Efficacy and safety of Vonoprazan to prevent peptic ulcer recurrence in people using NSAIDs

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Created On: 02/02/2023

A 12-month, prospective, observational, real-world study intended to evaluate Vonoprazan's safety and efficacy to prevent the recurrence of ulcers in individuals on long-term nonsteroidal anti-inflammatory drugs (NSAIDs).

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Key take away

Long-term administration of 10 mg Vonoprazan for up to 12 months is safe and effective to prevent NSAID-associated recurrence of peptic ulcers.

Background

Method

Examination of people with a history of duodenal or gastric ulcers who commenced using once-daily 10 mg oral Vonoprazan fumarate tablets and were taking low-dose aspirin for embolism/thrombosis suppression or NSAIDs for pain was done. In this post-marketing surveillance study, the major endpoint was adverse drug reactions (ADRs) incidence.

Result

Vonoprazan was administered to most of the individuals (86.7% [1099/1268]) for a minimum of six months. Out of 1268 patients, 98.6% patients (n = 1250) were given 10 mg Vonoprazan, 38.3% (n = 486) were given cyclooxygenase-2 inhibitors and 61.7% (n = 782) were administered other NSAIDs.

Notably, 0.71% (9/1268) was the overall occurrence of ADRs. Hepatobiliary system (0.16%), nervous system (0.16%), and gastrointestinal (0.32%) diseases were the most frequently reported ADRs. The overall occurrence of recurrence of duodenal or gastric ulcers was found to be 1.04%.

Conclusion

To prevent secondary ulcers or bleeding in individuals on long-term NSAIDs, Vonoprazan was not related to any new safety concerns. In this at-risk patient population, Vonoprazan's efficacy in preventing ulcer recurrence was validated.

Source:

Expert Opinion on Drug Safety

Link:

https://www.tandfonline.com/doi/full/10.1080/14740338.2023.2136163

Article:

Long-term safety and effectiveness of Vonoprazan for prevention of gastric and duodenal ulcer recurrence in patients on nonsteroidal anti-inflammatory drugs in Japan: a 12-month post-marketing surveillance study