Key result
A fixed combination of Amlodipine and Lisinopril provided a significantly greater decrease in systolic blood pressure compared to free combinations (24.9% vs 17.8% and 19.0%; p<0.01).
Why the study?
Personalization of pharmacotherapy for cardiovascular diseases remains an urgent problem in cardiology.
Does a fixed combination of amlodipine and lisinopril improve blood pressure reduction and left ventricular hypertrophy regression compared to free combinations in patients with high-risk arterial hypertension?
RCT (n=120)
randomized into three groups
Does a fixed combination of amlodipine and lisinopril improve blood pressure reduction and left ventricular hypertrophy regression compared to free combinations in patients with high-risk arterial hypertension?
p-value: p=<0.01
A fixed-dose combination of amlodipine and lisinopril provides superior blood pressure reduction and left ventricular hypertrophy regression compared to free combinations in high-risk hypertensive patients.
Favors fixed-dose amlodipine-lisinopril for superior SBP reduction in high-risk hypertension; extends evidence for fixed over free combinations.
Introduction: Personalization of pharmacotherapy of cardiovascular diseases is one of the urgent problems of cardiology. Material and methods: The study includes 120 patients with grades 2-3 arterial hypertension with the criteria of high and very high risk of developing cardiovascular complications. The patients were randomized into three groups with differentstarting regimens of pharmacotherapy – fixed and free combinations of ACE inhibitors and dihydropyridine CCB. Evaluation of the efficacy, safety and individualization of a therapy was carried out by using pharmacokinetic, pharmacoeconomic, sonographic, and laboratory methods. Results and discussion: Antihypertensive treatment with the inclusion of Amlodipine and Lisinopril or Ramipril in patients with arterial hypertension, having a slow and very slow oxidative metabolism phenotype, is characterized by the development of a more pronounced hypotensive effect in this group of patients (p<0.05-0.001) (Δ% SBP from 12.7 to 24.6 and from 19.6 to 27.9, respectively; Δ% DBP from 10.6 to 19.1 and from 15.9 to 23.6, respectively) in comparison to the group of patients with a fast phenotype (Δ% SBP from 6.42 to 9.34; Δ% DBP from 1.04 to 5.66), which allows administering a personalized pharmacotherapy. For patients with arterial hypertension of high and very high risk, the use of a fixed combination of Amlodipine and Lisinopril as a basic variant of the two-four-component therapy compared with treatment options based on free combinations of the studied drugs provided a significantly more pronounced decrease in systolic blood pressure (24.9%, 17.8 %, 19.0%, respectively, p<0.01), a greater degree of regression of left ventricular myocardial hypertrophy (8.70%, 5.67%, 5.84%, respectively, p<0.05), significant (p<0.05-0.001) improvement in a number of parameters of the patients’ quality of life, and was characterized by the greatest economic efficiency according to various criteria of hypotensive action. Conclusion: The results obtained in the study demonstrate the advantages of a fixed combination over free combinations of antihypertensive drugs and demonstrate the possibility of a pharmacokinetic approach to individualization of pharmacotherapy.
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Svetlana Gridina (2018) conducted an RCT in arterial hypertension (n=120). Fixed combination of Amlodipine and Lisinopril vs. Free combinations of ACE inhibitors and dihydropyridine CCB was evaluated on Decrease in systolic blood pressure (p=<0.01). A fixed combination of Amlodipine and Lisinopril provided a significantly greater decrease in systolic blood pressure compared to free combinations (24.9% vs 17.8% and 19.0%; p<0.01).
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