Risk of serious upper gastrointestinal and cardiovascular thromboembolic complications with meloxicam.
OBJECTIVE
To assess the risk of serious gastrointestinal and thromboembolic complications with approved doses of meloxicam.


METHODS
We pooled data from clinical trials of meloxicam at doses of 7.5 or 15 mg/d. A blinded gastrointestinal adjudication committee used prespecified criteria to identify gastric or duodenal perforation, gastric outlet obstruction, or hemodynamically important upper gastrointestinal bleeding. For analysis of thromboembolic complications, investigator-reported events were analyzed without adjudication.


RESULTS
We analyzed data from 24,196 patients from 28 trials, most of whom had been followed for up to 60 days. Of these patients, 13,118 received meloxicam (10,158 received a daily dose of 7.5 mg and 2960 received 15 mg), 5283 were treated with diclofenac 100 mg, 181 received diclofenac 150 mg, 5371 were treated with piroxicam 20 mg, and 243 received naproxen 500 mg twice daily. Patients who received 7.5 mg of meloxicam daily had a 0.03% risk of serious upper gastrointestinal events, which was significantly lower than the risk in those who received diclofenac, naproxen, or piroxicam (P <0.02). With the 15 mg daily dose of meloxicam, this risk was significantly different only when compared with piroxicam (P = 0.03). The risk of thromboembolic events in patients treated with meloxicam at either dose was lower than with diclofenac, but similar to that observed with piroxicam and naproxen.


CONCLUSIONS
This pooled analysis of 24,196 patients demonstrates that meloxicam has a favorable gastrointestinal and thromboembolic safety profile. However, only a small number of patients were followed for more than 60 days, and meaningful comparisons were not possible in this subgroup.
Singh
Gurkirpal
G
Divisions of Immunology and Rheumatology, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA. gsingh@stanford.edu
Lanes
Stephan
S
Triadafilopoulos
George
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects*; D002319:Cardiovascular System / Q000187:drug effects* / Q000473:pathology; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D005060:Europe / Q000453:epidemiology; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D008297:Male; D000077239:Meloxicam; D008875:Middle Aged; D009288:Naproxen / Q000008:administration & dosage / Q000009:adverse effects; D009656:North America / Q000453:epidemiology; D010894:Piroxicam / Q000008:administration & dosage / Q000009:adverse effects; D012307:Risk Factors; D012720:Severity of Illness Index; D013843:Thiazines / Q000008:administration & dosage / Q000009:adverse effects*; D013844:Thiazoles / Q000008:administration & dosage / Q000009:adverse effects*; D013923:Thromboembolism / Q000139:chemically induced* / Q000453:epidemiology*; D013997:Time Factors; D017211:Treatment Failure; D041742:Upper Gastrointestinal Tract / Q000187:drug effects* / Q000473:pathology
D000894:Anti-Inflammatory Agents, Non-Steroidal; D013843:Thiazines; D013844:Thiazoles; D010894:Piroxicam; D004008:Diclofenac; D009288:Naproxen; D000077239:Meloxicam