Perindopril arginine and amlodipine besylate for hypertension: a safety evaluation

References

• Benjamin EJ, Blaha MJ, Chiuve SE, et al., Heart disease and stroke statistics—2017 update. A report from the American Heart Association. Circulation. 2017;135:e146–e603. Available from:https://doi.org/10.1161/CIR.0000000000000485
   PubMed Web of Science ®Google Scholar
• Forouzanfar MH, Afshin A, Alexander LT, et al. Global, regional, and national comparative risk assessment of 79 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2015: a systematic analysis for the global burden of disease study 2015. Lancet. 2016;388:1659–1724.
   PubMed Web of Science ®Google Scholar
• Yusuf S, Rangarajan S, Teo K, et al. Cardiovascular risk and events in 17 low-, middle-, and high-income countries. N Engl J Med. 2014;371:818–827.
   PubMed Web of Science ®Google Scholar
• Falaschetti E, Mindell J, Knott C, et al. Hypertension management in England: A serial cross-sectional study from 1994 to 2011. Lancet. 2014;383:1912–1919.
   PubMed Web of Science ®Google Scholar
• Padwal RS, Bienek A, McAlister FA, et al. Epidemiology of hypertension in Canada: an update. Can J Cardiol. 2016;32:687–694.
   PubMed Web of Science ®Google Scholar
• Olsen MH, Angell SY, Asma S, et al. A call to action and a lifecourse strategy to address the global burden of raised blood pressure on current and future generations: the Lancet commission on hypertension. Lancet. 2016;388:2665–2712.
   PubMed Web of Science ®Google Scholar
• James PA, Oparil S, Carter BL, et al. 2014 evidence-based guidelines 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;311:507–520.
   PubMed Web of Science ®Google Scholar
• Weber MA, Schiffrin EL, White WB, et al. Clinical practice guidelines for the management of hypertension in the community: a statement by the American Society of Hypertension and the International Society of Hypertension. J Clin Hypertens (Greenwich). 2014;16:14–26.
   PubMed Web of Science ®Google Scholar
• Mancia G, Fagard R, Narkiewicz K, et al. 2013 practice guidelines for the management of arterial hypertension of the European Society of Hypertension (ESH) and the European Society of Cardiology (ESC): ESH/ESC task force for the management of arterial hypertension. J Hypertens. 2013;31:1925–1938.
   PubMed Web of Science ®Google Scholar
• Higgins B, Williams B, Williams H, et al. United Kingdom National Health Service: National Institute for Health and Clinical Excellence. NICE clinical guideline 127: Hypertension: Clinical management of primary hypertension in adults. first accessed 2011 AUG 24. most recent access 2017 JUL 27. Available from: http://www.nice.org.uk/CG127.
   Google Scholar
• Wright JT Jr, Fine LJ, Lackland DT, et al. Evidence supporting a systolic blood pressure goal of less than 150 mm Hg in patients aged 60 years or older: the minority view. Ann Intern Med. 2014;160:499–503.
   PubMed Web of Science ®Google Scholar
• Wright JT Jr, Williamson JD, Whelton PK, et al. A randomized trial of intensive versus standard blood-pressure control. N Engl J Med. 2015;373:2103–2116.
   PubMed Web of Science ®Google Scholar
• Qaseem A, Wilt TJ, Rich R, et al. Pharmacologic treatment of hypertension in adults aged 60 years or older to higher versus lower blood pressure targets: a clinical practice guideline from the American College of Physicians and the American Academy of Family Physicians. Ann Intern Med. 2017;166:430–437.
   PubMed Web of Science ®Google Scholar
• Gupta AK, Arshad S, Poulter NS. Compliance, safety, and effectiveness of fixed-dose combinations of antihypertensive agents: a meta-analysis. Hypertension. 2010;55:399–407.
