Изучение возможностей хронотерапии при назначении фиксированной комбинации периндоприла 10 мг и индапамида 2,5 мг (Нолипрел А Би-форте) у пациентов с недостаточной степенью снижения артериального давления в ночное время
Изучение возможностей хронотерапии при назначении фиксированной комбинации периндоприла 10 мг и индапамида 2,5 мг (Нолипрел А Би-форте) у пациентов с недостаточной степенью снижения артериального давления в ночное время
Аксенова А.В., Елфимова Е.М., Литвин А.Ю., Чазова И.Е. Изучение возможностей хронотерапии при назначении фиксированной комбинации периндоприла 10 мг и индапамида 2,5 мг (Нолипрел А Би-форте) у пациентов с недостаточной степенью снижения артериального давления в ночное время. Системные гипертензии. 2016; 13 (2): 37–45.
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Aksenova A.V., Elfimova E.M., Litvin A.Yu., Chazova I.E. Chronotherapy’s opportunities of a fixed combination of perindopril 10 mg/indapamide 2.5 mg in patients with a lack of night reduction in blood pressure. Systemic Hypertension. 2016; 13 (2): 37–45.
Изучение возможностей хронотерапии при назначении фиксированной комбинации периндоприла 10 мг и индапамида 2,5 мг (Нолипрел А Би-форте) у пациентов с недостаточной степенью снижения артериального давления в ночное время
Аксенова А.В., Елфимова Е.М., Литвин А.Ю., Чазова И.Е. Изучение возможностей хронотерапии при назначении фиксированной комбинации периндоприла 10 мг и индапамида 2,5 мг (Нолипрел А Би-форте) у пациентов с недостаточной степенью снижения артериального давления в ночное время. Системные гипертензии. 2016; 13 (2): 37–45.
________________________________________________
Aksenova A.V., Elfimova E.M., Litvin A.Yu., Chazova I.E. Chronotherapy’s opportunities of a fixed combination of perindopril 10 mg/indapamide 2.5 mg in patients with a lack of night reduction in blood pressure. Systemic Hypertension. 2016; 13 (2): 37–45.
В настоящее время важной остается проблема адекватного снижения уровня артериального давления (АД) в ночное время у больных артериальной гипертензией. Изучение возможностей хронотерапии при однократном приеме антигипертензивных препаратов в сутки позволит достичь более полного контроля АД при сохранении высокой приверженности лечению. Цель: оценить эффективность, переносимость, безопасность разных режимов назначения фиксированной комбинации периндоприл 10 мг/индапамид 2,5 мг (Нолипрел А Би-форте, «Сервье», Франция) у пациентов с недостаточной степенью снижения АД в ночное время. Дизайн и методы. В исследовании участвовали 30 пациентов (20 мужчин и 10 женщин, 56±9,3 года, индекс массы тела 30,5±5,3 кг/м2, продолжительность наличия артериальной гипертензии 7,1±5,8 года) на неэффективной двухкомпонентной и более антигипертензивной терапии (АД>140/90 мм рт. ст.). Исходно проводились суточное мониторирование АД (СМАД), анализы крови. Затем предыдущая терапия отменялась и назначалась фиксированная комбинация периндоприл 10 мг/индапамид 2,5 мг (Нолипрел А Би-форте). Пациенты рандомизовались в 2 группы: утреннего и вечернего режимов приема терапии. После 8 нед лечения вновь были проведены СМАД и анализы крови. Статистический анализ проводился после дополнительного разделения пациентов на группы с достаточной («дипперы») и недостаточной («нон-дипперы») степенями снижения АД в ночное время. Результаты. В группе «нон-дипперов» уровень среднедневного систолического АД (САД) снизился с 149,4±11,7 до 129,8±10,6 мм рт. ст. (p<0,01), среднедневного диастолического АД (ДАД) – с 94,7±12,3 до 78,3±8,6 мм рт. ст. (ns), средненочного САД – со 146,6±16,1 до 121,8±15,7 мм рт. ст. (p<0,01), средненочного ДАД – с 86,2±9,2 до 70,3±6,5 мм рт. ст. (p<0,01). Степень ночного снижения (СНС) САД увеличилась с 1,9±5,8 до 6,2±9,3% (p<0,05), СНС ДАД – с 6,2±3,9 до 9,6±8,2% (ns). Значения СМАД «нон-дипперов» в группах вечернего и утреннего приема терапии через 2 мес терапии статистически достоверно не отличались между собой, кроме показателя вариабельности дневного ДАД (p<0,05). Статистически недостоверной была разница в показателях СНС АД. Однако и СНС САД, и СНС ДАД были выше в группе вечернего приема препарата: СНС САД 4,1±11,1% и СНС ДАД 8,9±11,0% – в группе утреннего приема препарата и 7,8±7,9% и 10,2±5,5% соответственно – в группе вечернего приема. Анализы крови за время исследования оставались в пределах нормальных значений. Заключение. Фиксированная комбинация периндоприл 10 мг/индапамид 2,5 мг (Нолипрел А Би-форте) эффективна и безопасна у пациентов как с нормальной, так и с недостаточной степенью снижения АД в ночное время. Назначение препарата в вечернее время у пациентов-«нон-дипперов» может иметь дополнительные преимущества влияния на суточный профиль АД. Необходимо проведение дальнейших исследований.
