Praktyczne zagadnienia dotyczące złożonej terapii hipotensyjnej na podstawie aktualnych wytycznych Artykuł przeglądowy
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Opublikowane:
wrz 30, 2015
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nadciśnienie tętnicze, terapia złożona, leki generyczne
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Abstrakt
U większości pacjentów z nadciśnieniem tętniczym konieczne jest zastosowanie 2 lub więcej leków należących do różnych klas w celu kontroli ciśnienia tętniczego. Obecnie dostępne są liczne preparaty złożone zawierające inhibitor ACE oraz antagonistę wapnia. Takie połączenie leków w małych dawkach może wykazywać większą skuteczność oraz lepszą tolerancję niż stosowanie leków w dużych dawkach w monoterapii. W ostatnim czasie koszty terapii hipotensyjnej uległy znacznej redukcji, co jest zasługą pojawienia się na rynku wielu generycznych odpowiedników. Preparaty te są równie skuteczne i bezpieczne, zwiększają dostępność leczenia oraz przestrzeganie zaleceń lekarskich. Jednak pomimo korzyści ekonomicznych pewne wątpliwości budzi nadal wiele kwestii, takich jak: 1) definicja biorównoważności w procesie rejestracji leku, 2) wpływ leków generycznych na ciśnienie tętnicze oraz redukcję ryzyka zdarzeń sercowo-naczyniowych, 3) wpływ tańszych leków generycznych na przestrzeganie zaleceń lekarskich, 4) preferencje lekarza oraz pacjenta odnośnie do wyboru leku generycznego i oryginalnego. W niniejszym artykule podsumowano najnowsze wytyczne Polskiego Towarzystwa Nadciśnienia Tętniczego w odniesieniu do stosowania terapii złożonej, ze szczególnym uwzględnieniem leków złożonych oraz preparatów generycznych.
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Jak cytować
Postuła , M., & Kosior , D. (2015). Praktyczne zagadnienia dotyczące złożonej terapii hipotensyjnej na podstawie aktualnych wytycznych. Medycyna Faktów , 8(3(28), 44-50. Pobrano z https://journalsmededu.pl/index.php/jebm/article/view/2295
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Bibliografia
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2. Chobanian A.V., Bakris G.L., Black H.R. et al.: Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003; 42(6): 1206-1252.
3. Pool J., Kaihlanen P., Lewis G. et al.: Once-daily treatment of patients with hypertension: a placebo-controlled study of amlodipine and benazepril vs amlodipine or benazepril alone. J. Hum. Hypertens. 2001; 15(7): 495-498.
4. Taddei S., Omboni S., Ghiadoni L. et al.: Combination of lisinopril and nifedipine GITS increases blood pressure control compared with single drugs in essential hypertensive patients. J. Cardiovasc. Pharmacol. 2003; 41(4): 579-585.
5. Edelman D.A., Paul R.A.: Does combination therapy with a calcium channel blocker and an ACE inhibitor have additive effects on blood pressure reduction? Int. J. Clin. Pract. 2000; 54(2): 105-109.
6. Zannad F.: Practical relevance of the 24-hour trough: peak ratio of antihypertensive drugs. J. Hypertens. Suppl. 1995; 13(2): S109-S112.
7. Meredith P.A., Elliott H.L.: FDA guidelines on trough: peak ratios in the evaluation of antihypertensive agents. J. Cardiovasc. Pharmacol. 1994; 23(supl. 5): S26-S30.
8. Osterberg L., Blaschke T.: Adherence to medication. N. Engl. J. Med. 2005; 353(5): 487-497.
9. Elliott H.L.: Trough: peak ratio and twenty-four-hour blood pressure control. J. Hypertens. Suppl. 1994; 12(5): S29-S33.
10. Mounier-Vehier C., Bernaud C., Carre A. et al.: Compliance and antihypertensive efficacy of amlodipine compared with nifedipine slow-release. Am. J. Hypertens. 1998; 11(4 Pt 1): 478-486.
11. Meredith P.A.: 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): 1423-1429.
12. Chi V.X., Chau N.P.: Antihypertensive effect of drugs: statistical distribution of the trough-to-peak ratio. Biometrics 1996; 52(1): 286-290.
13. Zanchetti A.: Trough: peak ratio of the blood pressure response to dihydropyridine calcium antagonists. J. Hypertens. Suppl. 1994; 12(8): S97-S106.
14. Routledge F., McFetridge-Durdle J.: Nondipping blood pressure patterns among individuals with essential hypertension: a review of the literature. Eur. J. Cardiovasc. Nurs. 2007; 6(1): 9-26.
15. White W.B.: Importance of blood pressure control over a 24-hour period. J. Manag. Care Pharm. 2007; 13(8 supl. B): S34-S39.
16. De la Sierra A., Redon J., Banegas J.R. et al.: Prevalence and factors associated with circadian blood pressure patterns in hypertensive patients. Hypertension 2009; 53(3): 466-472.
17. Mancia G., Parati G., Castiglioni P. et al.: Daily life blood pressure changes are steeper in hypertensive than in normotensive subjects. Hypertension 2003; 42(3): 277-282.
