Tegoprazan matches lansoprazole for preventing NSAID-related peptic ulcers over 24 weeks

Source

Source: Extracted PubMed-style abstract for Kim SG et al. in Gut Liver, reporting a phase III randomized, double-blind, active-controlled, multicenter trial of tegoprazan vs lansoprazole for prevention of NSAID-induced peptic ulcer in long-term NSAID users (ClinicalTrials.gov identifier NCT04840550).

A randomized, double-blind, active-controlled multicenter trial evaluated whether tegoprazan 25 mg can provide ulcer prevention comparable to lansoprazole 15 mg in patients requiring continuous NSAID therapy.

The clinical problem

Long-term NSAID use increases the risk of gastroduodenal ulcers, creating a need for effective, tolerable gastroprotection during sustained anti-inflammatory therapy.

Study at a glance

Design

Phase III, randomized, double-blind, active-controlled, multicenter

Population

Patients requiring continuous NSAID therapy

Test arm

Tegoprazan 25 mg

Comparator

Lansoprazole 15 mg

Primary endpoint met

Tegoprazan was non-inferior to lansoprazole for preventing gastroduodenal ulcers at 24 weeks

The study supports non-inferiority for ulcer prevention, not superiority. Per-group ulcer incidence magnitudes were not provided in the brief, so the endpoint is shown as a verdict panel rather than a comparative bar chart.

Non-inferiority test p=0.0004 Primary endpoint: peptic ulcer incidence at week 24

Tegoprazan 25 mg

Lansoprazole 15 mg

Efficacy & symptom outcomes

Endpoint	Finding	Reported statistic	Interpretation
Peptic ulcer incidence at week 24	Tegoprazan 25 mg was non-inferior to lansoprazole 15 mg	p=0.0004	Primary endpoint met; supports comparable ulcer prevention.
Heartburn-free rate at week 12	Higher with tegoprazan than lansoprazole	p=0.0421	Symptom signal favoring tegoprazan at week 12.
Other NSAID-induced GI symptom-free rates	No significant difference reported	Not significant	Broadly comparable symptom control across other assessed symptoms.

Chart omitted intentionally: the brief reports statistical conclusions and p-values but not per-group outcome magnitudes for ulcer incidence or symptom-free rates.

Safety profile

Adverse drug reactions

Reported as comparable between tegoprazan and lansoprazole in the study summary.

Serious adverse events

No meaningful imbalance was highlighted in the provided brief; overall tolerability was comparable.

Tegoprazan may be presented as a clinically effective alternative to lansoprazole for gastroprotection in patients needing long-term NSAIDs, with comparable safety and tolerability; frame the evidence as non-inferiority, not superiority for ulcer prevention.

AbbreviationsQuick

NSAIDs=nonsteroidal anti-inflammatory drugs; ADRs=adverse drug reactions; SAEs=serious adverse events; DOI=digital object identifier; PMID=PubMed identifier.

Bibliography1

Kim SG, Kim TO, Jung SW, et al. A Phase III, Randomized, Double-Blind, Active-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Tegoprazan for the Prevention of Peptic Ulcer in Patients on Continuous Long-Term Treatment with Nonsteroidal Anti-Inflammatory Drugs. Gut Liver. 2026 Jun 22. Online ahead of print. doi:10.5009/gnl260057. PMID: 42325011. (DOI: 10.5009/gnl260057)

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