Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"

The drug being tested in this study is called Vonoprazan. Vonoprazan is being tested to treat people who have a history of gastric or duodenal ulcers.

This study will look at the safety and efficacy of long-term administration of Vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving NSAIDs.

The study will enroll approximately 1000 participants.

• Vonoprazan 10 mg

This multi-center observational survey will be conducted in Japan.

• Vonoprazan (Drug), also known as Takecab tablets, TAK-438: Vonoprazan tablets

Primary outcomes

• Percentage of Participants Who Had One or More Adverse Drug Reactions [Up to 12 months]: An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.

Secondary outcomes

• Percentage of Participants With Gastric Ulcers [Up to 12 months]: The presence or absence of onset of gastric ulcers was reported. Reporting data was total percentage of participants with gastric ulcers.
• Percentage of Participants With Duodenal Ulcers [Up to 12 months]: The presence or absence of onset of duodenal ulcers was reported. Reporting data was total percentage of participants with duodenal ulcers.
• Percentage of Participants With Gastric Hemorrhagic Lesions [Up to 12 months]: The presence or absence of onset of gastric hemorrhagic lesions was reported. Reporting data was total percentage of participants with gastric hemorrhagic lesions.
• Percentage of Participants With Duodenal Hemorrhagic Lesions [Up to 12 months]: The presence or absence of onset of duodenal hemorrhagic lesions was reported. Reporting data was total percentage of participants with duodenal hemorrhagic lesions.

Sex: All

Inclusion Criteria:

\- Participants with a history of gastric or duodenal ulcer

Exclusion Criteria:

* Participants with gastric or duodenal ulcer at initiation of vonoprazan therapy
* Participants with active upper gastrointestinal haemorrhage at initiation of vonoprazan therapy
* Participants with a history of hypersensitivity to any ingredients of vonoprazan Tablets
* Participants receiving atazanavir sulfate or rilpivirine hydrochloride

Participant flow

Outcome results

• Percentage of Participants Who Had One or More Adverse Drug Reactions (Primary), Number, Percentage of Participants: Vonoprazan 10 mg 0.71
• Percentage of Participants With Gastric Ulcers (Secondary), Number, Percentage of Participants: Vonoprazan 10 mg 0.56
• Percentage of Participants With Duodenal Ulcers (Secondary), Number, Percentage of Participants: Vonoprazan 10 mg 0.16
• Percentage of Participants With Gastric Hemorrhagic Lesions (Secondary), Number, Percentage of Participants: Vonoprazan 10 mg 0.24
• Percentage of Participants With Duodenal Hemorrhagic Lesions (Secondary), Number, Percentage of Participants: Vonoprazan 10 mg 0.08

Adverse events

Time frame: Up to 12 months

Serious adverse events by term

Other adverse events by term

• Results publication: Kawai T, Suzuki C, Honda Y, Fernandez JL. 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. Expert Opin Drug Saf. 2023 Jan-Jun;22(5):425-431. doi: 10.1080/14740338.2023.2136163. Epub 2022 Oct 20. PMID 36264125

• Study Protocol (PDF, 2020-06-12)
• Statistical Analysis Plan (PDF, 2020-11-09)

• Study Director, Study director, Takeda