, but the therapeutic response to various NSAIDs often differs in individual
patients.
Methods
This was a 3-month, randomized, double-blind, multicenter, parallel-group study conducted
in adult patients with RA. The study had 2 phases: a 3-to 14-day washout period and
a 12-week treatment period. During the treatment phase, the tolerability and efficacy
of nabumetone 2000 mg/d were compared with those of naproxen 1000 mg/d. The change
from baseline in efficacy variables, including global assessments, number of tender
or swollen joints, and pain, was evaluated. The study was sized to provide an 80%
power to detect a 15% difference in the percentage improvement on the physician's
global assessment (α = 0.05). GI safety was assessed by monitoring the occurrence
of clinically important adverse GI events.
Results
A total of 346 RA patients at 31 US rheumatology centers were randomly assigned to
treatment (173 patients per group). The study population was predominantly white (87.0%)
and female (70.5%), with a mean age of 54 years. Both treatments improved the signs
and symptoms of RA, with no statistically significant differences between groups for
any efficacy variables. No serious GI adverse events occurred with either NSAID. The
most frequent treatment-related adverse events in both groups were predominantly GI
in origin, as were those that resulted in withdrawal from the study. Diarrhea with
lower abdominal pain was the most common adverse event in the nabumetone group; upper
abdominal pain was the most common adverse event in the naproxen group. The only significant
difference between the 2 groups was a higher incidence of diarrhea (P < 0.01) in patients receiving nabumetone.
Key words
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Clinical TherapeuticsAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Relationship between clinical efficacy and laboratory correlates of inflammatory and immunologic activity in rheumatoid arthritis patients treated with nonsteroidal antiinflammatory drugs.Arthritis Rheum. 1990; 33: 623-633
- From experiment to experience: Side effects of nonsteroidal anti-inflammatory drugs.Am J Med. 1983; 74: 820-828
- Epidemiology of NSAID induced gastrointestinal complications.J Rheumatol. 1999; 26: 18-24
- Risk for serious gastrointestinal complications related to use of nonsteroidal anti-inflammatory drugs: A meta-analysis.Ann Intern Med. 1991; 115: 787-796
- Risk factors for serious nonsteroidalinduced gastrointestinal complications: Regression analysis of the MUCOSA trial.Fam Med. 1996; 28: 204-210
- Epidemiology of nonsteroidal anti-inflammatory drug-associated gastrointestinal injury.Am J Med. 1998; 104: 23S-29S
- NSAIDs: Gastrointestinal injury and cytoprotection.Gastroenterol din North Am. 1996; 25: 279-298
- Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs.Lancet. 1994; 343: 769-772
- Comparative GI toxicity of NSAIDs.Arthritis Rheum. 1997; 40 (Abstract): S115
- Variability in risk of gastrointestinal complications with individual non-steroidal anti-inflammatory drugs: Results of a collaborative meta-analysis.Br Med J. 1996; 312: 1563-1566
- Association of upper gastrointestinal toxicity of non-steroidal anti-inflammatory drugs with continued exposure: Cohort study.Br Med J. 1997; 315: 1333-1337
- Clinical update of the relative safety of nabumetone in long-term clinical trials.Inflammopharmacology. 1995; 3: 351-361
- Gastroduodenal tolerability of nabumetone versus naproxen in the treatment of rheumatic patients.Am J Gastroenterol. 1995; 90: 1485-1488
- A long-term endoscopic evaluation of patients with arthritis treated with nabumetone vs. naproxen.J Rheumatol. 1994; 21: 1118-1123
- Efficacy of nabumetone versus diclofenac, naproxen, ibuprofen, and piroxicam in osteoarthritis and rheumatoid arthritis.Am J Med. 1993; 95: 2S-9S
- Safety experience with nabumetone versus diclofenac, naproxen, ibuprofen, and piroxicam in osteoarthritis and rheumatoid arthritis.Am J Med. 1993; 95: 10S-18S
- The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis.Arthritis Rheum. 1988; 31: 315-324
- Therapeutic criteria in rheumatoid arthritis.JAMA. 1949; 140: 659-662
- The American College of Rheumatology 1991 revised criteria for the classification of global functional status in RA.Arthritis Rheum. 1992; 35: 498-502
- AIMS2. The content and properties of a revised and expanded Arthritis Impact Measurement Scales Health Status questionnaire.Arthritis Rheum. 1992; 35: 1-10
- The Rapid Assessment of Disease Activity in Rheumatology (RADAR) questionnaire. Validity and sensitivity to change of a patient self-report measure of joint count and clinical status.Arthritis Rheum. 1992; 35: 156-162
- Gastrointestinal disease associated with nonsteroidal antiinflammatory drugs: New insights from observational studies and functional status questionnaires.Am J Med. 1991; 90: 209-212
- Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs. A randomized, double-blind, placebo-controlled trial.Ann Intern Med. 1995; 123: 241-249
- A controlled study comparing the effects of nabumetone, ibuprofen and ibuprofen plus misoprostol on the upper gastrointestinal tract mucosa.Arch Intern Med. 1993; 153: 2565-2571
- Long-term treatment of rheumatoid arthritis comparing nabumetone with aspirin.Am J Med. 1987; 83: 44-49
- Nabumetone compared with naproxen in the treatment of rheumatoid arthritis: A multicenter, double-blind, randomized, parallel group trial in hospital outpatients.J Rheumatol. 1992; 19: 41-47
Article info
Publication history
Accepted:
November 8,
1999
Identification
Copyright
© 2000 Published by Elsevier Inc.
