Document Detail

Double-blind study comparing the long-term efficacy of the COX-2 inhibitor nimesulide and naproxen in patients with osteoarthritis.
MedLine Citation:
PMID:  11695069     Owner:  NLM     Status:  MEDLINE    
This double-blind one-year study compares the long-term efficacy and safety of nimesulide with naproxen in patients with osteoarthritis (OA) of the knee or hip. Patients were randomised to nimesulide 100 mg twice daily (n = 183) or naproxen 250 mg morning, 500 mg evening (n = 187). The primary efficacy variable was change in pain intensity (WOMAC A scale) at 6 months. Nimesulide tablets showed at least equivalent efficacy to naproxen tablets in reducing pain intensity at 6 and 12 months (nimesulide -22.5% at 6 and 12 months; naproxen -22.4% at 6 months, -19.9% at 12 months; non-inferiority proven). At 6 months the investigator assessed efficacy as 'good' or 'excellent' in 59.3% of nimesulide and 56.4% of naproxen-treated patients, with corresponding values for patient assessment of 57% and 52.7%. Both treatments were well tolerated, with fewer related gastrointestinal adverse events reported with nimesulide (77 cases, 47.5%) than with naproxen (96 cases, 54.5%). This study shows nimesulide to be as effective as naproxen in the long-term treatment of OA and to be associated with fewer gastrointestinal side-effects.
W Kriegel; K J Korff; J C Ehrlich; K Lehnhardt; A Macciocchi; C Moresino; C Pawlowski
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  International journal of clinical practice     Volume:  55     ISSN:  1368-5031     ISO Abbreviation:  Int. J. Clin. Pract.     Publication Date:  2001 Oct 
Date Detail:
Created Date:  2001-11-06     Completed Date:  2001-12-07     Revised Date:  2007-02-14    
Medline Journal Info:
Nlm Unique ID:  9712381     Medline TA:  Int J Clin Pract     Country:  England    
Other Details:
Languages:  eng     Pagination:  510-4     Citation Subset:  IM    
St Willibrord Hospital, Emmerich, Germany.
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MeSH Terms
Aged, 80 and over
Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
Cyclooxygenase Inhibitors / therapeutic use*
Double-Blind Method
Middle Aged
Naproxen / therapeutic use*
Osteoarthritis / drug therapy*
Severity of Illness Index
Sulfonamides / therapeutic use*
Treatment Outcome
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 0/Cyclooxygenase Inhibitors; 0/Sulfonamides; 22204-53-1/Naproxen; 51803-78-2/nimesulide

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