November 12, 2010 (Atlanta, Georgia) — Diclofenac sodium topical solution 1.5% w/w (Pennsaid, Coviden) appears to be as effective as oral diclofenac in the management of osteoarthritis of the knee, but has significantly fewer gastrointestinal (GI) and cardiovascular adverse effects.
Sanford H. Roth, MD, from Arizona State University in Phoenix, and colleagues presented the findings here at the American College of Rheumatology 2010 Annual Meeting.
“Oral NSAIDs [nonsteroidal anti-inflammatory drugs] are commonly used in the management of osteoarthritis, but their use is associated with serious GI and cardiovascular risks,” Dr. Roth told Medscape Medical News. He added that less than 1% of topical diclofenac is absorbed systemically; much more is absorbed when the agent is taken orally.
A pooled analysis of 2 randomized, double-blind, multicenter, 12-week clinical trials was performed to compare the safety (927 patients) and efficacy (909 patients) of topical and oral diclofenac therapy in patients with chronic knee pain associated with osteoarthritis.
Significantly fewer GI-related (25.2% vs 39.0%; P < .001) and cardiovascular (1.5% vs 3.7%; P = .037) adverse effects were reported with topical than with oral diclofenac treatment, although dry skin at the application site was significantly more common (24.3% vs 1.9%; P < .001).
A patient global assessment and the pain and physical function variables of the Western Ontario and McMaster University Arthritis (WOMAC) index indicated that the efficacy of topical and oral diclofenac treatments was comparable.
Analyses of topical diclofenac therapy in phase 3 clinical trials (911 patients treated for 4 to 12 weeks) and an open-label study (793 patients; 463 treated for at least 6 months and 144 for at least 12 months) revealed that application site adverse reactions were the most common adverse events, and included dry skin (32%), contact dermatitis characterized by skin erythema and induration (9%), contact dermatitis with vesicles (2%), and pruritus (4%).
Other adverse effects that were more common with topical diclofenac than
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