| Autor: |
Kawai, Takashi, Suzuki, Chihiro, Honda, Youichirou, Fernandez, Jovelle L. |
| Zdroj: |
Expert Opinion on Drug Safety; May 2023, Vol. 22 Issue: 5 p425-431, 7p |
| Abstrakt: |
ABSTRACTBackgroundThis study assessed the safety and effectiveness of vonoprazan for prevention of duodenal and gastric ulcer recurrence in patients on long-term nonsteroidal anti-inflammatory drugs (NSAIDs) in routine clinical practice.Research design and methodsThis 12-month, prospective, observational study (145 sites, Japan, September 2016–April 2020) analyzed patients with a history of gastric or duodenal ulcer who started once-daily vonoprazan and were receiving NSAIDs for pain. The primary outcome was the incidence of adverse drug reactions (ADRs).ResultsMost patients (86.7% [1099/1268]) received vonoprazan for at least 6 months. Most patients (98.6% [1250/1268]) received the 10-mg dose of vonoprazan, 38.3% (486/1268) received cyclooxygenase-2 inhibitors, and 61.7% (782/1268) received other NSAIDs. The overall incidence of ADRs was 0.71% (9/1268). Most commonly reported ADRs were gastrointestinal (0.32%), nervous system (0.16%), and hepatobiliary system (0.16%) disorders. The overall incidence of gastric or duodenal ulcer recurrence was 1.04% (95% CI 0.56–1.78).ConclusionsNo new safety concerns were reported for vonoprazan for prevention of secondary ulcer or bleeding in patients receiving long-term NSAIDs. Vonoprazan was effective for preventing NSAID-related peptic ulcer recurrence in this real-world study.Trial registrationClinicalTrials.gov: NCT03214198; Japan Pharmaceutical Information Center Clinical Trials Information: JapicCTI-163436. |
| Databáze: |
Supplemental Index |
| Externí odkaz: |
|
