Leki złożone w nadciśnieniu tętniczym – postęp farmakoterapii czy przerost formy nad treścią? Przegląd w oparciu o dowody EBM Artykuł przeglądowy
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Opublikowane:
mar 31, 2011
Słowa kluczowe:
nadciśnienie tętnicze, leczenie skojarzone, preparaty złożone – stałe dawki, współpraca, skuteczność leczenia, EBM
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Abstrakt
Żeby uzyskać docelowe wartości ciśnienia tętniczego, u większości pacjentów z nadciśnieniem tętniczym należy zastosować więcej niż jeden lek. Skuteczność terapii hipotensyjnej wzrasta, jeśli łączy się leki z różnych klas. Dodatkowo, kombinacja leków poprawia tolerancję (leki różnych klas mogą nawzajem znosić swoje działania niepożądane). Gotowe preparaty złożone o ustalonej dawce składników poprawiają współpracę z chorym i przestrzeganie przez niego zaleceń, mogą również obniżać koszt terapii. Terapia preparatami złożonymi poprawia kontrolę ciśnienia i skraca czas do osiągnięcia jego wartości docelowych. Przy występowaniu wskazań do leczenia skojarzonego możliwe jest rozpoczynanie terapii preparatem złożonym od niskich dawek. Duże badania kliniczne oparte na zasadach EBM udowodniły, że terapia nadciśnienia tętniczego preparatami złożonymi poprawia skuteczność leczenia, upraszcza schematy terapeutyczne, poprawia tolerancję, zmniejsza liczbę przypadków zaniechania leczenia. Dodatkowo badania te pozwoliły ustalić skuteczne połączenia i optymalne dawki leków w preparacie złożonym. Wydaje się, że leczenie skojarzone może stać się podstawową formą terapii u wielu pacjentów z nadciśnieniem tętniczym.
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Grzywanowska-Łaniewska, I., & Kuch , M. (2011). Leki złożone w nadciśnieniu tętniczym – postęp farmakoterapii czy przerost formy nad treścią? Przegląd w oparciu o dowody EBM . Medycyna Faktów , 4(1(10), 45-55. Pobrano z https://journalsmededu.pl/index.php/jebm/article/view/2549
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Bibliografia
1. Law M.R., Morris J.K., Wald N.J.: 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.
2. Zdrojewski T., Wyrzykowski B., Szczech R. et al.: Epidemiology and prevention of arterial hypertension In Poland. Blood Press. Suppl. 2005; 2: 10-16.
3. Kardas P.: Nieprzestrzeganie zaleceń lekarskich przyczyną nieskuteczności terapii. Pol. Merk. Lek. 2003; 9: 732-735.
4. Wald D.S., Law M., Morris J.K. et al.: Combination therapy versus monotherapy in reducing blood pressure: meta-analysis on 11,00 participants from 42 trials. Am. J. Med. 2009; 122(3): 290-300.
5. Mancia G., De Backer G., Dominiczak A. et al.: 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J. Hypertens. 2007; 25: 1105-1187.
6. Gupta A.K., Arshad S., Poulter N.R.: Compliance, safety and effectivness of fixed- dose combinations of antihypertensive agents: a metaanalysis. Hypertension 2010; 55: 399-407.
7. Zasady postępowania w nadciśnieniu tętniczym – 2008 rok. Wytyczne Polskiego Towarzystwa Nadciśnienia Tętniczego oraz Kolegium Lekarzy Rodzinnych w Polsce. Nadciśnienie Tętnicze 2008; 12: C1-C30.
8. Mancia G., Laurent S., Agabiti-Rosei E. et al.: Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. J. Hypertens. 2009; 27: 2121-2158.
9. Chobanian A.V., Bakris G.L., Black H.R. et al.: The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA 2003; 289: 2560-2572.
10. Gradman A.H., Basile J.N., Carter B.L. et al.: Combination therapy in hypertension. J. Am. Soc. Hypertens. 2010; 4: 90-98.
11. Mann J.F., Schmieder R.E., McQueen M. et al.; ONTARGET investigators: Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study): a multicentre, randomized, double-blind, controlled trial. Lancet 2008; 372: 547-553.
