Haemodynamic and clinical effects of ularitide in decompensated heart failure

Aims: Ularitide is a synthetic form of urodilatin, a natriuretic peptide produced in the kidney with vasodilating, natriuretic, and diuretic effects, that offers promise for the management of decompensated heart failure (DHF). We assessed the efficacy and safety of ularitide in treating patients with DHF. Methods and results: In this Phase II randomized, double-blind, placebo-controlled trial, 221 DHF patients received either placebo (n=53) or ularitide at 7.5 ng/kg/min (n=60), 15 ng/kg/min (n=53), or 30 ng/kg/min (n=55) as a 24-h continuous infusion. At 6 h, ularitide demonstrated a significant decrease in pulmonary capillary wedge pressure (P=0.052, P=0.000004, P=0.000002, respectively) and improved dyspnoea score in the 7.5, 15, and 30 ng/kg/min ularitide group (P=0.0026, P=0.0026, P=0.0013, respectively). Ularitide reduced systemic vascular resistance and increased cardiac index for the 15 and 30 ng/kg/min groups (P=0.017, P=0.00002, respectively). Systolic blood pressure (BP) decreased dose dependency. Heart rate and serum creatinine were unchanged through day 3. Most frequently reported drug-related adverse events through day 3 in all ularitide groups were dose-dependent BP decrease and hypotension. Conclusion: Ularitide lowered cardiac filling pressures and improved dyspnoea without apparent early deleterious effects on renal function in DHF patients. These results suggest that ularitide may play a role in the management of DHF. © The European Society of Cardiology 2006. All rights reserved.

Mitrovic V.1 , Seferovic P.M.2 , Simeunovic D.2 , Ristic A.D.2 , Miric M.3 , Moiseyev V.S. 4 , Kobalava Z. 4 , Nitsche K.5 , Forssmann W.-G.6 , Lüss H.7 , Meyer M.7
Номер выпуска
  • 1 Kerckhoff-Klinik, Bad Nauheim, Germany
  • 2 Department of Cardiology, Institute for Cardiovascular Diseases, University Medical Center of Serbia, Belgrade
  • 3 'Zvezdara' University Clinical, Medical Center, Belgrade
  • 4 Russian Peoples Friendship University, Moscow, Russian Federation
  • 5 Hospital St. Vincenz, Limburg, Germany
  • 6 Division of Experimental and Clinical Peptide Research, Center of Pharmacology and Toxicology, Hannover Medical School, Hannover, Germany
  • 7 CardioPep Pharma GmbH, Karl-Wiechert-Allee 76, D-30625 Hannover, Germany
Ключевые слова
Congestive heart failure; Decompensated heart failure; Natriuretic peptide; Randomized clinical trial; Ularitide; Urodilatin
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Dubova E.A., Shchyogolev A.I., Chekmaryova I.A., Filatkina N.V., Chizhov D.V., Yegiev V.N.
Бюллетень экспериментальной биологии и медицины Клеточные технологии в биологии и медицине. New York Consultants BureauSpringer / Автономная некоммерческая организация Издательство Российской академии медицинских наук. Том 142. 2006. С. 729-733