Combined pharmacotherapy practical issues based on actual guidelines Review article
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Published:
Sep 30, 2015
Keywords:
arterial hypertension, combined therapy, generic drugs
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Abstract
Most patients with hypertension require 2 or more agents from different classes to achieve BP control. Several fixed-dose combinations are available, often combining agents that target the renin–angiotensin system like angiotensin-converting enzyme (ACE) inhibitors and calcium channel blockers (CCBs). At low doses, these combinations may have greater efficacy and better tolerability than the respective high-dose monotherapies. The most recent estimates of the cost of hypertension have been greatly reduced, presumably by the fact that many antihypertensive drugs are now available as generic formulations. Generic antihypertensive drugs are likely to be safe and effective, may increase the probability of medication availability and adherence for many patients. While this economic trend is presumably beneficial to society as a whole, questions remain about: 1) the definition of “equivalence” to approve a generic drug, 2) whether generic antihypertensive drugs are effective in lowering blood pressure and reducing adverse cardiovascular outcomes, 3) whether availability of less expensive, generic drugs impact patient adherence and 4) patient and prescriber preferences regarding generic vs. branded drug formulations. This review summarizes the current guidelines of the Polish Society of Hypertension on combined pharmacotherapy and focuses on fixed-dose combinations and some issues related to generic drugs.
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Postuła , M., & Kosior , D. (2015). Combined pharmacotherapy practical issues based on actual guidelines. Medycyna Faktow (J EBM), 8(3(28), 44-50. Retrieved from https://www.journalsmededu.pl/index.php/jebm/article/view/2295
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References
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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.
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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.