Rationale for the use of a fixed-dose combination in the management of hypertension: Efficacy and tolerability of lercanidipineenalapril

Clinical Drug Investigation

Volumn 30, Issue 12, 2010, Pages 843-854

  Borghi, Claudio ^a   Cicero, Arrigo F G ^a  

^a UNIVERSITY OF BOLOGNA   (Italy)

Author keywords

ACE inhibitors, therapeutic use; Calcium channel antagonists, therapeutic use; Enalapril, therapeutic use; Hypertension, treatment; Lercanidipine, therapeutic use; Lercanidipineenalapril, therapeutic use; Research and development

Indexed keywords

AMLODIPINE PLUS BENAZEPRIL; CALCIUM CHANNEL BLOCKING AGENT; CAPTOPRIL; CILNIDIPINE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; ENALAPRIL; ENALAPRIL PLUS LERCANIDIPINE; HYDROCHLOROTHIAZIDE; LERCANIDIPINE; RAMIPRIL; TELMISARTAN; UNCLASSIFIED DRUG;

ANGIONEUROTIC EDEMA; ANTIHYPERTENSIVE ACTIVITY; ANTIHYPERTENSIVE THERAPY; BLOOD PRESSURE REGULATION; CARDIOVASCULAR RISK; CLINICAL TRIAL; COUGHING; DRUG EFFICACY; DRUG MECHANISM; DRUG TOLERABILITY; HUMAN; HYPERTENSION; HYPOTENSION; MORBIDITY; MORTALITY; PERIPHERAL EDEMA; PRIORITY JOURNAL; RENIN ANGIOTENSIN ALDOSTERONE SYSTEM; REVIEW; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT;

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; ANTIHYPERTENSIVE AGENTS; BLOOD PRESSURE; CALCIUM CHANNEL BLOCKERS; DIHYDROPYRIDINES; DRUG COMBINATIONS; ENALAPRIL; EVIDENCE-BASED MEDICINE; HUMANS; HYPERTENSION; RENIN-ANGIOTENSIN SYSTEM; TREATMENT OUTCOME;

EID: 77957790023     PISSN: 11732563     EISSN: 11791918     Source Type: Journal    
DOI: 10.2165/11584470-000000000-00000     Document Type: Review

References (95)

