Статья
Фиксированная комбинация индапамида и амлодипина в лечении изолированной систолической артериальной гипертонии: анализ исследования АРБАЛЕТ
Цель. В условиях реальной клинической практики оценить эффективность лечения фиксированной комбинацией (ФК) индапамида/амлодипина у амбулаторных пациентов старше 55 лет с неконтролируемой изолированной систолической артериальной гипертонией (ИСАГ).Материал и методы. Ретроспективный анализ данных участников многоцентрового наблюдательного открытого исследования АРБАЛЕТ, проведенного в России среди пациентов с артериальной гипертонией 1-2 степени, ранее не получавших антигипертензивную терапию, либо с отсутствием контроля артериального давления (АД) на принимаемых препаратах. Эффективность ФК индапамида/амлодипина оценивалась по изменению уровня офисного систолического АД (САД) и скорости достижения целевого уровня САД (<140 мм рт.ст.) через 2 нед., 1 мес. и 3 мес. в четырех возрастных группах: 55-59 лет, 60-69 лет, 70-79 лет и 80 лет и старше.Результаты. В исследовании АРБАЛЕТ приняли участие 2217 пациентов, из которых 626 имели ИСАГ и были включены в данный дополнительный анализ (средний возраст 66,1±7,8 года; 165 мужчин [26,4%]). Целевое САД <140 мм рт.ст. было достигнуто у 43%, 75% и 93% пациентов через 2 нед., 1 и 3 мес., соответственно. По сравнению с исходным уровнем САД снизилось на 18,8±10,5 мм рт.ст., 27,2±10,6 мм рт.ст. и 31,8±9,9 мм рт.ст. через 2 нед., 1 и 3 мес., соответственно. Снижение САД через 3 мес. по сравнению с исходным уровнем в подгруппах 55-60 лет, 60-69 лет, 70-79 лет и ≥80 лет составило, соответственно 30,3±9,4 мм рт.ст., 32,4±9,7 мм рт.ст., 32,5±10,7, и 28,9±9,6 мм рт.ст., соответственно.Заключение. Прием ФК индапамида и амлодипина ассоциирован со значимым снижением САД и высокой частотой достижения целевого АД у пациентов с ИСАГ старше 55 лет, получавших лечение в условиях реальной клинической практики.
1. Кобалава Ж. Д., Конради А. О., Недогода С. В. и др. Артериальная гипертензия у взрослых. Клинические рекомендации 2024. Российский кардиологический журнал. 2024;29(9):6117. doi: 10.15829/1560-4071-2024-6117.
2. Mancia G, Kreutz R, Brunström M, et al. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). J Hypertens. 2023;41(12):1874-2071. doi:10.1097/HJH.0000000000003480.
3. Palatini P, Rosei EA, Avolio A, et al. Isolated systolic hypertension in the young: a position paper endorsed by the European Society of Hypertension. J Hypertens. 2018;36(6):122236. doi:10.1097/HJH.0000000000001726.
4. Yano Y, Stamler J, Garside DB, et al. Isolated systolic hypertension in young and middleaged adults and 31-year risk for cardiovascular mortality: the Chicago Heart Association Detection project in industry study. J Am Coll Cardiol. 2015;65:327-35. doi:10.1016/j.jacc.2014.10.060.
5. Кобалава Ж. Д., Шаварова Е. К., Хомова И. А. и др. Фиксированная комбинация амлодипина и индапамида-ретард в лечении неконтролируемой артериальной гипертонии у лиц старше 55 лет. Артериальная гипертензия. 2018;24(5):586-95. doi:10.18705/1607-419X-2018-24-5-586-595.
6. Vishnevsky A, Andreev E, Timonin S. Mortality from cardiovascular diseases and life expectancy in Russia. Demographic review, 2017;4(5):45-70. doi:10.17323/demreview.v4i5.8566.
7. Liu X, Rodriguez CJ, Wang K. Prevalence and trends of isolated systolic hypertension among untreated adults in the United States. J Am Soc Hypertens. 2015;9(3):197-205. doi:10.1016/j.jash.2015.01.002.
