Comparative efficacy and predictive value of fixed combination of amlodipine and angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker in patients with coronary heart disease, post-infarction cardiosclerosis and hypertension

The aim of the work – to analyze the effectiveness of a fixed combination of amlodipine and angiotensin-converting enzyme (ACE) inhibitor (lisinopril) or angiotensin II receptor blocker (valsartan) in patients with coronary heart disease (CHD), post-infarction cardiosclerosis (PIC), arterial hypertension (AH) regarding the blood pressure (BP) control and impact on a composite endpoint. Materials and methods. General clinical examination of 108 patients with PIC and AH was done at the Cardiology Department of Shupyk National Healthcare University of Ukraine within 12 months. Patients were divided into two groups. The first group patients (n = 50) were assigned to receive a fixed combination of valsartan and amlodipine (160 mg and 5 mg, respectively), and the second group patients (n = 58) were treated with a fixed combination of lisinopril and amlodipine (10 mg and 5 mg, respectively). Patients were followed-up for 12 months, including general clinical examination, office BP measurements, 24-hour BP monitoring, echodopplerography, monitoring of the composite endpoint. Exclusion criteria were hemodynamically significant heart valve lesions, permanent or temporary cardiac pacing, acute heart failure and implanted cardioverter-defibrillator, permanent form of atrial fibrillation, acute cerebrovascular disorder, decompensation of severe somatic pathology. Statistical analysis of the data obtained was performed using Microsoft Excel, IBM SPSS Statistics v. 23. Descriptive data were presented as arithmetic mean ± standard deviation (M ± SD) in the case of normal distribution of variables, data with distribution other than normal were presented in Me format (Q25; Q75), where Me was the median, Q25, Q75 – lower and upper quartiles (Q25; Q75), or as a percentage for categorical values with Pearson’s Chi-square (χ2) calculation. Differences in mean values were considered statistically significant at a level of Р < 0.05. Results. According to all statistical criteria, BP indicators did not differ in both patient groups. Systolic office BP in the first group was 133.00 (123.00; 140.25) mm Hg., in the second group – 130.00 (122.00; 140.00) mm Hg. In the first group, diastolic office BP was 81.00 (79.50; 81.00) mm Hg and in the second group – 80.00 (75.00; 86.00) mm Hg. No statistically significant differen­ces were found in the study groups when assessing mean BP levels during the 24-hour monitoring. In the assessment of index values, systolic BP load was higher than normal in 58 % of patients in the first group and in 56.9 % of patients in the second group (χ2 = 0.01; P = 0.53). The assessment of diastolic BP load indices revealed increased diastolic BP index in 72 % of patient in the first group and in 75.9 % – in the second group (χ2 = 0.2; P = 0.4). The number of patients with BP higher or less than 130/80 mm Hg was compared. Systolic BP was above and below 130 mm Hg in 56 % and 44 %, respectively, of the first group patients; the distribution was 37.9 % and 62.1 % in the second group. Therefore, the percentage of patients with target systolic BP was higher in the second group (χ2 = 3.52; P = 0.046). Analyzing the composite endpoint, a statistically significant difference in the Kaplan–Meier curves via the statistical criterion using a log-rank test (P = 0.007) was detected. Conclusions. No statistically significant differences were found in the analysis of office blood pressure and 24-hour blood pressure monitoring between amlodipine with lisinopril and amlodipine with valsartan groups. The detailed analysis revealed a greater percentage of patients with target blood pressure below 130/80 mm Hg among those under 65 years of age receiving amlodipine with lisinopril (χ2 = 3.52; P = 0.046). The better prognostic value of the fixed combination of amlodipine with lisinopril compared to the combination of amlodipine with valsartan (P = 0.007) was demonstrated by the endpoint analysis