Clinical problem
Long-term NSAID therapy increases peptic ulcer risk and often requires ongoing gastroprotection.
Theme
NSAID gastroprotection evidence update
Tegoprazan matched lansoprazole for preventing NSAID-related peptic ulcers over 24 weeks
Source
Source: Gut Liver online-ahead-of-print publication of a phase III randomized, double-blind, active-controlled, multicenter study evaluating tegoprazan for prevention of peptic ulcer in patients on continuous long-term NSAID treatment. The study reports ClinicalTrials.gov identifier NCT04840550.
Hero fact: Tegoprazan 25 mg was non-inferior to lansoprazole 15 mg for preventing NSAID-induced gastroduodenal ulcers at 24 weeks.
Study design
Phase III, randomized, double-blind, active-controlled, multicenter trial with follow-up to 24 weeks.
Clinical meaning
Tegoprazan may offer an effective alternative for patients who need continuous NSAID treatment.
Treatment comparison
| Arm | Dose | Context |
|---|---|---|
| Tegoprazan | 25 mg | NSAID continuation |
| Lansoprazole | 15 mg | Active comparator |
Analysis population
392
patients randomized
269
per-protocol patients
The per-protocol set was used for the primary endpoint assessment.
Main endpoint findings
| Endpoint | Finding | Interpretation |
|---|---|---|
| Gastroduodenal ulcer prevention at 24 weeks | Tegoprazan was non-inferior to lansoprazole | Primary efficacy objective met |
| Overall safety | Similar between treatment groups | No meaningful safety disadvantage reported |
| Heartburn-free rate at week 12 | Higher with tegoprazan | Symptom benefit signal |
| Other GI symptom-free rates | Not significantly different | Comparable broader symptom outcomes |
Key finding
392 patients were randomized to tegoprazan or lansoprazole.
Primary analysis
269 patients were included in the per-protocol endpoint analysis.
Symptom signal
Week 12 heartburn-free rate was higher with tegoprazan; other GI symptoms were similar.
Takeaway
For patients requiring continuous long-term NSAID treatment, tegoprazan 25 mg appears to be a well-tolerated gastroprotective alternative to lansoprazole 15 mg for peptic 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, 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. PMID: 42325011. (DOI: 10.5009/gnl260057)
👀 View Mode