1. Ong KL, Cheung BM, Man YB, et al. Prevalence awareness treatment and control of hypertension among United States adults 1999-2004. Hypertension 2007 Jan; 49(1): 69-75.
2. Wolf-Maier K, Cooper RS, Banegas JR, et al. Hypertension prevalence and blood pressure levels in 6 European coun tries, Canada and the United States. JAMA 2003; 289 (18): 2363-78
3. 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 ofCardiology (ESC). J Hypertens 2007 Jun; 25 (6): 1105-87
4. Nesbitt SD. Antihypertensive combination therapy: optimizing blood pressure control and cardiovascular risk reduction. J Clin Hypertens 2007 Nov; 9 (11 Suppl. 4): 26-32
5. Prisant LM. Target-organ protection with combination renin-angiotensin- system blockade. Clin Cardiol 2009 Jan; 32 (1): 4-12
6. Smith DHG. Fixed-dose combination antihypertensives and reduction in target organ damage: are they all the same? Am J Cardiovasc Drugs 2007; 7 (6): 413-22
7. Cutler JA, Sorlie PD, Wolz M, et al. Trends in hypertension prevalence, awareness, treatment, and control rates in United States adults between 1988-1994 and 1999-2004. Hypertension 2008 Nov; 52 (5): 818-27
8. Sica DA. Rationale for fixed-dose combinations in the treatment of hypertension: the cycle repeats. Drugs 2002; 62 (3): 443-62
9. Estacio RO, Jeffers BW, Hiatt WR, et al. The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension. N Engl J Med 1998 Mar 5; 338 (10): 645-52
10. Hansson L, Zanchetti A, Carruthers SG, et al. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group. Lancet 1998 Jun 13; 351 (9118): 1755-62
11. Peterson JC, Adler S, Burkart JM, et al. Blood pressure control, proteinuria, and the progression of renal disease: the Modification of Diet in Renal Disease Study. Ann Intern Med 1995 Nov 15; 123 (10): 754-62
12. Tuomilehto J, Rastenyte D, Birkenhager WH, et al. Effects ofcalcium-channel blockade in older patients with diabetes and systolic hypertension. Systolic Hypertension in Europe Trial Investigators. N Engl J Med 1999 Mar 4; 340 (9): 677-84
13. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998 Sep 12; 317 (7160): 703-13
14. Chobanian AV, Bakris GL, Black HR, 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 May 21; 289 (19): 2560-72
15. McInnes GT. Antihypertensive drugs in combination: additive or greater than additive? J Hum Hypertens 2007 Dec; 21 (12): 914-6
16. Morgan TO, Anderson A, Jones E. Comparison and interaction of low dose felodipine and enalapril in the treatment of essential hypertension in elderly subjects. Am J Hypertens 1992 Apr; 5 (4 Pt 1): 238-43
17. Lewin AJ, Lueg MC, Targum S, et al. A clinical trial evaluating the 24-hour effects ofbisoprolol/hydrochlorothiazide 5mg/6.25mg combination in patients with mild to moder-ate hypertension. Clin Cardiol 1993 Oct; 16 (10): 732-6
18. Epstein M. The benefits of ACE inhibitors and calcium antagonists in slowing progressive renal failure: focus on fixed-dose combination antihypertensive therapy. Ren Fail 1996 Nov; 18 (6): 813-32
19. Kuschnir E, Acuna E, Sevilla D, et al. Treatment ofpatients with essential hypertension: amlodipine 5mg/benazepril 20 mg compared with amlodipine 5 mg, benazepril 20 mg, and placebo. Clin Ther 1996 Nov-Dec; 18 (6): 1213-24
20. Sanford M, Keam S. Olmesartan medoxomil/amlodipine. Drugs 2009; 69 (6): 717-29
21. Dalla Vestra M, Pozza G, Mosca A, et al. Effect oflercanidipine compared with ramipril on albumin excretion rate in hypertensive type 2 diabetic patients with microalbumin-uria: DIAL study (Diabete, Ipertensione, Albuminuria, Lercanidipina). Diabetes Nutr Metab-Clin Experiment 2004 Oct; 17 (5): 259-66
22. Robles NR, Ocon J, Gomez CF, et al. Lercanidipine in patients with chronic renal failure: the ZAFRA study. Ren Fail 2005; 27 (1): 73-80
23. Eisen SA, Miller DK, Woodward RS, et al. The effect of prescribed daily dose frequency on patient medication compliance. Arch Intern Med 1990 Sep; 150 (9): 1881-4
24. 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
25. Neutel JM. Low-dose antihypertensive combination therapy: its rationale and role in cardiovascular risk manage-ment. Am J Hypertens 1999 Aug; 12 (8 Pt 2): 73S-9S
26. Taylor AA, Shoheiber O. Adherence to antihypertensive therapy with fixed-dose amlodipine besylate/benazepril HCl versus comparable component-based therapy. Congest Heart Fail 2003 Nov-Dec; 9 (6): 324-32
27. Barrios V, Escobar C, Echarri R. Fixed combinations in the management of hypertension: perspectives on lercanidi-pine-enalapril. Vasc Health Risk Manage 2008; 4 (4): 847-53
28. ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in high-risk hypertensive patients ran-domized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA 2002 Dec 18; 288 (23): 2981-97
29. Brown MJ, Palmer CR, Castaigne A, et al. Morbidity and mortality in patients randomised to double-blind treatment with a long-acting calcium-channel blocker or diuretic in the international nifedipine GITS study: Intervention as a Goal in Hypertension Treatment (INSIGHT). Lancet 2000 Jul 29; 356 (9227): 366-72
30. Dahlof 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 Sep 10-16; 366 (9489): 895-906
31. Hansson L, Hedner T, Lund-Johansen P, et al. Randomised trial of effects of calcium antagonists compared with di-uretics and beta-blockers on cardiovascular morbidity and mortality in hypertension: the Nordic Diltiazem (NORDIL) study. Lancet 2000 Jul 29; 356 (9227): 359-65
32. Julius S, Kjeldsen SE, Weber M, et al. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet 2004 Jun 19; 363 (9426): 2022-31
33. Wang JG, Staessen JA. Conventional therapy and newer drug classes for cardiovascular protection in hypertension. J Am Soc Nephrol 2002 Nov; 13 Suppl. 3: S208-15
34. Segura J, Garcia-Donaire JA, Ruilope LM. Calcium channel blockers and renal protection: insights from the latest clinical trials. J Am Soc Nephrol 2005; 16 (3 Suppl. 1): S64-6
35. Weir MR. Effects of renin-angiotensin system inhibition on end-organ protection: can we do better? Clin Therap 2007 Sep; 29 (9): 1803-24
36. DzauVJ, Bernstein K, Celermajer D, et al. The relevance of tissue angiotensin-converting enzyme: manifestations in mechanistic and endpoint data. Am J Cardiol 2001 Nov 8; 88 (9A): 1L-20L
37. Ferrari R. Angiotensin-converting enzyme inhibition in cardiovascular disease: evidence with perindopril. Expert Rev Cardiovasc Ther 2005 Jan; 3 (1): 15-29
38. Ferrari R, Fox K. Insight into the mode of action of ACE inhibition in coronary artery disease: the ultimate 'EUROPA' story. Drugs 2009; 69 (3): 265-77
39. Barra S, Vitagliano A, Cuomo V, et al. Vascular and metabolic effects of angiotensin II receptor blockers. Expert Opin Pharmacother 2009; 10 (2): 173-89
40. Ferrario CM. Role of angiotensin II in cardiovascular disease therapeutic implications of more than a century of research. J Renin Angiotensin Aldosterone Syst 2006 Mar; 7 (1): 3-14
41. Smith Jr SC, Allen J, Blair SN, et al. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update en-dorsed by the National Heart, Lung, and Blood Institute. J Am Coll Cardiol 2006 May 16; 47 (10): 2130-9
42. Pfeffer MA, Braunwald E, Moye LA, et al. Effect ofcaptopril on mortality and morbidity in patients with left ven-tricular dysfunction after myocardial infarction: results of the Survival And Ventricular Enlargement trial. The SAVE Investigators. N Engl J Med 1992 Sep 3; 327 (10): 669-77
43. YusufS, Sleight P, Pogue J, et al. Effects of an angiotensinconverting- enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Preven-tion Evaluation Study Investigators. N Engl J Med 2000 Jan 20; 342 (3): 145-53
44. Lewis EJ, Hunsicker LG, Bain RP, et al. The effect of angiotensin-converting-enzyme inhibition on diabetic ne-phropathy. The Collaborative Study Group. N Engl J Med 1993 Nov 11; 329 (20): 1456-62
45. Maschio G, Alberti D, Janin G, et al. Effect of the angiotensin- converting-enzyme inhibitor benazepril on the progression of chronic renal insufficiency. The Angiotensin-Converting-Enzyme Inhibition in Progressive Renal Insufficiency Study Group. N Engl J Med 1996 Apr 11; 334 (15): 939-45
46. Buczko W, Kramkowski K, Mogielnicki A. Are the endothelial mechanisms of ACE-Is already established? Pharmacol Rep: PR 2006; 58 Suppl.: 126-31
47. DahlofB, Devereux RB, Kjeldsen SE, et al. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a ran-domised trial against atenolol. Lancet 2002 Mar 23; 359 (9311): 995-1003
48. Lewis EJ, Hunsicker LG, Clarke WR, et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med 2001 Sep 20; 345 (12): 851-60
49. Brenner BM, Cooper ME, de Zeeuw D, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med 2001 Sep 20; 345 (12): 861-9
50. Verdecchia P, Reboldi G, Angeli F, et al. Angiotensinconverting enzyme inhibitors and calcium channel blockers for coronary heart disease and stroke prevention. Hyper-tension 2005 Aug; 46 (2): 386-92
