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J. Clin. Med. 2018, 7(9), 262; https://doi.org/10.3390/jcm7090262

Correction of Hyponatremia May Be a Treatment Stratification Biomarker: A Two-Stage Systematic Review and Meta-Analysis

1
Pharmacology and Therapeutics, Faculty of Medicine, University of Valladolid, Avenida Ramón y Cajal, 7, 47005 Valladolid, Spain
2
Nephrology, Hospital Virgen de la Concha—Sanidad de Castilla y León, 49022 Zamora, Spain
3
Intensive Care Medicine, Hospital Virgen de la Concha—Sanidad de Castilla y León, 49022 Zamora, Spain
4
Research Unit, Hospital Virgen de la Concha—Sanidad de Castilla y León, 49022 Zamora, Spain
5
Cardiac Surgery, Hospital Clínico Universitario de Valladolid—Sanidad de Castilla y León, 47003 Valladolid, Spain
6
Nephrology, Dialysis and Transplantation, Centre Hospitalier Universitaire de Saint-Etienne, 42270 Saint-Priest-en-Jarez, France
7
CEIm Área de Salud Valladolid Este, Hospital Clínico Universitario de Valladolid—Sanidad de Castilla y León, 47003 Valladolid, Spain
*
Author to whom correspondence should be addressed.
Received: 4 August 2018 / Revised: 29 August 2018 / Accepted: 6 September 2018 / Published: 7 September 2018
(This article belongs to the Section Hematology)
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Abstract

Changes in serum sodium concentration ([Na+]serum) can permit evaluation of the treatment effect of vasopressin antagonists (vaptans) in patients with worsening heart failure (HF) or cirrhotic ascites; that is, they may act as a treatment stratification biomarker. A two-stage systematic review and meta-analysis were carried out and contextualized by experts in fluid resuscitation and translational pharmacology (registration ID in the International Prospective Register of Systematic Reviews (PROSPERO): CRD42017051440). Meta-analysis of aggregated dichotomous outcomes was performed. Pooled estimates for correction of hyponatremia (normalization or an increase in [Na+]serum of at least 3–5 mEq/L) under treatment with vaptans (Stage 1) and for clinical outcomes in both worsening HF (rehospitalization and/or death) and cirrhotic ascites (ascites worsening) when correction of hyponatremia is achieved (Stage 2) were calculated. The body of evidence was assessed. Correction of hyponatremia was achieved under vaptans (odds ratio (OR)/95% confidence interval (95% CI)/I2/number of studies (n): 7.48/4.95–11.30/58%/15). Clinical outcomes in both worsening HF and cirrhotic ascites improved when correction of hyponatremia was achieved (OR/95% CI/I2/n: 0.51/0.26–0.99/52%/3). Despite the appropriateness of the study design, however, there are too few trials to consider that correction of hyponatremia is a treatment stratification biomarker. Patients with worsening HF or with cirrhotic ascites needing treatment with vaptans, have better clinical outcomes when correction of hyponatremia is achieved. However, the evidence base needs to be enlarged to propose formally correction of hyponatremia as a new treatment stratification biomarker. Markers for use with drugs are needed to improve outcomes related to the use of medicines. View Full-Text
Keywords: hyponatremia; biomarkers; drug evaluation; heart failure; ascites hyponatremia; biomarkers; drug evaluation; heart failure; ascites
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Herrera-Gómez, F.; Monge-Donaire, D.; Ochoa-Sangrador, C.; Bustamante-Munguira, J.; Alamartine, E.; Álvarez, F.J. Correction of Hyponatremia May Be a Treatment Stratification Biomarker: A Two-Stage Systematic Review and Meta-Analysis. J. Clin. Med. 2018, 7, 262.

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