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Medicines Co's Emergency Hypertensive Acute Heart Failure Study PRONTO Demonstrates Clevidipine Superior To Standard of Care


Monday, 5 Nov 2012 05:30pm EST 

Medicines Co announced the presentation of PRONTO, a study of emergency patients with acute heart failure associated with high blood pressure enrolled within hours of their hospital arrival, making it the earliest examination of acute heart failure treatment ever performed in a clinical trial. The primary objective and the main secondary objective of the PRONTO clinical trial were met. Patients randomized to early treatment with Cleviprex (clevidipine) Injectable Emulsion demonstrated more rapid and greater blood pressure reductions (p-value < 0.001). Patients reported that shortness of breath, their most distressing symptom, resolved more rapidly than with the current standard of care (SOC) (overall p-value 0.037). Safety measures were similar for both randomized treatments. PRONTO Study Methods, Results and Limitations A randomized open-label, multi-center trial, PRONTO (A Safety and Efficacy Study of Blood Pressure Control in Acute Heart Failure -- A Pilot Study), enrolled 104 emergency department hypertensive acute heart failure patients who exhibited pulmonary congestion. After setting a 30-minute target systolic blood pressure (SBP) range, patients were randomly treated with clevidipine or SOC (predominantly nitroglycerin and nicardipine), each administered per approved labeling. 

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24 Jul 2014