Defining Renal Recovery in Patients With Hepatorenal Syndrome‐Acute Kidney Injury: Experience From North American Studies
ABSTRACT Introduction The degree of improvement in serum creatinine (SCr) has previously been suggested as a sensitive indicator of treatment response in patients with hepatorenal syndrome‐acute kidney injury (HRS‐AKI), while HRS reversal remains the primary endpoint in clinical trials. Methods A to...
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Wiley
2024-12-01
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| Series: | JGH Open |
| Online Access: | https://doi.org/10.1002/jgh3.70058 |
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| author | Muhammad A. Mujtaba Hussien Elsiesy Sara Faiz Syed A. Hussain Ann Kathleen N. Gamilla‐Crudo Aftab Karim Mohammad Irfan Khan Muhammad Waqar Khattak Zunaira Zafar Michael Kueht Khurram Jamil |
| author_facet | Muhammad A. Mujtaba Hussien Elsiesy Sara Faiz Syed A. Hussain Ann Kathleen N. Gamilla‐Crudo Aftab Karim Mohammad Irfan Khan Muhammad Waqar Khattak Zunaira Zafar Michael Kueht Khurram Jamil |
| author_sort | Muhammad A. Mujtaba |
| collection | DOAJ |
| description | ABSTRACT Introduction The degree of improvement in serum creatinine (SCr) has previously been suggested as a sensitive indicator of treatment response in patients with hepatorenal syndrome‐acute kidney injury (HRS‐AKI), while HRS reversal remains the primary endpoint in clinical trials. Methods A total of ≥ 30% SCr improvement was analyzed as an exploratory prespecified endpoint in the CONFIRM trial. In this post hoc analysis, intent‐to‐treat population data from three Phase 3 studies (OT‐0401, REVERSE, and CONFIRM) conducted in North America in patients with HRS‐AKI were pooled to assess the incidence of > 30% improvement in SCr and its association with clinical outcomes. Results Significantly more patients treated with terlipressin achieved > 30% improvement in SCr compared with those who received a placebo (42.9% vs. 23.4%; p < 0.001). Compared with patients who did not achieve > 30% improvement in SCr, those who achieved this threshold had a lower incidence of renal replacement therapy (RRT) (55.2% vs. 14%, respectively; p < 0.001) and greater overall survival at Day 90 (41.6% vs. 71.1%, respectively; p < 0.001); a greater proportion achieved durability of HRS reversal (1% [95% confidence interval, 95% CI: 0] vs. 68.9% [95% CI: 0.6, 0.8]) and more patients were alive without RRT (22.7% vs. 61.6%, respectively; p < 0.001) or transplant (11.6% vs. 43.0%, respectively; p < 0.0001). Additionally, the overall survival and RRT‐free survival in the group that achieved > 30% improvement in SCr without HRS reversal were comparable to the overall group that achieved HRS reversal. Conclusion A total of > 30% improvement in SCr levels even without HRS reversal may serve as a clinically meaningful endpoint to define renal recovery in patients with HRS‐AKI. |
| format | Article |
| id | doaj-art-c92a7822d87f40f798bb660f2f95a248 |
| institution | Kabale University |
| issn | 2397-9070 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Wiley |
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| series | JGH Open |
| spelling | doaj-art-c92a7822d87f40f798bb660f2f95a2482024-12-30T04:16:37ZengWileyJGH Open2397-90702024-12-01812n/an/a10.1002/jgh3.70058Defining Renal Recovery in Patients With Hepatorenal Syndrome‐Acute Kidney Injury: Experience From North American StudiesMuhammad A. Mujtaba0Hussien Elsiesy1Sara Faiz2Syed A. Hussain3Ann Kathleen N. Gamilla‐Crudo4Aftab Karim5Mohammad Irfan Khan6Muhammad Waqar Khattak7Zunaira Zafar8Michael Kueht9Khurram Jamil10University of Texas Medical Branch Galveston Texas USATexas Christian University Fort Worth Texas USAUniversity of Texas Medical Branch Galveston Texas USAUniversity of Texas Medical Branch Galveston Texas USAUniversity of Texas Medical Branch Galveston Texas USATexas Health Presbyterian Hospital Dallas Texas USAThomas Jefferson University Hospital Philadelphia Pennsylvania USAUniversity of Illinois Peoria Peoria Illinois USASt. Mary Medical Center, Langhorne Pennsylvania USAUniversity of Texas Medical Branch Galveston Texas USAMallinckrodt Pharmaceuticals Bridgewater New Jersey USAABSTRACT Introduction The degree of improvement in serum creatinine (SCr) has previously been suggested as a sensitive indicator of treatment response in patients with hepatorenal syndrome‐acute kidney injury (HRS‐AKI), while HRS reversal remains the primary endpoint in clinical trials. Methods A total of ≥ 30% SCr improvement was analyzed as an exploratory prespecified endpoint in the CONFIRM trial. In this post hoc analysis, intent‐to‐treat population data from three Phase 3 studies (OT‐0401, REVERSE, and CONFIRM) conducted in North America in patients with HRS‐AKI were pooled to assess the incidence of > 30% improvement in SCr and its association with clinical outcomes. Results Significantly more patients treated with terlipressin achieved > 30% improvement in SCr compared with those who received a placebo (42.9% vs. 23.4%; p < 0.001). Compared with patients who did not achieve > 30% improvement in SCr, those who achieved this threshold had a lower incidence of renal replacement therapy (RRT) (55.2% vs. 14%, respectively; p < 0.001) and greater overall survival at Day 90 (41.6% vs. 71.1%, respectively; p < 0.001); a greater proportion achieved durability of HRS reversal (1% [95% confidence interval, 95% CI: 0] vs. 68.9% [95% CI: 0.6, 0.8]) and more patients were alive without RRT (22.7% vs. 61.6%, respectively; p < 0.001) or transplant (11.6% vs. 43.0%, respectively; p < 0.0001). Additionally, the overall survival and RRT‐free survival in the group that achieved > 30% improvement in SCr without HRS reversal were comparable to the overall group that achieved HRS reversal. Conclusion A total of > 30% improvement in SCr levels even without HRS reversal may serve as a clinically meaningful endpoint to define renal recovery in patients with HRS‐AKI.https://doi.org/10.1002/jgh3.70058 |
| spellingShingle | Muhammad A. Mujtaba Hussien Elsiesy Sara Faiz Syed A. Hussain Ann Kathleen N. Gamilla‐Crudo Aftab Karim Mohammad Irfan Khan Muhammad Waqar Khattak Zunaira Zafar Michael Kueht Khurram Jamil Defining Renal Recovery in Patients With Hepatorenal Syndrome‐Acute Kidney Injury: Experience From North American Studies JGH Open |
| title | Defining Renal Recovery in Patients With Hepatorenal Syndrome‐Acute Kidney Injury: Experience From North American Studies |
| title_full | Defining Renal Recovery in Patients With Hepatorenal Syndrome‐Acute Kidney Injury: Experience From North American Studies |
| title_fullStr | Defining Renal Recovery in Patients With Hepatorenal Syndrome‐Acute Kidney Injury: Experience From North American Studies |
| title_full_unstemmed | Defining Renal Recovery in Patients With Hepatorenal Syndrome‐Acute Kidney Injury: Experience From North American Studies |
| title_short | Defining Renal Recovery in Patients With Hepatorenal Syndrome‐Acute Kidney Injury: Experience From North American Studies |
| title_sort | defining renal recovery in patients with hepatorenal syndrome acute kidney injury experience from north american studies |
| url | https://doi.org/10.1002/jgh3.70058 |
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