Efficacy, Safety, and Tolerability of Oral Furosemide Among Patients Receiving Hemodialysis : A Pilot Study
© 2022 International Society of Nephrology. Published by Elsevier Inc..
Introduction: Diuretic use may reduce volume-related complications in hemodialysis. We evaluated the efficacy, safety, and tolerability of furosemide in patients with hemodialysis-dependent kidney failure.
Methods: We conducted an open label, single-arm, 18-week, dose titration pilot study of oral furosemide (maximum dose 320 mg/day) among patients receiving maintenance hemodialysis who reported at least 1 cup of urine output per day. The primary efficacy outcome was an increase from baseline to a specified threshold of 24-hour urine volume, with the threshold based on baseline urine volume (<200 ml/day vs. ≥200 ml/day). Safety outcomes included hypokalemia and hypomagnesemia, and tolerability was assessed by prespecified patient-reported symptoms.
Results: Of the 39 participants, 28 (72%) received the expected furosemide dose, 3 (8%) underwent dose reduction, 5 (12%) discontinued furosemide without dose reduction, and 3 (8%) underwent dose reduction and subsequently discontinued furosemide. The median (quartile 1, quartile 3) baseline 24-hour urine volume was 290 ml (110, 740), and the maximum, average daily study furosemide dose ranged from 69 mg/day to 320 mg/d. The urine output efficacy outcome was met by 12 (33%), 11 (33%), and 7 (22%) participants at weeks 5, 12, and 18, respectively, in the intention-to-treat analysis, and by 12 (39%), 9 (35%), and 7 (28%) participants at weeks 5, 12, and 18, respectively, in the on-treatment analysis. There were no electrolyte, furosemide level, or patient-reported hearing change safety events.
Conclusion: Furosemide was generally safe and well tolerated, but only one-third of participants met the efficacy definition at week 5. The clinical importance of the efficacy findings is uncertain.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:7 |
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| Enthalten in: |
Kidney international reports - 7(2022), 10 vom: 05. Okt., Seite 2186-2195 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Flythe, Jennifer E [VerfasserIn] |
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| Links: |
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| Themen: |
Diuretic |
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| Anmerkungen: |
Date Revised 20.09.2023 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1016/j.ekir.2022.07.003 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM34732732X |
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| 100 | 1 | |a Flythe, Jennifer E |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy, Safety, and Tolerability of Oral Furosemide Among Patients Receiving Hemodialysis |b A Pilot Study |
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| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2022 International Society of Nephrology. Published by Elsevier Inc. | ||
| 520 | |a Introduction: Diuretic use may reduce volume-related complications in hemodialysis. We evaluated the efficacy, safety, and tolerability of furosemide in patients with hemodialysis-dependent kidney failure | ||
| 520 | |a Methods: We conducted an open label, single-arm, 18-week, dose titration pilot study of oral furosemide (maximum dose 320 mg/day) among patients receiving maintenance hemodialysis who reported at least 1 cup of urine output per day. The primary efficacy outcome was an increase from baseline to a specified threshold of 24-hour urine volume, with the threshold based on baseline urine volume (<200 ml/day vs. ≥200 ml/day). Safety outcomes included hypokalemia and hypomagnesemia, and tolerability was assessed by prespecified patient-reported symptoms | ||
| 520 | |a Results: Of the 39 participants, 28 (72%) received the expected furosemide dose, 3 (8%) underwent dose reduction, 5 (12%) discontinued furosemide without dose reduction, and 3 (8%) underwent dose reduction and subsequently discontinued furosemide. The median (quartile 1, quartile 3) baseline 24-hour urine volume was 290 ml (110, 740), and the maximum, average daily study furosemide dose ranged from 69 mg/day to 320 mg/d. The urine output efficacy outcome was met by 12 (33%), 11 (33%), and 7 (22%) participants at weeks 5, 12, and 18, respectively, in the intention-to-treat analysis, and by 12 (39%), 9 (35%), and 7 (28%) participants at weeks 5, 12, and 18, respectively, in the on-treatment analysis. There were no electrolyte, furosemide level, or patient-reported hearing change safety events | ||
| 520 | |a Conclusion: Furosemide was generally safe and well tolerated, but only one-third of participants met the efficacy definition at week 5. The clinical importance of the efficacy findings is uncertain | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a diuretic | |
| 650 | 4 | |a efficacy | |
| 650 | 4 | |a furosemide | |
| 650 | 4 | |a hemodialysis | |
| 650 | 4 | |a hypervolemia | |
| 650 | 4 | |a safety | |
| 700 | 1 | |a Assimon, Magdalene M |e verfasserin |4 aut | |
| 700 | 1 | |a Tugman, Matthew J |e verfasserin |4 aut | |
| 700 | 1 | |a Narendra, Julia H |e verfasserin |4 aut | |
| 700 | 1 | |a Singh, Simran K |e verfasserin |4 aut | |
| 700 | 1 | |a Jin, Wanting |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Quefeng |e verfasserin |4 aut | |
| 700 | 1 | |a Bansal, Nisha |e verfasserin |4 aut | |
| 700 | 1 | |a Hostetter, Thomas H |e verfasserin |4 aut | |
| 700 | 1 | |a Dember, Laura M |e verfasserin |4 aut | |
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