Covidien (NYSE: COV), a leading global provider of healthcare products, announced the results of an analysis that will be presented at the American College of Rheumatology's Annual Scientific Meeting. A pooled analysis of safety data suggests that patients with knee osteoarthritis (OA) receiving the topical PENNSAID® (diclofenac sodium topical solution) 1.5% w/w had significantly fewer gastrointestinal (GI)-related adverse events than those receiving an oral non-steroidal anti-inflammatory drug (NSAID).
“These results are positive because some knee OA patients may find effective pain relief with the potential for fewer GI-related safety risks.”
The study assessed the safety and tolerability profiles of topical versus oral diclofenac by analyzing two randomized, double-blind, multi-center, 12-week clinical trials of 1,397 patients with chronic knee OA pain. The most common adverse events occurring with topical diclofenac were application-site reactions, primarily skin dryness.
"NSAID pain relievers are critical in managing debilitating osteoarthritis pain, but they have been associated with serious GI risks," said Sanford Roth, M.D., Lead Study Investigator and CEO and Medical Director, Arizona Research and Education. "The pooled analysis results suggest topical NSAIDs may have a superior GI safety profile, which is encouraging news for patients with OA of the knee."
Knee OA affects more than 10 million Americans. It is a chronic condition in which joint cartilage, the smooth tissue that cushions the bone and allows easy joint movement, breaks down, leading to pain, stiffness and loss of movement in the joint.
"Knee osteoarthritis is one of the top five causes of disability, so balancing safety and efficacy when deciding on treatment options is crucial," said Herbert Neuman, M.D., Vice President, Medical Affairs and Chief Medical Officer, Pharmaceuticals, Covidien. "These results are positive because some knee OA patients may find effective pain relief with the potential for fewer GI-related safety risks."
This analysis, funded by Covidien, is consistent with prior findings showing a lower incidence of GI adverse events with topical NSAIDs versus oral. Study results also showed that topical NSAIDs carry higher rates of GI adverse events than placebo.