The efficacy of antihypertensive therapy according to the results of the CONSONANCE program: is achieving the target blood pressure level the sole criterion?

Abstract

Objective . This study aims to assess the efficacy of single-pill combination ramipril/indapamide (Konsilar-D 24) in patients with grade 1 and 2 hypertension who did not achieve blood pressure (BP) control through previous therapy or did not receive antihypertensive treatment in routine clinical practice. The assessment is based on home BP monitoring (HBPM), long-term BP variability, and quality of life according to the visual analog scale (VAS) EuroQol. Design and methods . A multicenter open observational program involved 358 CONSONANCE program patients who provided home BP monitoring (HBPM) data and self-monitoring diaries for all visits. Among them, 326 patients (91,1 %) evaluated their well-being using VAS at each visit. The program protocol was approved by the independent ethics committee of the Almazov National Medical Research Centre (protocol № 200219 от 11.02.2019). All participants provided written informed consent before inclusion. Clinical BP changes were evaluated at baseline, 0,5, 1, 3 and 6 months into treatment. Patients measured their BP daily for the initial 2 weeks and then at least 3 times a week. The average of two consecutive measurements represented each reading. The effectiveness criterion for HBPM was achieving an average BP < 135/85 mm Hg. Visit-to-visit BP variability was assessed using standard deviation (SD). Patients self-assessed their quality of life by the VAS EuroQol scale from 1 to 100 points. Statistical analysis was performed with the use of Statistica 10. Quantitative variables were presented as means and standard deviations, and their changes were evaluated using paired Student’s t-test. Qualitative features were compared using McNemar’s test with Yates’ continuity correction. A p-value < 0,05 denoted statistical significance. Results . After 2 weeks of treatment, 268 (74,9 %) patients achieved clinical BP < 140/90 mm Hg, the number increased up to 356 (99,4 %) after 6 months. For home BP, 271 (75,7 %) and 326 (91,1 %) patients reached the target after 2 weeks and after 6 months, respectively. Visit-to-visit BP variability, while on unchanged antihypertensive therapy, was 4,1 ± 2,3 / 2,5 ± 1,1 mm Hg for clinical BP and 4,5 ± 3,5 / 2,8 ± 1,9 mm Hg for home BP. The initial VAS score was 54,7 ± 19,1 points, increasing to 86,6 ± 6,1 points after 6 months of treatment (a change of 31,9 ± 18,5 points; p < 0,0001). Conclusions . Optimizing antihypertensive therapy with the single-pill combination ramipril/indapamide (Consilar D 24) effectively reduces both clinical and home BP, leading to the swift achievement of the target BP level for most patients with previously uncontrolled arterial hypertension. Treatment with this single-pill combination also reduces visit-to-visit BP variability and enhances patients’ quality of life in real clinical settings.