title: Efficacy and tolerability of pantoprazole versus ranitidine in the treatment of reflux esophagitis and the influence of Helicobacter pylori infection on healing rate.
abstract: 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.
authors.affiliation: Division of Gastroenterology, Department of Medicine, Medical School of Ribeirão Preto, Brazil. ugmenegh@fmrp.usp.br
authors.forename: U G
authors.initials: UG
authors.lastname: Meneghelli
authors.forename: S
authors.initials: S
authors.lastname: Boaventura
authors.forename: J P P
authors.initials: JP
authors.lastname: Moraes-Filho
authors.forename: O
authors.initials: O
authors.lastname: Leitão
authors.forename: A P
authors.initials: AP
authors.lastname: Ferrari
authors.forename: J R
authors.initials: JR
authors.lastname: Almeida
authors.forename: A F N
authors.initials: AF
authors.lastname: Magalhães
authors.forename: L P
authors.initials: LP
authors.lastname: Castro
authors.forename: M T
authors.initials: MT
authors.lastname: Haddad
authors.forename: M
authors.initials: M
authors.lastname: Tolentino
authors.forename: J L
authors.initials: JL
authors.lastname: Jorge
authors.forename: E
authors.initials: E
authors.lastname: Silva
authors.forename: I
authors.initials: I
authors.lastname: Maguilnik
authors.forename: R
authors.initials: R
authors.lastname: Fischer
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004942:Esophagitis, Peptic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000150:complications* / Q000175:diagnosis; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000031:analogs & derivatives; D000077402:Pantoprazole; D011336:Probability; D011899:Ranitidine / Q000008:administration & dosage* / Q000009:adverse effects; D018570:Risk Assessment; D013454:Sulfoxides / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects / Q000502:physiology
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D001562:Benzimidazoles; D013454:Sulfoxides; D011899:Ranitidine; D000077402:Pantoprazole; D009853:Omeprazole