Efficacy and tolerability of meloxicam in an observational, controlled cohort study in patients with rheumatic disease.
BACKGROUND
Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase-2 without affecting platelet aggregation.


OBJECTIVE
The goal of this study was to assess the efficacy and tolerability of meloxicam under natural prescribing conditions for up to 6 months.


METHODS
This was a multicenter, prospective, observational cohort study. Participating centers were randomized to 1 of 2 groups: the meloxicam-only group, and the group who received comparator NSAIDs (ie, diclofenac, ibuprofen, piroxicam, or indomethacin).


RESULTS
A total of 4526 patients received either meloxicam (n = 2530) or a comparator NSAID (n = 1996). Treatment groups were comparable in terms of observed efficacy measures. Meloxicam patients had significantly lower rates of reported gastrointestinal (GI) adverse drug reactions (1.80% vs 3.20%; P = 0.003), including dyspepsia (0.08% vs 0.35%; P = 0.049), abdominal pain (0.91% vs 1.90%; P = 0.006), gastritis (0.08% vs 0.60%; P = 0.002), and GI bleeding (0.08% vs 0.50%; P = 0.007), compared with those receiving comparator NSAIDs.


CONCLUSIONS
There was evidence that meloxicam was prescribed preferentially to patients who had not responded to NSAIDs previously, who had previously experienced NSAID-induced side effects (and so were at high risk for developing NSAID-induced GI toxicity), or who were more seriously impaired. The nonrandomized and unblinded nature of this study limits the conclusions that can be drawn concerning efficacy or tolerability. Nevertheless, the study results are consistent with the favorable GI tolerability seen with meloxicam in double-blind comparative trials.
Degner
F
F
Therapeutic Area CNS/General Diseases, Boehringer Ingelheim GmbH, Germany.
Sigmund
R
R
Zeidler
H
H
D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D004311:Double-Blind Method; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D000077239:Meloxicam; D008875:Middle Aged; D011446:Prospective Studies; D012216:Rheumatic Diseases / Q000188:drug therapy*; D012307:Risk Factors; D013843:Thiazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013844:Thiazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D013843:Thiazines; D013844:Thiazoles; D000077239:Meloxicam