Rolofylline administration increased early dyspnoea relief in acute heart failure patients (HR 1.30; 95% CI 1.08-1.57) but did not significantly reduce 30-day mortality (HR 0.65; P=0.107).
RCT
Double-blind
Does rolofylline improve early dyspnoea relief and mortality in patients hospitalized for acute heart failure?
Early dyspnoea relief in acute heart failure is associated with greater weight loss and reduced short-term mortality; while rolofylline increases early dyspnoea relief, it does not improve long-term survival.
Effect estimate: HR 1.30 (95% CI 1.08-1.57)
AIMS: Dyspnoea and pulmonary and/or peripheral congestion are the most frequent manifestations of acute heart failure (AHF) and are important targets for therapy. We have assessed changes in dyspnoea, their relationship with mortality, and the effects of the adenosine A1 receptor antagonist rolofylline on these endpoints in patients enrolled in the PROTECT trial. METHODS AND RESULTS: PROTECT was a prospective, double-blind, placebo-controlled study assessing the effect of rolofylline in patients hospitalized for AHF with dyspnoea, fluid overload, increased plasma natriuretic peptides, and mild-to-moderate renal dysfunction. Early dyspnoea relief, prospectively defined as moderately or markedly better dyspnoea at both 24 and 48 h after the start of study drug administration, occurred in 49.8% of the patients. Early dyspnoea relief was associated with greater weight loss and with reduced mortality at Days 14 and 30 hazard ratio (HR) 0.28, 95% confidence interval (CI): 0.15, 0.50; and 0.35, 95% CI: 0.22, 0.55, respectively. Rolofylline administration was associated with an increase in the proportion of patients showing early dyspnoea relief (HR 1.30; 95% CI: 1.08, 1.57) and with a numerically lower mortality at 14 and 30 days, largely driven by the mortality due to HF at 30 days, HR (95% CI, P-value): 0.65 (0.38-1.10, P= 0.107). Rolofylline did not reduce episodes of in-hospital worsening HF or post-discharge re-admissions, nor did it improve survival at 60 or 180 days. CONCLUSION: The present analysis from PROTECT demonstrated that more weight loss was associated with early dyspnoea relief and reduced short-term mortality.
Metra et al. (Tue,) conducted a rct in Acute heart failure. Rolofylline vs. Placebo was evaluated on Early dyspnoea relief (moderately or markedly better dyspnoea at both 24 and 48 h) (HR 1.30, 95% CI 1.08-1.57). Rolofylline administration increased early dyspnoea relief in acute heart failure patients (HR 1.30; 95% CI 1.08-1.57) but did not significantly reduce 30-day mortality (HR 0.65; P=0.107).