Randomised Clinical Trial

Vonoprazan Versus Lansoprazole for the Initial Relief of Heartburn in Patients With Erosive Oesophagitis

Tadayuki Oshima; Eitatsu Arai; Masato Taki; Takashi Kondo; Toshihiko Tomita; Hirokazu Fukui; Jiro Watari; Hiroto Miwa

Disclosures

Aliment Pharmacol Ther. 2019;49(2):140-146. 

In This Article

Abstract and Introduction

Abstract

Background: Proton pump inhibitors (PPIs) are widely used to treat gastro-oesophageal reflux disease (GORD). However, the onset of action is considered slow and PPIs cannot completely block acid secretion at night. A new potassium-competitive acid blocker (P-CAB) can rapidly block acid secretion. However, whether this P-CAB can relieve GORD symptoms quickly and adequately soon after starting treatment is unknown.

Aim: To determine how rapidly vonoprazan and lansoprazole provide heartburn relief.

Methods: Patients (n = 32) with endoscopically confirmed erosive oesophagitis who experienced heartburn at least once a week were randomised in a double-blind manner to receive either daily vonoprazan (20 mg) or lansoprazole (30 mg) before breakfast for 14 days. Day time and night time heartburn were assessed daily throughout the study using a five-point Likert scale. The primary endpoint was the first day of complete day and night heartburn relief for at least seven consecutive days. The ethics committees of the participating institutions approved the study protocol.

Results: Heartburn was relieved sooner with vonoprazan than with lansoprazole (P < 0.05, log-rank test). Heartburn was completely relieved in 31.3% and 12.5% of patients on day 1 with vonoprazan and lansoprazole, respectively. Significantly more patients achieved complete nocturnal heartburn relief with vonoprazan than lansoprazole (P < 0.01). Both regimens were well tolerated.

Conclusions: Complete sustained heartburn relief was achieved sooner with vonoprazan than with lansoprazole during the first week of therapy. (UMIN000018776)

Introduction

Gastro-oesophageal reflux disease (GORD) is highly prevalent worldwide, and it adversely affects the quality of life (QOL) of patients.[1] Proton pump inhibitors (PPIs) have been used for over two decades as a first-line treatment for GORD, but some issues require improvement.[2,3] The maximal effects take several days,[4–6] GORD symptoms are not sufficiently relieved after the first dose of PPIs in two-thirds of patients because of a slow onset of action[7,8] and half of all patients remain symptomatic even after 3 days of treatment.[8] Furthermore, PPIs cannot completely block acid secretion at night[9–11] and heartburn occurs at night as well as during the day. A nationwide telephone survey found that symptoms affected sleep in 79% of 1000 adults who experience heartburn at least once a week, and that the ability to function during the following day was problematic in 40% of them.[12] Furthermore, 71% of those with night time heartburn were using over-the-counter medications, but only 29% rated this approach as effective.[12] Heartburn at night also disturbs sleep and worsens the QOL of patients with GORD.[13]

Therefore, GORD symptoms should be relieved during the night and as quickly as possible. The new potassium-competitive acid blocker (P-CAB), vonoprazan, can rapidly block acid secretion and is now marketed in Japan. However, whether it can relieve GORD symptoms quickly and adequately soon after starting treatment is unknown.[14] Therefore, we compared how rapidly vonoprazan and the ordinal PPI, lansoprazole, can provide heartburn relief within 2 weeks of treatment.

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