12. Dahlöf B., Sever P.S., Poulter N.R. 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 randomized controlled trial. Lancet 2005; 366: 895-906.
13. Bakl V.K., Jadhav U.M., Thacker H.P.: Management of hypertension with the fixed combination of perindopril and amlodipine in daily clinical practice: results from the STRONG prospective, observational, multicenter study. Am. J. Cardiovasc. Drugs 2009; 9(3): 135-142.
14. Jamerson K.A., Weber M.A., Bakris G.L. et al.; ACCOMPLISH Trial Investigators: Benazepril plus amlodipine or hydrochlorothiazide for hypertensin In high-risk patients. N. Engl. J. Med. 2008; 359: 2417-2428.
15. Chen J.M., Heran B.S., Wright J.M.: Blood pressure lowering efficacy of diuretics as second-line therapy for primary hypertension. Cochrane Database Syst. Rev. 2009; 4: CD007187.
16. Bakris G., Molitch M., Hewkin A. et al.; STAR Investigators: Differences in glucose tolerance between fixed-dose antihypertensive drug combinations in people with metabolic syndrome. Diabetes Care 2006; 29: 2592-7.
17. Bakris G., Molitch M., Zhou Q. et al.: Reversal of diuretic-associated impaired glucose tolerance and new-onset diabetes: results of the STARLET study. J. Cardiometab. Syndr. 2008; 3: 18-25.
18. Pepine C.J., Handberg E.M., Cooper-DeHoff R.M. et al.; INVEST Investigators: A calcium antagonist vs a non-calcium antagonist hypertension treatment strategy for patients with coronary artery disease. The International Verapamil-Trandolapril Study (INVEST): a randomized controlled trial. JAMA 2003; 290: 2805-16.
19. Allemann Y., Fraile B., Lambert M. et al.: 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. J. Clin. Hypertens. (Greenwich) 2008; 10: 185-94.
20. Mochizuki S., Dahlöf B., Shimizu M. et al.: Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study. Lancet 2007; 369: 1431-9.
21. Dahlöf B., Devereux R.B., Kjeldsen S.E. et al.: Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomized trial against atenolol. Lancet 2002; 359: 995-1003.
22. White W.B., Calhoun D.A., Samuel R. et al.: Improving blood pressure control: increase the dose of diuretic or switch to a fixed-dose angiotensin receptor blocker/diuretic? The valsartan hydrochlorothiazide diuretic for initial control and titration to achieve optimal therapeutic effect (Val-DICTATE) trial. J. Clin. Hypertens. (Greenwich) 2008; 1: 450-8.
23. Patel A.; 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 randomized controlled trial. Lancet 2007; 370: 829-840.
24. PROGRESS Collaborative Group: Randomised trial of a perindopril-based blood pressure-lowering regimen among 6105 individuals with previous stroke or transient ischaemic attack. Lancet 2001; 358: 1033-41.
25. Beckett N.S., Peters R., Fletcher A.E. et al.; HYVET Study Group: Treatment of hypertension in patients 80 years of age or older. N. Engl. J. Med. 2008; 358: 1887-98.
26. Weber M.A., Julius S., Kjeldsen S.E. et al.: Blood pressure dependent and independent effects of antihypertensive treatment on clinical events in the VALUE Trial. Lancet 2004; 363: 2049-2051.
27. Liu L., Zhang Y., Liu G. et al.; FEVER Study Group: The Felodipine Event Reduction (FEVER) Study: a randomized long-term placebo controlled trial in Chinese hypertensive patients. J. Hypertens. 2005; 23: 2157-2172.
28. Zanchetti A., Bond M.G., Hennig M. et al.; European Lacidipine Study on Atherosclerosis investigators: Calcium antagonist lacidipine slows down progression of asymptomatic carotid atherosclerosis: principal resulta of the European Lacidipine Study on Atherosclerosis (ELSA) – a randomized, double-blind, long-term trial. Circulation 2002; 106: 2422-2427.
