Topical Diclofenac Reduces Pain of Knee Osteoarthritis
From Medscape Medical News.
NEW YORK (Reuters Health) Dec 22 - Topical diclofenac gel applied four times daily relieves symptoms of osteoarthritis (OA) of knee, results of a German study demonstrate.
Oral nonsteroidal anti-inflammatory drugs (NSAIDs) have considerable gastrointestinal toxicity, Dr. Fritz U. Niethard and colleagues note in the Journal of Rheumatology for December, whereas systemic exposure from topical NSAIDs is estimated at 10% of that following oral administration.
Dr. Niethard, from Universitatsklinikum Aachen and his team enrolled patients with unilateral OA of the knee, with radiographic signs, pain scores of at least 50 mm on a 100-mm visual analog scale and at least "moderate" pain on a 4-point scale.
After a washout phase in which they discontinued analgesic medication, patients were randomly assigned to topical diclofenac diethylamine gel 1.16% (Voltaren Emulgel, Novartis) or placebo to be rubbed into the knee 4 times daily for 3 weeks. The intent-to-treat analysis included 117 in the diclofenac arm and 119 in the placebo arm. Patients were permitted up to four tablets per day of acetaminophen 500 mg as rescue medication.
"Efficacy developed over the course of the first week, reached a peak during the second week, and was maintained over the third week," the authors observe in their report.
According to diaries that the patients kept, diclofenac was significantly superior to placebo gel in pain-on-movement averaged over days 8-21 (average difference 6 mm on the visual analog scale, p = 0.005). During the same period, diclofenac was associated with a lower rating of spontaneous pain (p = 0.02).
Those on active treatment were also more likely than those on placebo treatment to rate the effectiveness of the gel as good, very good, or excellent (69% versus 58%). At week 3, pain score on the Western Ontario and McMaster (WOMAC) Osteoarthritis Index Questionnaire had improved by 47% and 29%, respectively.
Adverse events and results of hematology, serum chemistry and urinary laboratory measures were identical in the two groups. The use of rescue medication was similar in the two groups.
"Diclofenac gel ... should be considered as an appropriate first-line option for the treatment of pain in OA of small and large joints," Dr. Niethard and his associates maintain.
This study was supported by Novartis Consumer Health.
J Rheumatol 2005;32:2384-2392.
NEW YORK (Reuters Health) Dec 22 - Topical diclofenac gel applied four times daily relieves symptoms of osteoarthritis (OA) of knee, results of a German study demonstrate.
Oral nonsteroidal anti-inflammatory drugs (NSAIDs) have considerable gastrointestinal toxicity, Dr. Fritz U. Niethard and colleagues note in the Journal of Rheumatology for December, whereas systemic exposure from topical NSAIDs is estimated at 10% of that following oral administration.
Dr. Niethard, from Universitatsklinikum Aachen and his team enrolled patients with unilateral OA of the knee, with radiographic signs, pain scores of at least 50 mm on a 100-mm visual analog scale and at least "moderate" pain on a 4-point scale.
After a washout phase in which they discontinued analgesic medication, patients were randomly assigned to topical diclofenac diethylamine gel 1.16% (Voltaren Emulgel, Novartis) or placebo to be rubbed into the knee 4 times daily for 3 weeks. The intent-to-treat analysis included 117 in the diclofenac arm and 119 in the placebo arm. Patients were permitted up to four tablets per day of acetaminophen 500 mg as rescue medication.
"Efficacy developed over the course of the first week, reached a peak during the second week, and was maintained over the third week," the authors observe in their report.
According to diaries that the patients kept, diclofenac was significantly superior to placebo gel in pain-on-movement averaged over days 8-21 (average difference 6 mm on the visual analog scale, p = 0.005). During the same period, diclofenac was associated with a lower rating of spontaneous pain (p = 0.02).
Those on active treatment were also more likely than those on placebo treatment to rate the effectiveness of the gel as good, very good, or excellent (69% versus 58%). At week 3, pain score on the Western Ontario and McMaster (WOMAC) Osteoarthritis Index Questionnaire had improved by 47% and 29%, respectively.
Adverse events and results of hematology, serum chemistry and urinary laboratory measures were identical in the two groups. The use of rescue medication was similar in the two groups.
"Diclofenac gel ... should be considered as an appropriate first-line option for the treatment of pain in OA of small and large joints," Dr. Niethard and his associates maintain.
This study was supported by Novartis Consumer Health.
J Rheumatol 2005;32:2384-2392.
posted by Ricardo Pocurull at 9:54 AM
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