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

Authors

DOI:

https://doi.org/10.14739/2310-1210.2021.6.240999

Keywords:

combination drug therapy, ACE inhibitor, amlodipine, angiotensin 2 receptor blocker, coronary heart disease, post-cardiac cardiosclerosis, combination drug, blood pressure

Abstract

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.

Author Biographies

M. M. Dolzhenko, Shupyk National Healthcare University of Ukraine, Kyiv

MD, PhD, DSc, Professor, Head of the Department of Cardiology

S. A. Bondarchuk, Shupyk National Healthcare University of Ukraine, Kyiv

MD, Postgraduate student of the Department of Cardiology

References

National Center for Health Statistics. (2021). Health, United States, 2019. https://doi.org/10.15620/cdc:100685

Reeh, J., Therming, C. B., Heitmann, M., Højberg, S., Sørum, C., Bech, J., Husum, D., Dominguez, H., Sehestedt, T., Hermann, T., Hansen, K. W., Simonsen, L., Galatius, S., & Prescott, E. (2019). Prediction of obstructive coronary artery disease and prognosis in patients with suspected stable angina. European Heart Journal, 40(18), 1426-1435. https://doi.org/10.1093/eurheartj/ehy806

Benjamin, E. J., Blaha, M. J., Chiuve, S. E., Cushman, M., Das, S. R., Deo, R., de Ferranti, S. D., Floyd, J., Fornage, M., Gillespie, C., Isasi, C. R., Jiménez, M. C., Jordan, L. C., Judd, S. E., Lackland, D., Lichtman, J. H., Lisabeth, L., Liu, S., Longenecker, C. T., Mackey, R. H., … American Heart Association Statistics Committee and Stroke Statistics Subcommittee. (2017). Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation, 135(10), e146-e603. https://doi.org/10.1161/CIR.0000000000000485

Kotseva, K., De Bacquer, D., De Backer, G., Rydén, L., Jennings, C., Gyberg, V., Abreu, A., Aguiar, C., Conde, A. C., Davletov, K., Dilic, M., Dolzhenko, M., Gaita, D., Georgiev, B., Gotcheva, N., Lalic, N., Laucevicius, A., Lovic, D., Mancas, S., Miličić, D., … On Behalf Of The Euroaspire Investigators. (2016). Lifestyle and risk factor mana¬gement in people at high risk of cardiovascular disease. A report from the European Society of Cardiology European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EUROASPIRE) IV cross-sectional survey in 14 European regions. European Journal of Preventive Cardiology, 23(18), 2007-2018. https://doi.org/10.1177/2047487316667784

Ettehad, D., Emdin, C. A., Kiran, A., Anderson, S. G., Callender, T., Emberson, J., Chalmers, J., Rodgers, A., & Rahimi, K. (2016). Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. The Lancet, 387(10022), 957-967. https://doi.org/10.1016/S0140-6736(15)01225-8

Brunström, M., & Carlberg, B. (2018). Association of Blood Pressure Lowering With Mortality and Cardiovascular Disease Across Blood Pressure Levels: A Systematic Review and Meta-analysis. JAMA Internal Medicine, 178(1), 28-36. https://doi.org/10.1001/jamainternmed.2017.6015

Canoy, D., & Rahimi, K. (2018). Blood pressure-lowering treatment lowers mortality and cardiovascular disease risk, but whether effects differ at an arbitrary threshold of 140 mm Hg systolic blood pressure requires further research. BMJ Evidence-Based Medicine, 23(5), 189-190. https://doi.org/10.1136/bmjebm-2018-110934

Xie, X., Atkins, E., Lv, J., Bennett, A., Neal, B., Ninomiya, T., Woodward, M., MacMahon, S., Turnbull, F., Hillis, G. S., Chalmers, J., Mant, J., Salam, A., Rahimi, K., Perkovic, V., & Rodgers, A. (2016). Effects of intensive blood pressure lowering on cardiovascular and renal outcomes: updated systematic review and meta-analysis. The Lancet, 387(10017), 435-443. https://doi.org/10.1016/S0140-6736(15)00805-3

Wokhlu, A., Smith, S. M., Gong, Y., Handberg, E. M., Elgendy, I. Y., Bavry, A. A., Cooper-DeHoff, R. M., & Pepine, C. J. (2018). Mortality implications of lower DBP with lower achieved systolic pressures in coronary artery disease: long-term mortality results from the INternational VErapamil-trandolapril STudy US cohort. Journal of Hypertension, 36(2), 419-427. https://doi.org/10.1097/HJH.0000000000001559

Messerli, F. H., Mancia, G., Conti, C. R., Hewkin, A. C., Kupfer, S., Champion, A., Kolloch, R., Benetos, A., & Pepine, C. J. (2006). Dogma Disputed: Can Aggressively Lowering Blood Pressure in Hypertensive Patients with Coronary Artery Disease Be Dangerous? Annals of Internal Medicine, 144(12), 884-893. https://doi.org/10.7326/0003-4819-144-12-200606200-00005

