The efficacy offixed combination of bisoprolol and amlodipine in patients with arterial hypertension, ischemic heart disease and metabolic syndrome

The aim of the studyis to evaluate the efficacy of the fixed combination of beta adrenergic receptor blocking agents (β-AB) bisoprolol and dihydropyridine calcium channel inhibitor (CCI) amlodipine in patients with uncontrolled arterial hypertension (AH), stableischemic heart disease (IHD) and metabolic syndrome (MS) in actual clinical practice.Material and methods. The study enrolled 61 patients with uncontrolled AH, stable IHD and MS in the open prospective randomized study. The patients were randomized into 2 groups, using opaque and sealed envelopes. Patients in group 1 (n =30) had been receiving angiotensin-converting enzyme inhibitor (ACE inhibitor or ACE-i) - ramipril in dose of 10 mg/day (Hartil, Egis), fixed combination of bisoprolol and amlodipine (Concor AM, Takeda) in different doses. Patients in group 2 (control, n=31) should have been treated at the discretion of the doctor, necessarily the treatment should have included the free combination of ACE inhibitors, generic b-AB and dihydropyridine CCI. Initially, and after 12 weeks of treatment we conducted 24-hour ambulatory blood pressure monitoring (APBM) with the assessment of key indicators of 24-hour blood pressure monitoring results, the parameters of the blood vessel hardness and central blood pressure. The Statistical analyses of the results were carried out using the software package Statistica 6.1 (StatSoft Inc., United States).Results. After 12 weeks of therapy, the target level of BP was - 96,7% in the 1st group and 87,1% in the 2nd group of patients. The application of Concor AM was accompanied by significant improvements of the indicators of APBM and of the blood vessel hardness and central blood pressure characteristics. In addition, the usage of Concor AM provides the normalization of 24-hour ambulatory blood pressure monitoring results in 73% of patients. In the control group we determined the positive, but less significant changes in the indicators of APBM and rarer normalization of 24-hour ambulatory blood pressure monitoring results than in the group of patients, administrating Concor AM.Conclusion. In patients with AH, IHD and MS the administration of Concor AM is provided a significant antihypertensive and vasoprotective effects, which are more effective by the side of using free combination of β-AB and dihydropyridine CCI.

arterial hypertension, ischemic heart disease, fixed-dose combinations, the blood vessel hardness, central blood pressure

1. Dahlof B, Sever P, Wedel H et al. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomized controlled trial. Lancet 2005; 366: 895-906.

2. Jamerson K, Weber M, Bakris G et al. ACCOMPLISH Trial Investigators. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high - risk patients. N Engl J Med 2008; 359: 2417-28.

3. Nissen S, Tuzcu E, Libby P et al. CAMELOT Investigators. Effect of antihypertensive agents on cardiorprovascular events in patients with coronary disease and normal blood pressure: the CAMELOT study: a randomized controlled trial. JAMA 2004; 292: 2217-25.

4. Von Arnim T. Prognostic significance of transient ischemic episodes: response to treatment shows improved prognosis. Results of the Total Ischemic Burden Bisoprolol Study (TIBBs) follow - up. J Am Coll Cardiol 1996; 28: 20-4.

5. Rana R, Patil A. Efficacy and safety of bisoprolol plus amlodipine fixed dose combination in essential hypertension. Indian Pract 2008; 61: 225-34.

6. Чесникова А.И., Сафроненко В.А., Коломацкая О.Е. Оценка эффективности фиксированной комбинации бисопролола и амлодипина в амбулаторном лечении больных артериальной гипертензией и ишемической болезнью сердца. Кардиология. 2014; 10: 30-6.

7. The Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Europ Heart J 2013; 34: 2159-219.

8. Dahlof B et al. for the ASCOT investigators. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial - Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomized controlled trial. Lancet 2005; 366: 895-906.

9. Диагностика и лечение метаболического синдрома. Российские рекомендации. М.; 2009; c. 2-21.

10. Диагностика и лечение артериальной гипертензии. Российские рекомендации (4-й пересмотр). Системные гипертензии. 2010; 3: 5-26.

11. Stefanadis C, Dernellis J, Tsiamis E et al. Arterial stiffness as a risk factor for recurrent acute coronary events in patients with ischaemic heart disease. Eur Heart J 2000; 21: 390-6.

12. Laurent S, Katsahian S, Fassot C et al. Aortic stiffness is an independent predictor of fatal stroke in essential hypertension. Stroke 2003; 34: 1203-6.

13. Roman M.J, Devereux R.B, Kizer J.R et al. Central pressure more strongly relates to vascular disease and outcome than does brachial pressure: the Strong Heart Study. Hypertension 2007; 50: 197-203.

14. Pini R, Cavallini M.C, Palmieri V et al. Central but not brachial blood pressure predicts cardiovascular events in an unselected geriatric population: the ICARe Dicomano Study. J Am Coll Cardiol 2008; 51: 2432-9.

15. Morgan T, Lauri J, Bertram D, Anderson A. Effect of different аntihypertensive drug classes on central aortic pressure. Am J Hypertens 2004; 17: 118-23.

16. Mackenzie I.S, McEniery C.M, Dhakam Z et al. Comparison of the effects of antihypertensive agents on central blood pressure and arterial stiffness in isolated systolic hypertension. Hypertension 2009; 54: 409-13.

17. Williams B, Lacy P.S, Thom S.M et al. CAFE Investigators; Anglo-Scandinavian Cardiac Outcomes Trial Investigators; CAFE Steering Committee and Writing Committee. Differential impact of blood pressure - lowering drugs on central aortic pressure and clinical outcomes: principal results of the Conduit Artery Function Evaluation (CAFE) study. CAFE Investigators. Circulation 2006; 113: 1213-25.

18. Kampus P, Serg M, Kals J et al. Differential effects of nebivolol and metoprolol on central aortic pressure and left ventricular wall thickness. Hypertension 2011; 57: 1122-8.

19. Gupta A.S, Poulter N. Compliance, safety and effectiveness of fixed - dose combinations of antihypertensive drugs: a meta - analysis. Hypertension 2010; 55: 399-407.