The gastroduodenal safety and efficacy of the fixed combination of diclofenac and misoprostol in the treatment of osteoarthritis.
A double-blind, randomized, parallel group study was conducted to compare the gastroduodenal safety and antiarthritic efficacy of a fixed combination of diclofenac 50 mg and misoprostol 200 micrograms with that of a combination of diclofenac 50 mg and placebo in patients with osteoarthritis. Three hundred and sixty-one patients with no significant gastroduodenal lesions were enrolled and received study medication two or three times daily for 4 weeks. Post-treatment endoscopic examination of the gastroduodenal mucosa revealed ulcers in 4% of patients in the diclofenac/placebo group compared with none in the diclofenac/misoprostol group (P = 0.015). There were no clinically or statistically significant differences between the two treatment groups in formal assessments of osteoarthritis after either 2 or 4 weeks. It was concluded that diclofenac/misoprostol was associated with significantly less gastroduodenal damage than diclofenac, whilst being as effective as diclofenac alone in the treatment of osteoarthritis.
Bolten
W
W
Rheumaklinik Bad Rappenau, Germany.
Gomes
J A
JA
Stead
H
H
Geis
G S
GS
D000328:Adult; D000368:Aged; D004008:Diclofenac / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D004386:Duodenum / Q000187:drug effects*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008099:Liver / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D010003:Osteoarthritis / Q000188:drug therapy* / Q000503:physiopathology; D010437:Peptic Ulcer / Q000139:chemically induced; D012720:Severity of Illness Index; D013270:Stomach / Q000187:drug effects*
D004338:Drug Combinations; D016595:Misoprostol; D004008:Diclofenac