Currently, adequate reduction of blood pressure (BP) during the night in patients with arterial hypertension remains important problem. To study chronotherapy’s opportunities to achieve better BP control by a single dose of antihypertensive drugs while maintaining high compliance. Aim. To evaluate the efficacy, tolerability, safety of various prescription regimes of fixed combination: perindopril 10 mg and indapamide 2.5 mg in patients with insufficient degree of BP reduction at night. Design and methods. The study included 30 patients (20 men and 10 women, 56±9.3 years, body mass index 30.5±5.3 kg/m2, the duration of arterial hypertension – 7.1±5.8 years), on ineffective dual antihypertensive therapy (BP>140/90 mm Hg). Initially, ambulatory BP monitoring (ABPM) and blood tests were performed. Then, previous therapy was terminated and fixed combination of perindopril 10 mg/indapamide 2.5 mg (Noliprel A Bi-forte) was administered. Patients were randomized into two groups: morning and evening regimens of therapy. After 8 weeks of treatment ABPM and blood tests were repeated. Statistical analysis was done after further separation of patients into groups with sufficient (dippers) and insufficient (non-dippers) degree of BP reduction at night. Results. In the group of "non-dippers" average ambulatory systolic BP (SBP) during wakefulness declined from 149.4±11.7 mm Hg to 129.8±10.6 mmHg (p<0.01), the average ambulatory diastolic BP (DBP) during wakefulness – from 94.7±12.3 mm Hg to 78.3±8.6 mm Hg (ns), ambulatory SBP during sleep – from 146.6±16.1 mm Hg to 121.8±15.7 mm Hg (p<0.01), ambulatory DBP during sleep – from 86.2±9.2 mm Hg to 70.3±6.5 mm Hg (p<0.01). The reduction of nighttime SBP increased from 1.9±5.8% to 6.2±9.3% (p<0.05), the reduction of nighttime DBP from 6.2±3.9% to 9.6±8.2% (ns). ABPM measurements of "non-dipper" sub-groups, who received treatment in the evening or in the morning after 2 months had no significant difference, except the variability of DBP during wakefulness (p<0.05). We didn’t observe statistically significant difference in terms of the nighttime BP reduction. However, nighttime BP reduction was higher in the evening dosing group: SBP – 4.1±11.1% (morning group), 7.8±7.9% (evening group) and DBP – 8.9±11.0 (morning group) and 10.2±5.5 (evening group). Blood tests were in the normal range during the whole study. Conclusion. A fixed combination of perindopril 10 mg/indapamide 2.5 mg (Noliprel A Bi-forte) is effective and safe in patients with both normal and with insufficient degree of reduction in BP at night. Prescription of medication in the evening in non-dipper patients can have the added benefit on the BP profile. Further research is needed.
1. Franklin SS, Larson MG, Khan SA et al. Does the relation of blood pressure to coronary heart disease change with aging? The Framingham Heart Study. Circulation 2001; 103: 1245–9.
2. Palmas W, Pickering TG, Teresi J et al. Ambulatory blood pressure monitoring and all-cause mortality in elderly people with diabetes mellitus Hypertension 2009; 53: 120–7.
3. Hill L. Arterial pressure in man while sleeping, resting, waking, bathing. J Physiol (London) 1898; 22: xxvi–xxix.
4. O’Brien E, Sheridan J, O’Malley K. Dippers and non-dippers. Lancet 1988; 2: 397.
5. Birkenhäger AM, van den Meiracker AH. Causes and consequences of a non-dipping blood pressure profile. Neth J Med 2007; 65 (4): 127–31.