8. McEniery CM, Yasmin, Wallace S, et al.; ENIGMA Study Investigators. Increased stroke volume and aortic stiffness contribute to isolated systolic hypertension in young adults. Hypertension. 2005;46(1):221-6. doi:10.1161/01.HYP.0000165310.84801.e0.
9. O’Donnell CJ, Ridker PM, Glynn RJ, et al. Hypertension and borderline isolated systolic hypertension increase risks of cardiovascular disease and mortality in male physicians. Circulation. 1997;95(5):1132-7. doi:10.1161/01.cir.95.5.1132.
10. Yano Y. Blood Pressure in Young Adults and Cardiovascular Disease Later in Life. Am J Hypertens. 2021;34(3):250-7. doi:10.1093/ajh/hpab005. PMID: 33821946.
11. Atasoy S, Middeke M, Johar H, et al. Cardiovascular mortality risk in young adults with isolated systolic hypertension: findings from population-based MONICA/KORA cohort study. J Hum Hypertens. 2022;36(12):1059-65. doi:10.1038/s41371-021-00619-z.
12. Bae EH, Lim SY, Jung JH, et al. Chronic Kidney Disease Risk of Isolated Systolic or Diastolic Hypertension in Young Adults: A Nationwide Sample Based-Cohort Study. J Am Heart Assoc. 2021;10(7):e019764. doi:10.1161/JAHA.120.019764.
13. Scott H, Barton MJ, Johnston ANB. Isolated systolic hypertension in young males: a scoping review. Clin Hypertens. 2021;27(1):12. doi:10.1186/s40885-021-00169-z.
14. Eeftinck Schattenkerk DW, van Gorp J, Vogt L, et al. Isolated systolic hypertension of the young and its association with central blood pressure in a large multi-ethnic population. The HELIUS study. Eur J Prev Cardiol. 2018;25(13):1351-9. doi:10.1177/2047487318777430.
15. Kobalava ZD, Shavarova EK, Burtsev YP. Evaluation of the effectiveness of single-pill combination with indapamide and amlodipine in patients older 55 years in real-world practice in Russia (ARBALET study). J Hypertens. 2019;37:p e106. doi:10.1097/01.hjh.0000571372.74309.88.
16. Кобалава Ж. Д., Толкачева В. В., Багманова Н. Х., Хасанова Э. Р. Эффективность и переносимость Арифама у пациентов с артериальной гипертонией старше 55 лет: основные результаты наблюдательной программы АРБАЛЕТ. Российский кардиологический журнал. 2018;(12):64-74. doi:10.15829/1560-4071-2018-12-64-74.
17. Unger T, Borghi C, Charchar F, et al. 2020 International Society of Hypertension global hypertension practice guidelines. J Hypertens. 2020;38(6):982-1004. doi:10.1097/HJH.0000000000002453.
18. Kim JH, Thiruvengadam R. Hypertension in an ageing population: Diagnosis, mechanisms, collateral health risks, treatments, and clinical challenges. Ageing Res Rev. 2024;98:102344. doi:10.1016/j.arr.2024.102344.
19. Ekundayo OJ, Allman RM, Sanders PW, et al. Isolated systolic hypertension and incident heart failure in older adults: a propensity-matched study. Hypertension. 2009;53(3):458-65. doi:10.1161/HYPERTENSIONAHA.108.119792.
20. Li Y, Wei FF, Thijs L, et al.; International Database on Ambulatory blood pressure in relation to Cardiovascular Outcomes (IDACO) Investigators. Ambulatory hypertension subtypes and 24-hour systolic and diastolic blood pressure as distinct outcome predictors in 8341 untreated people recruited from 12 populations. Circulation. 2014;130(6):46674. doi:10.1161/CIRCULATIONAHA.113.004876.
