Theme

NSAID gastroprotection Phase III evidence

Tegoprazan offers PPI-comparable protection against NSAID-induced peptic ulcers over 24 weeks

Source
Source: Gut Liver online-ahead-of-print phase III randomized, double-blind, active-controlled multicenter trial of tegoprazan for prevention of NSAID-induced peptic ulcer. The study is registered as ClinicalTrials.gov identifier NCT04840550.

Long-term NSAID therapy raises peptic ulcer risk, creating a need for effective gastroprotection in patients who must continue anti-inflammatory treatment.

Study at a glance

Active-controlled comparison in patients continuing NSAIDs for long-term therapy.

Tegoprazan 25 mg Lansoprazole 15 mg
Design
Phase III, randomized, double-blind, active-controlled, multicenter
Population
392 patients randomized
Follow-up
24 weeks of NSAID continuation
Comparator
Tegoprazan 25 mg vs lansoprazole 15 mg
Central finding
Tegoprazan 25 mg was non-inferior to lansoprazole 15 mg for preventing NSAID-induced gastroduodenal ulcers at week 24.
p=0.0004 non-inferiority result
Week 24 primary ulcer-prevention assessment
How to read the evidence
Primary efficacy focus
Prevention of gastroduodenal ulcers at 24 weeks.
Symptom focus
NSAID-related gastrointestinal symptom-free rates, including heartburn-free rate.
Safety focus
Adverse drug reactions and serious adverse events compared between treatment groups.

Key findings by endpoint

No per-group ulcer or symptom percentages were provided in the brief, so outcomes are presented as reported rather than charted as invented magnitudes.

Non-inferiority met
Ulcer prevention
p=0.0004
Tegoprazan met the non-inferiority criterion versus lansoprazole for gastroduodenal ulcer prevention.
Assessment timepoint: week 24.
Symptom outcome
p=0.0421
Heartburn-free rate at week 12 was higher with tegoprazan.
Other GI symptom-free rates were broadly comparable.
Safety profile
Comparable
Adverse drug reactions and serious adverse events were broadly similar between groups.
No numerical ADR or SAE rates were provided in the brief.

Endpoint evidence table

Clinical domain Endpoint / measure Reported finding Exact statistic available
Efficacy Gastroduodenal ulcer prevention at week 24 Tegoprazan 25 mg was non-inferior to lansoprazole 15 mg. p=0.0004
Symptoms Heartburn-free rate at week 12 Higher with tegoprazan. p=0.0421
Symptoms Other NSAID-related GI symptom-free rates Broadly comparable between treatment groups. Per-group rates not specified in brief
Safety Adverse drug reactions and serious adverse events Broadly comparable between treatment groups. Event counts / rates not specified in brief
Numbers to know
392 patients randomized
269 patients in per-protocol analysis
24 weeks of ulcer-prevention follow-up
p=0.0004 primary non-inferiority result
p=0.0421 week-12 heartburn-free rate
Takeaway
For patients requiring continuous long-term NSAID therapy, tegoprazan may be presented as a clinically effective alternative to lansoprazole for peptic ulcer prevention, with similar tolerability and a potential early heartburn-related benefit.
AbbreviationsQuick
NSAIDs = nonsteroidal anti-inflammatory drugs; ADRs = adverse drug reactions; SAEs = serious adverse events.
Bibliography1
  1. Kim SG, Kim TO, Jung SW, Min BH, Oh JH, Kim HS, 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)