Dimethaid's Pennsaid safer than pills, says study
2004-09-30 15:07 ET - News Release
Ms. Jodi Peake reports
TOPICAL ANTI-ARTHRITIC SAFER THAN PILLS
The Journal of Rheumatology has published a clinical study sponsored by Dimethaid Research Inc., demonstrating that Pennsaid, the company's anti-arthritic lotion, has an overall better safety profile than pills containing the same active ingredient. The 12-week trial also shows that Pennsaid works as well as the maximum daily dose of comparable oral medication at relieving knee osteoarthritis symptoms.
In an accompanying editorial, J. Rheum editor, Dr. R. Andrew Moore, describes the pyramid of evidence supporting topical NSAID efficacy and his view that "... the pinnacle is this new trial, demonstrating equivalence of topical and oral diclofenac in a large, valid, high-quality trial."
"Without doubt, Pennsaid is as effective as the oral anti-arthritics," said Patrick Gushue, Dimethaid's director, marketing and sales. "Couple that with the recent, worldwide withdrawal of Vioxx and we're obviously sitting on a winner. Over the next two weeks, patients will be walking into doctors' offices asking what they should do. As Dr. Tugwell's study shows, Pennsaid offers a realistic and safer alternative."
The study, which included 622 patients at 41 Canadian sites, found that oral diclofenac and Dimethaid's topical formulation of the same active drug were equally effective at relieving pain and improving physical function when evaluated by the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). The two treatments also produced a statistically equivalent increase in patient global assessment (PGA), a standard measure of all round well-being.
"These results strongly support our strategy of creating commercial success based on a topical drug application," said Dimethaid's president and chief executive officer, Dr. Henrich Guntermann. "They send a clear signal to doctors, especially given the severe side effects other NSAIDs can cause."
Pennsaid, which is spread on the skin, uses a chemical carrier to deliver drugs directly to the disease site. Unlike pills, the topical treatment exposes the bloodstream to negligible amounts of active drug. Dimethaid credits its patented technology for the low incidence of side effects reported in this latest peer-reviewed publication.
The article points out that patients treated with Pennsaid experienced noticeably fewer gastrointestinal adverse events -- dyspepsia, diarrhea, nausea, flatulence and abdominal pain -- and in particular, a lower incidence of GI events classified as severe. These patients also had a much smaller change in liver enzyme, hemoglobin, creatinine and creatinine clearance levels.
Pennsaid-treated patients did have more skin-related adverse events, mostly mild cases of dry skin, although some experienced rash, itching or minor blisters at the application site. During follow-up, these reactions disappeared quickly when patients stopped treatment. To make sure all skin reactions were detected, the study protocol prohibited using emollients.
The Journal of Rheumatology paper was authored by lead investigator, Dr. Peter S. Tugwell, director, Centre for Global Health, University of Ottawa, along with Dr. George A. Wells, chair and professor, department of epidemiology and community medicine, University of Ottawa, and Dr. J. Zev Shainhouse, Dimethaid's medical director. Initial results were presented at the 4th European Congress of Rheumatology in Lisbon, Portugal, and published as an abstract in the June, 2003, edition of Annals of the Rheumatic Diseases. The full paper will be available on-line at www.jrheum.com.
Results from an earlier placebo-controlled Pennsaid study, recently published in the Canadian Medical Association Journal by rheumatologist Dr. Arthur Bookman, chair of the Arthritis Society's medical advisory committee, can be found at cmaj.ca.
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