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Проблема определения эффективности вмешательств в эпоху доказательной медицины: мировой и отечественный опыт
Проблема определения эффективности вмешательств в эпоху доказательной медицины: мировой и отечественный опыт
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Аннотация
В статье обсуждаются современные подходы к выбору эффективных средств для профилактики осложнений сердечно-сосудистых заболеваний, включая ингибиторы ангиотензинпревращающего фермента и блокаторы рецепторов ангиотензина II. Рассматриваются доказательные основы применения таких средств и принципы определения эффективной терапии в определенных клинических ситуациях. Приводятся данные не только рандомизированных клинических исследований, но и относительно недавно полученные результаты обсервационных исследований, отражающих реальную практику применения антигипертензивных средств.
Ключевые слова: артериальная гипертензия, ингибиторы ангиотензинпревращающего фермента, блокаторы рецепторов ангиотензина.
Key words: arterial hypertension, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers.
Ключевые слова: артериальная гипертензия, ингибиторы ангиотензинпревращающего фермента, блокаторы рецепторов ангиотензина.
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Key words: arterial hypertension, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers.
Полный текст
Список литературы
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23. Sharplin P, Beckham C, Televantou F, Chamberlain G. Early vs. late usage of angiotensin receptor blockers in the antihypertensive treatment pathway. Presnted at American Society of Hypertension; May 14–17, 2008; New Orleans, LA.
24. Sharplin P, Beckham C, Televantou F, Chamberlain G. An analysis of the antihypertensive effectiveness of ARBsvs. ACE inhibitors. Presented at International Society for Pharmacoeconomics and Outcomes Research; November 8–11, 2008; Athens, Greece.
25. Sharplin P, Chamberlain G, Beckham C, Wisniacki N. Antihypertensive effect of angiotensin receptor blockers vs. other classes of antihypertensives in UK primary care. Presented at American College of Cardiology; March 29 – April 1, 2008; Chicago, IL.
26. Petrella R.J., Charki M. Ananalysis of the antihypertensive effectiveness of combination therapies containing ARBs versus ACE inhibitors. Presented at ISPOR 12th Annual European Congress; October 24–27, 2009; Paris, France. Poster PCV21.
27. Petrella R., Michailidis P. Retrospective analysis of real-world efficacy of angiotensin receptor blockers versus other classes of antihypertensive agents in blood pressure management. Clin Ther 2011; 33: 1190–203.
28. Bobrie G, Delonca J, Moulin C et al. A home blood pressure monitoring study comparing the antihypertensive efficacy two angiotensin II receptor antagonist fixed combinations. Am J Hypertens 2005; 18: 1482–8.
29. Neutel JM, Smith D. Ambulatory blood pressure comparison of the anti-hypertensive efficacy of fixed combinations of irbesartan/hydrochlorothiazide and losartan/hydrochlorothiazide in patients with mild-to-moderate hypertension. J Int Med Res 2005; 33: 620–31.
2. Savarese G, Costanzo P, ClelandJ G et al. A meta-analysis reporting effects of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients without heartfailure. J Am Coll Cardiol 2013; 61: 131–42.
3. Moher D, Liberati A, Tetzlaff J, Altman DG. PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol 2009; 62: 1006–12.
4. Mancia G, Fagard R, Narkiewicz K et al. 2013 ESH/ESC guidelines for the management of arterial hypertension: the Task Forceforthe Managementof Arterial Hypertensionof the European Societyof Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J 2013; 34: 2159–219.
5. 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 contex to fexpectations from prospective epidemiological studies. BMJ 2009; 338: b1665.
6. Blood Pressure Lowering Treatment Trialists' Collaboration. Effects of different blood pressure-lowering regimens on major cardiovascular events in individuals with and without diabetes mellitus: results of prospectively designed overviews of randomized trials. Arch Intern Med 2005; 165: 1410–19.
7. Blood Pressure Lowering Treatment Trialists' Collaboration. Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomized trials. Lancet 2003; 362: 1527–35.
