Vonoprazon

1. Vonoprazan Triple and Dual Therapy
for Helicobacter pylori Infection in
the United States and Europe:
Randomized Clinical Trial
Gastroenterology 2022;163:3
Published on 6 June 2022
MODERATOR: Dr. K Romeo Singh
PRESENTER: Dr. P Kireeti

2. INTRODUCTION
• H. pylori is a leading cause of peptic ulcer, gastric
adenocarcinoma, gastric MALT lymphoma
• Treatment is by PPI based antibiotic therapy
• Eradication rates dropped to <80%, mainly due to
clarithromycin resistance
• Antibiotic action is influenced by intragastric pH, so
sustained control of pH may improve eradication rates

3. OBJECTIVE
• To evaluate the efficacy of vonoprazan, a
potassium-competitive acid blocker, vs
standard treatment on H pylori eradication in
the United States and Europe.

4. METHODS
• STUDY DESIGN : randomized controlled, phase 3 trial
• STUDY SETTING: multiple sites in the US and
Europe
• STUDY DURATION :2 yrs, Dec 2019 to Feb 2022
• SAMPLE SIZE: 1046 , 349- vonoprazan triple therapy,
349- vonoprazan dual, 348- lansoprazole triple therapy

5. INCLUSION CRITERIA
• ≥18 years old and had at least 1 of the following :
• dyspepsia;
• a recent/new diagnosis of non bleeding peptic ulcer;
• history of peptic ulcer not previously treated for H pylori
infection; H pylori infection diagnosed with a positive
13C-urea breath test (UBT)

6. EXCLUSION CRITERIA
• Patients with
• gastric cancer,
• gastric or duodenal ulcer with current or recent
bleeding,
• GI bleeding within 4 weeks of randomization

7. PROCEDURE
• Patients were randomly assigned 1:1:1 to
• Vonoprazan dual therapy (vonoprazan 20 mg BD and
amoxicillin 1 g TDS),
• Triple therapy with either vonoprazan 20 mg twice daily,
or lansoprazole 30 mg BD, each given with amoxicillin 1
g BD, and clarithromycin 500 mg BD for 14 days.
• H pylori status was assessed by 13C-UBT at week 6

10. OUTCOMES
• PRIMARY OUTCOME
• Noninferiority in eradication rates in patients
without clarithromycin- and amoxicillin-resistant
strains
• SECONDARY OUTCOME
• Superiority in eradication rates in clarithromycin-
resistant infections

11. STATISTICAL ANALYSIS
• Farrington and Manning test with a non inferiority
margin of 10% for the primary and secondary outcomes
• All statistical tests were 2-sided, with 95% CI and a
significance level of 0.05 (P value)
• Statistical analyses were performed using SAS for
Windows, version 9.4

12. RESULTS
• Primary outcome – eradication rates in non
resistant strains
• Vonoprazan triple therapy -84.7%
• Lansoprazole dual therapy-78.5%
• Lansoprazole triple therapy-78.8%
• Secondary outcome-eradication rates in resistant
strains strains
• Vonoprazan triple therapy - 65.8%
• Lansoprazole dual therapy- 69.6%
• Lansoprazole triple therapy-31.9%
• Frequency of TEAEs was similar between
vonoprazan and lansoprazole regimens

16. LIMITATIONS
• Previously treated pts are not included
• Study sites were not evenly distributed geographically
across the US and included only 5 European countries,
thus limiting generalizability to other geographic
regions
• The data were not adjusted for biases associated with
multiple sites

18. DISCUSSION
• Vonoprazan is a potassium-competitive acid blocker,
currently approved for the treatment of H pylori
infection and other acid-related diseases in several
countries. It ↑ intragastric pH rapidly and potently and
maintains it to a greater degree than PPIs; this has been
associated with higher H pylori eradication rates

19. • Optimizing current regimens offers the potential to
increase eradication rates and reduce additional antibiotic
usage, thereby promoting and improving antimicrobial
stewardship
• Vonoprazan therapy had the higher eradication rate and a
greater therapeutic gain over lansoprazole therapy
• All regimens were generally well tolerated. Most TEAEs
were mild to moderate in severity. Serious TEAEs were
uncommon and none was considered related to study
drugs.

20. CONCLUSION
• Vonoprazan-based triple and dual regimens were
noninferior and to lansoprazole-based triple therapy
for eradication of H pylori infection

21. THANK YOU