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Background: Gastroesophageal reflux disease (GERD) has a prevalence of 10% to 20% in the pediatric population. The 24-hour pHmetry is still considered the "gold standard" for its correct diagnosis. Omeprazole is the elective drug for a proper treatment. However, there are no adequate pharmaceutical presentation forms for infants., Objective: To assess the acid suppression capacity of a new pharmaceutical association of omeprazole with sodium bicarbonate and sodium alginate (OBA), powder for oral suspension, in small infants with GERD. The response was measured according to the gastric variations of pH after a 3-day treatment with OBA., Patients and Method: This is a pilot, prospective, open study in infants with no congenital nor associated anomalies under 12 months of age with GERD. Two double channel pHmetry with gastric sensor were performed on different days in the same patient. The first one to establish the diagnosis (day 0) and the second one (day 3) after receiving omeprazole (OBA) at 1.5 mg/kg/day in a twice/dose/day (BID)., Results: The comparison between the frst and the second gastric pHmetry showed a statistically significant reduction in gastric acidity. No adverse events were observed in infants and the suspension flavor was palatable., Conclusions: This new presentation of omeprazole (OBA) with sodium bicarbonate and sodium alginate powder for oral suspension is capable of a significant and intense acid suppression, necessary for treatment of infants with GERD. The taste of the solution was well accepted by all the babies, which is a very important finding for this age group.

Background: Nonerosive reflux disease (NERD) has a chronic and benign course. On-demand therapy would constitute a useful strategy for its management., Objective: To assess efficacy of on-demand treatment with omeprazole powder (OBA: omeprazole 20 mg, sodium bicarbonate 1680 mg, alginic acid 250 mg) versus omeprazole capsules 20 mg (OMZ) in the control of symptoms., Method: In this multicenter, open-label, randomized, crossover study, patients with NERD, of both genders and 21 to 65 years old, were included. They underwent alternate treatments, 42 days with each pharmaceutical form (PF), wash out 6 days, beginning with a cycle of 7 consecutive days after the first symptomatic manifestation and repeating the same cycles in the event of similar circumstances. Efficacy was assessed with patient global impression (PGI), visual analogue scale (VAS) for heartburn and time to relieve symptoms. Tolerability was assessed., Results: Forty-eight patients (40 women, average age 37 years old) entered the study. Both PF were effective according to PGI: 98% with OBA and 92% with OMZ. VAS for heartburn was: baseline 7.29 +/- 1.51; post-OMZ 2.82 +/- 1.85; post-OBA 2.25 +/- 1.61. The percentage of patients who received 7 days' cycles with each treatment were: OMZ 1-2: 29.17%; 3-4: 58.33%; 5-6: 12.5%; OBA 1-2: 43.75%; 3-4: 52.08%; 5-6: 4.17%. Dose was doubled in 35% of cases. OBA acted faster than OMZ for 83% of the patients (87 min versus 140 min, P < 0.01). Both PF were well tolerated., Conclusions: On-demand treatment of NERD with omeprazole in cycles of 7 days was equally effective for both PE OBA acted faster to relieve symptoms.

Objective: To perform meta-analyses of studies on outcome of bleeding ulcers of different proton-pump inhibitors (PPIs) regimens, after stratification of patients by endoscopic stigmata, and analysis of studies with and without endotherapy., Methods: A total of 35 randomized trials comparing PPIs to placebo and/or H2-receptor antagonists (H2RAs) in 4,843 patients with high-risk endoscopic stigmata were retrieved. Outcomes were rebleeding, surgery, and mortality., Results: Monotherapy with oral or bolus PPIs was superior to placebo and H2RAs in reducing rebleeding in both bleeders and nonbleeders at index endoscopy; the need for surgery was reduced only when compared to H2RAs. In nonbleeders, PPI monotherapy was as effective as a combination of endotherapy with H2RAs. A combination of endotherapy with PPIs was superior to monotherapy in reducing bleeding and surgery, and superior to endotherapy alone in minimizing rebleeding, but not surgery; the benefit was lost when confronted to endotherapy plus H2RAs, whether PPIs were given as infusion or bolus. By pooling data from studies comparing high doses of PPIs as continuous infusion versus regular doses as intermittent bolus, rebleeding, surgery, and mortality were not significantly different., Conclusions: Combination of endotherapy with either PPIs or H2RAs is indicated for nonbleeding ulcers at endoscopy with the intent to reduce rebleeding and surgery. Its value may extend to bleeding lesions, but current data are scanty. The benefit appears to be independent from route and doses of PPIs, as oral, bolus, or infusional methods are all effective.

Objective: To compare the acid-supressing capacity of omeprazole (OZ) 20 mg tablets vs pantoprazole (PZ) 20 and 40 mg tablets, in healthy volunteers, with 24-h intragastric pH-metry., Material and Methods: Open, randomized, cross-over trial in 10 healthy volunteers; on days 0.8 and 22, 24-h intragastric pH-metry. Day 0, basal, thereafter 7 days with OZ or PZ 20 mg/day; day 8, pH-metry, then "wash out" for 7 days and thereafter 7 more days' therapy with PZ or OZ. On day 22 a 24-h intragastric pH control was performed again. In the last treatment stage, all of them were administered pantoprazole 40 mg/day for 8 days again with a 24-h pH recording at the end., Results: 24-h pH-metry expressed as the time (hours) in which the pH was < or = 4 and the values as mean +/- standard deviation. BASAL 22.12 +/- 1.54, POST-OZ 9.78 +/- 6.72, POST-PZ 20 15.65 +/- 5.65, POST-PZ 40 8.57 +/- 5.93. Statistical evaluation with two way repeated measures ANOVA p < 0.0001. Newman Keuls post-hoc test: (1) vs (2) p < 0.003; (1) vs (3) p < 0.03; (2) vs (4) 0.65., Conclusions: According to the results it might be stated that both proton pump inhibitors have acid-supressing capacity and omeprazole in equal dosis is more effective than pantoprazole as acid-supressor, with statistically significative differences. There was no difference between 20 mg omeprazole and 40 mg pantoprazole.