51. Strauss MH, Lonn EM, Verma S. Is the jury out? Class specific differences on coronary outcomes with ACE-inhibitors and ARBs: insight from meta-analysis and The Blood Pressure Lowering Treatment Trialists' Collabora-tion. Eur Heart J 2005 Nov; 26 (22): 2351-3
52. Volpe M, Mancia G, Trimarco B. Angiotensin II receptor blockers and myocardial infarction: deeds and misdeeds. J Hypertens 2005 Dec; 23 (12): 2113-8
53. Verdecchia P, Angeli F, Gattobigio R, et al. Do angiotensin II receptor blockers increase the risk of myocardial in-farction? Eur Heart J 2005 Nov; 26 (22): 2381-6
54. Cheung BM, Cheung GT, Lauder IJ, et al. Meta-analysis of large outcome trials of angiotensin receptor blockers in hypertension. J Hum Hypertens 2006 Jan; 20 (1): 37-43
55. McDonald MA, Simpson SH, Ezekowitz JE, et al. Angiotensin receptor blockers and risk ofmyocardial infarction: systematic review. BMJ 2005; 331: 873-6
56. Elliott W, Basu S, Meyer PM. Initial drugs for coronary heart disease prevention in hypertensive patients: network and Bayesian meta-analyses of clinical trial data [abstract no. OR-15]. J Clin Hypertens 2009; 11 Suppl. A (4): A7
57. Yusuf S, Teo KK, Pogue J, et al. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med 2008 Apr 10; 358 (15): 1547-59
58. McMurray J, Solomon S, Pieper K, et al. The effect ofvalsartan, captopril, or both on atherosclerotic events after acute myocardial infarction: an analysis of the VALsartan In Acute myocardial iNfarction Trial (VALIANT). J Am Coll Cardiol 2006; 47: 726-33
59. Mann JF, Schmieder RE, McQueen M, et al. Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study): a multicentre, randomised, double-blind, controlled trial. Lancet 2008 Aug 16; 372 (9638): 547-53
60. Tani S, Nagao K, Anazawa T, et al. Effects ofenalapril and losartan in left ventricular remodeling after acute myo-cardial infarction: a possible mechanism of prevention of cardiac events by angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in high-risk myocardial infarction. Intern Med 2009; 48 (11): 877-82
61. Volpe M, Tocci G, Sciarretta S, et al. Angiotensin II receptor blockers and myocardial infarction: an updated analysis of randomized clinical trials. J Hypertens 2009 May; 27 (5): 941-6
62. Hoogwerf BJ. Renin-angiotensin system blockade and cardiovascular and renal protection. Am J Cardiol 2010 Jan 4; 105 (1 Suppl.): 30A-5A
63. Reboldi G, Gentile G, Angeli F, et al. Choice of ACE inhibitor combinations in hypertensive patients with type 2 diabetes: update after recent clinical trials. Vasc Health Risk Manage 2009; 5: 411-27
64. Calhoun DA, Zhu S. Pretreatment with enalaprilat blunts nicardipine-induced sympathetic activation in sponta-neously hypertensive and Wistar-Kyoto rats. J Hypertens 1999 Apr; 17 (4): 507-12
65. Bellet M, Sassano P, Guyenne T, et al. Converting-enzyme inhibition buffers the counter-regulatory response to acute administration ofnicardipine. Br J Clin Pharmacol 1987 Oct; 24 (4): 465-72
66. Menard J, Bellet M. Calcium antagonists-ACE inhibitors combination therapy: objectives and methodology of clin-ical development. J Cardiovasc Pharmacol 1993; 21 Suppl. 2: S49-54
67. Leonetti G, Terzoli L, Rupoli L, et al. Renal effects offelodipine in hypertension. Drugs 1987; 34 Suppl. 3: 59-66
68. Taylor AA, Sunthornyothin S. The case for combining angiotensin- converting enzyme inhibitors and calcium-channel blockers. Curr Hypertens Rep 1999 Oct; 1 (5): 446-53
69. Ferrari R. Angiotensin converting enzyme inhibitor-calcium antagonist combination: an alliance for cardioprotection? J Hypertens 1997 Mar Suppl.; 15 (2): S109-17
70. Jamerson K, Weber A, Bakris GL, et al. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high risk patients. N Engl J Med 2008; 359 (23): 2417-28
71. Kim K, Jeong MH, Cho SH, et al. Clinical effects ofcalcium channel blocker and angiotensin converting enzyme in-hibitor on endothelial function and arterial stiffness in patients with angina pectoris. J Korean Med Sci 2009; 24: 223-31
72. Weder AB. ACCOMPLISH trial findings: combination benazepril-amlodipine or hydrochlorothiazide is effective for treating hypertension. Commentary. Postgrad Med 2009 Mar; 121 (2): 199-201
73. Bakris G, Smith AC, Richardson DJ, et al. Impact of an ACE inhibitor and calcium antagonist on microalbumin-uria and lipid subfractions in type 2 diabetes: a random-ised, multicenter pilot study. J Hum Hypertens 2002; 16: 185-91