18. Sever P.S., Dahlof B., Poulter N.R. et al.: Rationale, design, methods and baseline demography of participants of the Anglo-Scandinavian Cardiac Outcomes Trial. ASCOT investigators. J. Hypertens. 2001; 19(6): 1139-1147.
19. Rothwell P.M., Howard S.C., Dolan E. et al.: Effects of beta blockers and calcium-channel blockers on within-individual variability in blood pressure and risk of stroke. Lancet Neurol. 2010; 9(5): 469-480.
20. Aalbers J. Reduced blood pressure variability in ASCOT-BPLA trial favours use of amlodipine/perindopril combination to reduce stroke risk. Cardiovasc. J. Afr. 2010; 21(2): 115.
21. Goyal D., Chong A.Y., Watson R.L. et al.: Assessment of single versus twice daily dosing of ramipril by ambulatory blood pressure monitoring in patients similar to those included in the HOPE study. J. Hum. Hypertens. 2007; 21(7): 525-530
22. Svensson P., de Faire U., Sleight P. et al: Comparative effects of ramipril on ambulatory and office blood pressures: a HOPE substudy. Hypertension 2001; 38(6): E28-E32.
23. Kario K., Shimada K.: Differential effects of amlodipine on ambulatory blood pressure in elderly hypertensive patients with different nocturnal reductions in blood pressure. Am. J. Hypertens. 1997; 10(3): 261-268.
24. Cramer J.A., Benedict A., Muszbek N. et al.: The significance of compliance and persistence in the treatment of diabetes, hypertension and dyslipidaemia: a review. Int. J. Clin. Pract. 2008; 62(1): 76-87.
25. Schroeder K., Fahey T., Ebrahim S.: How can we improve adherence to blood pressure-lowering medication in ambulatory care? Systematic review of randomized controlled trials. Arch. Intern. Med. 2004; 164(7): 722-732.
26. Iskedjian M., Einarson T.R., MacKeigan L.D. et al.: Relationship between daily dose frequency and adherence to antihypertensive pharmacotherapy: evidence from a meta-analysis. Clin. Ther. 2002; 24(2): 302-316.
27. Claxton A.J., Cramer J., Pierce C.: A systematic review of the associations between dose regimens and medication compliance. Clin. Ther. 2001; 23(8): 1296-1310.
28. Andrejak M., Genes N., Vaur L. et al.: Electronic pill-boxes in the evaluation of antihypertensive treatment compliance: comparison of once daily versus twice daily regimen. Am. J. Hypertens. 2000; 13(2): 184-190.
29. Chudek J.: Ocena profilu bezpieczeństwa stosowania produktu Egiramlon w populacji polskich pacjentów (EG/NT/2012/018) – edycje 1–5. Świat Med. Farm. 2015; 4(167): 84-89.
30. Generic Pharmaceutical Association Annual Report 2008 [online: http://www.gphaonline.org].
31. Kesselheim A.S., Misono A.S., Lee J.L. et al.: Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA 2008; 300: 2514-2526.
32. Moore N., Berdaï D., Bégaud B.: Are generic drugs really inferior medicines? Clin. Pharmacol. Ther. 2010; 88: 302-304.
33. Angeli D.G., Trezza C.: Quality and stability of ramipril generics/copies versus reference ramipril (Tritace): a 3-month stability comparative study. Clin. Drug Investig. 2009; 29(10): 667-676.
34. Shah V.P., Lennernäs H., Amidon G.L. et al.: A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability, Pharm. Res 1995; 12: 413-420, backstory of BCS. AAPS J. 2014; 16(5): 894-898.
2. Chobanian A.V., Bakris G.L., Black H.R. et al.: Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003; 42(6): 1206-1252.
3. Pool J., Kaihlanen P., Lewis G. et al.: Once-daily treatment of patients with hypertension: a placebo-controlled study of amlodipine and benazepril vs amlodipine or benazepril alone. J. Hum. Hypertens. 2001; 15(7): 495-498.
4. Taddei S., Omboni S., Ghiadoni L. et al.: Combination of lisinopril and nifedipine GITS increases blood pressure control compared with single drugs in essential hypertensive patients. J. Cardiovasc. Pharmacol. 2003; 41(4): 579-585.
5. Edelman D.A., Paul R.A.: Does combination therapy with a calcium channel blocker and an ACE inhibitor have additive effects on blood pressure reduction? Int. J. Clin. Pract. 2000; 54(2): 105-109.
6. Zannad F.: Practical relevance of the 24-hour trough: peak ratio of antihypertensive drugs. J. Hypertens. Suppl. 1995; 13(2): S109-S112.
7. Meredith P.A., Elliott H.L.: FDA guidelines on trough: peak ratios in the evaluation of antihypertensive agents. J. Cardiovasc. Pharmacol. 1994; 23(supl. 5): S26-S30.
8. Osterberg L., Blaschke T.: Adherence to medication. N. Engl. J. Med. 2005; 353(5): 487-497.
9. Elliott H.L.: Trough: peak ratio and twenty-four-hour blood pressure control. J. Hypertens. Suppl. 1994; 12(5): S29-S33.
