Efficacy of Vonoprazan 10 mg and 20 mg for Patients With Proton Pump Inhibitor‐Refractory Functional Dyspepsia: A Double‐Blinded, Randomized Study
ABSTRACT Background A proportion of patients with functional dyspepsia (FD) have inadequate symptom control with proton pump inhibitors (PPIs) treatment. Vonoprazan demonstrates higher efficacy in acid reduction than PPI; however, the existing efficacy data for vonoprazan in treating PPI‐refractory...
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Wiley
2024-12-01
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| Online Access: | https://doi.org/10.1002/jgh3.70082 |
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| author | Chalermrat Bunchorntavakul Pantaree Jaigla |
| author_facet | Chalermrat Bunchorntavakul Pantaree Jaigla |
| author_sort | Chalermrat Bunchorntavakul |
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| description | ABSTRACT Background A proportion of patients with functional dyspepsia (FD) have inadequate symptom control with proton pump inhibitors (PPIs) treatment. Vonoprazan demonstrates higher efficacy in acid reduction than PPI; however, the existing efficacy data for vonoprazan in treating PPI‐refractory FD is limited. Methods This double‐blinded, randomized controlled trial study was conducted at Rajavithi Hospital, Bangkok between December 2022 and 2023. Patients with FD who were unresponsive to the standard dose PPI were randomly assigned (1:1) to receive either 10 mg or 20 mg of vonoprazan for a 4‐week duration, with a subsequent 4‐week follow‐up after treatment. The primary outcome was changes in the Global Overall Symptoms Scale (GOSS). Results Sixty patients were randomized without significant differences in baseline characteristics between both groups. The mean GOSS between the 10‐mg vonoprazan and the 20‐mg vonoprazan arm were 25.73 and 26.17 at week 0, 14.33 and 15.50 at week 2, 9.37 and 10.04 at week 4, and 9.79 and 9.33 at week 8, respectively (all p < 0.001 vs. baseline and p > 0.05 between groups). The quality of life was improved, with the Nepean dyspepsia index changing −4.13 and −4.25 at week 4, respectively (all p < 0.001 vs. baseline; p = 0.853 between groups). Symptom response rates (> 50% improvement in GOSS) were 72.4% and 75.9% at week 8, respectively (p = 0.24 between groups). No serious adverse events were observed. Conclusion Vonoprazan demonstrated significant effects in the alleviation of symptoms in PPI‐refractory FD patients. There was no statistically significant difference in symptom alleviation between the 10 mg and 20 mg doses of vonoprazan. |
| format | Article |
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| language | English |
| publishDate | 2024-12-01 |
| publisher | Wiley |
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| spelling | doaj-art-c1a4d3dbc5574e879b08e2b1ceb77cde2025-08-20T02:39:50ZengWileyJGH Open2397-90702024-12-01812n/an/a10.1002/jgh3.70082Efficacy of Vonoprazan 10 mg and 20 mg for Patients With Proton Pump Inhibitor‐Refractory Functional Dyspepsia: A Double‐Blinded, Randomized StudyChalermrat Bunchorntavakul0Pantaree Jaigla1Division of Gastroenterology and Hepatology, Rajavithi Hospital, College of Medicine Rangsit University Bangkok ThailandDivision of Gastroenterology and Hepatology, Rajavithi Hospital, College of Medicine Rangsit University Bangkok ThailandABSTRACT Background A proportion of patients with functional dyspepsia (FD) have inadequate symptom control with proton pump inhibitors (PPIs) treatment. Vonoprazan demonstrates higher efficacy in acid reduction than PPI; however, the existing efficacy data for vonoprazan in treating PPI‐refractory FD is limited. Methods This double‐blinded, randomized controlled trial study was conducted at Rajavithi Hospital, Bangkok between December 2022 and 2023. Patients with FD who were unresponsive to the standard dose PPI were randomly assigned (1:1) to receive either 10 mg or 20 mg of vonoprazan for a 4‐week duration, with a subsequent 4‐week follow‐up after treatment. The primary outcome was changes in the Global Overall Symptoms Scale (GOSS). Results Sixty patients were randomized without significant differences in baseline characteristics between both groups. The mean GOSS between the 10‐mg vonoprazan and the 20‐mg vonoprazan arm were 25.73 and 26.17 at week 0, 14.33 and 15.50 at week 2, 9.37 and 10.04 at week 4, and 9.79 and 9.33 at week 8, respectively (all p < 0.001 vs. baseline and p > 0.05 between groups). The quality of life was improved, with the Nepean dyspepsia index changing −4.13 and −4.25 at week 4, respectively (all p < 0.001 vs. baseline; p = 0.853 between groups). Symptom response rates (> 50% improvement in GOSS) were 72.4% and 75.9% at week 8, respectively (p = 0.24 between groups). No serious adverse events were observed. Conclusion Vonoprazan demonstrated significant effects in the alleviation of symptoms in PPI‐refractory FD patients. There was no statistically significant difference in symptom alleviation between the 10 mg and 20 mg doses of vonoprazan.https://doi.org/10.1002/jgh3.70082functional dyspepsiapotassium‐competitive acid blockersproton pump inhibitorsrefractoryvonoprazan |
| spellingShingle | Chalermrat Bunchorntavakul Pantaree Jaigla Efficacy of Vonoprazan 10 mg and 20 mg for Patients With Proton Pump Inhibitor‐Refractory Functional Dyspepsia: A Double‐Blinded, Randomized Study JGH Open functional dyspepsia potassium‐competitive acid blockers proton pump inhibitors refractory vonoprazan |
| title | Efficacy of Vonoprazan 10 mg and 20 mg for Patients With Proton Pump Inhibitor‐Refractory Functional Dyspepsia: A Double‐Blinded, Randomized Study |
| title_full | Efficacy of Vonoprazan 10 mg and 20 mg for Patients With Proton Pump Inhibitor‐Refractory Functional Dyspepsia: A Double‐Blinded, Randomized Study |
| title_fullStr | Efficacy of Vonoprazan 10 mg and 20 mg for Patients With Proton Pump Inhibitor‐Refractory Functional Dyspepsia: A Double‐Blinded, Randomized Study |
| title_full_unstemmed | Efficacy of Vonoprazan 10 mg and 20 mg for Patients With Proton Pump Inhibitor‐Refractory Functional Dyspepsia: A Double‐Blinded, Randomized Study |
| title_short | Efficacy of Vonoprazan 10 mg and 20 mg for Patients With Proton Pump Inhibitor‐Refractory Functional Dyspepsia: A Double‐Blinded, Randomized Study |
| title_sort | efficacy of vonoprazan 10 mg and 20 mg for patients with proton pump inhibitor refractory functional dyspepsia a double blinded randomized study |
| topic | functional dyspepsia potassium‐competitive acid blockers proton pump inhibitors refractory vonoprazan |
| url | https://doi.org/10.1002/jgh3.70082 |
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