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ARTHROTEC® (misoprostol, diclofenac sodium) Clinical Studies

14 CLINICAL STUDIES

Osteoarthritis

Diclofenac sodium, as a single ingredient or in combination with misoprostol, has been shown to be effective in the management of the signs and symptoms of osteoarthritis.

Rheumatoid arthritis

Diclofenac sodium, as a single ingredient or in combination with misoprostol, has been shown to be effective in the management of the signs and symptoms of rheumatoid arthritis.

Upper gastrointestinal safety

Diclofenac, and other NSAIDs, have caused serious gastrointestinal toxicity, such as bleeding, ulceration, and perforation of the stomach, small intestine or large intestine. Misoprostol has been shown to reduce the incidence of endoscopically diagnosed NSAID-induced gastric and duodenal ulcers. In a 12-week, randomized, double-blind, dose-response study, misoprostol 200 mcg administered four, three or two times a day, was significantly more effective than placebo in reducing the incidence of gastric ulcer in OA and RA patients using a variety of NSAIDs. The three times a day regimen was therapeutically equivalent to misoprostol 200 mcg four times a day with respect to the prevention of gastric ulcers. Misoprostol 200 mcg given two times a day was less effective than 200 mcg given three or four times a day. The incidence of NSAID-induced duodenal ulcer was also significantly reduced with all three regimens of misoprostol compared to placebo (see Table 3).

Table 3
Misoprostol 200 mcg Dosage Regimen
Placebo two times a day three times a day four times a day
N=1623; 12 weeks
*
Misoprostol significantly different from placebo (p<0.05)
Gastric ulcer 11% 6%* 3%* 3%*
Duodenal ulcer 6% 2%* 3%* 1%*

Results of a study in 572 patients with osteoarthritis demonstrate that patients receiving ARTHROTEC have a lower incidence of endoscopically defined gastric ulcers compared to patients receiving diclofenac sodium (see Table 4).

Table 4
Osteoarthritis patients with history of ulcer or erosive disease (N=572), 6 weeks Incidence of ulcers
Gastric Duodenal
*
Statistically significantly different from diclofenac (p<0.05)
ARTHROTEC 50 three times a day 3%* 6%
ARTHROTEC 75 two times a day 4%* 3%
Diclofenac sodium 75 mg two times a day 11% 7%
Placebo 3% 1%

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