10. Mounier-Vehier C., Bernaud C., Carre A. et al.: Compliance and antihypertensive efficacy of amlodipine compared with nifedipine slow-release. Am. J. Hypertens. 1998; 11(4 Pt 1): 478-486.
11. Meredith P.A.: 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): 1423-1429.
12. Chi V.X., Chau N.P.: Antihypertensive effect of drugs: statistical distribution of the trough-to-peak ratio. Biometrics 1996; 52(1): 286-290.
13. Zanchetti A.: Trough: peak ratio of the blood pressure response to dihydropyridine calcium antagonists. J. Hypertens. Suppl. 1994; 12(8): S97-S106.
14. Routledge F., McFetridge-Durdle J.: Nondipping blood pressure patterns among individuals with essential hypertension: a review of the literature. Eur. J. Cardiovasc. Nurs. 2007; 6(1): 9-26.
15. White W.B.: Importance of blood pressure control over a 24-hour period. J. Manag. Care Pharm. 2007; 13(8 supl. B): S34-S39.
16. De la Sierra A., Redon J., Banegas J.R. et al.: Prevalence and factors associated with circadian blood pressure patterns in hypertensive patients. Hypertension 2009; 53(3): 466-472.
17. Mancia G., Parati G., Castiglioni P. et al.: Daily life blood pressure changes are steeper in hypertensive than in normotensive subjects. Hypertension 2003; 42(3): 277-282.
18. Sever P.S., Dahlof B., Poulter N.R. et al.: Rationale, design, methods and baseline demography of participants of the Anglo-Scandinavian Cardiac Outcomes Trial. ASCOT investigators. J. Hypertens. 2001; 19(6): 1139-1147.
19. Rothwell P.M., Howard S.C., Dolan E. et al.: Effects of beta blockers and calcium-channel blockers on within-individual variability in blood pressure and risk of stroke. Lancet Neurol. 2010; 9(5): 469-480.
20. Aalbers J. Reduced blood pressure variability in ASCOT-BPLA trial favours use of amlodipine/perindopril combination to reduce stroke risk. Cardiovasc. J. Afr. 2010; 21(2): 115.
21. Goyal D., Chong A.Y., Watson R.L. et al.: Assessment of single versus twice daily dosing of ramipril by ambulatory blood pressure monitoring in patients similar to those included in the HOPE study. J. Hum. Hypertens. 2007; 21(7): 525-530
22. Svensson P., de Faire U., Sleight P. et al: Comparative effects of ramipril on ambulatory and office blood pressures: a HOPE substudy. Hypertension 2001; 38(6): E28-E32.
23. Kario K., Shimada K.: Differential effects of amlodipine on ambulatory blood pressure in elderly hypertensive patients with different nocturnal reductions in blood pressure. Am. J. Hypertens. 1997; 10(3): 261-268.
24. Cramer J.A., Benedict A., Muszbek N. et al.: The significance of compliance and persistence in the treatment of diabetes, hypertension and dyslipidaemia: a review. Int. J. Clin. Pract. 2008; 62(1): 76-87.
25. Schroeder K., Fahey T., Ebrahim S.: How can we improve adherence to blood pressure-lowering medication in ambulatory care? Systematic review of randomized controlled trials. Arch. Intern. Med. 2004; 164(7): 722-732.
26. Iskedjian M., Einarson T.R., MacKeigan L.D. et al.: Relationship between daily dose frequency and adherence to antihypertensive pharmacotherapy: evidence from a meta-analysis. Clin. Ther. 2002; 24(2): 302-316.
27. Claxton A.J., Cramer J., Pierce C.: A systematic review of the associations between dose regimens and medication compliance. Clin. Ther. 2001; 23(8): 1296-1310.
28. Andrejak M., Genes N., Vaur L. et al.: Electronic pill-boxes in the evaluation of antihypertensive treatment compliance: comparison of once daily versus twice daily regimen. Am. J. Hypertens. 2000; 13(2): 184-190.
29. Chudek J.: Ocena profilu bezpieczeństwa stosowania produktu Egiramlon w populacji polskich pacjentów (EG/NT/2012/018) – edycje 1–5. Świat Med. Farm. 2015; 4(167): 84-89.
30. Generic Pharmaceutical Association Annual Report 2008 [online: http://www.gphaonline.org].
31. Kesselheim A.S., Misono A.S., Lee J.L. et al.: Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA 2008; 300: 2514-2526.
32. Moore N., Berdaï D., Bégaud B.: Are generic drugs really inferior medicines? Clin. Pharmacol. Ther. 2010; 88: 302-304.
33. Angeli D.G., Trezza C.: Quality and stability of ramipril generics/copies versus reference ramipril (Tritace): a 3-month stability comparative study. Clin. Drug Investig. 2009; 29(10): 667-676.
34. Shah V.P., Lennernäs H., Amidon G.L. et al.: A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability, Pharm. Res 1995; 12: 413-420, backstory of BCS. AAPS J. 2014; 16(5): 894-898.