8. Chassin MR. Is healthcare ready for Six Sigmaquality? Milbank Q 1998; 76: 510, 565–91.
9. Mancia G. Role of outcome trials in providing information on antihypertensive treatment: importance and limitations. Am J Hypertens 2006; 19: 1–7.
10. Woolf SH, Grol R, Hutchinson A et al. Clinical guidelines: potential benefits, limitations, and harms ofclinical guidelines. BMJ 1999; 318: 527–30.
11. Zanchetti A. Evidence-based medicine in hypertension: what type of evidence? J Hypertens 2005; 23: 1113–20.
12. Cardinal H, Monfared AA, Dorais M, Le Lorier J. A compare is on between persistence to therapy in ALLHAT and in every day clinical practice: a generaliz ability issue. Can J Cardiol 2004; 20: 417–21.
13. Craig P, Dieppe P, Macintyre S et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008; 337: a1655.
14. Hannan EL. Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations. JACC Cardiovasc Int 2008; 1: 211–7.
15. Ligthelm RJ, Borzi V, Gumprecht J et al. Importance of observational studies in clinical practice. Clin Ther 2007; 29 (Spec. No): 1284–92.
16. Bramlage P, Pittrow D, Kirch W. The effect of irbesartan in reducing cardiovascular risk in hypertensive type 2 diabetic patients: an observational study in 16,600 patients in primary care. Curr Med Res Opin 2004; 20: 1625–31.
17. Bramlage P, Schonrock E, Odoj P. Metabolic effects of an AT1-receptor blockade combined with HCTZ in cardiacrisk patients: a non interventional study in primary care. BMC Cardiovasc Dis 2008; 8: 30.
18. Kintscher U, Bramlage P, Paar WD et al. Irbesartan for the treatment of hypertension in patients with the metabolic syndrome: a subanalysis of the Treatto Targetpost authorization survey. Prospective observational, two armed study in 14,200 patients. Cardiovasc Diabetol 2007; 6: 12.
19. Mann R, Mackay F, Pearce G e tal. Losartan: a study of pharmacovigilance data on 14,522 patients. J Hum Hypertens 1999; 13: 551–7.
20. Morales-Olivas FJ, Aristegui I, Estan L et al. The KARTAN study: a postmarketing assessment of irbesartan in patients with hypertension. Clin Ther 2004; 26: 232–44.
21. Robles NR, Martin-Agueda B, Lopez-Munoz F, Alamo C. Effectiveness of eprosartan in diabetic hypertensive patients. Eur J Intern Med 2008; 19: 27–31.
22. Strutz F, Bramlage P, Paar WD. Effect of three months’ treatment with irbesartan on blood and pulse pressure of hypertensive type 2 diabetic patients: open, observational study in 31,793 patients. Curr Med Res Opin 2005; 21: 1433–40.
23. Sharplin P, Beckham C, Televantou F, Chamberlain G. Early vs. late usage of angiotensin receptor blockers in the antihypertensive treatment pathway. Presnted at American Society of Hypertension; May 14–17, 2008; New Orleans, LA.
24. Sharplin P, Beckham C, Televantou F, Chamberlain G. An analysis of the antihypertensive effectiveness of ARBsvs. ACE inhibitors. Presented at International Society for Pharmacoeconomics and Outcomes Research; November 8–11, 2008; Athens, Greece.
25. Sharplin P, Chamberlain G, Beckham C, Wisniacki N. Antihypertensive effect of angiotensin receptor blockers vs. other classes of antihypertensives in UK primary care. Presented at American College of Cardiology; March 29 – April 1, 2008; Chicago, IL.
26. Petrella R.J., Charki M. Ananalysis of the antihypertensive effectiveness of combination therapies containing ARBs versus ACE inhibitors. Presented at ISPOR 12th Annual European Congress; October 24–27, 2009; Paris, France. Poster PCV21.
27. Petrella R., Michailidis P. Retrospective analysis of real-world efficacy of angiotensin receptor blockers versus other classes of antihypertensive agents in blood pressure management. Clin Ther 2011; 33: 1190–203.
28. Bobrie G, Delonca J, Moulin C et al. A home blood pressure monitoring study comparing the antihypertensive efficacy two angiotensin II receptor antagonist fixed combinations. Am J Hypertens 2005; 18: 1482–8.
