CRD - Research - Drug Trials

Randomized, Double Blind Trial of Rofecoxib compared to Diclofenac in Osteoarthritis (OA) knees: An Indian Study.

ARVIND CHOPRA, SALUJA M, KHANNA D, JUNEJA J, JOG V, HARDIKAR SM, PAWAR D.

Objective

To evaluate the efficacy and safety of rofecoxib in OA knees

Methods

160 patients of OA knees were randomized into a multicentric, double blind drug trial of 4 weeks duration as per the protocol. Rofecoxib (ROFF/12.5 mg daily) was compared to Diclofenac (DFC/100 mg slow release daily). Paracetamol on prn basis was permitted and use monitored; nil else allowed. Eligibility criteria (pain VAS>4cms) ensured active symptomatic disease. Standard ACR efficacy measures, including WOMAC (modified and validated for Indian use) were used. Sample size was driven by the hypothesis of equal efficacy and regulatory needs. An intent to treat analysis at P < 0.05 significance was done (95% Cl for the difference between means computed and shown in parenthesis).

Results

	no significant difference in efficacy for pain relief (-0.9~0.4) and WOMAC change (-8.9~2.6) between ROFF and DFC
	though not significantly different, ROFF demonstrated better gut tolerability (Max AE, 26% DFC Vs 15% ROFF, and nausea only reported by DFC); no significant changes in the blood pressure recorded from baseline.
	in within group analysis, both the drugs showed improvement in several efficacy measures.
	though not significant, more withdrawals observed in ROFF (16% Vs 11% DFC)
	paracetamol consumption similar in both groups at all end points.

Conclusion

The efficacy of Rofecoxib, even in a relatively lower daily dose of 12.5 mg, is similar to that of Diclofenac in popular routine daily dose of 100 mg slow release in the symptomatic management of OA knees. Even at 4 weeks usage, Rofecoxib has a superior safety profile compared to Diclofenac.

Abstracts – 10th Asia Pacific League of Associations for Rheumatology Congress 2002; 142

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