Cross-Over Comparison of Dilevalol and Nicardipine in Patients with Mild to Moderate Hypertension

Kim, Jeong Hyun; Lim, Heon Kil; Lee, Bang Hun; Lee, Chung Kyun; Bae, Jong Hwa; Kim, Sam Soo

Abstract

The antihypertensive efficacy and safety of Dilevalol, compared with Nicardipine, were evaluated in mild to moderate hypertensive patients in a randomized crossover study. Following a 3 week placebo washout (phase I), the first crossover (phase II) was initiated with 63 patients randomized to dilevalol and 62 to nicardipine. The 6 weeks of treatment was initiated with 100mg of dilevalol once daily or 40mg of nicardipine (20mg B.I.D.). After 2 weeks, patients not achieving a sitting DBP to < or =90mmHg or a decrease of > or =10mmhg were uptitrated to 200mg Dilevalol once daily or 60mg Nicardipine twice daily. A second three week placebo washout (phase III) followed by a second 6 week active treatment phase (phase IV) during which patients were crossed over to the alternative therapy as during phase II if the sitting DBP again met the entrance criteria. 18 patients were only evaluable for the first washout and treatment period because of early discontinuation or protocol violations. They were included in the safety evaluation. phass II patients treated with Dilevalol (n=63) were mean age of 52.9 years, 49% male and 51% mild hypertensives (< or =105mmHg). Phase ??patients treated with Nicardipine (n=62) were mean age of 51.2 years 55% male and 66% mild hypertensives. Both Dilevalol and Nicardipine significantly and equivalently lowered blood pressure relative to baseline (71% versus 67% normalization). Dilevalol slightly but significantly lowered heart rate (-5 beat/min versus -1 beat/min). Dilevalol significantly increased HDL cholesterol (2.1mg/dl, 4.2%) and decreased total cholesterol (9.6mg/dl, 4.2%) while Nicardipine produced only a small but not significant reduction in total cholesterol (3.2mg/dl, 1.2%). The incidence of adverse effects were lower with Dilevalol than with Nicardipine and especially flushing and ankle edema occurred significantly more often with Nicardipine. in conclusion, dilevalol is equally effective but has a superior safety profile to nicardipine in the treatment of mild to moderate hypertension.