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Empagliflozin as a novel therapy for cirrhotic refractory ascites: a randomized controlled study
BackgroundCirrhotic 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 car...
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| Published in: | Egyptian Liver Journal 2024-10, Vol.14 (1), p.76-10 |
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| container_title | Egyptian Liver Journal |
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| creator | Bakosh, Mohamed Fathy Ghazy, Ramy Mohamed Ellakany, Walid Ismail Kamal, Ahmed |
| description | BackgroundCirrhotic 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.MethodsPatients 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).ResultsForty-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 |
| doi_str_mv | 10.1186/s43066-024-00383-y |
| format | article |
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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.MethodsPatients 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).ResultsForty-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.ConclusionsEmpagliflozin may be an effective option for use as an add-on therapy in the management of RA, with an accepted safety profile.Trial registrationThe 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.</description><identifier>ISSN: 2090-6218</identifier><identifier>EISSN: 2090-6226</identifier><identifier>DOI: 10.1186/s43066-024-00383-y</identifier><language>eng</language><publisher>Menoufiya: Springer Nature B.V</publisher><subject>Ascites ; Asymptomatic ; Blood pressure ; Creatinine ; Diabetes ; Diabetic ketoacidosis ; Diuretics ; Drug dosages ; Empagliflozin ; Glucose ; Hypoglycemia ; Hyponatremia ; Kidneys ; Liver cirrhosis ; Muscle pain ; Natriuretic agents ; Patients ; Sodium ; Sodium-glucose transporter 2 inhibitors ; Ultrasonic imaging ; Urinary tract diseases ; Urinary tract infections ; Urine ; Urogenital system</subject><ispartof>Egyptian Liver Journal, 2024-10, Vol.14 (1), p.76-10</ispartof><rights>The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/3119855137/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/3119855137?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,25752,27923,27924,37011,44589,74997</link.rule.ids></links><search><creatorcontrib>Bakosh, Mohamed Fathy</creatorcontrib><creatorcontrib>Ghazy, Ramy Mohamed</creatorcontrib><creatorcontrib>Ellakany, Walid Ismail</creatorcontrib><creatorcontrib>Kamal, Ahmed</creatorcontrib><title>Empagliflozin as a novel therapy for cirrhotic refractory ascites: a randomized controlled study</title><title>Egyptian Liver Journal</title><description>BackgroundCirrhotic 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.MethodsPatients 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).ResultsForty-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.ConclusionsEmpagliflozin may be an effective option for use as an add-on therapy in the management of RA, with an accepted safety profile.Trial registrationThe 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.</description><subject>Ascites</subject><subject>Asymptomatic</subject><subject>Blood pressure</subject><subject>Creatinine</subject><subject>Diabetes</subject><subject>Diabetic ketoacidosis</subject><subject>Diuretics</subject><subject>Drug dosages</subject><subject>Empagliflozin</subject><subject>Glucose</subject><subject>Hypoglycemia</subject><subject>Hyponatremia</subject><subject>Kidneys</subject><subject>Liver cirrhosis</subject><subject>Muscle pain</subject><subject>Natriuretic agents</subject><subject>Patients</subject><subject>Sodium</subject><subject>Sodium-glucose transporter 2 inhibitors</subject><subject>Ultrasonic imaging</subject><subject>Urinary tract diseases</subject><subject>Urinary tract infections</subject><subject>Urine</subject><subject>Urogenital