Tegoprazan-Based Triple Therapy for Helicobacter pylori Eradication: A Phase III Multicenter Randomized Clinical...

Area of Science:

• Gastroenterology
• Infectious Diseases
• Pharmacology

Background:

• Potassium-competitive acid blockers (P-CABs) like tegoprazan show promise for potent acid inhibition.
• Improving Helicobacter pylori eradication rates is a key clinical goal.

Purpose of the Study:

• To compare the efficacy and safety of tegoprazan-based triple therapy against lansoprazole for first-line H. pylori eradication.
• To evaluate two different dosing regimens of tegoprazan (50mg and 100mg).

Main Methods:

• A randomized, double-blind, active-controlled, multicenter trial involving 382 treatment-naïve H. pylori-infected adults.
• Patients received 14-day triple therapy with either tegoprazan (50mg or 100mg) or lansoprazole, plus amoxicillin and clarithromycin.
• The primary endpoint was the H. pylori eradication rate in the modified intention-to-treat (mITT) population.

Main Results:

• Eradication rates were 86.0% for tegoprazan 50mg, 85.5% for tegoprazan 100mg, and 78.7% for lansoprazole.
• Both tegoprazan regimens met non-inferiority criteria compared to lansoprazole.
• Higher eradication rates were observed with tegoprazan in clarithromycin-resistant cases, though not statistically significant. Safety profiles were comparable.

Conclusions:

• Tegoprazan-based triple therapies (50mg and 100mg) are non-inferior to lansoprazole-based therapy for H. pylori eradication.
• These regimens are well-tolerated and represent a viable first-line treatment option.
• Further investigation into tegoprazan's efficacy in clarithromycin-resistant H. pylori may be warranted.