Why it matters
Long-term NSAID use increases the risk of gastric and duodenal ulcers, creating a need for reliable prevention.
Phase III evidence supports tegoprazan as an effective gastroprotective option for patients continuing long-term NSAID therapy.
Long-term NSAID use increases the risk of gastric and duodenal ulcers, creating a need for reliable prevention.
Randomized, double-blind, active-controlled, multicenter Phase III trial conducted over up to 24 weeks.
Tegoprazan 25 mg was compared with lansoprazole 15 mg in patients continuing NSAIDs.
Patients randomized
Included in the per-protocol analysis
Tegoprazan was non-inferior to lansoprazole for preventing gastroduodenal ulcers at week 24.
Non-inferiority p = 0.0004
| Endpoint | Finding | Direction |
|---|---|---|
| Peptic ulcer prevention at week 24 | Tegoprazan 25 mg was as effective as lansoprazole 15 mg | Non-inferior; p = 0.0004 |
| Heartburn-free rate at week 12 | Higher with tegoprazan | Favored tegoprazan |
| Other NSAID-related GI symptom-free rates | No significant difference between groups | Comparable |
| Safety measure | Comparison | Interpretation |
|---|---|---|
| Adverse drug reactions | Tegoprazan vs lansoprazole | Comparable tolerability |
| Serious adverse events | Assessed across both groups | No safety disadvantage highlighted |
Tegoprazan is a clinically effective alternative for gastroprotection in patients requiring long-term NSAID therapy, with safety and tolerability comparable to lansoprazole.