29. Neutel JM, Smith D. Ambulatory blood pressure comparison of the anti-hypertensive efficacy of fixed combinations of irbesartan/hydrochlorothiazide and losartan/hydrochlorothiazide in patients with mild-to-moderate hypertension. J Int Med Res 2005; 33: 620–31.
2. Savarese G, Costanzo P, ClelandJ G et al. A meta-analysis reporting effects of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients without heartfailure. J Am Coll Cardiol 2013; 61: 131–42.
3. Moher D, Liberati A, Tetzlaff J, Altman DG. PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol 2009; 62: 1006–12.
4. Mancia G, Fagard R, Narkiewicz K et al. 2013 ESH/ESC guidelines for the management of arterial hypertension: the Task Forceforthe Managementof Arterial Hypertensionof the European Societyof Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J 2013; 34: 2159–219.
5. 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 contex to fexpectations from prospective epidemiological studies. BMJ 2009; 338: b1665.
6. Blood Pressure Lowering Treatment Trialists' Collaboration. Effects of different blood pressure-lowering regimens on major cardiovascular events in individuals with and without diabetes mellitus: results of prospectively designed overviews of randomized trials. Arch Intern Med 2005; 165: 1410–19.
7. Blood Pressure Lowering Treatment Trialists' Collaboration. Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomized trials. Lancet 2003; 362: 1527–35.
8. Chassin MR. Is healthcare ready for Six Sigmaquality? Milbank Q 1998; 76: 510, 565–91.
9. Mancia G. Role of outcome trials in providing information on antihypertensive treatment: importance and limitations. Am J Hypertens 2006; 19: 1–7.
10. Woolf SH, Grol R, Hutchinson A et al. Clinical guidelines: potential benefits, limitations, and harms ofclinical guidelines. BMJ 1999; 318: 527–30.
11. Zanchetti A. Evidence-based medicine in hypertension: what type of evidence? J Hypertens 2005; 23: 1113–20.
12. Cardinal H, Monfared AA, Dorais M, Le Lorier J. A compare is on between persistence to therapy in ALLHAT and in every day clinical practice: a generaliz ability issue. Can J Cardiol 2004; 20: 417–21.
13. Craig P, Dieppe P, Macintyre S et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008; 337: a1655.
14. Hannan EL. Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations. JACC Cardiovasc Int 2008; 1: 211–7.
15. Ligthelm RJ, Borzi V, Gumprecht J et al. Importance of observational studies in clinical practice. Clin Ther 2007; 29 (Spec. No): 1284–92.
16. Bramlage P, Pittrow D, Kirch W. The effect of irbesartan in reducing cardiovascular risk in hypertensive type 2 diabetic patients: an observational study in 16,600 patients in primary care. Curr Med Res Opin 2004; 20: 1625–31.
17. Bramlage P, Schonrock E, Odoj P. Metabolic effects of an AT1-receptor blockade combined with HCTZ in cardiacrisk patients: a non interventional study in primary care. BMC Cardiovasc Dis 2008; 8: 30.
18. Kintscher U, Bramlage P, Paar WD et al. Irbesartan for the treatment of hypertension in patients with the metabolic syndrome: a subanalysis of the Treatto Targetpost authorization survey. Prospective observational, two armed study in 14,200 patients. Cardiovasc Diabetol 2007; 6: 12.
19. Mann R, Mackay F, Pearce G e tal. Losartan: a study of pharmacovigilance data on 14,522 patients. J Hum Hypertens 1999; 13: 551–7.
20. Morales-Olivas FJ, Aristegui I, Estan L et al. The KARTAN study: a postmarketing assessment of irbesartan in patients with hypertension. Clin Ther 2004; 26: 232–44.
21. Robles NR, Martin-Agueda B, Lopez-Munoz F, Alamo C. Effectiveness of eprosartan in diabetic hypertensive patients. Eur J Intern Med 2008; 19: 27–31.
