Randomized double‐blind clinical drug trials of meloxicam in rheumatoid arthritis and osteoarthritis knees: an Indian experience

Background: Indian data from controlled drug trials on the use of meloxicam (a new preferential COX‐2 inhibitor) and other non‐steroidal anti‐inflammatory drugs (NSAIDs) in arthritis is sparse. Aim: To evaluate the clinical efficacy and safety of meloxicam. Patients and methods: One hundred and twenty‐one patients with rheumatoid arthritis (RA) and 133 patients with osteoarthritis (OA) knees were randomized into two different multicentric, double‐blind, drug trials of four‐weeks duration each. Meloxicam 7.5 mg (OA study) and 15 mg (RA study) was compared to diclofenac 100 mg and piroxicam 20 mg in daily dosages, respectively. Strict eligibility criteria ensured active symptomatic disease. Standard ACR efficacy measures of pain and function (including validated Indian versions of HAQ & WOMAC) were used. Protocol‐driven evaluations were carried out throughout the study. An intent‐to‐treat efficacy analysis (significance at P < 0.05) was carried out to test the hypothesis of equal efficacy between meloxicam and comparator. Results: (i) There were no significant differences between meloxicam and piroxicam in the RA study. (ii) While joint count for pain/tenderness was improved (P < 0.05) by both meloxicam and piroxicam, only meloxicam showed significant improvement (95% CI ≈ 0.7,5.6) in swollen joint count. (iii) In the OA study, though painVAS reduction was marginally better (95% CI ≈ −15,−0.6) with diclofenac, both meloxicam and diclofenac were equally effective (95% CI ≈ −10,2.0) in improving WOMAC‐physical function. (iv) Overall, meloxicam demonstrated a superior safety and gut tolerability profile as compared to piroxicam (maximum adverse events, 29.3%) and diclofenac. (iv) Maximum dyspepsia (6.2%) was reported by the diclofenac group. (v) Overall, the drug toxicity seen in the trials was mild, and only one patient (on diclofenac) was withdrawn due to haematuria. (vi) All treatment groups consumed paracetamol (P > 0.05) as a rescue analgesic. Conclusions: When compared to piroxicam and diclofenac, meloxicam has equal clinical efficacy and a better safety profile. Multicentric control drug trials are feasible in our population.