TERAPIA DI MANTENIMENTO PER UN ANNO CON ANTI-H2 NELL'ULCERA PEPTICA DELL'ANZIANO: IMPORTANZA DELLA SINTOMATOLOGIA COME MARKER DI RECIDIVA

With the aim of evaluating the efficacy, safety and compliance of the long-term treatment with ranitidine (R) and nizatidine (N) for gastric ulcer (GU) and duodenal ulcer (DU) and to identify the presence of markers for relapse of the disease in elderly patients, a randomized, double-blind study was performed in 202 subjects over age 65 (141 with DU and 61 with GU) endoscopically diagnosed in scar phase in 49 G.I. endoscopic centers. All patients were treated in double-blind with R or N 150 mg/day for 6 months and successively the healed patients were treated, in open, for another 6 months with N 150 mg/die. Clinical controls were performed every 3 months while the endoscopic and biochemical controls were scheduled after 6 and 12 months. After 6 months of therapy, relapse rates were 1.75% for GU and 9.30% for DU: no differences were observed between N and R. After 12 months cumulative relapse rates were 6.97% for GU and 26.08% for DU. Adverse side effects were very rare and the compliance was good also in subjects who were treated with different drugs plus H2-blockers (29.8% of GU and 27.1% of DU patients). DU patients with relapse in the first 6 months period had significantly more gastric pain (p < 0.0001), pyrosis (p = 0.001), nausea (p < 0.0001) and vomiting (p < 0.0001) than DU healed patients. These symptoms were also present in DU subjects with relapse during the second 6 months follow up period. In conclusion R and N 150 mg/day resulted both effective and safe for the longterm treatment in the elderly; the presence of epigastric pain, pyrosis, nausea and vomiting in DU elderly patients during maintenance H2-blockers therapy strongly suggests relapse of the disease.