MULTICENTER CLINICAL-TRIAL OF ZINC ACEXAMATE IN THE PREVENTION OF NONSTEROIDAL ANTIINFLAMMATORY DRUG-INDUCED GASTROENTEROPATHY

Objective. To assess in a multicenter double blind clinical trial the gastroenteroprotective effect of zinc acexamate (ZAC). Methods. 276 pa tients with rheumatic disease and history of peptic ulcer or intoleran ce to nonsteroidal antiinflammatory drugs (NSAID), and requiring treat ment with these drugs were included. An initial normal endoscopy was n eeded for inclusion. Patients were treated with one NSAID (diclofenac, piroxicam, naproxen or ketoprofen) and one capsule (300 mg) of either ZAC (141 patients) or placebo (135 patients) at single nocturnal dose . After 28 days, patients underwent a clinical and endoscopic control. Results. 26 patients withdrew from the trial (10 of ZAC and 16 of pla cebo) and 41 were lost to followup (22 of ZAC and 19 of placebo). Gast roduodenal mucosal damage was graded according to a modified Lanza sco re. The incidence of gastric ulcer was null with ZAC and 6.0% with pla cebo (6 cases) (p < 0.05). The incidence of duodenal ulcer was 0.9% wi th ZAC (1 case) and 6.0% with placebo (6 cases) (p < 0.05). Overall ul cer incidence was 0.9% with ZAC (1 case) and 12% with placebo (12 case s) (p < 0.001). Nine patients of ZAC group (8%) and 25 of placebo (25% ) presented some gastric damage (p < 0.001), and 5 (5%) and 19 (19%) r espectively presented some duodenal damage (p < 0.005). After treatmen t, 88% of patients treated with ZAC and 66% with placebo had a complet ely normal endoscopy (p < 0.0005). No major side effects were reported through the study.Conclusion. ZAC has shown to be effective and well tolerated for the prevention of NSAID induced gastroduodenal damage in patients with rheumatic disease at risk. The incidence of gastric and duodenal ulcers decreased in 92% (13 times the risk), when compared t o placebo.