Real clinical experience after one year of treatment with tolvaptan in patients with autosomal dominant polycystic kidney disease

BackgroundTolvaptan (TV) is the first vasopressin-receptor antagonist approved for the treatment of autosomal dominant polycystic kidney disease (ADPKD). No publications report TV experience in real clinical practice during the first year of treatment.MethodsA prospective study of an initial cohort...

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Main Authors: Javier Naranjo, Francisco Borrego, José Luis Rocha, Mercedes Salgueira, Maria Adoración Martín-Gomez, Cristhian Orellana, Ana Morales, Fernando Vallejo, Pilar Hidalgo, Francisca Rodríguez, Remedios Garófano, Isabel González, Rafael Esteban, Mario Espinosa
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-09-01
Series:Frontiers in Medicine
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Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2022.987092/full
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author Javier Naranjo
Francisco Borrego
José Luis Rocha
Mercedes Salgueira
Maria Adoración Martín-Gomez
Maria Adoración Martín-Gomez
Cristhian Orellana
Ana Morales
Fernando Vallejo
Pilar Hidalgo
Francisca Rodríguez
Remedios Garófano
Isabel González
Rafael Esteban
Rafael Esteban
Rafael Esteban
Mario Espinosa
author_facet Javier Naranjo
Francisco Borrego
José Luis Rocha
Mercedes Salgueira
Maria Adoración Martín-Gomez
Maria Adoración Martín-Gomez
Cristhian Orellana
Ana Morales
Fernando Vallejo
Pilar Hidalgo
Francisca Rodríguez
Remedios Garófano
Isabel González
Rafael Esteban
Rafael Esteban
Rafael Esteban
Mario Espinosa
author_sort Javier Naranjo
collection DOAJ
description BackgroundTolvaptan (TV) is the first vasopressin-receptor antagonist approved for the treatment of autosomal dominant polycystic kidney disease (ADPKD). No publications report TV experience in real clinical practice during the first year of treatment.MethodsA prospective study of an initial cohort of 220 rapidly progressing patients treated with TV for 12 months. The tolerability of TV, the evolution of the estimated glomerular filtration rate (eGFR), analytical parameters, and blood pressure were analyzed.ResultsA total of 163 patients (78.2%) received TV for 1 year. The main causes of treatment withdrawal were the aquaretic effects (11%), eGFR deterioration (5%), and hepatic toxicity (2.3%). eGFR decreased significantly after 1 month of treatment without further changes. The decrease in eGFR in the first month was higher in patients with an initially higher eGFR. The eGFR drop during the first year of treatment with TV was lower than that reported by patients in the 2 years prior to TV treatment (–1.7 ± 7.6 vs. –4.4 ± 4.8 mL/min, p = 0.003). Serum sodium and uric acid concentrations increased, and morning urinary osmolality decreased in the first month, with no further changes. Blood pressure decreased significantly without changes in antihypertensive medication.ConclusionTV treatment is well tolerated by most patients. Liver toxicity is very rare and self-limited. TV reduces eGFR in the first month without showing further changes during the first year of treatment. Patients with a higher starting eGFR will suffer a greater initial drop, with a longer recovery. We suggest using the eGFR observed after a month of treatment as the reference for future comparisons and calculating the rate of eGFR decline in patients undergoing TV treatment.