22. Strutz F, Bramlage P, Paar WD. Effect of three months’ treatment with irbesartan on blood and pulse pressure of hypertensive type 2 diabetic patients: open, observational study in 31,793 patients. Curr Med Res Opin 2005; 21: 1433–40.
23. Sharplin P, Beckham C, Televantou F, Chamberlain G. Early vs. late usage of angiotensin receptor blockers in the antihypertensive treatment pathway. Presnted at American Society of Hypertension; May 14–17, 2008; New Orleans, LA.
24. Sharplin P, Beckham C, Televantou F, Chamberlain G. An analysis of the antihypertensive effectiveness of ARBsvs. ACE inhibitors. Presented at International Society for Pharmacoeconomics and Outcomes Research; November 8–11, 2008; Athens, Greece.
25. Sharplin P, Chamberlain G, Beckham C, Wisniacki N. Antihypertensive effect of angiotensin receptor blockers vs. other classes of antihypertensives in UK primary care. Presented at American College of Cardiology; March 29 – April 1, 2008; Chicago, IL.
26. Petrella R.J., Charki M. Ananalysis of the antihypertensive effectiveness of combination therapies containing ARBs versus ACE inhibitors. Presented at ISPOR 12th Annual European Congress; October 24–27, 2009; Paris, France. Poster PCV21.
27. Petrella R., Michailidis P. Retrospective analysis of real-world efficacy of angiotensin receptor blockers versus other classes of antihypertensive agents in blood pressure management. Clin Ther 2011; 33: 1190–203.
28. Bobrie G, Delonca J, Moulin C et al. A home blood pressure monitoring study comparing the antihypertensive efficacy two angiotensin II receptor antagonist fixed combinations. Am J Hypertens 2005; 18: 1482–8.
29. Neutel JM, Smith D. Ambulatory blood pressure comparison of the anti-hypertensive efficacy of fixed combinations of irbesartan/hydrochlorothiazide and losartan/hydrochlorothiazide in patients with mild-to-moderate hypertension. J Int Med Res 2005; 33: 620–31.
________________________________________________
2. Savarese G, Costanzo P, ClelandJ G et al. A meta-analysis reporting effects of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients without heartfailure. J Am Coll Cardiol 2013; 61: 131–42.
3. Moher D, Liberati A, Tetzlaff J, Altman DG. PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol 2009; 62: 1006–12.
4. Mancia G, Fagard R, Narkiewicz K et al. 2013 ESH/ESC guidelines for the management of arterial hypertension: the Task Forceforthe Managementof Arterial Hypertensionof the European Societyof Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J 2013; 34: 2159–219.
5. 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 contex to fexpectations from prospective epidemiological studies. BMJ 2009; 338: b1665.
6. Blood Pressure Lowering Treatment Trialists' Collaboration. Effects of different blood pressure-lowering regimens on major cardiovascular events in individuals with and without diabetes mellitus: results of prospectively designed overviews of randomized trials. Arch Intern Med 2005; 165: 1410–19.
7. Blood Pressure Lowering Treatment Trialists' Collaboration. Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomized trials. Lancet 2003; 362: 1527–35.
8. Chassin MR. Is healthcare ready for Six Sigmaquality? Milbank Q 1998; 76: 510, 565–91.
9. Mancia G. Role of outcome trials in providing information on antihypertensive treatment: importance and limitations. Am J Hypertens 2006; 19: 1–7.
10. Woolf SH, Grol R, Hutchinson A et al. Clinical guidelines: potential benefits, limitations, and harms ofclinical guidelines. BMJ 1999; 318: 527–30.
11. Zanchetti A. Evidence-based medicine in hypertension: what type of evidence? J Hypertens 2005; 23: 1113–20.
12. Cardinal H, Monfared AA, Dorais M, Le Lorier J. A compare is on between persistence to therapy in ALLHAT and in every day clinical practice: a generaliz ability issue. Can J Cardiol 2004; 20: 417–21.
13. Craig P, Dieppe P, Macintyre S et al. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008; 337: a1655.
14. Hannan EL. Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations. JACC Cardiovasc Int 2008; 1: 211–7.
15. Ligthelm RJ, Borzi V, Gumprecht J et al. Importance of observational studies in clinical practice. Clin Ther 2007; 29 (Spec. No): 1284–92.
