EVALUATION OF THE SAFETY AND EFFICACY ON SYMPTOM RELIEF OF EUPANTOL(R) IN A LARGE POPULATION OF PATIENTS WITH ACID-RELATED DISEASES

Eupantol(R) is a proton pump inhibitor (PPI) that inhibits the gastric H+/K+ ATPase by binding to two key cysteines, A study was conducted t o assess the safety and efficacy in terms of symptom relief of Eupanto l in patients with acid-related diseases, Methods: multicenter, open-l abel study in 1309 patients (intention-to-treat population) selected b y 610 general practitioners and included by 295 gastroenterologists af ter endoscopic documentation of a gastroduodenal ulcer (GU/DU) or of e sophagitis (ES) was obtained, Each patient took Eupantol 40 mg, one ta blet per day for four to eight weeks, with no concomitant antacids. Re sults: typical ulcer-related pain was the most common presenting sympt om (63%) in patients with GU (n=60 per protocol patients) and abated w ithin se-yen days in 95% of cases, In patients with DU (n=197 per prot ocol patients), the most common presenting symptom was also typical ul cer-related pain (69%) which abated within seven days in 90% of cases, The most common presenting symptoms of esophagitis (grade I, 57%; gra de II, 31%, grade III, 7%; and grade IV, 5%; n: 791 per protocol patie nts) were heartburn (76%) and acid regurgitation (73%). In all three d iagnosis groups, median time to symptom relief was three days. In pati ents with ES, time to symptom relief was not influenced by the initial stage of the lesions, and 75% and 89% of patients were free of sympto ms on D7 and D28, respectively. Eupantol(R) was well tolerated. Advers e events were recorded in 13.8% of patients, and one third were consid ered unrelated to the treatment. The most common adverse events were h eadache (2.8%), diarrhea (2.4%), other gastrointestinal symptoms (2.2% ), abdominal pain/distension (1.8%), asthenia (1.5%), nausea/vomiting (1.2%), vertigo (1.2%), and constipation (1.1%). Of the six serious ad verse events, none were considered treatment-related by the investigat ors. Conclusion: this study in a large cohort of patients confirms tha t Eupantol(R) alone provides prompt symptom relief and is very well to lerated.