Theme

Phase III gastroprotection NSAID-related ulcer prevention

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

Source
Source: Gut Liver online-ahead-of-print publication reporting a phase III, randomized, double-blind, active-controlled, multicenter study of tegoprazan for prevention of NSAID-induced peptic ulcer in patients on long-term NSAID therapy. Trial identifier: ClinicalTrials.gov NCT04840550.

Long-term NSAID therapy increases peptic ulcer risk; acid suppression is commonly used for gastroprotection.

Design
Phase III randomized, double-blind, active-controlled, multicenter trial
Population
392 patients randomized 1:1
Arms
Tegoprazan 25 mg Lansoprazole 15 mg
Duration
24 weeks of prevention follow-up
Hero fact

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

The primary prevention endpoint favored a clinically comparable gastroprotective interpretation versus the active PPI comparator.

Non-inferiority met
p=0.0004 Primary non-inferiority analysis
25 mg Tegoprazan
15 mg Lansoprazole
Randomized set
392 patients randomized 1:1
Per-protocol set
269 included in efficacy analysis
Primary endpoint
24 week peptic ulcer incidence
Efficacy results

Endpoint-by-endpoint evidence summary

Outcome chart omitted: no per-arm event magnitudes provided
Endpoint Timepoint Finding Exact reported value Interpretation
Peptic / gastroduodenal ulcer prevention Week 24 Tegoprazan met non-inferiority criteria versus lansoprazole p=0.0004 Comparable efficacy
Heartburn-free rate Week 12 Higher with tegoprazan Directional result reported; group percentages not provided in brief Symptom signal
Other gastrointestinal symptom-free rates Study follow-up No significant difference Exact rates not provided in brief Similar symptom profile
Adverse drug reactions Safety follow-up Comparable between treatment arms Exact rates not provided in brief Tolerability comparable
Serious adverse events Safety follow-up Comparable between treatment arms Exact rates not provided in brief Safety comparable
Numbers to know
392 randomized
269 per-protocol
24 weeks
p=0.0004 non-inferiority
Symptoms & safety
Heartburn-free rate Week 12 favored tegoprazan

Other gastrointestinal symptom-free rates were not significantly different.

Adverse drug reactions Comparable
Serious adverse events Comparable
Takeaway

Tegoprazan is a clinically effective alternative gastroprotective option for patients requiring long-term NSAID therapy, with efficacy comparable to lansoprazole and a similarly tolerable safety profile.

AbbreviationsQuick
NSAIDs, nonsteroidal anti-inflammatory drugs; ADRs, adverse drug reactions; SAEs, serious adverse events.
Bibliography1
  1. 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)