Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection

Summary

To compare the efficacy of Helicobacter pylori (HP) eradication with vonoprazan dual and triple therapy regimens versus lansoprazole triple therapy regimen in participants with HP infection, excluding participants who had a clarithromycin or amoxicillin resistant strain of HP at baseline.

Timeline

Start

2019-12-10

Primary completion

2021-03-10

Completion

2021-03-18

Outcome

Met primary endpoint

registry analysis (non-inferiority test); Vonoprazan Dual Therapy vs Lansoprazole Triple Therapy; p = 0.0037; Percentage Difference -0.3 (95% CI -7.39 to 6.76); Farrington and Manning test NCT04167670 ↗

registry analysis (non-inferiority test); Vonoprazan Triple Therapy vs Lansoprazole Triple Therapy; p <0.0001; Percentage Difference 5.9 (95% CI -0.75 to 12.62); Farrington and Manning test NCT04167670 ↗

paper Primary outcome eradication rates (nonresistant strains): vonoprazan triple therapy 84.7%, dual therapy 78.5%, vs lansoprazole triple therapy 78.8% (both noninferior; PMID 35679950 ↗

Publications

• Megraud F, Graham DY, Howden CW, Trevino E, Weissfeld A, Hunt B, Smith N, Leifke E, Chey WD. Rates of Antimicrobial Resistance in Helicobacter pylori Isolates From Clinical Trial Patients Across the US and Europe. Am J Gastroenterol. 2023 Feb 1;118(2):269-275. doi: 10.14309/ajg.0000000000002045. Epub 2022 Sep 30.
• Chey WD, Megraud F, Laine L, Lopez LJ, Hunt BJ, Howden CW. Vonoprazan Triple and Dual Therapy for Helicobacter pylori Infection in the United States and Europe: Randomized Clinical Trial. Gastroenterology. 2022 Sep;163(3):608-619. doi: 10.1053/j.gastro.2022.05.055. Epub 2022 Jun 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amoxicillin	Other / unclassified	1 g	Oral
Subject	Clarithromycin	Small molecule	500 mg	Oral
Comparator	Lansoprazole	Other / unclassified	30 mg	Oral
Subject	Vonoprazan	Other / unclassified	20 mg	Oral

Indications