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| |  Rolofylline Does Not Benefit Hospitalised Patients With Acute Decompensated HF, Renal Impairment: Presented at HFSA BOSTON -- September 19, 2009 -- Early treatment with rolofylline does not facilitate early clinical improvement, reduce the risk of worsening renal function or reduce the rate of postdischarge death and readmissions for cardiovascular and renal causes in patients with acute decompensated heart failure (ADHF) and renal impairment, researchers stated here at the 13th Annual Scientific Meeting of the Heart Failure Society of America (HFSA). Christopher M. O’Connor, MD, Duke University Medical Center, Durham, North Carolina, presented the results of the Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal Function (PROTECT) on a September 14. The primary endpoint was a 3 category, ordered outcome of treatment success, lack of change, or treatment failure, assessed through day 7 or discharge. Treatment success was defined as moderate to marked improvement in dyspnoea at both 24 and 48 hours after randomisation in the absence of treatment failure. The secondary composite endpoint of the study was death or cardiovascular or renal hospitalisation. Results of the study showed that rolofylline was not associated with an improvement in the primary study endpoint or the 2 secondary endpoints in patients with ADHF and renal impairment. The multicentre, randomised, double-blind, placebo-controlled trial included patients hospitalised for ADHF manifesting dyspnoea at rest and signs of volume overload requiring intravenous (IV) loop diuretic therapy. A total of 1,356 participants were randomised to infusions of rolofylline 30 mg/day for 4 hours per day for up to 3 days and 677 were randomised a similar regimen with placebo. Rolofylline was associated with more successes, but also more failure, than placebo for the primary endpoint of treatment success, no change or treatment failure (P = .348). The secondary composite endpoint of death or cardiovascular or renal hospitalisation occurred in 30.7% of rolofylline patients (25.7% were hospitalised and 8.9% died) and 31.9% of placebo patients (25.6% were hospitalised and 9.5% died), yielding a time to first event hazard ratio of 0.98; 95% confidence interval, 0.83-1.17; P = .86). Rolofylline did not reduce the incidence of renal impairment compared with placebo (15.0% vs 13.7%; P = .44). The number of patients experiencing 1 or more adverse events was similar between the rolofylline group (62.9%) and the placebo group (61.4%). However, 11 patients in the rolofylline group experienced seizure and 16 patients had a stroke. Of the patients receiving placebo, none experience a seizure and 3 patients had a stroke. “It’s unclear whether these results should alter any developments in future trials to further investigate the effects of rolofylline on this patient population,” said Dr. O’Connor. [Presentation title: Effects of Rolofylline, A Selective Adenosine A1 Antagonist in Patients Hospitalized for ADHF and Renal Impairment: Findings From the PROTECT Study. Late-Breaking Clinical Presentation]
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