Background Meloxicam is a novel NSAID that has been widely used in >100 countries with > 40 million prescriptions over the last 6 years. Meloxicam has been shown in numerous clinical trials to be effective, and to have lower rates of gastrointestinal adverse events than other NSAIDs such as diclofenac, piroxicam and naproxen. However, the renal and cardiovascular toxicity of meloxicam has not been extensively studied before. This is an important clinical issue because recent studies have raised considerable concern about cardiovascular and renal safety profile of some new Cox-2 selective NSAIDs.
Objectives To document the risk of acute myocardial infarction, congestive heart failure, oedema and hypertension in patients taking 7.5–30 mg doses of meloxicam, and traditional NSAIDs (diclofenac 100–150 mg, naproxen 500–750 mg, piroxicam 20 mg) in a pooled analysis of 27,039 patients.
Methods We pooled data from all Meloxicam clinical trials that were at least 3 weeks in duration and included at least 20 patients per arm. Thirty-five trials with 27,039 patients on Meloxicam, comparator NSAID?s, or placebo were included in the analysis. Nearly 39% (8109) patients were over age 65. Since trials were of varying durations, we report event rates as incidence per 100 patient-years of exposure.
Results Of the 27,039 patients studied, 15,071 received meloxicam in doses of 7.5 ? 30 mg daily. A total of 11,078 patients took diclofenac, naproxen or piroxicam. An additional 736 patients were randomised to placebo. The number of patients with cardiovascular and renal events adverse events is shown in the Table 1 below. Incidence rates in parenthesis refer to rates per 100 patient years.
Conclusion Meloxicam in doses of 7.5–30 mg is not associated with increased incidence of cardiovascular or renal toxicity.
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