Why it matters
Long-term NSAID use raises the risk of gastroduodenal peptic ulcers, so gastroprotection is often needed when anti-inflammatory therapy must continue.
Study at a glance
Design
Phase III, randomized, double-blind, active-controlled, multicenter
Population
Patients continuing NSAID therapy
Arms
Tegoprazan 25 mg vs lansoprazole 15 mg
Follow-up
Up to 24 weeks
Central finding
Tegoprazan arm
25 mg
Investigational gastroprotective regimen
Primary endpoint met
Non-inferior
Peptic ulcer incidence at week 24
p=0.0004
Non-inferiority analysis
Comparator arm
15 mg
Active comparator: lansoprazole
Trial size
392
patients randomized
269
included in the per-protocol analysis
Efficacy
Met NI
tegoprazan was non-inferior to lansoprazole for ulcer prevention at week 24
p=0.0004
primary endpoint
Symptoms & safety
Week 12
heartburn-free rate favored tegoprazan
No sig. difference
adverse drug reactions and serious adverse events
Endpoint evidence board
| Domain | Endpoint / timepoint | Reported quantitative result | Interpretation |
|---|---|---|---|
| Efficacy | Peptic ulcer incidence Primary endpoint, week 24 |
Non-inferiority met
p=0.0004
|
Tegoprazan matched lansoprazole for prevention of NSAID-induced gastroduodenal ulcers over 24 weeks. |
| Symptoms | Heartburn-free rate Week 12 |
Favored tegoprazan
Exact percentage not provided in the supplied brief.
|
Symptom signal favored tegoprazan at week 12. |
| Safety | Adverse drug reactions |
Comparable
No significant between-group difference reported.
|
Overall tolerability was similar between tegoprazan and lansoprazole. |
| Safety | Serious adverse events |
Comparable
No significant between-group difference reported.
|
No meaningful safety separation was reported between treatment groups. |
Numbers to know
392
randomized patients
269
per-protocol analysis set
24
weeks of ulcer-prevention follow-up
25 mg vs 15 mg
tegoprazan vs lansoprazole dose comparison