Nicardipine Hydrochloride Injectable Phase IV Clinical Trial-Study on the antihypertensive effect and safety of nicardipine for acute aortic dissection

Kim, Kyung Hwan; Moon, In Sung; Park, Jang Sang; Koh, Yong Bok; Ahn, Hyuk

Abstract

BACKGROUND: We performed a phase IV clinical trial to examine the usefulness of a continuous infusion of nicardipine hydrochloride to control hypertension in patients with acute aortic dissection. MATERIAL AND METHOD: Systolic/diastolic blood pressure, and heart rate were monitored before and after the intravenous administration of nicardipine in 31 patients with aortic diseases. The period of nicardipine administration in each patient was from 3 to 14 days. Efficacy was evaluated by determining the average amount of blood pressure reduction on the 3rd day of drug administration. The dosage of another antihypertensive agent was slowly tapered down, and ultimately replaced by the test drug. RESULT: 28 patients were diagnosed as acute aortic dissection, 2 patients as rupture of the aortic arch aneurysm, and 1 patient as traumatic aortic rupture. Mean age was 53.9 +/- 14.9(29~89) years, and 21 patients(67.7%) were male. 14 patients(32.3%) had complications associated with underlying aortic disease: aortic insufficiency in 7, hemopericardium in 6, acute renal failure in 1, paraplegia in 1, lower extremity ischemia in 1, and hemothorax in 1. The time needed to reach the target blood pressure was within 15 minutes in 16, from 15 to 30 minutes in 10, from 30 to 45 minutes in 3 and from 45 to 60 minutes in 2, and their baseline average systolic, diastolic, and mean arterial blood pressures(mmHg) were 147 +/- 23, 82.3 +/- 18.6, and 104 +/- 18, respectively. Average systolic, diastolic, and mean arterial blood pressures(mmHg) on the third day of nicardipine infusion were 119 +/- 12, 69 +/- 9, and 86 +/- 8, and they all showed statistically significant decrease(p < 0.05). The average systolic, diastolic, and meanarterial blood pressure(mmHg) after the discontinuation of the nicardipine infusion were 119 +/- 15, 71 +/- 14, and 86 +/- 13, respectively. No significant difference was observed between the average pressures measured on the third day and those measured after the discontinuation of the nicardipine infusion, and no definite side effects were observed during the study period.
CONCLUSION
Nicardipine hydrochloride was both effective and safe at controlling blood pressure in patients with acute aortic dissection.