Efficacy and Safety of Bevantolol HCl in Treating Essential Hypertension

ABSTRACT

BACKGROUND: Bevantolol HCl was developed as the first antihypertensive agent that has selective beta1 and alpha1 blocking effects with an additional calcium antagonistic activity. It's expected that antihypertensive effect is comparable to other beta-blockers without any significant adverse effect on lipid and glucose metabolism observed in other drugs, and It has less negative inotropic effect due to peripheral vasodilatation mediated through alpha1 and calcium channel blocking effects. To evaluate the antihypertensive effect and safety of bevantolol HCl, we investigated 73 patients with mild to moderately severe essential hypertension. METHODS: Patients who showed either systolic blood pressure 150-209 mmHg or diastolic pressure 95-119 mmHg, were enrolled in this study. Following placebo period of 2weeks, bevantolol HCl was administered in daily dose of 100-200 mg for 12 weeks. RESULTS: Of the 73 patients, 55 patients who were able to receive bevantolol HCl were observed for the safety and 45 patients who completed this study were evaluated for the antihypertensive effect of the drug. 1) Antihypertensive effect The mean systolic and diastolic blood pressure significantly decreased from 156.7+/-11.7 mmHg to 144.0+/-16.7 mmHg and from 101.6+/-6.4 mmHg to 93.2+/-9.7 mmHg in two weeks of observation in 37/45 patients (82.2%) and was consistently effective for 12 weeks (p<0.01). Blood pressure under 139/89 mmHg was achieved in 20 out of 45 patients (44.4%). The heart rate also declined from 74.9+/-10.5/min to 69.1+/-14.2/min and the effect lasted for 12 weeks (p<0.01). 2) Safety Mild adverse effects were observed in 27 out of 55 patients. Only one patient developed a significant bradycardia with heart rate of 40/min, which required withdrawal of the drug. No significant changes in the lipid profiles were observed. CONCLUSION: Bevantolol HCl is highly effective and generally well tolerated with an acceptable safety profile in patients with mild to moderately severe essential hypertension.