Nicardipine Hydrochloride Injectable Phase IV Open-Label Clinical Trial: Study on the Anti-Hypertensive Effect and Safety of Nicardipine for Acute Aortic Dissection

Abstract

We performed a multicentre, phase IV, open-label clinical trial to examine the clinical usefulness of a continuous infusion of nicardipine hydrochloride to control hypertension in 31 patients with acute aortic dissection. Target blood pressure levels were reached within 15 min in 16 patients; in 15-30 min in 10 patients; in 30-45 min in three patients; and in 45-60 min in two patients. Baseline average systolic, diastolic and mean arterial blood pressures were 147 +/- 23 mmHg, 82 +/- 18 mmHg and 104 +/- 18 mmHg, respectively, with third-day pressures significantly reduced at 119 +/- 12 mmHg, 69 +/- 9 mmHg and 86 +/- 8 mmHg. Blood pressures after discontinuation of the infusion were not significantly different from those measured on the third day of infusion and no definite adverse effects attributable to the treatment were observed. Nicardipine hydrochloride was both effective and safe at controlling blood pressure in patients with acute aortic dissection.

2010 ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease

“…Intravenous sodium nitroprusside is the most established agent and offers the advantage of being rapidly titratable (61). Nicardipine (348), nitroglycerin, fenoldopam, and various other intravenous antihypertensive agents are appropriate for this situation. Vasodilator therapy without prior beta blockade may cause reflex tachycardia and increased force of ventricular contraction leading to greater aortic wall stress and potentially causing false lumen propagation (42).…”

Cardiovascular Hypertensive Emergencies

“…Other agents that can be used in hypertensive emergencies include nicardipine (dihydropyridine calcium channel blocker), which is a useful agent for patients with coronary artery disease due to its beneficial effect on coronary blood flow or clevidipine, which is a relatively new short-acting, intravenous dihydropyridine calcium channel blocker with non-weight-based dosing regimen, allowing prolonged infusion and successful transition to oral therapy [20][21][22].…”

2010 ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM Guidelines for the Diagnosis and Management of Patients with Thoracic Aortic Disease

“…Intravenous sodium nitroprusside is the most established agent and offers the advantage of being rapidly titratable. 61 Nicardipine, 348 nitroglycerin, fenoldopam, and various other intravenous antihypertensive agents are appropriate for this situation. Vasodilator therapy without prior beta blockade may cause reflex tachycardia and increased force of ventricular contraction leading to greater aortic wall stress and potentially causing false lumen propagation.…”