@chasingthealpha $CRTX quote from recent publication

European Journal of Heart Failure (2012) 14, 642–651

"The efficacy and safety of lixivaptan in outpatients with heart failure and volume overload: results of a multicentre, randomized, double-blind, placebo-controlled, parallel-group study

Lixivaptan added to standard HF therapy demonstrated a favourable safety profile in our study. Among the most common treatment-emergent AEs in participants who received lixivaptan were thirst and polyuria. Lixivaptan was not associated with hypotension, increases in heart rate, clinically significant hypokalaemia, or worsening renal function. Mean changes from baseline in serum sodium levels were minimal and mean levels remained within normal limits throughout the study in both treatment groups. Hypernatraemia (.146 mmol/L) was reported in ,10% of participants who received lixivaptan.

Further investigation is needed to identify the ideal lixivaptan dosing regimen to optimize fluid/electrolyte balance in participants with HF, as the current study used a fixed-dose regimen. Further, this study enrolled participants with HF and volume overload, irrespective of their sodium level. It would be interesting to know whether the diuretic effect of lixivaptan is more enhanced in the subset of participants with HF, volume overload, and hyponatraemia. THE BALANCE study, a randomized, double-blind, placebo-controlled assessment that evaluated the effects of lixivaptan 50–200 mg daily in patients hospitalized with worsening HF and with hyponatraemia, was recently completed and the study results should further define the role of lixivaptan in patients with HF, hypervolaemia, and hyponatraemia."

In my opinion, this does not sound promising for the BALANCE Study results in support of their NDA for hyponatraemia.

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