Key result
In patients with a history of peptic ulcer receiving long-term NSAIDs, vonoprazan was associated with a 0.71% incidence of adverse drug reactions and a 1.04% rate of ulcer recurrence over 12 months.
Why the study?
This study assessed the safety and effectiveness of vonoprazan for preventing duodenal and gastric ulcer recurrence in patients on long-term NSAIDs in routine clinical practice.
Does vonoprazan safely prevent gastric and duodenal ulcer recurrence in patients on long-term NSAIDs?
Observational (n=1,268)
Yes
Does vonoprazan safely prevent gastric and duodenal ulcer recurrence in patients on long-term NSAIDs?
Vonoprazan is safe and effective for preventing NSAID-related peptic ulcer recurrence in routine clinical practice in Japan.
Low ADR (0.71%) and recurrence (1.04%) rates observed in practice; leaves open need for RCTs to confirm effectiveness.
BACKGROUND: This 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 METHODS: This 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). RESULTS: Most 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). CONCLUSIONS: No 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 REGISTRATION: ClinicalTrials.gov: NCT03214198; Japan Pharmaceutical Information Center Clinical Trials Information: JapicCTI-163436.
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Kawai et al. (2022) conducted an observational in History of gastric or duodenal ulcer in patients receiving NSAIDs (n=1,268). Vonoprazan was evaluated on Incidence of adverse drug reactions (ADRs). In patients with a history of peptic ulcer receiving long-term NSAIDs, vonoprazan was associated with a 0.71% incidence of adverse drug reactions and a 1.04% rate of ulcer recurrence over 12 months.
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