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DICLOFENAC Sodium AND MISOPROSTOL Tablets (GREENSTONE LLC) 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 osteoarthritis and rheumatoid arthritis 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
Placebotwo times a daythree times a dayfour times a day
N=1623; 12 weeks
*
Misoprostol significantly different from placebo (p<0.05)
Gastric ulcer11%6%*3%*3%*
Duodenal ulcer6%2%*3%*1%*

Results of a study in 572 patients with osteoarthritis demonstrate that patients receiving diclofenac sodium/misoprostol 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 weeksIncidence of ulcers
GastricDuodenal
*
Statistically significantly different from diclofenac (p<0.05)
Diclofenac sodium/misoprostol 50 three times a day3%*6%
Diclofenac sodium/misoprostol 75 two times a day4%*3%
Diclofenac sodium 75 mg two times a day11%7%
Placebo3%1%
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