   PubMed Web of Science ®Google Scholar
• De Cates AN, Farr MRB, Wright N, et al. Fixed-dose combination therapy for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2014; 4, Art. No.: CD009868, 10.1002/14651858:CD009868.pub2
   PubMed Web of Science ®Google Scholar
• Todd PA, Fitton A. Perindopril: a review of its pharmacological properties and therapeutic use in cardiovascular disorders. Drugs. 1991;42:90–114.
   PubMed Web of Science ®Google Scholar
• Hurst M, Jarvis B. Perindopril: an updated review of its use in hypertension. Drugs. 2001;61:867–896.
   PubMed Web of Science ®Google Scholar
• Ghiadoni L. Perindopril for the treatment of hypertension. Expert Opin Pharmacother. 2011;12:1633–1642.
   PubMed Web of Science ®Google Scholar
• Telejko E. Perindopril arginine: benefits of a new salt of the ACE-inhibitor perindopril. Curr Med Res Opin. 2007;23:953–960.
   PubMed Web of Science ®Google Scholar
• Haria M, Wagstaff AJ. Amlodipine: a reappraisal of its pharmacological properties and therapeutic use in cardiovascular disease. Drugs. 1995;50:560–586.
   PubMed Web of Science ®Google Scholar
• Elliott WJ. Rationale for a single-pill combination of perindopril arginine and amlodipine besylate. J Am Soc Hypertens. 2015;9:257–265.
   PubMed Web of Science ®Google Scholar
• Thacker HP. S-amlodipine—the 2007 clinical review. J Indian Med Assoc. 2007;105:180–182.
   PubMedGoogle Scholar
• Zheng X, Liu T, Chen X, et al. Investigation of a potential pharmacokinetic interaction between perindopril arginine and amlodipine when administered as a single perindopril/amlodipine fixed-dose combination tablet in healthy Chinese male volunteers. Int J Clin Pharmacol Ther. 2016;54:43–51.
   PubMed Web of Science ®Google Scholar
• Bishop A, Elliott WJ, Feldstein JD Bioavailability of arginine vs. erbumine formulations of perindopril in healthy subjects. Submitted.
   Google Scholar
• Pitt B, Byington RP, Furberg CD, et al. Effect of amlodipine on progression of atherosclerosis and the occurrence of clinical events. Circulation. 2000;102:1503–1510.
   PubMed Web of Science ®Google Scholar
• 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;292:2217–2225.
   PubMed Web of Science ®Google Scholar
• Elliott WJ, Whitmore J, Feldstein JD, et al. Efficacy and safety of perindopril arginine + amlodipine in hypertension. J Am Soc Hypertens. 2015;9:266–274.
   PubMed Web of Science ®Google Scholar
• 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;33:653–662.
   PubMed Web of Science ®Google Scholar
• 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;33:401–411.
   PubMed Web of Science ®Google Scholar
• Redon J, Pichler G, for the Missed Dose Study Group. Comparative study of the efficacy of olmesartan/amlodipine vs. perindopril/amlodipine in peripheral blood pressure after missed dose in type 2 diabetics. J Hypertens. 2016;34:359–367.
   PubMed Web of Science ®Google Scholar
• 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: 1086–1099. errata: 2015; 32:184-5.
   PubMed Web of Science ®Google Scholar
• Ruilope L, for the SEVITENSION Study Investigators. Fixed- combination olmesartan/amlodipine was superior to perindopril + amlodipine in reducing central systolic blood pressure in hypertensive patients with diabetes. J Clin Hypertens. 2015;18:528–535.
   Web of Science ®Google Scholar
• Angeloni E, Vitaterna A, Lombardo P, et al. Single-pill combination therapy in the initial treatment of marked hypertension: a propensity-matched analysis. Clin Exp Hypertens. 2015;37:404–410.
   PubMed Web of Science ®Google Scholar
• 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;9:135–142.
   PubMed Web of Science ®Google Scholar
• Hatala R, Pella D, Hatalová K, et al. Optimization of blood pressure treatment with fixed-combination perindopril/amlodipine in patients with arterial hypertension. Clin Drug Invest. 2012;32:603–612.
