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Despite missing primary efficacy endpoint, ATOMIC-AHF identifies positive trends
Date:9/2/2013

AMSTERDAM, The Netherlands Omecamtiv mecarbil, a cardiac myosin-activator, did not achieve its primary efficacy endpoint in reducing dyspnoea (shortness of breath) in patients with acute heart failure, according to the results of the phase II ATOMIC-AHF (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure) study.

However, a cohort which received the highest dose of the drug showed greater dyspnoea relief compared with placebo, and there were also other favourable dose and concentration-related trends, noted lead investigator John R. Teerlink, MD, Professor of Clinical Medicine at the University of California San Francisco and Director of Heart Failure at the San Francisco Veterans Affairs Medical Center, USA.

"The study was a real success for its purpose, as a dose-finding, safety and tolerability study," he said. "The main objective of ATOMIC-AHF was to investigate the pharmacokinetics and tolerability of intravenous omecamtiv mecarbil in the acute heart failure (AHF) population, and like most Phase II studies, it was not powered or designed around the efficacy endpoint," he explained.

"We are pleased to see as much efficacy signal as was apparent, and the study provides essential data to inform the dosing regimen for future Phase 3 trials of the intravenous formulation."

ATOMIC-AHF enrolled 613 patients with left ventricular systolic dysfunction who were acutely hospitalised with dyspnoea at rest or minimal exertion.

The subjects, from 106 sites in North America, Europe and Australia, were randomly assigned to receive 48 hours of intravenous placebo or omecamtiv mecarbil (OM) in 3 ascending dose cohorts designed to achieve plasma concentrations of 115, 230, and 310 ng/mL.

The primary efficacy endpoint was the effect on dyspnoea at 6, 24 and 48 hours, with secondary endpoints of safety, tolerability, pharmacokinetics, and echocardiographic indices of cardiac funct
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Contact: ESC Press Office
press@escardio.org
44-773-005-7146
European Society of Cardiology
Source:Eurekalert

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