74. Luscher T, Pieper M, Tendera M, et al. A randomized placebo-controlled study on the effect of nifedipine on coronary endothelial function and plaque formation in patients with coronary artery disease: the ENCORE II study. Eur Heart J 2009; 30: 1590-7
75. Lundy A, Lutfi N, Beckey C. Review ofnifedipine GITS in the treatment of high risk patients with coronary artery disease and hypertension. Vasc Health Risk Management 2009; 5: 429-40
76. Otero M. Manidipine-delapril combination in the management of hypertension. Vasc Health Risk Management 2007; 3 (3): 255-63
77. Hair PI, Scott LJ, Perry CM. Fixed-dose combination lercanidipine/ enalapril. Drugs 2007; 67 (1): 95-106
78. Acanfora D, Gheorghiade M, Trojano L, et al. A randomized, double-blind comparison of lercanidipine 10 and 20 mg in patients with stable effort angina: clinical evalua-tion of cardiac function by ambulatory ventricular scinti-graphic monitoring. Am J Therap 2004 Nov-Dec; 11 (6): 423-32
79. Cavalieri L, Cremonesi G. Metabolic effects ofmanidipine. Am J Cardiovasc Drugs 2009; 9 (3): 163-76
80. Bang LM, Chapman TM, Goa KL. Lercanidipine: a review of its efficacy in the management of hypertension. Drugs 2003; 63 (22): 2449-72
81. McClellan KJ, Jarvis B. Lercanidipine: a review of its use in hypertension. Drugs 2000 Nov; 60 (5): 1123-40
82. Meredith PA. Lercanidipine: a novel lipophilic dihydropyridine calcium antagonist with long duration of action and high vascular selectivity. Expert Opin Investig Drugs 1999 Jul; 8 (7): 1043-62
83. Rachmani R, Levi Z, Zadok BS, et al. Losartan and lercanidipine attenuate low-density lipoprotein oxidation in patients with hypertension and type 2 diabetes mellitus: a randomized, prospective crossover study. Clin Pharmacol Therap 2002 Sep; 72 (3): 302-7
84. Barrios V, Escobar C, de la Figuera M, et al. High doses of lercanidipine are better tolerated than other dihydropyri-dines in hypertensive patients with metabolic syndrome: results from the TOLERANCE study. Int J Clin Pract 2008 May; 62 (5): 723-8
85. Viviani GL. Lercanidipine in type II diabetic patients with mild to moderate arterial hypertension. J Cardiovasc Pharmacol 2002 Jul; 40 (1): 133-9
86. Robles NR, Pastor L, Manjon M, et al. Lercanidipine in diabetic patients with renal failure. Nefrologia 2004; 24 (4): 338-43
87. OSMED (Osservatorio Nazionale sull'Impiego dei Medicinali, Italian Observatory on Drug Use) report 2009 [online]. Available from URL: http://www.healthsearch.it/Osmed/Rapporto-Osmed%202008.pdf[Accessed 2010 May 1]
88. Ravid M, Brosh D, Levi Z, et al. Use of enalapril to attenuate decline in renal function in normotensive, normoalbuminuric patients with type 2 diabetes mellitus: a randomized, controlled trial. Ann Int Med 1998 Jun 15; 128 (12 Pt 1): 982-8
89. Rosei EA, Rizzoni D, Muiesan ML, et al. Effects of candesartan cilexetil and enalapril on inflammatory mar-kers of atherosclerosis in hypertensive patients with non-insulin-dependent diabetes mellitus. J Hypertens 2005 Feb; 23 (2): 435-44
90. Hosomi N, Mizushige K, Ohyama H, et al. Angiotensinconverting enzyme inhibition with enalapril slows pro-gressive intima-media thickening of the common carotid artery in patients with non-insulin-dependent diabetes mellitus. Stroke 2001 Jul; 32 (7): 1539-45
91. Minai K, Matsumoto T, Horie H, et al. Bradykinin stimulates the release of tissue plasminogen activator in human coronary circulation: effects of angiotensin-converting enzyme inhibitors. J Am Coll Cardiol 2001 May; 37 (6): 1565-70
92. Agrawal R, Marx A, Haller H. Efficacy and safety of lercanidipine versus hydrochlorothiazide as add-on to enalapril in diabetic populations with uncontrolled hyper-tension. J Hypertens 2006 Jan; 24 (1): 185-92
93. Data on file, Recordati SpA. Efficacy and tolerability of a combination oflercanidipine and enalapril in patients with mild to moderate essential hypertension not adequately controlled by enalapril treatment (add-on to enalapril) [CLP1-0019]. Milan: 2004
94. Data on file, Recordati SpA. Efficacy and tolerability of a combination oflercanidipine and enalapril in patients with mild to moderate essential hypertension not adequately controlled by lercanidipine treatment (add-on to lercani-dipine) [CLP1-0018]. Milan: 2004
95. Puig JG, Calvo C, Luurila O, et al. Lercanidipine, enalapril and their combination in the treatment ofelderly hyperten-sive patients: placebo-controlled, randomized, crossover study with four ABPM. J Hum Hypertens 2007 Dec; 21 (12): 917-24