   PubMed Web of Science ®Google Scholar
• Zhang Y, Ly C, Yannoutsos A, et al. Effect of a fixed-dose 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;7:163–169.
   PubMed Web of Science ®Google Scholar
• Kobalava Z, Kotovskaia I, Luk’ianova EA. Combined therapy of arterial hypertension with the fixed combination of perindopril arginine/amlodipine in real clinical practice: the organization and the main results of the program CONSTANTA [in Russian]. Kardiologiia. 2013;53: 25–34. Also reported by: Kobalava ZhD, Kotovskaya YuV, Khodorovich NA. Optimization of treatment in hypertensive patients in real clinical practice: Role of a fixed-dose perindopril A and amlodipine combination (Results of the Russian observational CONSTANTA trial) [in Russian]. Ter. Arkh. 2015;87:66-70.
   PubMed Web of Science ®Google Scholar
• Bansal S, Chauhan DK, Ramesh D, et al. Blood pressure control and acceptability of perindopril and its fixed dose combinations with amlodipine or indapamide, in younger patients with hypertension. Indian Heart J. 2014;66:635–639.
   PubMedGoogle Scholar
• Sobhy M, Saleh MA, Hamid MA. Efficacy of combination perindopril/amlodipine with or without diuretics in Egyptian patients with uncontrolled hypertension: the CONTROL study [abstract]. J Hypertens. 2015;33(Suppl. 1):e20.
   PubMedGoogle Scholar
• Manolis A, Grammatikou V, Kallistratos M, et al. Blood pressure reduction and control with fixed-dose combination perindopril/amlodipine: a Pan-Hellenic prospective observational study. J Renin Angiotensin Aldosterone Syst. 2015;16:930–935.
   PubMed Web of Science ®Google Scholar
• Karpov YA, Gorbunov VM, Deev AD. Effectiveness of fixed-dose perindopril/amlodipine on clinic, ambulatory, and self-monitored blood pressure and blood pressure variability: an open-label, non comparative study in the general practice. High Blood Press Cardiovasc Prev. 2015;22:417–425.
   PubMed Web of Science ®Google Scholar
• Glezer, for the MG Program Participants. The use of fixed perindopril A/amlodipine combination provides high compliance to therapy, effective and safe arterial pressure lowering in patients with previous inefferctive therapy. The POTENTIAL program [in Russian]. Kardiologiia. 2015;55:17–24.
   Web of Science ®Google Scholar
• Ahmed M, Alanbaci M, El Tamimi H, et al. Efficacy and safety assessment of hypertension management with Coveram (perindopril/amlodipine fixed combination) in patients with previous angiotensin receptor blocker treatment: Arabian Gulf STRONG Study. Curr Vasc Pharmacol. 2016;14:570–575.
   PubMed Web of Science ®Google Scholar
• Hatalova K, Pella D, Sidlo R, et al. Switching from a free association of perindopril/amlodipine to a fixed-dose combination: increased antihypertensive efficacy and tolerability. Clin Drug Invest. 2016;36:591–598.
   PubMed Web of Science ®Google Scholar
• Abdelhady A, Khader S, Sinnugrut S, et al. The efficacy of perindopril/amlodipine in reaching blood pressure targets: results of the CONTROL study. Clin Drug Invest. 2016;36:357–366.
   PubMed Web of Science ®Google Scholar
• Vlachopoulos C, Grammatikou V, Kallistratos M, et al. Effectiveness of perindopril/amlodipine fixed dose combination in everyday clinical practice: results of the EMERALD study. Curr Med Res Opin. 2016;32:1605–1610.
   PubMed Web of Science ®Google Scholar
• Hu D, Sun Y, Liao Y, et al. Efficacy and safety of fixed-dose perindopril arginine/amlodipine in hypertensive patients not adequately controlled with amlodipine 5 mg or perindopril tert-butyl amine 4 mg monotherapy. Cardiology. 2016;134:1–10.
