Key result
Amlodipine decreased systolic/diastolic blood pressure by 11.2/7.6 mm Hg compared to 10.0/7.1 mm Hg with spirapril (p<0.0001), and demonstrated better antihypertensive effect smoothness.
Why the study?
Does amlodipine improve ambulatory blood pressure profile and antihypertensive effect smoothness compared to spirapril in patients with arterial hypertension?
RCT (n=39)
Open-label
cross-over
Does amlodipine improve ambulatory blood pressure profile and antihypertensive effect smoothness compared to spirapril in patients with arterial hypertension?
p-value: p=<0.0001
Amlodipine provides a prominent and smooth antihypertensive effect comparable to spirapril, with potentially better individual smoothness index distribution.
Supports amlodipine for smoother BP control in hypertension; extends RCT evidence on CCB consistency versus ACE inhibitors.
Aim. To compare influence of amlodipine and spirapril on ambulatory blood pressure profile, including antihypertensive effect smoothness in patients with arterial hypertension (HT). Methods. 39 patients (aged 53,7±10,0 y.o.) with HT were included in the open, randomized, cross-over study, 30 patients completed study. The duration of every therapies was 4 weeks, initial control period and wash-out period between therapies lasted 1 week. The initial daily dose of amlodipine was 5 mg, standard dose of spirapril (6 mg/daily) was not changed during the trial. After 1-2 weeks of treatment amlodipine dose was increased up to 10 mg/daily as well as dihydrochlorothiazide was added, if necessary. Ambulatory blood pressure monitoring (ABPM) was performed initially and at the end of both therapies. Results. Both drugs demonstrated good antihypertensive effect according to ABPM data. Decrease of systolic/diastolic blood pressure was 11,2±1,8/7,6±1,2 mm Hg in amlodipine therapy and 10,0±1,8/7,1±1,2 in spirapril therapy (p<0,0001). The smoothness indexes (SI) were 0,65/0,45 and 0,55/0,45, respectively, differences between two therapies were not significant. However the individual analysis of the SI distribution (with SI=0,5 as a satisfactory criterion), showed that antihypertensive effect smoothness is better in amlodipine therapy than this in spirapril one. Conclusion. Amlodipine has prominent as well as smooth antihypertensive effect, that gives it advantages in the long-term antihypertensive therapy.
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Горбунов et al. (2009) conducted an RCT in arterial hypertension (n=39). Amlodipine vs. Spirapril (6 mg/daily) was evaluated on Decrease of systolic/diastolic blood pressure (p=<0.0001). Amlodipine decreased systolic/diastolic blood pressure by 11.2/7.6 mm Hg compared to 10.0/7.1 mm Hg with spirapril (p<0.0001), and demonstrated better antihypertensive effect smoothness.
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