Adding tolvaptan to a standardized furosemide regimen for patients hospitalized with acute heart failure (HF), dyspnea and congestion may not increase the number of responders at 24 hours, according to results from the TACTICS-HF study presented Sept. 18 at the Heart Failure Society of America’s Annual Scientific Meeting in Orlando, FL, and simultaneously published in the Journal of the American College of Cardiology (JACC).

In the TACTICS-HF study, G. Michael Felker, MD, MHS, FACC, and colleagues randomized 257 patients within 24 hours of acute HF presentation to either 30 mg of tolvaptan or a placebo. The proportion of patients defined as responders (having a significant improvement in dyspnea without the need for rescue therapy or death) at 24 hours was 16 percent for tolvaptan and 20 percent for placebo. Dyspnea relief by Likert scale was similar between tolvaptan and placebo at eight hours and at 24 hours. Need for rescue therapy was also similar at 24 hours.

Results showed that tolvaptan did result in greater weight loss and net fluid loss as well as trends toward greater dyspnea improvement at 48 and 72 hours. However, patients treated with tolvaptan were more likely to experience worsening renal function during treatment. There were no differences in length of stay or post-discharge outcomes out to 30 days between the tolvaptan and placebo groups.

The findings echo earlier data demonstrating a disconnect between short-term fluid and weight loss and improvements in long-term clinical outcomes. However, they authors note that it is unclear whether this suggests that short-term decongestion is unrelated to long-term outcomes or that available therapies for decongestion are unable to alter longer-term outcomes. The study’s authors ultimately assert that “the low incidence of successful decongestion in the current study underscores the ongoing unmet need to develop better strategies for decongestion in patients with acute HF.”

In an accompanying editorial, Randall C. Starling, MD, MPH, FACC, and James B. Young, MD, FACC, note that the TACTICS-HF trial “is an important report and perhaps the final dialogue for the drug tolvaptan and its role in HF.” They suggested that there is no justification for additional study of tolvaptan’s effectiveness in acute or chronic HF. Further, they recommend that the use of tolvaptan be discouraged due to its lack of efficacy and high cost. 

Keywords: Benzazepines, Dyspnea, Furosemide, Heart Failure, Incidence, Length of Stay, Starlings, Weight Loss

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