A 6-week, multicenter, double-masked, placebo-controlled, parallel-group study compared the upper gastrointestinal (UGI) safety of
Arthrotec 75 (
diclofenac sodium 75 mg-
misoprostol 200 microg; G.D. Searle & Co., Skokie, Illinois) administered twice daily with that of
nabumetone 1500 mg administered once daily in 1203 patients with symptomatic
osteoarthritis (OA) of the hip or knee. All patients had a documented clinical history of endoscopically confirmed gastric, pyloric-channel, or
duodenal ulcer or > or = 10 erosions in the stomach or duodenum. UGI endoscopy was performed at baseline and again at week 6 or early withdrawal. Treatment with
Arthrotec 75 resulted in a significantly lower combined incidence of endoscopically confirmed gastric and
duodenal ulcers compared with
nabumetone (4% vs 11%), and its rate of endoscopically confirmed ulceration was equivalent to that of placebo. The incidence of
gastric ulcers alone was also significantly lower with
Arthrotec 75 than with
nabumetone (1% vs 9%). The incidence of
duodenal ulcer with
Arthrotec 75 was not significantly different from that with
nabumetone (4% vs 3%). Types of adverse events were similar for all treatment groups, with GI adverse events predominating.
Arthrotec 75 was well tolerated by the majority of patients. The results of this study demonstrate that
Arthrotec 75 has a superior UGI safety profile, causing significantly fewer UGI
ulcers, in comparison with
nabumetone in patients with symptomatic OA and a documented history of
ulcers or > or = 10 erosions.