Key result
In a real-world clinical setting, tolvaptan treatment resulted in an increase in 24-hour urine volume by Day 2 in 76.9% of patients with heart failure and volume overload resistant to loop diuretics.
Why the study?
In Japan, tolvaptan is indicated for heart failure with volume overload resistant to other diuretics and can be used with normal sodium levels, prompting post-marketing evaluation of its real-world benefits and risks.
Does tolvaptan improve volume overload and congestive symptoms in patients with heart failure resistant to loop diuretics?
Observational (n=3,349)
Yes
Does tolvaptan improve volume overload and congestive symptoms in patients with heart failure resistant to loop diuretics?
In a real-world setting, tolvaptan effectively increased urine volume and reduced body weight and congestive symptoms in heart failure patients resistant to loop diuretics, with the 7.5 mg dose showing similar efficacy to 15 mg but a better safety profile.
Hypothesis-generating for tolvaptan in diuretic-resistant HF; prospective RCTs needed before clinical adoption.
BACKGROUND: In Japan, tolvaptan is indicated for patients with heart failure and volume overload who have inadequate response to other diuretics. In contrast to the USA and Europe, tolvaptan can be used in Japan in patients with normal sodium levels. METHODS AND RESULTS: In this multicenter, non-interventional, post-marketing surveillance study, prospective data from 3,349 patients treated with tolvaptan over a 5-year period were analyzed to identify benefits and risks. By Day 2 of treatment, 76.9% of evaluable patients had an increase in baseline 24-h urine volume (tolvaptan responders). Mean change in body weight was similar between 7.5 mg and 15 mg dosage groups (-3.6±3.9 kg and -3.7±4.0 kg, respectively). Improvement or disappearance rates for congestive symptoms from baseline to Day 14 ranged from 77.7% for lower limb edema to 51.1% for 3rd sound. Adverse drug reactions were reported in 18.1% of patients, most frequently thirst (8.4%). No case of central pontine myelinolysis was reported. All-cause mortality was significantly lower in patients with improved sodium concentration and increased 24-h urine volume. CONCLUSIONS: The effectiveness and safety of tolvaptan in real-world clinical settings was confirmed in this large-scale analysis. The 7.5-mg dose was equally as effective as the 15-mg dose and had a better safety profile. Improvements in all-cause mortality were suggested in tolvaptan responders.
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Kinugawa et al. (2019) conducted an observational in Heart failure with volume overload resistant to loop diuretics (n=3,349). Tolvaptan was evaluated on Increase in baseline 24-h urine volume by Day 2 (tolvaptan responders). In a real-world clinical setting, tolvaptan treatment resulted in an increase in 24-hour urine volume by Day 2 in 76.9% of patients with heart failure and volume overload resistant to loop diuretics.
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