21. Liu J, Bu X, Wei L, et al. Global burden of cardiovascular diseases attributable to hypertension in young adults from 1990 to 2019. J Hypertens. 2021;39(12):2488-96. doi:10.1097/HJH.0000000000002958.
22. McEniery CM, Franklin SS, Cockcroft JR, Wilkinson IB. Isolated Systolic Hypertension in Young People Is Not Spurious and Should Be Treated: Pro Side of the Argument. Hypertension. 2016;68(2):269-75. doi:10.1161/HYPERTENSIONAHA.116.06547.
23. Mancia G, Giannattasio C. Diagnostic and therapeutic problems of isolated systolic hypertension. J Hypertens. 2015;33:33-43. doi:10.1097/HJH.0000000000000424.
24. Yano Y, Reis JP, Colangelo LA, et al. Association of blood pressure classification in young adults using the 2017 American College of Cardiology/American Heart Association Blood Pressure Guideline with cardiovascular events later in life. JAMA. 2018;320:1774-82. doi:10.1001/jama.2018.13551.
25. Lee H, Yano Y, Cho SMJ, et al. Cardiovascular risk of isolated systolic or diastolic hypertension in young adults. Circulation. 2020;141:1778-86. doi:10.1161/CIRCULATIONAHA.119.044838
26. Yano Y, Reis JP, Lewis CE, et al. Association of blood pressure patterns in young adulthood with cardiovascular disease and mortality in middle age. JAMA Cardiol. 2020;5:382-9. doi:10.1001/jamacardio.2019.5682.
27. Nwabuo CC, Appiah D, Moreira HT, et al. Long-term cumulative blood pressure in young adults and incident heart failure, coronary heart disease, stroke, and cardiovascular disease: the CARDIA study. Eur J Prev Cardiol. 2021;28(13):1445-51. doi:10.1177/2047487320915342.
28. Julius S, Kjeldsen SE, Weber M, et al.; VALUE trial group. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet. 2004;363(9426):2022-31. doi:10.1016/S01406736(04)16451-9.
29. Jamerson K, Weber MA, Bakris GL, et al.; ACCOMPLISH Trial Investigators. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med. 2008;359(23):2417-28. doi:10.1056/NEJMoa0806182.
30. Lu F, Zhao Y, Liu Z, et al. A 48-week study of amlodipine plus amiloride / hydrochlorothiazide vs. amlodipine plus telmisartan in the treatment of hypertension. Int J Clin Pract. 2012;66(8):792-9. doi:10.1111/j.1742-1241.2012.02943.x.
31. Matsuzaki M, Ogihara T, Umemoto S, et al.; Combination Therapy of Hypertension to Prevent Cardiovascular Events Trial Group. Prevention of cardiovascular events with calcium channel blocker-based combination therapies in patients with hypertension: a randomized controlled trial. J Hypertens. 2011;29(8):1649-59. doi:10.1097/HJH.0b013e328348345d.
32. Ojji DB, Mayosi B, Francis V, et al.; CREOLE Study Investigators. Comparison of Dual Therapies for Lowering Blood Pressure in Black Africans. N Engl J Med. 2019;380(25):2429-39. doi:10.1056/NEJMoa1901113.
33. Beckett NS, Peters R, Fletcher AE, et al.; HYVET Study Group. Treatment of hypertension in patients 80 years of age or older. N Engl J Med. 2008;358(18):1887-98. doi:10.1056/NEJMoa0801369.
34. PATS Collaborating Group. Post-stroke antihypertensive treatment study. A preliminary result. Chin Med J (Engl). 1995;108(9):710-7.
35. PROGRESS Collaborative Group. Randomised trial of a perindopril-based blood-pressurelowering regimen among 6,105 individuals with previous stroke or transient ischaemic attack. Lancet. 2001;358(9287):1033-41. doi:10.1016/S0140-6736(01)06178-5.
36. ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and LipidLowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002;288(23):2981-97. doi:10.1001/jama.288.23.2981.
37. Dahlöf B, Sever PS, Poulter NR, et al.; 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 randomised controlled trial. Lancet. 2005;366(9489):895-906. doi:10.1016/S0140-6736(05)67185-1.
