슬관절 골관절염 환자에 대한 Meloxicam의 유효성 및 안전성 평가를 위한 Diclofenac과의 공개 비교 무작위 다기관 임상 시험

Abstract

Objective: To assess the clinical efficacy and safety of meloxicam 7.5mg versus diclofenac 100mg slow release (SR) in the Korean patients with osteoarthritis of the knee. Methods: Ninety-one patients of four university hospitals in 1999 were randomized to receive once daily oral meloxicam 7.5mg (N=45) or diclofenac 100mg SR (N=46) for 8 weeks. Clinical efficacy was evaluated using 100mm Visual Analogue Scale (VAS) for pain, Lequesne index after 4, 8 weeks of treatment as well as the physician`s and patient`s global assessment at the end of treatment. Evaluations for clinical safety were performed using the incidence of adverse events, physical examinations, laboratory finding and total ingestion of antacid during the treatment. Results: After 8 weeks of therapy, both groups had significant improvement in 100mm VAS and Lequesne index than baseline although the difference between two groups did not reach statistical significance. The physician`s and patient`s global assessment were similar in two groups. The incidence of gastrointestinal adverse events was significantly lower in meloxicam group (24.4%) than diclofenac group (50.0%) (p<0.05). Conclusion: Meloxicam 7.5mg is comparable to diclofenac 100mg SR in the treatment of Korean patients with osteoarthritis of the knee. Furthermore meloxicam 7.5mg was well tolerated for 8 weeks and has safe advantage of a significantly lower incidence of gastrointestinal adverse events.