29. The Systolic Hypertension in the Elderly Program (SHEP) Cooperative Research Group: Rationale and design of a randomized clinical trial on prevention of stroke in isolated systolic hypertension. The Systolic Hypertension in the Elderly Program (SHEP) Cooperative Research Group. J. Clin. Epidemiol.1988; 41: 1197-1208.
30. THE ALLHAT Officers, Coordinators for the ALLHAT Collaborative Research Group: Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Atihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial (ALLHAT). JAMA 2002; 288: 2981-2997.
31. Post-stroke antihypertensive treatment study. A preliminary results. PATS Collaborating Group. Chin. Med. J. (Engl.) 1995; 108: 710-7.
32. Mourad J.J., Waeber B., Zannad F. et al.; Investigators of the STRATHE Trial. On behalf of the investigators of the STRATHE trial: Comparison of different therapeutic strategies in hypertension: a low-dose combination of perindopril/indapamide versus a sequential monotherapy or a stepped care approach. J. Hypertens. 2004; 22: 2379-86.
33. Feldman R.D., Zou G.Y., Vandervoort M.K. et al.: A simplified approach to the treatment of uncomplicated hypertension: a cluster randomized, controlled trial. Hypertension 2009; 53: 646-653.
2. Zdrojewski T., Wyrzykowski B., Szczech R. et al.: Epidemiology and prevention of arterial hypertension In Poland. Blood Press. Suppl. 2005; 2: 10-16.
3. Kardas P.: Nieprzestrzeganie zaleceń lekarskich przyczyną nieskuteczności terapii. Pol. Merk. Lek. 2003; 9: 732-735.
4. Wald D.S., Law M., Morris J.K. et al.: Combination therapy versus monotherapy in reducing blood pressure: meta-analysis on 11,00 participants from 42 trials. Am. J. Med. 2009; 122(3): 290-300.
5. Mancia G., De Backer G., Dominiczak A. et al.: 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J. Hypertens. 2007; 25: 1105-1187.
6. Gupta A.K., Arshad S., Poulter N.R.: Compliance, safety and effectivness of fixed- dose combinations of antihypertensive agents: a metaanalysis. Hypertension 2010; 55: 399-407.
7. Zasady postępowania w nadciśnieniu tętniczym – 2008 rok. Wytyczne Polskiego Towarzystwa Nadciśnienia Tętniczego oraz Kolegium Lekarzy Rodzinnych w Polsce. Nadciśnienie Tętnicze 2008; 12: C1-C30.
8. Mancia G., Laurent S., Agabiti-Rosei E. et al.: Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. J. Hypertens. 2009; 27: 2121-2158.
9. Chobanian A.V., Bakris G.L., Black H.R. et al.: The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA 2003; 289: 2560-2572.
10. Gradman A.H., Basile J.N., Carter B.L. et al.: Combination therapy in hypertension. J. Am. Soc. Hypertens. 2010; 4: 90-98.
11. Mann J.F., Schmieder R.E., McQueen M. et al.; ONTARGET investigators: Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study): a multicentre, randomized, double-blind, controlled trial. Lancet 2008; 372: 547-553.
12. Dahlöf B., Sever P.S., Poulter N.R. 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 randomized controlled trial. Lancet 2005; 366: 895-906.
13. Bakl V.K., Jadhav U.M., Thacker H.P.: Management of hypertension with the fixed combination of perindopril and amlodipine in daily clinical practice: results from the STRONG prospective, observational, multicenter study. Am. J. Cardiovasc. Drugs 2009; 9(3): 135-142.
14. Jamerson K.A., Weber M.A., Bakris G.L. et al.; ACCOMPLISH Trial Investigators: Benazepril plus amlodipine or hydrochlorothiazide for hypertensin In high-risk patients. N. Engl. J. Med. 2008; 359: 2417-2428.
15. Chen J.M., Heran B.S., Wright J.M.: Blood pressure lowering efficacy of diuretics as second-line therapy for primary hypertension. Cochrane Database Syst. Rev. 2009; 4: CD007187.
16. Bakris G., Molitch M., Hewkin A. et al.; STAR Investigators: Differences in glucose tolerance between fixed-dose antihypertensive drug combinations in people with metabolic syndrome. Diabetes Care 2006; 29: 2592-7.
