RESUMO
OBJECTIVE: The aim of this study was to compare the effectiveness and tolerance of pantoprazole versus ranitidine in the treatment of duodenal ulcers in the Brazilian population. METHODS: A total of 222 patients with active duodenal ulcers (DU) were randomly allocated to a double dummy blind treatment, either with ranitidine (RAN) 300 mg (111, aged from 20-68 yr old, 56 female) or with pantoprazole (PANT) 40 mg (111 patients, 18-70 yr old, 45 female). After a 2-wk course of treatment, each patient was clinically and endoscopically assessed for ulcer healing. Failure to heal required a further 2-wk course of treatment and a new evaluation thereafter. RESULTS: In all, 77 of the 103 patients in the PANT group (74.8%) and 42 of the 94 patients in the RAN group (44.7%) who completed the study had ulcer healing after one 2-wk treatment course, and an additional 23 in the PANT group (22.3%) and 28 in the RAN group (29.8%) after the second 2-wk treatment course, totaling 100 (97.1%) and 70 (74.5%), respectively. Therapeutic gain in favor of pantoprazole was significant both at the end of the first and the second 2-wk treatment course (p<0.001). At 2 wk, symptoms remission was significantly higher in the PANT group (97.6%) than with the RAN group (77.5%) (p<0.001). The Intention-to-treat analysis showed results statistically similar to those observed in the per-protocol analysis. Minor adverse events were reported by four patients in the PANT group and three in the RAN group. No relevant laboratory abnormalities were seen. No patient withdrew from the study due to adverse events. CONCLUSIONS: Our results show that pantoprazole is more effective than ranitidine in the treatment of duodenal ulcer providing faster ulcer healing in most patients (97.1%), in 4 wk. Adverse events were rare and were similar in both groups, and had no influence on the therapeutic outcome.
Assuntos
Antiulcerosos/uso terapêutico , Benzimidazóis/uso terapêutico , Úlcera Duodenal/tratamento farmacológico , Antagonistas dos Receptores H2 da Histamina/uso terapêutico , Ranitidina/uso terapêutico , Sulfóxidos/uso terapêutico , 2-Piridinilmetilsulfinilbenzimidazóis , Adolescente , Adulto , Idoso , Antiulcerosos/efeitos adversos , Benzimidazóis/efeitos adversos , Método Duplo-Cego , Feminino , Antagonistas dos Receptores H2 da Histamina/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Omeprazol/análogos & derivados , Pantoprazol , Ranitidina/efeitos adversos , Sulfóxidos/efeitos adversosRESUMO
Famotidine was compared to ranitidine in a short-term study on the treatment of duodenal ulcer. Famotidine 20 mg. b.i.d., 40 mg. b.i.d. and 40 mg. nocte heal as many ulcer as ranitidine (90.9%, 91.7%, 83.3% and 100% respectively). A single 20 mg. bedtime dose shows to be effective on preventing ulcer recurrence for as long as 48 weeks; the 38% recurrence rate observed with famotidine was statistically different from the 78% observed with placebo. Diarrhoea was the most common complain observed during the short-term trial, followed by sleepiness and headache. The few and small biochemical alterations during the long-term treatment (increase in transaminases, alkaline phosphatase, glucose, BUN) could in no instance be directly related to the substances on use.
Assuntos
Antiulcerosos/uso terapêutico , Úlcera Duodenal/tratamento farmacológico , Ranitidina/uso terapêutico , Tiazóis/uso terapêutico , Ensaios Clínicos como Assunto , Método Duplo-Cego , Famotidina , Feminino , Humanos , Masculino , Distribuição Aleatória , Ranitidina/administração & dosagem , Tiazóis/administração & dosagemRESUMO
Famotidine was compared to ranitidine in a short-term study on the treatment of duodenal ulcer. Famotidine 20 mg. b.i.d., 40 mg. b.i.d. and 40 mg. nocte heal as many ulcer as ranitidine (90.9
, 91.7
, 83.3
and 100
respectively). A single 20 mg. bedtime dose shows to be effective on preventing ulcer recurrence for as long as 48 weeks; the 38
recurrence rate observed with famotidine was statistically different from the 78
observed with placebo. Diarrhoea was the most common complain observed during the short-term trial, followed by sleepiness and headache. The few and small biochemical alterations during the long-term treatment (increase in transaminases, alkaline phosphatase, glucose, BUN) could in no instance be directly related to the substances on use.
RESUMO
Ten patients with uncomplicated duodenal ulcer were given three different therapeutic regimens of antacid experiments II, III and IV, and a control regimen, without antacid, named experiment I. Experiment I consisted of a normal diet with three meals a day; experiment II, III and IV consisted of a diet as in experiment I plus 132,06 mEq, 265,92 mEq or 396,88 mEq respectively of antacid divided in six equal doses given one and three hours after breakfast, lunch and dinner. Having been carefully instructed, the patients were intubated with a gastric tube, which was kept in for five days, receiving in each day one of the aforementioned regimens, in a sequential order. The fifth day was reserved for the augmented Histalog test. Each hour from 8 a.m. to 10 p.m., in the first four days, a sample of the gastric juice was aspirated for pH measurement. The statistical evaluation of the acidity of the samples at different times showed that experiment III (265,92 mEq antacid/day) was able to keep the pH over 3 for longer periods of time when compared with experiments I and II and not different from experiment IV. The present investigation emphasize the necessity of clinical trials comparing therapeutic regimens of antacid with different neutralizing capacity, in order to find the most effective dose in the treatment of duodenal ulcer.