system</subject><issn>2090-6218</issn><issn>2090-6226</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNo9j0tLw0AUhQdRsGj_gKsB19F5Z-JOStVCwY2u48082ilpJk6mQvrrjVa8m3M4nPtxL0I3lNxRqtX9IDhRqiBMFIRwzYvxDM0YqUihGFPn_57qSzQfhh2ZRtOS8HKGPpb7HjZt8G08hg7DgAF38cu1OG9dgn7EPiZsQkrbmIPByfkEJsc0Tl0Tshsepo0EnY37cHQWm9jlFNt2skM-2PEaXXhoBzf_0yv0_rR8W7wU69fn1eJxXRhOSS4asJpZyzwRjAnOiCSE6ooyZaSFSimwqhRcayVII70thfKOAqtUyRtWUn6FVieujbCr-xT2kMY6Qqh_g5g2NaTpg9bVVIIkTWM8KCMo8xqcNVL9oIStvJxYtydWn-LnwQ253sVD6qbza05ppaWkvOTfyUBxEQ</recordid><startdate>20241023</startdate><enddate>20241023</enddate><creator>Bakosh, Mohamed Fathy</creator><creator>Ghazy, Ramy Mohamed</creator><creator>Ellakany, Walid Ismail</creator><creator>Kamal, Ahmed</creator><general>Springer Nature B.V</general><general>SpringerOpen</general><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>DOA</scope></search><sort><creationdate>20241023</creationdate><title>Empagliflozin as a novel therapy for cirrhotic refractory ascites: a randomized controlled study</title><author>Bakosh, Mohamed Fathy ; Ghazy, Ramy Mohamed ; Ellakany, Walid Ismail ; Kamal, Ahmed</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c310t-bad82dd2f04224320500189126c5da966ad674388640b5fd746fe1a29673b2713</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Ascites</topic><topic>Asymptomatic</topic><topic>Blood pressure</topic><topic>Creatinine</topic><topic>Diabetes</topic><topic>Diabetic ketoacidosis</topic><topic>Diuretics</topic><topic>Drug dosages</topic><topic>Empagliflozin</topic><topic>Glucose</topic><topic>Hypoglycemia</topic><topic>Hyponatremia</topic><topic>Kidneys</topic><topic>Liver cirrhosis</topic><topic>Muscle pain</topic><topic>Natriuretic agents</topic><topic>Patients</topic><topic>Sodium</topic><topic>Sodium-glucose transporter 2 inhibitors</topic><topic>Ultrasonic imaging</topic><topic>Urinary tract diseases</topic><topic>Urinary tract infections</topic><topic>Urine</topic><topic>Urogenital system</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bakosh, Mohamed Fathy</creatorcontrib><creatorcontrib>Ghazy, Ramy Mohamed</creatorcontrib><creatorcontrib>Ellakany, Walid Ismail</creatorcontrib><creatorcontrib>Kamal, Ahmed</creatorcontrib><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection (Proquest)</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Open Access: DOAJ - Directory of Open Access Journals</collection><jtitle>Egyptian Liver Journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bakosh, Mohamed Fathy</au><au>Ghazy, Ramy Mohamed</au><au>Ellakany, Walid Ismail</au><au>Kamal, Ahmed</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Empagliflozin as a novel therapy for cirrhotic refractory ascites: a randomized controlled study</atitle><jtitle>Egyptian Liver Journal</jtitle><date>2024-10-23</date><risdate>2024</risdate><volume>14</volume><issue>1</issue><spage>76</spage><epage>10</epage><pages>76-10</pages><issn>2090-6218</issn><eissn>2090-6226</eissn><abstract>BackgroundCirrhotic 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.MethodsPatients 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).ResultsForty-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.ConclusionsEmpagliflozin may be an effective option for use as an add-on therapy in the management of RA, with an accepted safety profile.Trial registrationThe 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.</abstract><cop>Menoufiya</cop><pub>Springer Nature B.V</pub><doi>10.1186/s43066-024-00383-y</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Egyptian Liver Journal, 2024-10, Vol.14 (1), p.76-10 |
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| subjects | Ascites Asymptomatic Blood pressure Creatinine Diabetes Diabetic ketoacidosis Diuretics Drug dosages Empagliflozin Glucose Hypoglycemia Hyponatremia Kidneys Liver cirrhosis Muscle pain Natriuretic agents Patients Sodium Sodium-glucose transporter 2 inhibitors Ultrasonic imaging Urinary tract diseases Urinary tract infections Urine Urogenital system |
| title | Empagliflozin as a novel therapy for cirrhotic refractory ascites: a randomized controlled study |
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