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Endocrine Abstracts (2015) 37 D1.2 | DOI: 10.1530/endoabs.37.D1.2

ECE2015 Debate How to manage hyponatraemia according to guidelines? (2 abstracts)

How to manage hyponatraemia according to guidelines? The USA perspective

Joseph Verbalis


Georgetown University, Washington, District of Columbia, USA.


In 2013, a panel of international experts in hyponatremia published our recommendations for clinicians caring for patients with hyponatremia (‘Diagnosis, Evaluation, and Treatment of Hyponatremia: Expert Panel Recommendations’). In 2014, a similar working group of experts from EU countries published their recommendations (‘Clinical Practice Guideline on Diagnosis and Treatment of Hyponatraemia’). Despite reviewing the same evidence databases, these two groups independently proposed quite different recommendations. The major reason for the differences is divergent interpretation of evidence, notably the quality of the evidence for use of vasopressin receptor antagonists (vaptans) in SIADH. The EU group severely downgraded the quality of evidence of the vaptan clinical trials largely because they were industry sponsored. In addition, they relied upon meta-analyses of combined clinical trials of multiple vaptans, including those not licensed for use anywhere in the world. Our group chose to focus instead on the Phase III pivotal studies of only those vaptans that succeeded in gaining regulatory approval in Canada, EU, and US. Similar to the EMA, FDA and Health Canada, we felt the quality of the Phase III clinical trials for approved vaptans was high, with no need to downgrade the level of evidence for placebo-controlled, randomised trials. We believe that our recommendations represent a more practical guide to treating hyponatremia based on the strongest available evidence from well-constructed clinical trials, whereas the EU group inexplicably recommended therapies (e.g., urea, loop diuretics with NaCl supplementation) with relatively little evidence for either efficacy or safety based on small numbers of non-randomised studies. It is abundantly clear to everyone who treats hyponatremic patients that there is not ‘one size that fits all’; rather therapy should be individualised to each patient’s unique clinical situation. Within that context, to recommend against the use of any of the effective pharmacological therapies for hyponatraemia, as the EU guidelines group has done in contrast to our recommendations, represents a disservice to the patients we have the responsibility to care for in the best manner possible.

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