16. Bramlage P, Pittrow D, Kirch W. The effect of irbesartan in reducing cardiovascular risk in hypertensive type 2 diabetic patients: an observational study in 16,600 patients in primary care. Curr Med Res Opin 2004; 20: 1625–31.
17. Bramlage P, Schonrock E, Odoj P. Metabolic effects of an AT1-receptor blockade combined with HCTZ in cardiacrisk patients: a non interventional study in primary care. BMC Cardiovasc Dis 2008; 8: 30.
18. Kintscher U, Bramlage P, Paar WD et al. Irbesartan for the treatment of hypertension in patients with the metabolic syndrome: a subanalysis of the Treatto Targetpost authorization survey. Prospective observational, two armed study in 14,200 patients. Cardiovasc Diabetol 2007; 6: 12.
19. Mann R, Mackay F, Pearce G e tal. Losartan: a study of pharmacovigilance data on 14,522 patients. J Hum Hypertens 1999; 13: 551–7.
20. Morales-Olivas FJ, Aristegui I, Estan L et al. The KARTAN study: a postmarketing assessment of irbesartan in patients with hypertension. Clin Ther 2004; 26: 232–44.
21. Robles NR, Martin-Agueda B, Lopez-Munoz F, Alamo C. Effectiveness of eprosartan in diabetic hypertensive patients. Eur J Intern Med 2008; 19: 27–31.
22. Strutz F, Bramlage P, Paar WD. Effect of three months’ treatment with irbesartan on blood and pulse pressure of hypertensive type 2 diabetic patients: open, observational study in 31,793 patients. Curr Med Res Opin 2005; 21: 1433–40.
23. Sharplin P, Beckham C, Televantou F, Chamberlain G. Early vs. late usage of angiotensin receptor blockers in the antihypertensive treatment pathway. Presnted at American Society of Hypertension; May 14–17, 2008; New Orleans, LA.
24. Sharplin P, Beckham C, Televantou F, Chamberlain G. An analysis of the antihypertensive effectiveness of ARBsvs. ACE inhibitors. Presented at International Society for Pharmacoeconomics and Outcomes Research; November 8–11, 2008; Athens, Greece.
25. Sharplin P, Chamberlain G, Beckham C, Wisniacki N. Antihypertensive effect of angiotensin receptor blockers vs. other classes of antihypertensives in UK primary care. Presented at American College of Cardiology; March 29 – April 1, 2008; Chicago, IL.
26. Petrella R.J., Charki M. Ananalysis of the antihypertensive effectiveness of combination therapies containing ARBs versus ACE inhibitors. Presented at ISPOR 12th Annual European Congress; October 24–27, 2009; Paris, France. Poster PCV21.
27. Petrella R., Michailidis P. Retrospective analysis of real-world efficacy of angiotensin receptor blockers versus other classes of antihypertensive agents in blood pressure management. Clin Ther 2011; 33: 1190–203.
28. Bobrie G, Delonca J, Moulin C et al. A home blood pressure monitoring study comparing the antihypertensive efficacy two angiotensin II receptor antagonist fixed combinations. Am J Hypertens 2005; 18: 1482–8.
29. Neutel JM, Smith D. Ambulatory blood pressure comparison of the anti-hypertensive efficacy of fixed combinations of irbesartan/hydrochlorothiazide and losartan/hydrochlorothiazide in patients with mild-to-moderate hypertension. J Int Med Res 2005; 33: 620–31.
Авторы
С.Р.Гиляревский
Кафедра клинической фармакологии и терапии ГБОУ ДПО РМАПО Минздрава России;
НИИ скорой помощи им. Н.В.Склифосовского, Москва
sgilarevsky@rambler.ru
sgilarevsky@rambler.ru
Кафедра клинической фармакологии и терапии ГБОУ ДПО РМАПО Минздрава России;
НИИ скорой помощи им. Н.В.Склифосовского, Москва
sgilarevsky@rambler.ru
________________________________________________
sgilarevsky@rambler.ru
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