YOU ARE NOW CONNECTED TO THE TOXLINE (1981 FORWARD, NON-ROYALTY) FILE. ==ARTHROTEC FOR ARTHRITIS== 4 AUTHOR Nasonova VA AUTHOR Sigidin IaA AUTHOR Murav'ev IuV AUTHOR Lebedeva OI AUTHOR Burtsev VI AUTHOR Rashchupkina ZP AUTHOR Krikunov VP AUTHOR Kuzin AV AUTHOR Nasonov EL AUTHOR Chichasova NV TITLE [A trial of the use of the preparation Arthrotec for treating rheumatic diseases] SOURCE Ter Arkh; VOL 67, ISS 1, 1995, P34-8 ABSTRACT A clinical trial of arthrotek (Searle) in 60 RA patients aged 16-77 years demonstrated its high anti-inflammatory activity in 47 of them. These patients have received a complete treatment course, 10 patients were not included in the overall estimations because of side affects (gastric pains and nausea) causing them to withdraw early in the treatment course, 3 patients were nonresponders. The responders experienced attenuation of joint pain, morning stiffness. Inflammation in some joints declined, the articular index decreased. 8 AUTHOR Downie WW TITLE Diclofenac/misoprostol: review of the major clinical trials evaluating its clinical efficacy and upper gastrointestinal tolerability in rheumatoid arthritis and osteoarthritis SOURCE Drugs; VOL 45 ISS Suppl 1 1993, P1-6, (REF 10) ABSTRACT IPA COPYRIGHT: ASHP A discussion is presented of 4 multicenter, double-blind studies comparing the efficacy and tolerability of an oral tablet containing a combination of 50 mg diclofenac and 200 mcg misoprostol (Arthrotec) with those of 50 mg diclofenac alone in patients with rheumatoid arthritis or osteoarthritis who were treated 2-3 times daily. In each study the treatments showed similar therapeutic efficacy. However, fewer patients receiving diclofenac/misoprostol had significant gastroduodenal mucosal erosions or ulcers at study completion than patients receiving diclofenac alone. It was concluded that diclofenac/misoprostol is as effective as diclofenac alone for the treatment of rheumatoid arthritis and osteoarthritis and is better tolerated. 10 AUTHOR Gagnier P TITLE Review of the safety of diclofenac/misoprostol SOURCE Drugs; VOL 45 ISS Suppl 1 1993, P31-35, (REF 18) ABSTRACT IPA COPYRIGHT: ASHP Studies of the toxicity of a fixed dose combination of 50 mg diclofenac and 200 mcg misoprostol (Arthrotec) are discussed. It was noted that in short-term studies, adverse effects were most frequently gastrointestinal in nature, with abdominal pain reported most often, followed by diarrhea, nausea, and dyspepsia. In long-term studies, adverse effects were also predominantly gastrointestinal and occurred most often during the first 6 months of therapy. After this time the rate of increase in the cumulative incidence of adverse events decreased with increasing duration of administration. 14 AUTHOR Geis GS TITLE Overall safety of Arthrotec. SOURCE Scand J Rheumatol Suppl; VOL 96, 1992, P33-6 ABSTRACT Data from four double-blind studies of the treatment of patients with rheumatoid arthritis or osteoarthritis were combined. For 4 to 12 weeks, 747 patients received Arthrotec, a combination of 50 mg of diclofenac and 200 micrograms of misoprostol, and 754 patients received 50 mg of diclofenac; the drugs were given twice or three times daily. The five most commonly reported adverse events were abdominal pain by 23.2% of the diclofenac/misoprostol patients and 19.8% of the diclofenac patients; diarrhea by 19.9% and 11.3%; nausea by 11.8% and 6.5%; dyspepsia by 11.2% and 7.8%; and flatulence by 8.0% and 3.1%. Other adverse events, reported by similar proportions of both treatment groups, included headache, gastritis, dizziness, vomiting, and constipation. In the diclofenac/misoprostol-treated patients, the abdominal pain and diarrhea were rated mild in 30.6% and 24.3%, moderate in 49.1% and 51.4%, and severe in 20.2% and 24.3%. Serious adverse events occurred in eight of the diclofenac/misoprostol-treated patients and in 13 of the diclofenac-treated patients; 12.6% and 10.1%, respectively, were withdrawn from the study because of adverse events. Results of laboratory tests of hepatic and renal function were similar in the two treatment groups.