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© 1996 British Society for Rheumatology

A Six-Month Double-Blind Trial to Compare the Efficacy and Safety of Meloxicam 7.5 mg Daily and Naproxen 750 mg Daily in Patients with Rheumatoid Arthritis

J.A. Wojtulewski*, M. Schattenkirchner{dagger}, P. Barceló{ddagger}, X. Le Loët§, P. J. R. Bevis, E. Bluhmki** and M. Distel**

* Eastbourne District General Hospital Kings Drive, Eastbourne BN212 UD
{dagger} Rheumatology Unit, Ludwig-Maximilians-Universität, Pettenkoferstraβe 8a, 80336 Munchen, Germany
{ddagger} Hospital Malalties de Reùmatiques, Descartes 4 08006 Barcelona, Spain
§ HépitaldeBoisguillaume, Service de Rheumatologie, 147 av.du Marechal Juin 76230 Boisguillaume, France
Boehringer Ingelheim, Ellesfield Avenue Bracknell, Berkshire
** Dr KarlThomae GmbH, Birkendorfer Straβe65 88397 BiberachI Riss, Germany

Correspondence to: Correspondence to: Dr J. A. Wojtulewski, Eastbourne District General Hospital, Kings Drive, Eastbourne BD20 2UD.


  Abstract

Mcloxicam is a new non-steroidal anti-inflammatory drug (NSAID) which preferentially inhibits cyclooxygenase-2 over cyclooxygenase-1, A double-blind, parallel-group trial compared meloxicam 7.5 mg once daily (n = 199) with naproxen 750 mg (n=180) in rheumatoid arthritis.There was no significant difference between the groups regarding the primary efficacy variables (global efficacy assessment by patient and investigator, number of painful/tender and swollen joints) and eight of the ten secondary efficacy endpoints.Only the swollen joint severity index and the number of discontinuations due to lack of efficacy favoured naproxen 750 mg significantly over meloxicam 7.5 mg. Meloxicam was better tolerated in the gastrointestinal (GI) tract, with fewer GI adverse events in the meloxicam-treated group (30.3%) than in the naproxen-treated group (44.7%), where two patients developed ulcers. No ulcers were seen in meloxicam patients. Significantly more patients discontinued due to GI adverse events in the naproxen group. Additionally, there was a significant decrease in haemoglobin and a significant increase in serum creatininc and urea in the naproxen group compared with the meloxicam group. In conclusion, meloxicam 7.5 mg once daily is a promising treatment in rheumatoid arthritis, with efficacy comparable to naproxen 750 mg. Meloxicam has the advantage of a significantly lower incidence of GI and renal side effects.

KEY WORDS: Meloxicam, Non-steroidal anti-inflammatory drug, Cyclooxygenase-2, Naproxen, Rheumatoid arthritis, Gastrointestinal


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