   PubMed Web of Science ®Google Scholar
• Nádházi Z, Dézsi CA. The results of ACES (Antihypertensive combinations’ long-term efficacy comparing study): analysis of metabolic effects of antihypertensive combination therapies. Clin Drug Invest. 2016;36:819–827.
   PubMed Web of Science ®Google Scholar
• Nedogoda SV, Strojanov VJ. Single-pill combination of perindopril/indapamide/amlodipine in patients with uncontrolled hypertension: a randomized clinical trial. Cardiol Ther. 2017;6:91–104.
   PubMed Web of Science ®Google Scholar
• Mourad -J-J, Amodeo C, De Champvallins M, et al. Blood pressure-lowering efficacy and safety of perindopril/indapamide/amlodipine single-pill combination in patients with uncontrolled essential hypertension: a multicenter, randomized, double-blind, controlled trial. J Hypertens. 2017;35:1481–1495.
   PubMedGoogle Scholar
• Tóth K, for the PIANIST Investigators. Antihypertensive efficacy of triple-combination perindopril/indapamide plus amlodipine in high-risk hypertensives: results of the PIANIST Study (Perindopril-Indapamide plus AmlodipiNe in high-rISk hypertensive patients). Am J Cardiovasc Drugs. 2014;14:137–145.
   PubMed Web of Science ®Google Scholar
• Páll D, Szántó I, Szabó Z. Triple combination therapy in hypertension: the antihypertensive efficacy of treatment with perindopril, amlodipine and indapamide SR. Clin Drug Invest. 2014;34:701–708.
   PubMed Web of Science ®Google Scholar
• Mazza A, Lenti S, Schiavon L, et al. Fixed-dose triple combination of antihypertensive drugs improves blood pressure control: from clinical trials to clinical practice. Adv Ther. 2017;34:975–985.
   PubMed Web of Science ®Google Scholar
• Abrahám G, Dézsi CA. The antihypertensive efficacy of the triple fixed combination of perindopril, indapamide, and amlodipine: the results of the PETRA study. Adv Ther. 2017;34:1753–1763.
   PubMed Web of Science ®Google Scholar
• Borovkova NJ, Kuznecova TE, Borovkov NN, et al. Therapy of arterial hypertension in patients with chronic heart failure and signs of chronic kidney disease with fixed perindopril/amlodipine combination [in Russian]. Kardiologiia. 2015;55:22–26.
   Web of Science ®Google Scholar
• Kuznetsova TE, Borovkova NY. Effectiveness of fixed combination of perindoprilarginine and amlodipine for the treatment of arterial hypertension with concomitant chronic cardiac insufficiency and signs of chronic kidney disease. Klin Med (Mosk). 2015;93:62–66.
   PubMedGoogle Scholar
• Liakos CI, Papadopoulos DP, Kotsis VT. Adherence to treatment, safety, tolerance, and effectiveness of perindopril/amlodipine fixed dose combination in Greek patients with hypertension and stable coronary artery disease: a Pan-Hellenic prospective observational study of daily clinical practice. Am J Cardiovasc Drugs. 2017;17:391-398.
   PubMed Web of Science ®Google Scholar
• Forster T, Dézsi CA. Short-term cardioprotective effects of the original perindopril/amlodipine fixed-dose combination in patients with stable coronary artery disease: results of the PAPA-CAD study. Adv Ther. 2016;33:1771–1781.
   PubMed Web of Science ®Google Scholar
• Kostis JB, Packer M, Black HR, et al. Omapatrilat and enalapril in patients with hypertension: the Omapatrilat cardiovascular treatment vs. Enalapril (OCTAVE) trial. Am J Hypertens. 2004;17:103–111.
   PubMed Web of Science ®Google Scholar
• Piller LB, Ford CE, Davis BR, et al. Incidence and predictors of angioedema in elderly hypertensive patients at high risk for cardiovascular disease: a report from the Antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). J Clin Hyperten (Greenwich). 2006;8:649–656.
   PubMedGoogle Scholar
• 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;366:895–906.
