RESUMO
BACKGROUND: Pantoprazole is a benzimidazole derivative which selectively inhibits the proton pump H+, K+-ATPase, necessary for the final step in gastric acid secretion. AIM: To assess safety and efficacy of oral pantoprazole (40 mg o.d.) used as a prophylaxis against relapse in patients with healed reflux oesophagitis during an open-label, 2-year study. METHODS: Outpatients (n=157) with healed stage II or III reflux oesophagitis (Savary-Miller classification) were enrolled into a long-term, multicentre maintenance study. Endoscopy was performed at entry into the study, after 12 and 24 months, or when disease-specific symptoms occurred on more than three consecutive days. Symptoms were assessed at 3-monthly intervals. Endoscopically confirmed relapses (at least stage I) were evaluated as treatment failures. RESULTS: Of the 178 adverse events, experienced by 88 (56%) patients (intention-to-treat population), 12 (7%) were assessed by the investigators as possibly related to the study medication. Median serum gastrin levels increased from a baseline of 46 ng/L to 90 ng/L, reaching a plateau after 9 months. For the intention-to-treat population the endoscopic remission rates after 12 and 24 months were 87% and 76%, respectively (Life-Table survival analysis, Kaplan-Meier). CONCLUSION: Pantoprazole 40 mg proved to be safe and efficacious during a 2-year prophylaxis treatment in patients with healed reflux oesophagitis.
Assuntos
Antiulcerosos/uso terapêutico , Benzimidazóis/uso terapêutico , Inibidores Enzimáticos/uso terapêutico , Esofagite Péptica/prevenção & controle , Inibidores da Bomba de Prótons , Sulfóxidos/uso terapêutico , 2-Piridinilmetilsulfinilbenzimidazóis , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antiulcerosos/efeitos adversos , Benzimidazóis/efeitos adversos , Inibidores Enzimáticos/efeitos adversos , Feminino , Seguimentos , Humanos , Tábuas de Vida , Masculino , Pessoa de Meia-Idade , Omeprazol/análogos & derivados , Pantoprazol , Recidiva , Sulfóxidos/efeitos adversos , Fatores de TempoRESUMO
BACKGROUND: Pantoprazole is a substituted benzimidazole which is a potent inhibitor of gastric acid secretion by its action upon H+, K+-ATPase. METHODS: Pantoprazole 40 mg and 80 mg were compared in a randomized double-blind study in 192 out-patients with stage II or III (Savary-Miller classification) reflux oesophagitis. Patients received either pantoprazole 40 mg (n = 97) or pantoprazole 80 mg (n = 95), once daily before breakfast for 4 weeks. Treatment was extended for a further 4 weeks if the oesophagitis had not healed. RESULTS: After 4 weeks complete healing of the reflux oesophagitis was seen in 78% of protocol-correct patients given pantoprazole 40 mg daily (n = 86), and in 72% in the 80 mg (n = 87) group. The cumulative healing rates after 8 weeks were 95 and 94%, respectively (P > 0.05, Cochran-Mantel-Haenszel), and time until healing of oesophagitis comparable in both groups. Differences between doses were also not significant in an intention-to-treat analysis. Both dosing schedules were well tolerated and the patients experienced remarkable symptom relief. No adverse event or changes in laboratory values of clinical significance could definitely be ascribed to the trial medication. CONCLUSION: The 40 mg pantoprazole dosage is comparable to 80 mg in reflux oesophagitis, both in efficacy and tolerability.
Assuntos
Benzimidazóis/administração & dosagem , Benzimidazóis/uso terapêutico , Inibidores Enzimáticos/administração & dosagem , Inibidores Enzimáticos/uso terapêutico , Esofagite Péptica/tratamento farmacológico , Inibidores da Bomba de Prótons , Sulfóxidos/administração & dosagem , Sulfóxidos/uso terapêutico , 2-Piridinilmetilsulfinilbenzimidazóis , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Benzimidazóis/efeitos adversos , Método Duplo-Cego , Inibidores Enzimáticos/efeitos adversos , Esofagite Péptica/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Omeprazol/análogos & derivados , Pantoprazol , Sulfóxidos/efeitos adversosRESUMO
UNLABELLED: Sucralfate binds with denuded protein to form a stable complex to protect the damaged mucosa. By utilising this property, technetium-99m-labelled sucralfate can be used to demonstrate ulceration in the upper gastro-intestinal tract. AIM: The aim of this study was to evaluate 99mTc-labelled sucralfate in the diagnosis of grade II-III reflux oesophagitis. METHODS: Ten patients with endoscopic proof of grade II-III reflux oesophagitis and 10 patients with normal findings on oesophagoscopy were evaluated after they had swallowed 5 ml 99mTc sucralfate. Radionuclide imaging was done until activity in the oesophagus had ceased. RESULTS: Retention of activity from 10 minutes up to 1 1/2 hours could be demonstrated in 9 patients with endoscopically proven oesophagitis. In the control group complete clearance of activity was seen in 7 patients. Gastro-oesophageal reflux could be demonstrated in 4 patients. CONCLUSION: In conclusion we found 99mTc sucralfate to be a sensitive and specific method for the non-invasive diagnosis of grade II or grade III oesophagitis when compared with endoscopy [corrected].