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Deprecated: Implicit conversion from float 278.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Aliment+Pharmacol+Ther 2015 ; 42 (6): 685-95 Nephropedia Template TP
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Randomised clinical trial: a dose?ranging study of vonoprazan, a novel potassium?competitive acid blocker, vs lansoprazole for the treatment of erosive oesophagitis #MMPMID26201312
Aliment Pharmacol Ther 2015[Sep]; 42 (6): 685-95 PMID26201312show ga
Background: The potassium?competitive acid blocker vonoprazan (VPZ) has potent acid?inhibitory effects and may offer clinical advantages over conventional therapy for acid?related disorders. Aim: To investigate the efficacy and safety of VPZ in patients with erosive oesophagitis (EO). Methods: In this multicentre, randomised, double?blind, parallel?group, dose?ranging study, patients ?20 years with endoscopically confirmed EO [Los Angeles (LA) grades A?D] received VPZ 5, 10, 20 or 40 mg, or lansoprazole (LPZ) 30 mg once daily for 8 weeks. The primary endpoint was the proportion of healed EO subjects as shown by endoscopy at week 4. Results: A total of 732 subjects received VPZ or LPZ. The proportion of healed EO subjects at week 4 was 92.3%, 92.5%, 94.4%, 97.0% and 93.2%, respectively, with VPZ 5, 10, 20 and 40 mg and LPZ 30 mg. All VPZ doses were non?inferior to LPZ when adjusted for baseline LA grades A/B and C/D. Among those with LA grades C/D, the proportions of healed EO subjects were 87.3%, 86.4%, 100%, 96.0% and 87.0%, respectively, with VPZ 5, 10, 20 and 40 mg and LPZ 30 mg. The incidence of adverse events was similar across the groups. Conclusions: Vonoprazan was effective and non?inferior to LPZ in healing EO. VPZ 20 mg or higher was highly efficacious for severe EO (LA grades C/D). VPZ was associated with no safety concern during this 8?week study, while there was a dose?dependent increase in serum gastrin. Once?daily VPZ 20 mg is the recommended clinical dose for treating EO.