Key result
The fixed triple combination of valsartan/amlodipine/hydrochlorothiazide reduced average 24-hour systolic blood pressure by 23.8 mmHg compared to 18.0 mmHg with the double combination, and achieved target ambulatory blood pressure in 95.2% of patients versus 77.3%.
Why the study?
The study evaluated the therapeutic efficacy on ambulatory BP of a generic fixed triple combination of valsartan/amlodipine/hydrochlorothiazide compared with a fixed double combination of valsartan/amlodipine in patients with arterial hypertension II-III degree.
Does a fixed triple combination of valsartan/amlodipine/hydrochlorothiazide improve ambulatory blood pressure reduction compared to a fixed double combination of valsartan/amlodipine in patients with grade 2-3 arterial hypertension?
RCT (n=50)
Open-label
Envelope method
No
Does a fixed triple combination of valsartan/amlodipine/hydrochlorothiazide improve ambulatory blood pressure reduction compared to a fixed double combination of valsartan/amlodipine in patients with grade 2-3 arterial hypertension?
Absolute Event Rate: 23.8% vs 18%
p-value: p=<0.05
A fixed triple combination of valsartan, amlodipine, and hydrochlorothiazide provides superior 24-hour ambulatory blood pressure reduction compared to a double combination in patients with moderate-to-severe hypertension.
Supports triple antihypertensive therapy for better control; leaves open confirmation in randomized outcome trials.
The objective of the research - to evaluate the therapeutic efficacy of the generic combination (a fixed triple combination of valsartan / amlodipine / hydrochlorothiazide compared with a double fixed combination of valsartan / amlodipine) in the treatment of patients with arterial hypertension II-III degree. The objectives of the study were: to study the therapeutic efficacy on ambulatory BP of a fixed triple and double combination in the treatment of arterial hypertension.Material and methods. The study included 50 patients with 2-3 grade hypertension. The office measurement of BP, ABMP, biochemical blood tests before and after 3 months fixed combination therapy val/aml or val/aml/HTZ. The study included patients with moderate and severe arterial hypertension without diabetes. Patients were divided into 2 groups. The first group (n = 25) received fixed triple combination of 160 mg valsartan / 5 mg amlodipine / 12.5 mg hydrochlorothiazide once daily, in the morning for 1 month. Patients in the second group (n = 25) received a double fixed combination of 160 mg valsartan / 5 mg amlodipine once a day, in the morning for 1 month. When necessary, if there was no achievement of the target level of office blood pressure <140/90 mm Hg, the dose was titrated to a daily dose of 320/10 / 12.5 mg (valsartan / amlodipine / hydrochlorothiazide) on a fixed triple combination and up to 320/10 mg (valsartan / amlodipine) on a fixed double combination. After three months of treatment, therapy was monitored.Results. The average age of patients was 54.9 ± 1.8 (25-75) years. The average BMI was 31.2 ± 0.7 kg / m2. The average of office SBP and DBP at the beginning of the study were 161.7 ± 1.8 mm Hg and 98.5 ± 1.4 mmHg. The average office heart rate was 70.7 ± 1.4 beats / min. The mean 24 blood pressure monitoring was 143.8 ± 1.1 mm Hg for SBP and 92.4 ± 1.2 mm Hg for DBP. The average daily heart rate was 71.5 ± 1.5 beats / min. The decrease in average 24BP was 18.0 / 16.1 mm Hg (p < 0,05) on double combination (val/aml) and 23,8 / 20,7 mm Hg (p < 0,05) on the triple combination (val/aml/HTZ). The decrease mean day time blood pressure was 19.4 / 17.8 mm Hg (p < 0,05) on double (val/aml) and 17,8 / 22,6 mm Hg (p < 0,05) on the triple combination (val/aml/HTZ). Decrease mean nocturnal blood pressure were 17.0 / 12.1 mm Hg. (p < 0,05) on double (val/aml) and 20,5 / 18,2 mm Hg (p < 0,05) on the triple (val/aml/ HTZ) combination. Achievement of target BP at ABPM was 77.3% - in the double (val/aml) combination and 95.2% in the triple (val/aml/HTZ) combination.Conclusions. The triple fixed combination (val/aml/HTZ) was more effective in reducing blood pressure with daily monitoring compared to a double fixed (val/ aml) combination which was not accompanied by an increase in side effects.
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Rekovets et al. (2020) conducted an RCT in Arterial hypertension (n=50). Valsartan/amlodipine/hydrochlorothiazide vs. Valsartan/amlodipine 160/5 mg up to 320/10 mg once daily was evaluated on Reduction in average 24-hour systolic blood pressure (mmHg) (p=<0.05). The fixed triple combination of valsartan/amlodipine/hydrochlorothiazide reduced average 24-hour systolic blood pressure by 23.8 mmHg compared to 18.0 mmHg with the double combination, and achieved target ambulatory blood pressure in 95.2% of patients versus 77.3%.
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