Ketoprofen Topical Gel as Effective as Oral Diclofenac for Osteoarthritis of the Hand: Presented at OARSI
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Ketoprofen Topical Gel as Effective as Oral Diclofenac for Osteoarthritis of the Hand: Presented at OARSI

By Louise Gagnon

MONTREAL -- September 17, 2009 -- Topical ketoprofen 2.5% gel is as effective as oral diclofenac in treating symptoms associated with osteoarthritis (OA) of the hand, researchers stated here on September 12 at the 2009 World Congress of the Osteoarthritis Research Society International (OARSI).

The randomised, double-blinded, double-dummy, multicentre trial included 395 men and women aged 45 to 75 years who had symptoms of hand OA according to American College of Rheumatology criteria. They also had a baseline visual analogue scale (VAS) of >40 mm and Dreiser score of >=5.

Patients were randomised to receive either ketoprofen gel and an oral placebo, or placebo gel with oral diclofenac 150 mg/day. Clinical assessments were performed 3 and 7 days after treatment began.

The study’s primary endpoint was the change in VAS at study entry compared with the final assessment.

“A score of zero indicated an absence of pain, and a score of 100 indicated maximal pain,” said Sam Kozma, MD, Menarini Laboratories, Rungis, France, in an interview with DocGuide.

Dr. Kozma explained that 61 patients were eliminated from the full-analysis set (FAS) of 395 patients, with most of those eliminated because of poor compliance to the study regimen. He noted that the FAS and per protocol (PP) groups were defined in the statistical analysis plan of the study.

In the PP population of 334 patients, where 164 patients received ketoprofen gel and 170 patients received diclofenac, researchers observed comparable changes in VAS scores at 7 days: -33.2 for ketoprofen and -36.9 for diclofenac. In addition, researchers found equivalent results for several secondary endpoints.

“Unfortunately, we were not able to demonstrate equivalence in the FAS population because we lost a lot of patients,” said Dr. Kozma.

They failed, however, to observe a statistically significant difference in tolerability between the 2 arms of the study.

“The scientific rationale was to show that the gel could provide efficacy with less adverse events, in particular gastrointestinal events,” he said. “In this study, both treatments were well tolerated. We did not show better tolerability of the gel.”

While this study did not prove a topical treatment produced fewer adverse events than a systemic treatment, other studies may demonstrate this in the future. “It is clear from the literature and meta-analyses that anti-inflammatory gels produce less adverse events than oral medications,” said Dr. Kozma.

Funding for this study was supported by Menarini Laboratories.

[Presentation title: Equivalent Efficacy of a Topical Form of Ketoprofen (Ketum 2.5% Gel) and Oral Diclofenac in the Treatment of Hand Osteoarthritis: Results From Artopik Study. Abstract 332]

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