   PubMed Web of Science ®Google Scholar
• Israili ZH, Hall WD. Cough and angioneurotic edema associated with angiotensin-converting enzyme inhibitor therapy: a review of the literature and pathophysiology. Ann Intern Med. 1992;117:234–242.
   PubMed Web of Science ®Google Scholar
• Elliott WJ. Higher incidence of discontinuation of ACE-inhibitors due to cough in blacks. Clin Pharmacol Ther. 1996;60:582–588.
   PubMed Web of Science ®Google Scholar
• Humbert X, Alexandre J, Sassier M, et al. Long delay to onset of ACE inhibitors-induced cough: reason for difficult diagnosis in primary care? Eur J Intern Med. 2017;37:e50–e51.
   PubMed Web of Science ®Google Scholar
• Bangalore S, Kumar S, Messerli FH. Angiotensin-converting enzyme inhibitor-associated cough: deceptive information from the physician’s desk reference. Am J Med. 2010;123:1016–1030.
   PubMed Web of Science ®Google Scholar
• Fogari R, Zoppi A, Tettamanti F, et al. Effects of nifedipine and indomethacin on cough induced by angiotensin-converting enzyme inhibitors: a double-blind, randomized, crossover study. J Cardiovasc Pharmacol. 1992;19:670–673.
   PubMed Web of Science ®Google Scholar
• Fogari R, Zoppi A, Mugellini A, et al. Effects of amlodipine, nifedipine GITS, and indomethacin on angiotensin-converting enzyme inhibitor-induced cough: a randomized, placebo-controlled, double-masked, crossover study. Curr Ther Res. 1999;60:121–128.
   Web of Science ®Google Scholar
• Dicpinigaitis PV. Angiotensin-converting enzyme inhibitor-induced cough. ACCP evidence-based clinical practice guidelines. Chest. 2006;129:169S–173S.
   PubMed Web of Science ®Google Scholar
• Makani H, Bangalore S, Romer J, et al. Effect of renin-angiotensin system blockade on calcium channel blocker-associated peripheral edema. Am J Med. 2011;124:128–135.
   PubMed Web of Science ®Google Scholar
• Makani H, Bangalore S, Romero J, et al. Peripheral edema associated with calcium channel blockers: incidence and withdrawal rate—a meta-analysis of randomized trials. J Hypertens. 2011;29:1270–1280.
   PubMed Web of Science ®Google Scholar
• Elliott WJ. Reduction of amlodipine-associated edema by inhibitors of the renin-angiotensin system: meta-analyses of parallel-group randomized clinical trials [abstract]. J Clin Hypertens (Greenwich). 2013;15(Suppl. 1):A22.
   Google Scholar
• Bahiru E, De Cates AN, Farr MR, et al. Fixed-dose combination therapy for the prevention of atherosclerotic cardiovascular diseases. Cochrane Database Syst Rev. 2017;3:CD009868. DOI:10.1002/14651858.CD009868,pub3.
   PubMedGoogle Scholar
• Webster R, Patel A, Selak V, et al. Effectiveness of fixed dose combination medication (‘polypills’) compared with usual care in patients with cardiovascular disease or at high risk: a prospective, individual patient data meta-analysis of 3140 patients in six countries. Int J Cardiol. 2016;205:147–156.
   PubMed Web of Science ®Google Scholar
• Sherrill B, Halpern M, Khan S, et al. Single-pill vs. free-equivalent combination therapies for hypertension: a meta-analysis of health care costs and adherence. J Clin Hypertens. 2011;13:898–909.
   PubMed Web of Science ®Google Scholar
• Bangalore S, Kamalakkannan G, Parkar S, et al. Fixed-dose combinations improve medication compliance: a meta-analysis. Am J Med. 2007;120:713–719.
   PubMed Web of Science ®Google Scholar
• Carlberg B, Samuelsson O, Lindholm LH. Atenolol in hypertension: is it a wise choice? Lancet. 2004;364:1684–1689.
   PubMed Web of Science ®Google Scholar