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Randomised trial of acid inhibition by vonoprazan 10/20 mg once daily vs rabeprazole 10/20 mg twice daily in healthy Japanese volunteers (SAMURAI pH study).
Takeuchi, T, Furuta, T, Fujiwara, Y, Sugimoto, M, Kasugai, K, Kusano, M, Okada, H, Suzuki, T, Higuchi, T, Kagami, T, et al
Alimentary pharmacology & therapeutics. 2020;(5):534-543
Abstract
BACKGROUND Vonoprazan (V), a potassium-competitive acid blocker, has a more durable acid-inhibitory effect as compared with standard-dose proton pump inhibitors (PPIs) but has not been compared with 2-4 times higher daily PPI doses administered in two divided doses. AIMS To evaluate the acid-inhibitory effect of V 10/20 mg once-daily (OD; V10/V20) vs rabeprazole (R) 10/20 mg twice-daily (BID; R20/R40) in healthy Japanese volunteers. METHODS This multicentre, randomised, open-label, two-period, crossover study compared V10 or V20 vs R20, or V20 vs R40 using three cohorts of 10 healthy Japanese adults. Within each cohort, subjects were randomised to receive V or R for 7 days and, following a washout period ≥7 days, the other treatment for 7 days. On day 6 of each period, 24-hours multichannel gastric impedance-pH monitoring was performed. Percent times pH ≥ 3, ≥4 and ≥5 (pH 3, 4 and 5 holding time ratios [HTRs]) in 24 hours were evaluated as primary pharmacodynamic endpoints. RESULTS Acid-inhibitory effect (24-hours pH 3 HTR) of V20 was greater than those of R20 (91.0% vs 65.3%; P = .0049) and R40 (98.5% vs 85.9%; P = .0073). Similar results were obtained for 24-hours pH 4 and 5 HTRs. V20 also achieved greater nocturnal pH 4 (91.5% vs 73.2%; P = .0319) and 5 HTRs (78.8% vs 62.2%; P = .0325) as compared with R40. One subject (20%) developed diarrhoea while receiving R40 which was considered treatment-related. CONCLUSIONS Compared with 2-4 times the standard daily dose of R, V20 exerts a more potent and durable acid-inhibitory effect. Trial identifier: UMIN000022198 (www.umin.ac.jp/ctr/index.htm).
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Oral pantoprazole in the form of granules or tablets are pharmacodynamically equivalent in suppressing acid output in patients with gastro-oesophageal reflux disease and a history of erosive oesophagitis.
Hogan, D, Pratha, V, Riff, D, Ducker, S, Schwartz, H, Soffer, E, Wang, W, Rath, N, Comer, GM
Alimentary pharmacology & therapeutics. 2007;(2):249-56
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Abstract
AIM: To demonstrate the pharmacodynamic comparability between oral 40 mg pantoprazole delayed-release granules and tablets. METHODS This was a multicentre, randomized, open-label, 2-period, 2-sequence, 9-week crossover study in patients aged 18-65 years with gastro-oesophageal reflux disease and documented erosive oesophagitis. The primary endpoint was a comparison of the inhibition of pentagastrin-stimulated maximum acid output (MAO) at steady state after once daily dosing for 1 week and 23 h after the last dose of pantoprazole granules and tablets. Basal acid output was measured prior to MAO. Standard safety evaluations were performed. The one-sided t-test was used to test the null hypothesis that granules - 1.2 x tablet ≥ 0 against the alternative hypothesis that this difference was <0 for both MAO and basal acid output values. RESULTS Sixty patients completed the study. The mean MAO values were 7.11 +/- 4.98 and 7.29 +/- 4.77 mmol/h, while the mean basal acid output values were 0.74 +/- 0.91 and 0.58 +/- 0.63 mmol/h for the granules and tablets, respectively. The two formulations were shown statistically to be pharmacodynamically equivalent in suppressing MAO (P = 0.006), safe and well tolerated. CONCLUSION Patients with gastro-oesophageal reflux disease who are unable to swallow the tablet may safely be prescribed the pantoprazole sodium granules.
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Comparison of two antacid preparations on intragastric acidity--a two-centre open randomised cross-over placebo-controlled trial.
Sulz, MC, Manz, M, Grob, P, Meier, R, Drewe, J, Beglinger, C
Digestion. 2007;(2-3):69-73
Abstract
BACKGROUND Rennie and Riopan Gel are 2 of the most well-known and popular over-the-counter antacids; for heartburn symptoms, pain relief is fast with both preparations. A direct comparison with respect to intragastric acidity has not been done yet. The aim of our study was therefore to compare the effects of both preparations on intragastric acidity of fasting volunteers. METHODS The study was conducted as an open, randomised, placebo-controlled, 2-centre cross-over study. On different days, 24 healthy adult volunteers (11 males and 13 females) received equimolar acid-neutralising amounts of either Riopan Gel (800 mg magaldrate) or 2 tablets of Rennie (680 mg calcium carbonate and 80 mg magnesium carbonate) or no drug (control) with a wash-out period of at least 4 days between applications. The intragastric pH was measured for 3 h by intragastric pH-metry. The primary endpoint was the median time lag before intragastric pH >3.0 was reached for 10 consecutive min after drug administration. RESULTS For both antacids, the median pH during the first 30 min after drug administration was statistically significantly different from placebo (p < 0.05), but there was a statistically significant increase in pH during the first 5 min for Riopan Gel only. CONCLUSION Compared to placebo, both antacids (Rennie and Riopan Gel) have short-lasting effects on intragastric acidity. There is no statistically significant difference between the 2 preparations, except in the first 5 min, indicating a faster onset of action for Riopan Gel. We conclude that the antacid formulation (tablet or liquid) has little influence on intragastric acidity.
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Intragastric acid control in non-steroidal anti-inflammatory drug users: comparison of esomeprazole, lansoprazole and pantoprazole.
Goldstein, JL, Miner, PB, Schlesinger, PK, Liu, S, Silberg, DG
Alimentary pharmacology & therapeutics. 2006;(8):1189-96
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BACKGROUND Studies to date have not directly compared the pharmacodynamic efficacies of different proton pump inhibitors in controlling intragastric acidity in patients treated with non-steroidal anti-inflammatory drugs. AIM: To compare acid suppression with once-daily esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg in patients receiving non-selective or cyclo-oxygenase-2-selective non-steroidal anti-inflammatory drug therapy. METHODS In this multicentre, open-label, comparative, three-way crossover study, adult patients (n = 90) receiving non-steroidal anti-inflammatory drugs were randomized to one of six treatment sequences. At the study site, patients were administered esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg for 5 days each, with a washout period of > or =10 days between each treatment. Twenty-four-hour pH testing was performed on day 5 of each dosing period. RESULTS The mean percentage of time during the 24-h pH monitoring period that gastric pH was >4.0 was significantly greater with esomeprazole (74.2%) compared with lansoprazole (66.5%; P < 0.001) and pantoprazole (60.8%; P < 0.001), and significantly greater with esomeprazole (P < 0.05) than with the comparators regardless of whether using non-selective vs. cyclo-oxygenase-2-selective non-steroidal anti-inflammatory drugs. CONCLUSIONS At the doses studied, esomeprazole treatment provides significantly greater gastric acid suppression than lansoprazole or pantoprazole in patients receiving non-selective or cyclo-oxygenase-2-selective non-steroidal anti-inflammatory drugs.