Efficacy and tolerability of pantoprazole versus ranitidine in the treatment of reflux esophagitis and the influence of Helicobacter pylori infection on healing rate

Patients with reflux esophagitis (grade II or III, Savary-Miller, intention-to-treat, n = 256, age range 19-82 years) were randomly assigned to a double-blind, double-dummy treatment with either pantoprazole 40 mg once daily or ranitidine 150 mg twice daily. After 4 weeks, each patient was clinically and endoscopically assessed. Failure to heal required a further 4 weeks of treatment and a new evaluation thereafter. After 4 weeks, healing of lesions was confirmed in 63% (69 out of 109) of patients receiving pantoprazole and in 22% (25 out of 113) receiving ranitidine (P < 0.001, per protocol population). After 8 weeks, the cumulative healing rates were 88% and 46%, respectively (P < 0.001). Complete freedom from esophagitis-related symptoms (acid eructation, heartburn, pain while swallowing) was greater in the pantoprazole than in ranitidine group after 2 and 4 weeks (74% vs. 47%; 87% vs. 52%, respectively, P < 0.001). After 4 weeks, the healing rate was 76% in Helicobacter pylori (Hp)-positive vs. 45% in Hp-negative patients treated with pantoprazole (P < 0.01). the Hp status did not influence healing rates in patients treated with ranitidine. the most frequent adverse events in the pantoprazole group were diarrhea and somnolence (2-3% of patients), and in the ranitidine group, headache, diarrhea, dizziness, increase of liver enzymes and pruritus (2-4% of patients). in conclusion, pantoprazole was more effective than ranitidine in the healing rate and relief from reflux esophagitis-associated symptoms, and Hp infection was associated with higher healing rate during therapy with pantoprazole but not with ranitidine.Med Sch Ribeirao Preto, Dept Med, Div Gastroenterol, Ribeirao Preto, BrazilUniv São Paulo, Med Sch São Paulo, Dept Gastroenterol, São Paulo, BrazilFed Univ Curitiba, Dept Gastroenterol, Curitiba, Parana, BrazilUniversidade Federal de São Paulo, Dept Gastroenterol, São Paulo, BrazilUniv Fed Pernambuco, Dept Gastroenterol, Recife, BrazilUniv Campinas, Dept Gastroenterol, Campinas, BrazilUniv Fed Minas Gerais, Univ Hosp, Gastroenterol & Digest Surg Unit, Belo Horizonte, MG, BrazilUniv Hosp Clementino Fraga Filho, Rio de Janeiro, BrazilHosp Base Setima Regiao Adm Bauru, Bauru, BrazilHosp Governador Celso Ramos, Florianopolis, SC, BrazilHosp Santa Isabel, Blumenau, BrazilClin Hosp Porto Alegre, Dept Gastroenterol, Porto Alegre, RS, BrazilByk Gulden Lomberg GmbH, Constance, GermanyUniversidade Federal de São Paulo, Dept Gastroenterol, São Paulo, BrazilWeb of Scienc