38. Nissen SE, Tuzcu EM, Libby P, et al.; CAMELOT Investigators. Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure: the CAMELOT study: a randomized controlled trial. JAMA. 2004;292(18):2217-25. doi:10.1001/jama.292.18.2217.
39. Pitt B, Byington RP, Furberg CD, et al. Effect of amlodipine on the progression of atherosclerosis and the occurrence of clinical events. PREVENT Investigators. Circulation. 2000;102(13):1503-10. doi:10.1161/01.cir.102.13.1503.
40. Staessen JA, Fagard R, Thijs L, et al. Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension. The Systolic Hypertension in Europe (Syst-Eur) Trial Investigators. Lancet. 1997;350(9080):757-64. doi:10.1016/s0140-6736(97)05381-6.
41. Hansson L, Lindholm LH, Ekbom T, et al. Randomised trial of old and new antihypertensive drugs in elderly patients: cardiovascular mortality and morbidity the Swedish Trial in Old Patients with Hypertension-2 study. Lancet. 1999;354(9192):1751-6. doi:10.1016/s0140-6736(99)10327-1.
42. Liu L, Wang JG, Gong L, et al. Comparison of active treatment and placebo in older Chinese patients with isolated systolic hypertension. Systolic Hypertension in China (SystChina) Collaborative Group. J Hypertens. 1998;16(12 Pt 1):1823-9. doi:10.1097/00004872199816120-00016.
43. Turnbull F, Neal B, Ninomiya T, et al. Effects of different regimens to lower blood pressure on major cardiovascular events in older and younger adults: meta-analysis of randomised trials. BMJ. 2008;336(7653):1121-3. doi:10.1136/bmj.39548.738368.BE.
44. Law MR, Morris JK, Wald NJ. Use of blood pressure lowering drugs in the prevention of cardiovascular disease: meta-analysis of 147 randomised trials in the context of expectations from prospective epidemiological studies. BMJ. 2009;338: b1665. doi:10.1136/bmj.b1665.
45. Akram J, Sheikh UE, Mahmood M, Donnelly R. Antihypertensive efficacy of indapamide SR in hypertensive patients uncontrolled with a background therapy: the NATIVE study. Curr Med Res Opin. 2007;23(12):2929-36. doi:10.1185/030079907X242674.
46. Jadhav U, Hiremath J, Namjoshi DJ, et al. Blood pressure control with a single-pill combination of indapamide sustained-release and amlodipine in patients with hypertension: the EFFICIENT study. PLoS One. 2014;9(4):e92955. doi:10.1371/journal.pone.0092955.
47. SHEP Cooperative Research Group. Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension: final results of the Systolic Hypertension in the Elderly Program (SHEP). JAMA. 1991;265(24):3255-64.
48. Emeriau JP, Knauf H, Pujadas JO, et al.; European Study Investigators. A comparison of indapamide SR 1.5 mg with both amlodipine 5 mg and hydrochlorothiazide 25 mg in elderly hypertensive patients: a randomized double-blind controlled study. J Hypertens. 2001;19(2):343-50. doi:10.1097/00004872-200102000-00023.
49. Medical Research Council trial of treatment of hypertension in older adults: principal results. MRC Working Party. BMJ. 1992;304(6824):405-12. doi:10.1136/bmj.304.6824.405.
50. Lurbe E, Redon J. Isolated Systolic Hypertension in Young People Is Not Spurious and Should Be Treated: Con Side of the Argument. Hypertension. 2016;68(2):276-80. doi:10.1161/HYPERTENSIONAHA.116.06548.
51. Kiru G, Roy A, Kondal D, et al.; TOPSPIN Investigators. Treatment optimisation for blood pressure with single-pill combinations in India (TOPSPIN) — Protocol design and baseline characteristics. Int J Cardiol Cardiovasc Risk Prev. 2024;23:200346. doi:10.1016/j.ijcrp.2024.200346.