Bilo, G., Dolan, E., O’Brien, E., Facchetti, R., Soranna, D., Zambon, A., Mancia, G., & Parati, G. (2020). The impact of systolic and diastolic blood pressure variability on mortality is age dependent: Data from the Dublin Outcome Study. European Journal of Preventive Cardiology, 27(4), 355-364. https://doi.org/10.1177/2047487319872572

Cruickshank, J. M. (1988). Coronary flow reserve and the J curve relation between diastolic blood pressure and myocardial infarction. British Medical Journal, 297(6658), 1227-1230. https://doi.org/10.1136/bmj.297.6658.1227

Kranenburg, G., Spiering, W., de Jong, P. A., Kappelle, L. J., de Borst, G. J., Cramer, M. J., Visseren, F., Aboyans, V., Westerink, J., & SMART study group. (2017). Inter-arm systolic blood pressure diffe¬rences, relations with future vascular events and mortality in patients with and without manifest vascular disease. International Journal of Cardiology, 244, 271-276. https://doi.org/10.1016/j.ijcard.2017.06.044

Williams, B., Mancia, G., Spiering, W., Agabiti Rosei, E., Azizi, M., Burnier, M., Clement, D. L., Coca, A., de Simone, G., Dominiczak, A., Kahan, T., Mahfoud, F., Redon, J., Ruilope, L., Zanchetti, A., Kerins, M., Kjeldsen, S. E., Kreutz, R., Laurent, S., Lip, G., … ESC Scientific Docu¬ment Group. (2018). 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH). European Heart Journal, 39(33), 3021-3104. https://doi.org/10.1093/eurheartj/ehy339

Ettehad, D., Emdin, C. A., Kiran, A., Anderson, S. G., Callender, T., Emberson, J., Chalmers, J., Rodgers, A., & Rahimi, K. (2016). Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. The Lancet, 387(10022), 957-967. https://doi.org/10.1016/S0140-6736(15)01225-8

Svanteson, M., Rollefstad, S., Kløw, N. E., Hisdal, J., Ikdahl, E., Semb, A. G., & Haig, Y. (2017). Associations between coronary and carotid artery atherosclerosis in patients with inflammatory joint diseases. RMD Open, 3(2), Article e000544. https://doi.org/10.1136/rmdopen-2017-000544

ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. (2002). Major Outcomes in High-Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs DiureticThe Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA, 288(23), 2981-2997. https://doi.org/10.1001/jama.288.23.2981

Potier, L., Roussel, R., Elbez, Y., Marre, M., Zeymer, U., Reid, C. M., Ohman, M., Eagle, K. A., Bhatt, D. L., Steg, P. G., & REACH Registry Investigators. (2017). Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in high vascular risk. Heart, 103(17), 1339-1346. https://doi.org/10.1136/heartjnl-2016-310705

Mann, J. F., Schmieder, R. E., McQueen, M., Dyal, L., Schumacher, H., Pogue, J., Wang, X., Maggioni, A., Budaj, A., Chaithiraphan, S., Dickstein, K., Keltai, M., Metsärinne, K., Oto, A., Parkhomenko, A., Piegas, L. S., Svendsen, T. L., Teo, K. K., Yusuf, S., & ONTARGET investigators. (2008). Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study): a multicentre, randomised, double-blind, controlled trial. The Lancet, 372(9638), 547-553. https://doi.org/10.1016/S0140-6736(08)61236-2

Braunwald, E., Domanski, M. J., Fowler, S. E., Geller, N. L., Gersh, B. J., Hsia, J., Pfeffer, M. A., Rice, M. M., Rosenberg, Y. D., Rouleau, J. L., & PEACE Trial Investigators. (2004). Angiotensin-Converting–Enzyme Inhibition in Stable Coronary Artery Disease. The New England Journal of Medicine, 351(20), 2058-2068. https://doi.org/10.1056/NEJMoa042739

Julius, S., Kjeldsen, S. E., Weber, M., Brunner, H. R., Ekman, S., Hansson, L., Hua, T., Laragh, J., McInnes, G. T., Mitchell, L., Plat, F., Schork, A., Smith, B., Zanchetti, A., & VALUE trial group. (2004). Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. The Lancet, 363(9426), 2022-2031. https://doi.org/10.1016/S0140-6736(04)16451-9

Peters, S., Trümmel, M., Meyners, W., Koehler, B., & Westermann, K. (2005). Valsartan versus ACE inhibition after bare metal stent implantation-results of the VALVACE trial. International Journal of Cardiology, 98(2), 331-335. https://doi.org/10.1016/j.ijcard.2004.05.062

