Skip to main content
SpringerLink
Log in

Perindopril/Amlodipine (Prestalia®): A Review in Hypertension

  • Adis Drug Evaluation
  • Published:
American Journal of Cardiovascular Drugs Aims and scope Submit manuscript

Abstract

Perindopril, an ACE inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, are established antihypertensive agents with complementary mechanisms of action. Recently, a once-daily, orally-administered, fixed-dose combination (FDC) of perindopril arginine plus amlodipine besylate (Prestalia®; hereafter referred to as perindopril/amlodipine FDC) was approved in the USA for the treatment of hypertension. This article reviews the efficacy and tolerability of perindopril/amlodipine FDC and briefly summarizes the agent’s pharmacologic properties. As demonstrated in short-term randomized controlled trials, perindopril/amlodipine FDC was significantly more effective in reducing blood pressure (BP) than monotherapy with either of the component drugs, and it appeared to be more effective than an up-titration scheme using valsartan and valsartan/amlodipine. The FDC agent was generally well tolerated, with the most common adverse events (peripheral edema, cough, headache, and dizziness) being consistent with the well-defined tolerability profiles of the individual component drugs. Furthermore, perindopril/amlodipine FDC was associated with a numerically lower incidence of peripheral edema compared with amlodipine monotherapy. Thus, perindopril/amlodipine FDC represents a useful option for the treatment of hypertension, including as initial therapy for patients likely to require multiple drugs to achieve their BP targets.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. World Health Organization. Global atlas on cardiovascular disease prevention and control. 2011. http://whqlibdoc.who.int/publications/2011/9789241564373_eng.pdf?ua=1. Accessed 10 Aug 2015.

  2. Gillespie CD, Hurvitz KA. Prevalence of hypertension and controlled hypertension—United States, 2007–2010. MMWR Surveill Summ. 2013;62(Suppl 3):144–8.

    PubMed  Google Scholar 

  3. Chobanian AV, Bakris GL, Black HR, et al. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003;42(6):1206–52.

    Article  CAS  PubMed  Google Scholar 

  4. Valderrama AL, Gillespie C, Coleman King S, et al. Vital signs: awareness and treatment of uncontrolled hypertension among adults—United States, 2003-2010. MMWR Morb Mortal Wkly Rep. 2012;61:703–9.

    Google Scholar 

  5. Gradman AH, Basile JN, Carter BL, et al. Combination therapy in hypertension. J Clin Hypertens. 2011;13(3):146–54.

    Article  Google Scholar 

  6. Neutel JM, Smith DHG. Hypertension management: rationale for triple therapy based on mechanisms of action. Cardiovasc Ther. 2013;31(5):251–8.

    Article  CAS  PubMed  Google Scholar 

  7. Bangalore S, Kamalakkannan G, Parkar S, et al. Fixed-dose combinations improve medication compliance: a meta-analysis. Am J Med. 2007;120(8):713–9.

    Article  PubMed  Google Scholar 

  8. Gupta AK, Arshad S, Poulter NR. Compliance, safety, and effectiveness of fixed-dose combinations of antihypertensive agents: a meta-analysis. Hypertension. 2010;55(2):399–407.

    Article  CAS  PubMed  Google Scholar 

  9. US FDA. Prestalia (perindopril arginine and amlodipine) tablets: US prescribing information. 2015. http://www.fda.gov. Accessed 10 Aug 2015.

  10. Elliott WJ. Rationale for a single-pill combination of perindopril arginine and amlodipine besylate. J Am Soc Hypertens. 2015;9(4):257–65.

    Article  CAS  PubMed  Google Scholar 

  11. Mourad J-J, Le Jeune S, Pirollo A, et al. Combinations of inhibitors of the renin-angiotensin system with calcium channel blockers for the treatment of hypertension: focus on perindopril/amlodipine. Curr Med Res Opin. 2010;26(9):2263–76.

    Article  CAS  PubMed  Google Scholar 

  12. Makani H, Bangalore S, Romero J, et al. Effect of renin-angiotensin system blockade on calcium channel blocker-associated peripheral edema. Am J Med. 2011;124(2):128–35.

    Article  CAS  PubMed  Google Scholar 

  13. Bahl VK, Jadhav UM, Thacker HP. 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):135–42.

    Article  CAS  PubMed  Google Scholar 

  14. Dahlöf B, Sever PS, Poulter NR, et al. 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.

    Article  PubMed  Google Scholar 

  15. Hatala R, Pella D, Hatalova K, et al. Optimization of blood pressure treatment with fixed-combination perindopril/ amlodipine in patients with arterial hypertension. Clin Drug Investig. 2012;32(9):603–12.

    CAS  PubMed  Google Scholar 

  16. Nagy VL. Twenty-four-hour ambulatory blood pressure reduction with a perindopril/amlodipine fixed-dose combination. Clin Drug Investig. 2013;33(7):469–76.

