Empagliflozin as a novel therapy for cirrhotic refractory ascites: a randomized controlled study
Abstract Background Cirrhotic refractory ascites (RA) patients have few alternatives for treatment. Empagliflozin is now known to have natriuretic and neurohormonal modulatory effects. This research investigated the safety and efficacy of empagliflozin in the management of RA when added to the stand...
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| Language: | English |
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SpringerOpen
2024-10-01
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| Series: | Egyptian Liver Journal |
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| Online Access: | https://doi.org/10.1186/s43066-024-00383-y |
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| author | Mohamed Fathy Bakosh Ramy Mohamed Ghazy Walid Ismail Ellakany Ahmed Kamal |
| author_facet | Mohamed Fathy Bakosh Ramy Mohamed Ghazy Walid Ismail Ellakany Ahmed Kamal |
| author_sort | Mohamed Fathy Bakosh |
| collection | DOAJ |
| description | Abstract Background Cirrhotic refractory ascites (RA) patients have few alternatives for treatment. Empagliflozin is now known to have natriuretic and neurohormonal modulatory effects. This research investigated the safety and efficacy of empagliflozin in the management of RA when added to the standard of care (SoC) compared to SoC alone. Methods Patients were randomized to receive either a fixed dose of 10 mg of empagliflozin plus standard of care (SoC) or SoC alone. Patients were followed up for 3 months. The primary endpoint was achieving no need for large-volume paracentesis (LVP). Results Forty-two patients were randomized equally, and intention-to-treat was performed. There was a statistically significant decrease in the need for LVP in the empagliflozin group compared to the SoC group (100% in the SoC vs. 42.9% in the empagliflozin group, p < 0.001). By the end of the study, the total resolution of ascites was reported in approximately 24% of patients. Muscle cramps and newly developed hyponatremia were more common in the empagliflozin group, but they were mild. Acute kidney injury was more common in the SoC group. Conclusions Empagliflozin may be an effective option for use as an add-on therapy in the management of RA, with an accepted safety profile. Trial registration The trial was registered at www.clinicaltrials.gov under the identifier NCT05430243. The registration was submitted on 18/06/2022. It is available at https://clinicaltrials.gov/study/NCT05430243 . Graphical Abstract |
| format | Article |
| id | doaj-art-15a50bbcfa6c412f8aedc5696734d9f5 |
| institution | OA Journals |
| issn | 2090-6226 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Egyptian Liver Journal |
| spelling | doaj-art-15a50bbcfa6c412f8aedc5696734d9f52025-08-20T02:11:24ZengSpringerOpenEgyptian Liver Journal2090-62262024-10-0114111010.1186/s43066-024-00383-yEmpagliflozin as a novel therapy for cirrhotic refractory ascites: a randomized controlled studyMohamed Fathy Bakosh0Ramy Mohamed Ghazy1Walid Ismail Ellakany2Ahmed Kamal3Hepatology Unit, Internal Medicine Department, Faculty of Medicine, Alexandria UniversityTropical Health Department, High Institute of Public Health, Alexandria UniversityTropical Medicine Department, Faculty of Medicine, Alexandria UniversityHepatology Unit, Internal Medicine Department, Faculty of Medicine, Alexandria UniversityAbstract Background Cirrhotic refractory ascites (RA) patients have few alternatives for treatment. Empagliflozin is now known to have natriuretic and neurohormonal modulatory effects. This research investigated the safety and efficacy of empagliflozin in the management of RA when added to the standard of care (SoC) compared to SoC alone. Methods Patients were randomized to receive either a fixed dose of 10 mg of empagliflozin plus standard of care (SoC) or SoC alone. Patients were followed up for 3 months. The primary endpoint was achieving no need for large-volume paracentesis (LVP). Results Forty-two patients were randomized equally, and intention-to-treat was performed. There was a statistically significant decrease in the need for LVP in the empagliflozin group compared to the SoC group (100% in the SoC vs. 42.9% in the empagliflozin group, p < 0.001). By the end of the study, the total resolution of ascites was reported in approximately 24% of patients. Muscle cramps and newly developed hyponatremia were more common in the empagliflozin group, but they were mild. Acute kidney injury was more common in the SoC group. Conclusions Empagliflozin may be an effective option for use as an add-on therapy in the management of RA, with an accepted safety profile. Trial registration The trial was registered at www.clinicaltrials.gov under the identifier NCT05430243. The registration was submitted on 18/06/2022. It is available at https://clinicaltrials.gov/study/NCT05430243 . Graphical Abstracthttps://doi.org/10.1186/s43066-024-00383-yAscitesSodium-glucose transporter 2 inhibitorsEmpagliflozinDiureticsNatriuretic agents |
| spellingShingle | Mohamed Fathy Bakosh Ramy Mohamed Ghazy Walid Ismail Ellakany Ahmed Kamal Empagliflozin as a novel therapy for cirrhotic refractory ascites: a randomized controlled study Egyptian Liver Journal Ascites Sodium-glucose transporter 2 inhibitors Empagliflozin Diuretics Natriuretic agents |
| title | Empagliflozin as a novel therapy for cirrhotic refractory ascites: a randomized controlled study |
| title_full | Empagliflozin as a novel therapy for cirrhotic refractory ascites: a randomized controlled study |
| title_fullStr | Empagliflozin as a novel therapy for cirrhotic refractory ascites: a randomized controlled study |
| title_full_unstemmed | Empagliflozin as a novel therapy for cirrhotic refractory ascites: a randomized controlled study |
| title_short | Empagliflozin as a novel therapy for cirrhotic refractory ascites: a randomized controlled study |
| title_sort | empagliflozin as a novel therapy for cirrhotic refractory ascites a randomized controlled study |
| topic | Ascites Sodium-glucose transporter 2 inhibitors Empagliflozin Diuretics Natriuretic agents |
| url | https://doi.org/10.1186/s43066-024-00383-y |
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