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Tolvaptan in hyponatraemia secondary to syndrome of inappropriate secretion of antidiuretic hormone: a guide to its use in the EU

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Abstract

Tolvaptan (Samsca®) is an orally administered highly selective vasopressin V2 receptor antagonist that increases the clearance of electrolyte-free water, thereby correcting low serum sodium levels. The drug is approved in the EU for the treatment of adults with hyponatraemia secondary to syndrome of inappropriate secretion of antidiuretic hormone (SIADH). In hyponatraemic patients with SIADH, tolvaptan 15–60 mg once daily, as an adjunct to standard medical treatment, increased serum sodium levels significantly more than placebo at day 4 and 30 in a subgroup analysis of the SALT trials. Mean serum sodium levels reached the target of >135 mmol/L within about 3–4 days and remained at that level throughout treatment, including treatment periods of up to 4 years. Once-daily tolvaptan is generally well tolerated, with most common adverse events being related to the aquaretic action of the drug.

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Acknowledgments

This article was reviewed by: D.G. Bichet, Department of Medicine, University of Montreal, Hôpital du Sacré-Coeur de Montréal, Montréal, QC, Canada, J.E.A. Blair, University of Chicago Pritzker School of Medicine, Section of Cardiology, Department of Medicine, Chicago, IL, USA, J.K. Ghali, Division of Cardiology, Mercer University School of Medicine, Macon, GA, USA. During the peer review process, the manufacturer of tolvaptan was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Kate McKeage

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  1. Kate McKeage
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Correspondence to Kate McKeage.

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The preparation of this review was not supported by any external funding.

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K. McKeage is a salaried employee of Adis/Springer, is responsible for the article content and declares no conflicts of interest.

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McKeage, K. Tolvaptan in hyponatraemia secondary to syndrome of inappropriate secretion of antidiuretic hormone: a guide to its use in the EU. Drugs Ther Perspect 32, 6–12 (2016). https://doi.org/10.1007/s40267-015-0266-1

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