    Article  CAS  PubMed  Google Scholar 

  17. Ruilope L, Schaefer A. The fixed-dose combination of olmesartan/amlodipine was superior in central aortic blood pressure reduction compared with perindopril/amlodipine: a randomized, double-blind trial in patients with hypertension. Adv Ther. 2013;30(12):1086–99.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  18. Zhang Y, Ly C, Yannoutsos A, et al. Effect of a fixed combination of perindopril and amlodipine on blood pressure control in 6256 patients with not-at-goal hypertension: the AVANT’AGE study. J Am Soc Hypertens. 2013;7(2):163–9.

    Article  CAS  PubMed  Google Scholar 

  19. Elliott WJ, Whitmore J, Feldstein JD, et al. Efficacy and safety of perindopril arginine + amlodipine in hypertension. J Am Soc Hypertens. 2015;9(4):266–74.

    Article  CAS  PubMed  Google Scholar 

  20. Laurent S, Parati G, Chazova I, et al. Randomized evaluation of a novel, fixed-dose combination of perindopril 3.5 mg/amlodipine 2.5 mg as a first-step treatment in hypertension. J Hypertens. 2015;33(3):653–62.

    Article  CAS  PubMed  Google Scholar 

  21. Mancia G, Asmar R, Amodeo C, et al. Comparison of single-pill strategies first line in hypertension: perindopril/amlodipine versus valsartan/amlodipine. J Hypertens. 2015;33(2):401–11.

    Article  CAS  PubMed  Google Scholar 

  22. Hurst M, Jarvis B. Perindopril: an updated review of its use in hypertension. Drugs. 2001;61(6):867–96.

    Article  CAS  PubMed  Google Scholar 

  23. Macfadyen RJ, Lees KR, Reid JL. Perindopril: a review of its pharmacokinetics and clinical pharmacology. Drugs. 1990;39(Suppl 1):49–63.

    Article  CAS  PubMed  Google Scholar 

  24. Todd PA, Fitton A. Perindopril: a review of its pharmacological properties and therapeutic use in cardiovascular disorders. Drugs. 1991;42(1):90–114.

    Article  CAS  PubMed  Google Scholar 

  25. Abernethy DR. Amlodipine: pharmacokinetic profile of a low-clearance calcium antagonist. J Cardiovasc Pharmacol. 1991;17(Suppl 1):S4–7.

    Article  PubMed  Google Scholar 

  26. Haria M, Wagstaff AJ. Amlodipine: a reappraisal of its pharmacological properties and therapeutic use in cardiovascular disease. Drugs. 1995;50(3):560–86.

    Article  CAS  PubMed  Google Scholar 

  27. Murdoch D, Heel RC. Amlodipine: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in cardiovascular disease. Drugs. 1991;41(3):478–505.

    Article  CAS  PubMed  Google Scholar 

  28. Telejko E. Perindopril arginine: benefits of a new salt of the ACE inhibitor perindopril. Curr Med Res Opin. 2007;23(5):953–60.

    Article  CAS  PubMed  Google Scholar 

  29. US FDA. Aceon (perindopril erbumine) tablets: US prescribing information. 2015. http://www.fda.gov. Accessed 10 Aug 2015.

  30. Faulkner JK, McGibney D, Chasseaud LF, et al. The pharmacokinetics of amlodipine in healthy volunteers after single intravenous and oral doses and after 14 repeated oral doses given once daily. Br J Clin Pharmacol. 1986;22(1):21–5.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  31. Stopher DA, Beresford AP, Macrae PV, et al. The metabolism and pharmacokinetics of amlodipine in humans and animals. J Cardiovasc Pharmacol. 1988;12(Suppl 7):S55–9.

    Article  CAS  PubMed  Google Scholar 

  32. Beresford AP, McGibney D, Humphrey MJ, et al. Metabolism and kinetics of amlodipine in man. Xenobiotica. 1988;18(2):245–54.

    Article  CAS  PubMed  Google Scholar 

  33. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507–20.

    Article  CAS  PubMed  Google Scholar 

  34. Fox KM, EUROPA Investigators. Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease: randomised, double-blind, placebo-controlled, multicentre trial (the EUROPA study). Lancet. 2003;362(9386):782–8.

    Article  CAS  PubMed  Google Scholar 

  35. Nissen SE, Tuzcu EM, Libby P, et al. Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure: the CAMELOT study: a randomized controlled trial. JAMA. 2004;292(18):2217–25.

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgments

During the peer review process, the manufacturer of perindopril/amlodipine FDC (Prestalia®) was offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Matt Shirley & Paul L. McCormack

Authors
  1. Matt Shirley
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Paul L. McCormack
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Matt Shirley.

Ethics declarations

Funding

The preparation of this review was not supported by any external funding.

Conflicts of interest

Matt Shirley and Paul McCormack are salaried employees of Adis/Springer, are responsible for the content, and declare no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: T. H. Le Jemtel, Heart and Vascular Institute, Tulane University School of Medicine, New Orleans, LA, USA; D. M. Riche, School of Pharmacy, University of Mississippi, Jackson, MS, USA.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Shirley, M., McCormack, P.L. Perindopril/Amlodipine (Prestalia®): A Review in Hypertension. Am J Cardiovasc Drugs 15, 363–370 (2015). https://doi.org/10.1007/s40256-015-0144-1

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40256-015-0144-1

Keywords

Search

Navigation