17. Bakris G., Molitch M., Zhou Q. et al.: Reversal of diuretic-associated impaired glucose tolerance and new-onset diabetes: results of the STARLET study. J. Cardiometab. Syndr. 2008; 3: 18-25.
18. Pepine C.J., Handberg E.M., Cooper-DeHoff R.M. et al.; INVEST Investigators: A calcium antagonist vs a non-calcium antagonist hypertension treatment strategy for patients with coronary artery disease. The International Verapamil-Trandolapril Study (INVEST): a randomized controlled trial. JAMA 2003; 290: 2805-16.
19. Allemann Y., Fraile B., Lambert M. et al.: 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. J. Clin. Hypertens. (Greenwich) 2008; 10: 185-94.
20. Mochizuki S., Dahlöf B., Shimizu M. et al.: Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study. Lancet 2007; 369: 1431-9.
21. Dahlöf B., Devereux R.B., Kjeldsen S.E. et al.: Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomized trial against atenolol. Lancet 2002; 359: 995-1003.
22. White W.B., Calhoun D.A., Samuel R. et al.: Improving blood pressure control: increase the dose of diuretic or switch to a fixed-dose angiotensin receptor blocker/diuretic? The valsartan hydrochlorothiazide diuretic for initial control and titration to achieve optimal therapeutic effect (Val-DICTATE) trial. J. Clin. Hypertens. (Greenwich) 2008; 1: 450-8.
23. Patel A.; 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 randomized controlled trial. Lancet 2007; 370: 829-840.
24. PROGRESS Collaborative Group: Randomised trial of a perindopril-based blood pressure-lowering regimen among 6105 individuals with previous stroke or transient ischaemic attack. Lancet 2001; 358: 1033-41.
25. Beckett N.S., Peters R., Fletcher A.E. et al.; HYVET Study Group: Treatment of hypertension in patients 80 years of age or older. N. Engl. J. Med. 2008; 358: 1887-98.
26. Weber M.A., Julius S., Kjeldsen S.E. et al.: Blood pressure dependent and independent effects of antihypertensive treatment on clinical events in the VALUE Trial. Lancet 2004; 363: 2049-2051.
27. Liu L., Zhang Y., Liu G. et al.; FEVER Study Group: The Felodipine Event Reduction (FEVER) Study: a randomized long-term placebo controlled trial in Chinese hypertensive patients. J. Hypertens. 2005; 23: 2157-2172.
28. Zanchetti A., Bond M.G., Hennig M. et al.; European Lacidipine Study on Atherosclerosis investigators: Calcium antagonist lacidipine slows down progression of asymptomatic carotid atherosclerosis: principal resulta of the European Lacidipine Study on Atherosclerosis (ELSA) – a randomized, double-blind, long-term trial. Circulation 2002; 106: 2422-2427.
29. The Systolic Hypertension in the Elderly Program (SHEP) Cooperative Research Group: Rationale and design of a randomized clinical trial on prevention of stroke in isolated systolic hypertension. The Systolic Hypertension in the Elderly Program (SHEP) Cooperative Research Group. J. Clin. Epidemiol.1988; 41: 1197-1208.
30. THE ALLHAT Officers, Coordinators for the ALLHAT Collaborative Research Group: Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Atihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial (ALLHAT). JAMA 2002; 288: 2981-2997.
31. Post-stroke antihypertensive treatment study. A preliminary results. PATS Collaborating Group. Chin. Med. J. (Engl.) 1995; 108: 710-7.
32. Mourad J.J., Waeber B., Zannad F. et al.; Investigators of the STRATHE Trial. On behalf of the investigators of the STRATHE trial: Comparison of different therapeutic strategies in hypertension: a low-dose combination of perindopril/indapamide versus a sequential monotherapy or a stepped care approach. J. Hypertens. 2004; 22: 2379-86.
33. Feldman R.D., Zou G.Y., Vandervoort M.K. et al.: A simplified approach to the treatment of uncomplicated hypertension: a cluster randomized, controlled trial. Hypertension 2009; 53: 646-653.