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spelling doaj.art-d05ba1f52546485cbf29ba449c183e8a2022-12-22T03:21:52ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2022-09-01910.3389/fmed.2022.987092987092Real clinical experience after one year of treatment with tolvaptan in patients with autosomal dominant polycystic kidney diseaseJavier Naranjo0Francisco Borrego1José Luis Rocha2Mercedes Salgueira3Maria Adoración Martín-Gomez4Maria Adoración Martín-Gomez5Cristhian Orellana6Ana Morales7Fernando Vallejo8Pilar Hidalgo9Francisca Rodríguez10Remedios Garófano11Isabel González12Rafael Esteban13Rafael Esteban14Rafael Esteban15Mario Espinosa16Department of Nephrology, Hospital Universitario Puerta del Mar, Cádiz, SpainDepartment of Nephrology, Complejo Hospitalario de Jaén, Jaén, SpainDepartment of Nephrology, Hospital Universitario Virgen del Rocío, Seville, SpainDepartment of Nephrology, Hospital Universitario Virgen del Macarena, Seville, SpainGrupo de Estudio de la Enfermedad Poliquística Autosómica Dominante (GEEPAD), Granada, SpainDepartment of Nephrology, Hospital de Poniente, El Ejido, SpainDepartment of Nephrology, Hospital Universitario Puerta del Mar, Cádiz, SpainDepartment of Nephrology, Hospital Universitario San Cecilio, Granada, SpainDepartment of Nephrology, Hospital Universitario Puerto Real, Puerto Real, SpainDepartment of Nephrology, Hospital Regional Universitario de Málaga, Málaga, Spain0Department of Nephrology, Hospital Costa del Sol, Marbella, Spain1Department of Nephrology, Hospital Universitario Torrecardenas, Almería, Spain2Department of Nephrology, Hospital Universitario Juan Ramón Jiménez, Huelva, SpainGrupo de Estudio de la Enfermedad Poliquística Autosómica Dominante (GEEPAD), Granada, Spain3Department of Nephrology, Hospital Universitario Virgen de las Nieves, Granada, Spain4Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain5Department of Nephrology, Hospital Universitario Reina Sofia, Córdoba, SpainBackgroundTolvaptan (TV) is the first vasopressin-receptor antagonist approved for the treatment of autosomal dominant polycystic kidney disease (ADPKD). No publications report TV experience in real clinical practice during the first year of treatment.MethodsA prospective study of an initial cohort of 220 rapidly progressing patients treated with TV for 12 months. The tolerability of TV, the evolution of the estimated glomerular filtration rate (eGFR), analytical parameters, and blood pressure were analyzed.ResultsA total of 163 patients (78.2%) received TV for 1 year. The main causes of treatment withdrawal were the aquaretic effects (11%), eGFR deterioration (5%), and hepatic toxicity (2.3%). eGFR decreased significantly after 1 month of treatment without further changes. The decrease in eGFR in the first month was higher in patients with an initially higher eGFR. The eGFR drop during the first year of treatment with TV was lower than that reported by patients in the 2 years prior to TV treatment (–1.7 ± 7.6 vs. –4.4 ± 4.8 mL/min, p = 0.003). Serum sodium and uric acid concentrations increased, and morning urinary osmolality decreased in the first month, with no further changes. Blood pressure decreased significantly without changes in antihypertensive medication.ConclusionTV treatment is well tolerated by most patients. Liver toxicity is very rare and self-limited. TV reduces eGFR in the first month without showing further changes during the first year of treatment. Patients with a higher starting eGFR will suffer a greater initial drop, with a longer recovery. We suggest using the eGFR observed after a month of treatment as the reference for future comparisons and calculating the rate of eGFR decline in patients undergoing TV treatment.https://www.frontiersin.org/articles/10.3389/fmed.2022.987092/fullglomerular filtration rate (eGFR)hepatic toxicitypolycystic kidney disease (PKD)tolvaptanurinary osmolality
spellingShingle Javier Naranjo
Francisco Borrego
José Luis Rocha
Mercedes Salgueira
Maria Adoración Martín-Gomez
Maria Adoración Martín-Gomez
Cristhian Orellana
Ana Morales
Fernando Vallejo
Pilar Hidalgo
Francisca Rodríguez
Remedios Garófano
Isabel González
Rafael Esteban
Rafael Esteban
Rafael Esteban
Mario Espinosa
Real clinical experience after one year of treatment with tolvaptan in patients with autosomal dominant polycystic kidney disease
Frontiers in Medicine
glomerular filtration rate (eGFR)
hepatic toxicity
polycystic kidney disease (PKD)
tolvaptan
urinary osmolality
title Real clinical experience after one year of treatment with tolvaptan in patients with autosomal dominant polycystic kidney disease
title_full Real clinical experience after one year of treatment with tolvaptan in patients with autosomal dominant polycystic kidney disease
title_fullStr Real clinical experience after one year of treatment with tolvaptan in patients with autosomal dominant polycystic kidney disease
title_full_unstemmed Real clinical experience after one year of treatment with tolvaptan in patients with autosomal dominant polycystic kidney disease
title_short Real clinical experience after one year of treatment with tolvaptan in patients with autosomal dominant polycystic kidney disease
title_sort real clinical experience after one year of treatment with tolvaptan in patients with autosomal dominant polycystic kidney disease
topic glomerular filtration rate (eGFR)
hepatic toxicity
polycystic kidney disease (PKD)
tolvaptan
urinary osmolality
url https://www.frontiersin.org/articles/10.3389/fmed.2022.987092/full
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