Azelnidipine and amlodipine produced similar reductions in 24-hour systolic blood pressure (-13 mmHg), but azelnidipine decreased pulse rate by 2 beats/min while amlodipine significantly increased it by 4 beats/min.
RCT (n=45)
Double-blind
randomized
Yes
Does azelnidipine improve 24-h blood pressure and pulse rate compared to amlodipine in patients with essential hypertension?
Azelnidipine and amlodipine provide similar 24-hour blood pressure reduction in essential hypertension, but azelnidipine favorably decreases pulse rate compared to an increase seen with amlodipine.
Absolute Event Rate: -13% vs -13%
p-value: p=0.7766
We objected: 1) To compare the effects of azelnidipine and amlodipine on 24-h blood pressure; 2) To monitor the plasma concentration vs. the time profile in order to assess the association between pharmacokinetics and hypotensive activity after administration of either drug for 6 weeks. Blood pressure and pulse rate were measured by 24-h monitoring with a portable automatic monitor in a randomized double-blind study of 46 patients with essential hypertension. Azelnidipine 16 mg (23 patients) or amlodipine 5 mg (23 patients) was administered once daily for 6 weeks. Pharmacokinetics were analyzed after the last dose was taken. Both drugs showed similar effects on the office blood pressure and pulse rate. During 24-h monitoring, both drugs caused a decrease in systolic blood pressure of 13 mmHg and had a similar hypotensive profile during the daytime period (07:00-21:30). The pulse rate decreased by 2 beats/min in the azelnidipine group, whereas it significantly increased by 4 beats/min in the amlodipine group. Similar trends in the blood pressure and pulse rate were observed during the nighttime (22:00-6:30) and over 24 h. Excessive blood pressure reduction during the nighttime was not seen in either group. The pharmacokinetic results indicated that the plasma half-life (t1/2) of amlodipine was 38.5 +/- 19.8 h and that of azelnidipine was 8.68 +/- 1.33 h. Despite this difference in pharmacokinetics, the hypotensive effects of amlodipine and azelnidipine were similar throughout the 24-h administration period.
Kuramoto et al. (Wed,) conducted a rct in essential hypertension (n=45). Azelnidipine vs. Amlodipine 5 mg once daily was evaluated on Change in 24-hour average systolic blood pressure from baseline (95% CI -5.5 to 4.1, p=0.7766). Azelnidipine and amlodipine produced similar reductions in 24-hour systolic blood pressure (-13 mmHg), but azelnidipine decreased pulse rate by 2 beats/min while amlodipine significantly increased it by 4 beats/min.