Arthrotec: a therapeutic option in the management of arthritis.

Arthrotec (Searle) is a new concept in NSAID therapy that provides powerful anti-inflammatory efficacy with enhanced upper GI safety. Arthrotec comprises an enteric-coated core of diclofenac sodium (50 mg) surrounded by a mantle of misoprostol (200 mcg). Two multicentre trials evaluated the efficacy of Arthrotec in rheumatoid arthritis (RA) and osteoarthritis (OA) patients who were randomised to receive either Arthrotec or diclofenac. The results of all arthritis assessments showed Arthrotec to be as effective as diclofenac in treating the signs and symptoms of RA and OA. Two endoscopic studies compared the antiarthritic efficacy and gastroduodenal safety of Arthrotec and diclofenac. In a 12-week study of RA patients, the antiarthritic efficacy of Arthrotec was equivalent to diclofenac; in addition, 60% fewer patients taking Arthrotec experienced ulcers than did those taking diclofenac (4.4% Arthrotec vs 11.1% diclofenac: P = 0.034). In a 4-week study of OA patients, Arthrotec's efficacy was equivalent to that of diclofenac and the Arthrotec group developed no ulcers, while 3.6% of the diclofenac group had ulcers (P = 0.015). In a trial conducted to compare the efficacy and upper gastroduodenal safety of Arthrotec with those of piroxicam and naproxen, patients with OA received either Arthrotec BID piroxicam 10 mg BID, or naproxen 375 BID for 4 weeks. Arthritis assessments showed Arthrotec to be at least as effective as piroxicam and naproxen in treating OA. Post-treatment endoscopy data indicated that gastroduodenal ulcers developed in 1.5% of patients receiving Arthrotec, 10.3% of patients receiving piroxicam, and 8.6% patients in the naproxen group.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes