Format

Send to

Choose Destination
Aliment Pharmacol Ther. 2015 Sep;42(6):685-95. doi: 10.1111/apt.13331. Epub 2015 Jul 22.

Randomised clinical trial: a dose-ranging study of vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the treatment of erosive oesophagitis.

Author information

1
Rakuwakai Otowa Hospital, Kyoto, Japan.
2
Takeda Pharmaceutical Company Ltd., Osaka, Japan.
3
Osaka University Graduate School of Medicine, Osaka, Japan.
4
Kobe University Graduate School of Medicine, Kobe, Japan.
5
Nippon Medical School Graduate School of Medicine, Tokyo, Japan.
6
Graduate School of Medicine and Faculty of Medicine, Kyoto University, Kyoto, Japan.

Abstract

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.

PMID:
26201312
PMCID:
PMC5014135
DOI:
10.1111/apt.13331
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Wiley Icon for PubMed Central
Loading ...
Support Center