Incidentally there is a topical NSAID (topical ketoprofen - Orudis) that is available OTC outside the US. (I buy it over the internet). It's absolutely magical for localised muscle and joint pain - works virtually instantly. Some systemic absorption, so not risk-free, but small compared to oral
Another topical, available in Canada, Britain and the Carribean and still awaiting FDA approval (for 3 years). This topical uses DMSO as the solvent which makes it different than every other topical (and somehow different to the FDA). The DMSO appears to shut down the normal extracellular transport of materials out of the cell into systemic circulation, so that the active Diclofenac NSAID diffuses from cell to cell eventually getting to the site of inflammation and pain. Almost no systemic absorption occurs. One typical NSAID pill is dissolved in a solution that can last a user a month of daily usage, as opposed to popping up to 6 pills per day of a typical NSAID.
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Topical anti-arthritic safer than pills
Rheumatology Journal Publishes Pennsaid(R) Oral Equivalence Trial
TORONTO, Sept. 30 /CNW/ - The Journal of Rheumatology has published a
clinical study sponsored by Dimethaid Research Inc. (TSX: DMX), demonstrating
that Pennsaid(R), 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 followup, 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 online 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. |
