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Vonoprazan effective as part of H. pylori eradication therapy
Vonoprazan, a novel potassium-competitive acid blocker, was effective and well tolerated as a component of first- and second-line triple therapies for eradicating Helicobacter pylori in patients with a history of gastric or duodenal ulcer, according to recent data published in Gut.
“Given the increasing resistance to clarithromycin and/or metronidazole and the declining rates of clinical response to [proton pump inhibitor]-based triple therapy that have become a globally compelling issue, vonoprazan may represent a novel option as a component of triple therapy for H. pylori eradication,” the researchers wrote.
In a randomized, double blind, multicenter, parallel-group study, researchers examined the safety, efficacy and tolerability of vonoprazan (Takecab, Takeda Pharmaceuticals) as part of H. pylori eradication therapy.
A total of 641 H. pylori-positive patients with a history of gastric or duodenal ulcer completed first-line triple therapy. The first 50 patients who failed first-line therapy and had good compliance completed open-label second-line vonoprazan-based triple therapy.
For the first-line therapy, vonoprazan 20 mg was compared with lansoprazole 30 mg (Prevacid, Takeda Pharmaceuticals) as part of a triple therapy further composed of amoxicillin 750 mg (Moxatag, Pragma Pharmaceuticals) and clarithromycin 200 mg or 400 mg (Biaxin XL, Abbott Laboratories). Second-line therapy components included vonoprazan 20 mg, amoxicillin 750 mg and metronidazole 250 mg (Metrogel, Galderma Laboratories).
Vonoprazan was shown to be noninferior to lansoprazole in first-line therapy with an H. pylori eradication rate of 92.6%, vs. an eradication rate of 75.9% with lansoprazole (P < .0001). The eradication rate was 98% in the 50 patients who underwent the second-line triple therapy. There were no notable difference in tolerance between the two groups randomly assigned the first-line triple therapies, and vonoprazen was also well tolerated in those who received second-line therapy.
“Study results demonstrated the non-inferiority of vonoprazan-based first-line triple therapy to lansoprazole-based first-line triple therapy with a non-inferiority margin of 10% (P < .0001),” the researchers wrote. “Furthermore, the eradication rate was shown to be 16.7% higher with vonoprazan-based first-line triple therapy than with lansoprazole-based first-line triple therapy and the 95% CI at the lower limit showed that the eradication rate was 11.2% better with vonoprazan-based first-line triple therapy, suggesting a statistically significant difference in favor of vonoprazan.” – by Suzanne Reist
Disclosures: Murakami reports he is an independent medical consultant providing expert advice to Takeda Pharmaceuticals. Please see the full study for a list of all other researchers’ relevant financial disclosures.