| アブストラクト | BACKGROUND: Vonoprazan has been launched as an alternative to proton-pump inhibitors (PPIs). This was the first study to compare the occurrence of upper gastrointestinal bleeding (UGIB) with vonoprazan treatment to that with PPI treatment in patients with ischemic heart disease (IHD) taking >/=2 antithrombotic agents, including those receiving dual antiplatelet therapy (DAPT). METHODS: Using Japanese Diagnosis Procedure Combination data from 2016 to 2017, we identified 16,415 patients with IHD who were prescribed >/=2 antithrombotic agents, including new antiplatelet medication with concurrent vonoprazan (n = 2226 or PPIs n = 14,189). UGIB occurrence was analyzed using an inverse probability-weighted Cox proportional hazards model. Non-inferiority of vonoprazan to PPI treatment for UGIB occurrence was assessed. RESULTS: Six-month incidence of UGIB in patients treated with vonoprazan and PPIs was 3.14% 70/2226 and 4.17% (591/14,189), respectively. The adjusted hazard ratio (aHR) of 0.84 was significantly below the non-inferiority margin (HR 2.06) (p < 0.0001), and thus demonstrated that vonoprazan treatment was non-inferior to PPIs in terms of occurrence of UGIB events. The difference between the 2 treatments was also not statistically significant [aHR 0.84; 95% confidence interval (CI): 0.65-1.07; p = 0.154). In a subgroup analysis, UGIB occurrence with vonoprazan and other PPI treatment in patients receiving DAPT was 2.82% (22/779) and 3.96% (209/5276) respectively; a non-significant difference (aHR 0.74; 95% CI: 0.48-1.16; p = 0.189) that demonstrated non-inferiority (p < 0.0001). CONCLUSIONS: Vonoprazan was non-inferior to PPIs in terms of UGIB occurrence over 6 months in patients with IHD receiving >/=2 antithrombotic agents, including new antiplatelet medication. |
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| ジャーナル名 | Journal of cardiology |
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| 投稿日 | 2020/3/19 |
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| 投稿者 | Tsujita, Kenichi; Deguchi, Hisato; Uda, Akihito; Sugano, Kentaro |
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| 組織名 | Department of Cardiovascular Medicine and Center for Metabolic Regulation of;Healthy Aging (CMHA), Graduate School of Medical Sciences, Kumamoto University,;Kumamoto, Japan. Electronic address: tsujita@kumamoto-u.ac.jp.;Japan Medical Affairs, Takeda Pharmaceutical Company Limited, Tokyo, Japan.;Department of Medicine, Jichi Medical University, Shimotsuke, Tochigi, Japan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/32184027/ |
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