Background A series of double-blind placebo and active comparator controlled studies meloxicam, a COX-2 inhibitor, has been found to be safe and effective in the treatment of osteoarthritis (OA) at dose of 7.5 mg daily. To assess the efficacy and the safety of meloxicam ?standard? and 15 mg daily doses a comparison of three OA treatment regiments in a typical population was performed.
Methods In the open multicenter parallel-group study 630 pts with confirmed knee OA and a flare were treated with oral administration of meloxicam tablets [at regimens of 7.5 mg (1st group) or 15 mg (2nd group) daily or increasing ineffective 7.5 mg/d to 15 mg/d after 1 week (3d group)]. Treatment was for 4 weeks, with regular assessment for drug safety and efficacy by evaluation of adverse events (AE), vital signs, Likert scales for pain at rest, at on movement, synovitis and joint function, and the patient’s and investigator’s overall assessment of disease activity.
Results The demographic, disease characteristics and gastrointestinal AE risk factors were similar across the treatment groups. Prior NSAID inefficacy was found in 25.5% pts. NSAID adverse events dropout have been estimated in 12.4% pts in past history. Anti-inflammatory and analgesics meloxicam properties were confirmed in three treatment regiments (p < 0.001). The incidence of all AE was lower and without dropout at 15 mg/d of meloxicam (3.8%) than for 7.5 mg/d of drug (7.8% with 3.6% dropout). The incidence of non-serious gastrointestinal AE was 1.6% and 3.4% (with 1.2% dropout) correspondingly. The total AE frequency among 630 OA pts was 6.5% (with 2.5% dropout).
Conclusion Meloxicam is a safe and effective medication for knee OA treatment, without dose-depended incidence of AE and dropout rates.
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