Rolofylline Preserves Renal Function in Patients With Acute Heart Failure: Presented at ACC

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Title: Rolofylline Preserves Renal Function in Patients With Acute Heart Failure: Presented at ACC
URL: http://www.pslgroup.com/dg/21F072.htm
Doctor's Guide
April 2, 2008

By Bruce Sylvester

CHICAGO -- April 2, 2008 -- A 30-mg/daily dosage of the investigative agent rolofylline appears to help preserve renal function (RF) in patients with acute heart failure (HF) compared with treatment with IV diuretics or placebo.

Researchers reported these findings from a phase 3, dose-ranging, pilot study on April 1 at the American College of Cardiology (ACC) 57th Annual Meeting.

This pilot study was conducted to define the dose of rolofylline, said lead investigator Barry Massie, MD, Chief of Cardiology, Veterans Administration Hospital, San Francisco, California. "But in looking at these phase 3 pilot study data, we found that we achieved the clinical goals that we wanted with these patients," he said.

In this double-blind, placebo-controlled study, the investigators enrolled 305 patients with acute heart failure (HF) who were randomised to rolofylline 10, 20, and 30 mg/daily or placebo for at least 3 days. The subjects were randomised within 24 hours of hospital admission for acute heart failure and had brain-type natriuretic peptide (BNP) levels greater than 250 pg/mL and N-terminal prohormone BNP greater than 1000 pg/mL.

Subjects also had renal impairment as defined by estimated creatinine clearance of 20 to 80 mL/min.

For the primary endpoint, the researchers evaluated the distribution of patients among 3 outcome categories: success (dyspnoea improvement); failure (death, HF readmission, worsening HF, Cr increase of at least 0.3 mg); or unchanged.

The investigators reported that the 30-mg/daily dosage was more effective than the other 2 doses of the drug and placebo with regard to the primary endpoint as well as to the change in serum creatinine through 14 days (+0.21 vs -0.04 mg, placebo vs 30 mg, respectively; P < .03) and all-cause mortality and rehospitalisation through 60 days.

The investigators concluded, "These results show that [rolofylline] can improve treatment of acute HF, maintain RF over the near-term, and may decrease intermediate mortality and rehospitalisations. [The ongoing trial] main phase is underway to confirm these results."

"Not only did we find the dosing we wanted ... but this dosing was also, in this study, associated with the prevention of the worsening of renal function and, in these patients, there were strong trends toward a reduction in death and readmission at 60 days, and this is for a drug that was only being given for the first 3 days of that period," Dr. Massie said.

The researchers have undertaken an ongoing trial of the 30-mg/daily dosage of rolofylline, the first study to look at an agent with the potential to prevent worsening renal function in the setting of acute heart failure, he added.

Funding for this study was provided by Merck & Co., Inc.

[Presentation title: Effects of Rolofylline, a New Adenosine A1 Receptor Antagonist, on Symptoms, Renal Function and Outcomes in Patients With Acute Heart Failure: Results of the PROTECT Pilot Study. Abstract 413-7]

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