6. Boggia J, Li Y, Thijs L, Hansen TW et al. Prognostic accuracy of day vs. night ambulatory blood pressure: a cohort study. Lancet 2007; 370: 1219–29.
7. Fagard RH, Thijs L, Staessen JA et al. Prognostic significance of ambulatory blood pressure in hypertensive patients with history of cardiovascular disease. Blood Press Monit 2008; 13: 325–32.
8. Minutolo R, Agarwal R, Borrelli S et al. Prognostic role of ambulatory blood pressure measurement in patients with nondialysis chronic kidney disease. Arch Intern Med 2011; 171: 1090–8.
9. Fagard RH, Thijs L, Staessen JA et al. Night-day blood pressure ratio and dipping pattern as predictors of death and cardiovascular events in hypertension. J Hum Hypertens 2009; 23: 645–53.
10. Mancia G, Bombelli M, Facchetti R et al. Long-term prognostic value of blood pressure variability in the general population: results of the Pressioni Arteriose Monitorate e Loro Associazioni Study. Hypertension 2007; 49: 1265–70.
11. Hermida RC, Ayala DE, Fernández JR, Calvo C. Chronotherapy Improves Blood Pressure Control and Reverts the Nondipper Pattern in Patients With Resistant Hypertension. Hypertension 2008; 51: 69–76.
12. Mahabala C, Kamath P, Bhaskaran U. Antihypertensive therapy: nocturnal dippers and nondippers. Do we treat them differently? Vasc Health Risk Manag 2013; 9: 125–33.
13. Zannad F. Practical relevance of the 24-hour trough: peak ratio of antihypertensive drugs. J Hypertens Suppl 1995; 13 (2): S109–S112.
14. Meredith PA, Elliott HL. FDA guidelines on trough: peak ratios in the evaluation of antihypertensive agents. J Cardiovasc Pharmacol 1994; 23 (Suppl. 5): S26–S30.
15. Meredith PA. New FDA guidelines on the treatment of hypertension: comparison of different therapeutic classes according to trough/peak blood pressure responses. Arch Mal Coeur Vaiss 1994; 87 (11): 1423–9.
16. Mallion JM, Asmar R, Boutelant S, Guez D. Twenty-four hour antihypertensive efficacy of indapamide, 1.5-mg sustained release: results of two randomized double-blind controlled studies. J Cardiovasc Pharmacol 1998; 32 (4): 673–8.
17. Guez D, Mallion JM, Degaute JP et al. Treatment of hypertension with indapamide 1.5 mg sustained-release form: synthesis of results. Arch Mal Coeur Vaiss 1996; 89 (Spec 4): 17–25.
18. 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.
19. Patel A, MacMahon S, Chalmers J et al; ADVANCE Collaborative Group. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with Type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet 2007; 370 (9590): 829–40.
20. 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.
21. Manisty CH, Zambanini A, Parker KH et al; Anglo-Scandinavian Cardiac Outcome Trial Investigators. Differences in the magnitude of wave reflection account for differential effects of amlodipine-versus atenolol-based regimens on central blood pressure: an Anglo-Scandinavian Cardiac Outcome Trial substudy. Hypertension 2009; 54 (4): 724–30.
22. Williams B, Lacy PS, Thom SM 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. Circulation 2006; 113 (9): 1213–25.
23. Dolan E, Stanton AV, Thom S et al. ASCOT Investigators. Ambulatory blood pressure monitoring predicts cardiovascular events in treated hypertensive patient – an Anglo–Scandinavian cardiac outcomes trial substudy. J Hypertens 2009; 27 (4): 876–85.
24. Диагностика и лечение артериальной гипертензии. Российские рекомендации (четвертый пересмотр). Системные гипертензии. 2010; 7 (3). / Diagnostika i lechenie arterial'noi gipertenzii. Rossiiskie rekomendatsii (chetvertyi peresmotr). Systemic Hypertension. 2010; 7 (3). [in Russian]
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1. Franklin SS, Larson MG, Khan SA et al. Does the relation of blood pressure to coronary heart disease change with aging? The Framingham Heart Study. Circulation 2001; 103: 1245–9.
2. Palmas W, Pickering TG, Teresi J et al. Ambulatory blood pressure monitoring and all-cause mortality in elderly people with diabetes mellitus Hypertension 2009; 53: 120–7.
3. Hill L. Arterial pressure in man while sleeping, resting, waking, bathing. J Physiol (London) 1898; 22: xxvi–xxix.
4. O’Brien E, Sheridan J, O’Malley K. Dippers and non-dippers. Lancet 1988; 2: 397.
5. Birkenhäger AM, van den Meiracker AH. Causes and consequences of a non-dipping blood pressure profile. Neth J Med 2007; 65 (4): 127–31.
