Yonsei Med J.  2017 Jan;58(1):105-113. 10.3349/ymj.2017.58.1.105.

Efficacy and Safety of Intravenous Urapidil for Older Hypertensive Patients with Acute Heart Failure: A Multicenter Randomized Controlled Trial

• Yang W
• Zhou YJ
• Fu Y
• Qin J
• Qin S
• Chen XM
• Guo JC
• Wang DZ
• Zhan H
• Li J
• He JY
• Hua Q

• KMID: 2374195
• DOI: http://doi.org/10.3349/ymj.2017.58.1.105

Abstract

PURPOSE
Urapidil is putatively effective for patients with hypertension and acute heart failure, although randomized controlled trials thereon are lacking. We investigated the efficacy and safety of intravenous urapidil relative to that of nitroglycerin in older patients with hypertension and heart failure in a randomized controlled trial.
MATERIALS AND METHODS
Patients (>60 y) with hypertension and heart failure were randomly assigned to receive intravenous urapidil (n=89) or nitroglycerin (n=91) for 7 days. Hemodynamic parameters, cardiac function, and safety outcomes were compared.
RESULTS
Patients in the urapidil group had significantly lower mean systolic blood pressure (110.1±6.5 mm Hg) than those given nitroglycerin (126.4±8.1 mm Hg, p=0.022), without changes in heart rate. Urapidil was associated with improved cardiac function as reflected by lower N terminal-pro B type natriuretic peptide after 7 days (3311.4±546.1 ng/mL vs. 4879.1±325.7 ng/mL, p=0.027) and improved left ventricular ejection fraction (62.2±3.4% vs. 51.0±2.4%, p=0.032). Patients given urapidil had fewer associated adverse events, specifically headache (p=0.025) and tachycardia (p=0.004). The one-month rehospitalization and all-cause mortality rates were similar.
CONCLUSION
Intravenous administration of urapidil, compared with nitroglycerin, was associated with better control of blood pressure and preserved cardiac function, as well as fewer adverse events, for elderly patients with hypertension and acute heart failure.

Keyword

Urapidil; hypertension; acute heart failure; randomized controlled trial

MeSH Terms

Acute Disease
Aged
Antihypertensive Agents/*administration & dosage
Blood Pressure/drug effects
Cause of Death
Female
Heart Failure/*drug therapy/physiopathology
Heart Rate/drug effects/physiology
Hemodynamics
Humans
Hypertension/*drug therapy/physiopathology
Injections, Intravenous
Male
Middle Aged
Natriuretic Peptide, Brain/blood
Nitroglycerin/administration & dosage
Peptide Fragments/blood
Piperazines/*administration & dosage
Ventricular Function, Left/drug effects/physiology
Antihypertensive Agents
Peptide Fragments
Piperazines
Natriuretic Peptide, Brain
Nitroglycerin

Figure

• 

  Fig. 1 Effects of intravenous urapidil and nitroglycerin on SBP (A), DBP (B), and heart rate (HR) (C) within 7 days after start of treatment for older patients with hypertension and AHF. *p<0.05 between the treatment groups at the indicated time point. SBP, systolic blood pressure; DBP, diastolic blood pressure; AHF, acute heart failure.

• 

  Fig. 2 Effects of intravenous urapidil and nitroglycerin on serum NT-proBNP (A), LVEF (B), and LVEDV (C) within 7 days after start of treatment for older patients with hypertension and AHF. *p<0.05 between the treatment groups at the indicated timepoint. LVEF, left ventricular ejection fraction; LVEDV, left ventricular end-diastolic volume; NT-proBNP, N-terminal B type natriuretic peptide.

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