Effect of Fixed-dose Combination Amlodipine/Valsartan in Comparison to Two Drug Combination Nebivolol/Valsartan on 24-Hour Ambulatory Blood Pressure.

Abstract

Background: Nebivolol has a dual mechanism of action, exerting a moderate b- blockade effect and reducing peripheral arterial resistance, as a result, the antihypertensive effect of nebivolol may be higher than that of a potent vasodilator CCB such as amlodipine.

Aim: The study evaluated the effect of two nebivolol/valsartan on 24 hour ambulatory blood pressure versus amlodipine/valsartan in grade II or III hypertension patients or having uncontrolled BP despite treatment. Ambulatory blood pressure monitoring is a powerful method to monitor the changes in blood pressure over the 24 hour.

Materials and methods: A total of 74 from 90 patients continued the study. Fourty patients received amlodipine 10 mg/valsartan 160 mg (group I), and thirty-four patients received nebivolol 5 mg/ valsartan 160 mg (group II). Peripheral blood pressure readings were measured at randomization at 6 and 12 weeks. Ambulatory blood pressure was measured at randomization and 12 weeks.

Results: Both drug combinations showed high efficacy in reducing peripheral and 24 hour ambulatory BP. There was no statistically significant difference between the groups in lowering peripheral systolic and diastolic blood pressure at 6 and 12 weeks. Furthermore, both groups failed to show any significant difference in reducing 24 hour SBP and DBP. Regarding day SBP, the blood pressure dropped by -5.63 ± 14.87 in group I and -6.25 ± 11.59 in group II (p = 0.844). Also, group I reduced the day DBP average by -2.53 ± 9.83 and group II by -3.61 ± 9.78 (p = 0.640). In addition, both drug combinations had no statistically significant difference in lowering night SBP and DBP average.

Conclusion: Both treatment groups reached the target ambulatory blood pressure, and there was no statistically significant difference between both groups as a regard reduction in all ambulatory blood pressure readings.