Xie, W., Zheng, F., Evangelou, E., Liu, O., Yang, Z., Chan, Q., Elliott, P., & Wu, Y. (2018). Blood pressure-lowering drugs and secondary prevention of cardiovascular disease: systematic review and meta-analysis. Journal of Hypertension, 36(6), 1256-1265. https://doi.org/10.1097/HJH.0000000000001720

Knuuti, J., Wijns, W., Saraste, A., Capodanno, D., Barbato, E., Funck-Brentano, C., Prescott, E., Storey, R. F., Deaton, C., Cuisset, T., Agewall, S., Dickstein, K., Edvardsen, T., Escaned, J., Gersh, B. J., Svitil, P., Gilard, M., Hasdai, D., Hatala, R., Mahfoud, F., … ESC Scientific Document Group. (2020). 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes: The Task Force for the diagnosis and management of chronic coronary syndromes of the European Society of Cardiology (ESC). European Heart Journal, 41(3), 407-477. https://doi.org/10.1093/eurheartj/ehz425

Pilote, L., Abrahamowicz, M., Eisenberg, M., Humphries, K., Behlouli, H., & Tu, J. V. (2008). Effect of different angiotensin-converting-enzyme inhibitors on mortality among elderly patients with congestive heart failure. CMAJ, 178(10), 1303-1311. https://doi.org/10.1503/cmaj.060068

Pedrazzini, G., Santoro, E., Latini, R., Fromm, L., Franzosi, M. G., Mocetti, T., Staszewsky, L., Barlera, S., Tognoni, G., Maggioni, A. P., & GISSI-3 Investigators. (2008). Causes of death in patients with acute myocardial infarction treated with angiotensin-converting enzyme inhibitors: findings from the Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto (GISSI)-3 trial. American Heart Journal, 155(2), 388-394. https://doi.org/10.1016/j.ahj.2007.10.015

Sawada, T., Yamada, H., Dahlof, B., & Matsubara, H. (2013). Retraction of: Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: KYOTO HEART Study [Eur Heart J (2009) 30:2461-2469, doi: 10.1093/eurheartj/ehp363]. European Heart Journal, 34(14), 1023. https://doi.org/10.1093/eurheartj/eht030

Khan, W., Moin, N., Iktidar, S., Sakrani, J., Abid, R., Afzal, J., Maheshwary, N., Kumar, K., Siddiqi, A., & Qadir, M. (2014). Real-life effectiveness, safety, and tolerability of amlodipine/valsartan or amlodipine/valsartan/hydrochlorothiazide single-pill combination in patients with hypertension from Pakistan. Therapeutic Advances in Cardiovascular Disease, 8(2), 45-55. https://doi.org/10.1177/1753944714525496

Allemann, Y., Fraile, B., Lambert, M., Barbier, M., Ferber, P., & Izzo, J. L., Jr. (2008). Efficacy of the Combination of Amlodipine and Valsartan in Patients With Hypertension Uncontrolled With Previous Monotherapy: The Exforge in Failure after Single Therapy (EX-FAST) Study. The Journal of Clinical Hypertension, 10(3), 185-194. https://doi.org/10.1111/j.1751-7176.2008.07516.x

Assaad-Khalil, S. H., & Nashaat, N. (2016). Real-life Effectiveness and Safety of Amlodipine/Valsartan Single-pill Combination in Patients with Hypertension in Egypt: Results from the EXCITE Study. Drugs – Real World Outcomes, 3(3), 307-315. https://doi.org/10.1007/s40801-016-0082-5

Smith, T. R., Philipp, T., Vaisse, B., Bakris, G. L., Wernsing, M., Yen, J., & Glazer, R. (2007). Amlodipine and Valsartan Combined and as Monotherapy in Stage 2, Elderly, and Black Hypertensive Patients: Subgroup Analyses of 2 Randomized, Placebo-Controlled Studies. The Journal of Clinical Hypertension, 9(5), 355-364. https://doi.org/10.1111/j.1524-6175.2007.06689.x

Tung, Y. C., Lin, Y. S., Wu, L. S., Chang, C. J., & Chu, P. H. (2015). Clinical Outcomes and Healthcare Costs in Hypertensive Patients Trea¬tedWith a Fixed-Dose Combination of Amlodipine/Valsartan. The Journal of Clinical Hypertension, 17(1), 51-58. https://doi.org/10.1111/jch.12449

Páll, D., Katona, E., Juhász, M., & Paragh, G. (2006). Komplex célszerv-védelem korszeru vérnyomáscsökkentokkel [Prevention of target organ damage with modern antihypertensive agents]. Orvosi hetilap, 147(32), 1505-1511.

Published

2021-10-29

How to Cite

1.
Dolzhenko MM, Bondarchuk SA. 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. Zaporozhye Medical Journal [Internet]. 2021Oct.29 [cited 2024Oct.5];23(6):791-9. Available from: http://zmj.zsmu.edu.ua/article/view/240999

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Original research