6. Boggia J, Li Y, Thijs L, Hansen TW et al. Prognostic accuracy of day vs. night ambulatory blood pressure: a cohort study. Lancet 2007; 370: 1219–29.
7. Fagard RH, Thijs L, Staessen JA et al. Prognostic significance of ambulatory blood pressure in hypertensive patients with history of cardiovascular disease. Blood Press Monit 2008; 13: 325–32.
8. Minutolo R, Agarwal R, Borrelli S et al. Prognostic role of ambulatory blood pressure measurement in patients with nondialysis chronic kidney disease. Arch Intern Med 2011; 171: 1090–8.
9. Fagard RH, Thijs L, Staessen JA et al. Night-day blood pressure ratio and dipping pattern as predictors of death and cardiovascular events in hypertension. J Hum Hypertens 2009; 23: 645–53.
10. Mancia G, Bombelli M, Facchetti R et al. Long-term prognostic value of blood pressure variability in the general population: results of the Pressioni Arteriose Monitorate e Loro Associazioni Study. Hypertension 2007; 49: 1265–70.
11. Hermida RC, Ayala DE, Fernández JR, Calvo C. Chronotherapy Improves Blood Pressure Control and Reverts the Nondipper Pattern in Patients With Resistant Hypertension. Hypertension 2008; 51: 69–76.
12. Mahabala C, Kamath P, Bhaskaran U. Antihypertensive therapy: nocturnal dippers and nondippers. Do we treat them differently? Vasc Health Risk Manag 2013; 9: 125–33.
13. Zannad F. Practical relevance of the 24-hour trough: peak ratio of antihypertensive drugs. J Hypertens Suppl 1995; 13 (2): S109–S112.
14. Meredith PA, Elliott HL. FDA guidelines on trough: peak ratios in the evaluation of antihypertensive agents. J Cardiovasc Pharmacol 1994; 23 (Suppl. 5): S26–S30.
15. Meredith PA. New FDA guidelines on the treatment of hypertension: comparison of different therapeutic classes according to trough/peak blood pressure responses. Arch Mal Coeur Vaiss 1994; 87 (11): 1423–9.
16. Mallion JM, Asmar R, Boutelant S, Guez D. Twenty-four hour antihypertensive efficacy of indapamide, 1.5-mg sustained release: results of two randomized double-blind controlled studies. J Cardiovasc Pharmacol 1998; 32 (4): 673–8.
17. Guez D, Mallion JM, Degaute JP et al. Treatment of hypertension with indapamide 1.5 mg sustained-release form: synthesis of results. Arch Mal Coeur Vaiss 1996; 89 (Spec 4): 17–25.
18. 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.
19. Patel A, MacMahon S, Chalmers J et al; ADVANCE Collaborative Group. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with Type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet 2007; 370 (9590): 829–40.
20. 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.
21. Manisty CH, Zambanini A, Parker KH et al; Anglo-Scandinavian Cardiac Outcome Trial Investigators. Differences in the magnitude of wave reflection account for differential effects of amlodipine-versus atenolol-based regimens on central blood pressure: an Anglo-Scandinavian Cardiac Outcome Trial substudy. Hypertension 2009; 54 (4): 724–30.
22. Williams B, Lacy PS, Thom SM 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. Circulation 2006; 113 (9): 1213–25.
23. Dolan E, Stanton AV, Thom S et al. ASCOT Investigators. Ambulatory blood pressure monitoring predicts cardiovascular events in treated hypertensive patient – an Anglo–Scandinavian cardiac outcomes trial substudy. J Hypertens 2009; 27 (4): 876–85.
24. Diagnostika i lechenie arterial'noi gipertenzii. Rossiiskie rekomendatsii (chetvertyi peresmotr). Systemic Hypertension. 2010; 7 (3). [in Russian]
Институт клинической кардиологии им. А.Л.Мясникова ФГБУ Российский кардиологический научно-производственный комплекс Минздрава России. 121552, Россия, Москва, ул. 3-я Черепковская, д. 15а
*alelitvin@yandex.ru
A.L.Myasnikov Institute of Clinical Cardiology, Russian Cardiological Scientific-Industrial Complex of the Ministry of Health of the Russian Federation. 121552, Russian Federation, Moscow, ul. 3-ia Cherepkovskaia, d. 15a
*alelitvin@yandex.ru