Risk of serious upper gastrointestinal and cardiovascular thromboembolic complications with meloxicam

Am J Med. 2004 Jul 15;117(2):100-6. doi: 10.1016/j.amjmed.2004.03.012.

Abstract

Purpose: 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.

Conclusion: 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Cardiovascular System / drug effects*
  • Cardiovascular System / pathology
  • Diclofenac / administration & dosage
  • Diclofenac / adverse effects
  • Dose-Response Relationship, Drug
  • Europe / epidemiology
  • Female
  • Gastrointestinal Diseases / chemically induced
  • Gastrointestinal Diseases / epidemiology
  • Humans
  • Male
  • Meloxicam
  • Middle Aged
  • Naproxen / administration & dosage
  • Naproxen / adverse effects
  • North America / epidemiology
  • Piroxicam / administration & dosage
  • Piroxicam / adverse effects
  • Risk Factors
  • Severity of Illness Index
  • Thiazines / administration & dosage
  • Thiazines / adverse effects*
  • Thiazoles / administration & dosage
  • Thiazoles / adverse effects*
  • Thromboembolism / chemically induced*
  • Thromboembolism / epidemiology*
  • Time Factors
  • Treatment Failure
  • Upper Gastrointestinal Tract / drug effects*
  • Upper Gastrointestinal Tract / pathology

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Thiazines
  • Thiazoles
  • Piroxicam
  • Diclofenac
  • Naproxen
  • Meloxicam