Fixed-dose combination enalapril/nitrendipine: A review of its use in mild-to-moderate hypertension

Drugs

Volumn 64, Issue 10, 2004, Pages 1135-1148

  Siddiqui, M Asif A ^a   Plosker, Greg L ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

AMLODIPINE; ENALAPRIL MALEATE PLUS NITRENDIPINE; HYDROCHLOROTHIAZIDE PLUS LOSARTAN;

ANKLE EDEMA; BIOEQUIVALENCE; BLOOD PRESSURE MONITORING; COMPARATIVE STUDY; DIZZINESS; DRUG ABSORPTION; DRUG EFFICACY; DRUG MEGADOSE; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; ESSENTIAL HYPERTENSION; FLUSHING; GASTROINTESTINAL TOXICITY; HUMAN; MONOTHERAPY; PATIENT COMPLIANCE; REVIEW; SINGLE DRUG DOSE; TITRIMETRY;

ANTIHYPERTENSIVE AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG COMBINATIONS; ENALAPRIL; HUMANS; HYPERTENSION; NITRENDIPINE; RANDOMIZED CONTROLLED TRIALS;

EID: 2942573027     PISSN: 00126667     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003495-200464100-00009     Document Type: Review

References (67)

1. Materson BJ, Reda DJ, Cushman WC, et al. Single-drug therapy for hypertension in men: a comparison of six antihypertensive agents with placebo. The Department of Veterans Affairs Cooperative Study Group on Antihypertensive Agents. N Engl J Med 1993; 328 (13): 914-21
2. Sever P. The heterogeneity of hypertension: why doesn't every patient respond to every antihypertensive drug? J Hum Hypertens 1995; 9 Suppl. 2: S33-6
3. Epstein M, Waeber B. Fixed-dose combination therapy with calcium antagonists. In: Epstein M, editor. Calcium antagonists in clinical medicine. 3rd ed. Philadelphia (PA): Hanley and Belfus, Inc., 2002: 713-30
4. Schmieder RE, Schlaich MP, Klingbeil AU, et al. Update on reversal of left ventricular hypertrophy in essential hypertension (a meta-analysis of all randomised double-blind studies until December 1996). Nephrol Dial Transplant 1998; 13 (3): 564-9
5. Messerli FH. Combinations in the treatment of hypertension: ACE inhibitors and calcium antagonists. Am J Hypertens 1999; 12 (8 Pt 2): 86S-90S
6. Weir MR. When antihypertensive monotherapy fails: fixed-dose combination therapy. South Med J 2000; 93 (6): 548-56
7. Mènard J, Bellet M. Calcium antagonists-ACE inhibitors combination therapy: objectives and methodology of clinical development. J Cardiovasc Pharmacol 1993; 21 Suppl. 2: S49-54
8. Zanchetti A. Nitrendipine and ACE inhibitors. J Cardiovasc Pharmacol 1988; 12 Suppl. 4: S80-5
9. Todd PA, Goa KL. Enalapril: a reappraisal of its pharmacology and therapeutic use in hypertension. Drugs 1992 Mar; 43 (3): 346-81
10. Goa KL, Sorkin EM. Nitrendipine: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the treatment of hypertension. Drugs 1987 Feb; 33 (2): 123-55
11. Wilde MI, Bryson HM, Goa KL. Enalapril: a review of quality-of-life and pharmacoeconomic aspects of its use in heart failure and mild to moderate hypertension. Pharmacoeconomics 1994 Aug; 6 (2): 155-82
12. Scriabine A, Vanov S, Deck K. Nitrendipine. Baltimore (MD): Urban and Schwarzenberg, 1984
13. Santiago TM, Lopez LM. Nitrendipine, a new dihydropyridine calcium-channel antagonist for the treatment of hypertension. Drug Intell Clin Pharm 1990; 24 (2): 167-75
14. Picca M, Bisceglia J, Zocca A, et al. Effects of enalapril and amlodipine on left ventricular hypertrophy and function in essential hypertension. Clin Drug Invest 1997; 13 Suppl. 1:29-35
15. Cuspidi C, Muiesan ML, Valagussa L, et al. Comparative effects of candesartan and enalapril on left ventricular hypertrophy in patients with essential hypertension: the candesartan assessment in the treatment of cardiac hypertrophy (CATCH) study. J Hypertens 2002; 20 (11): 2293-300
16. Devereux RB, Palmieri V, Sharpe N, et al. Effects of once-daily angiotensin-converting enzyme inhibition and calcium channel blockade-based antihypertensive treatment regimens on left ventricular hypertrophy and diastolic filling in hypertension: the prospective randomized enalapril study evaluating regression of ventricular enlargement (PRESERVE) trial. Circulation 2001; 104 (11): 1248-54
17. Rockstroh JK, Schobel HP, Vogt-Ladner G, et al. Blood pressure independent effects of nitrendipine on cardiac structure in patients after renal transplantation. Nephrol Dial Transplant 1997; 12 (7): 1441-7
18. Matsumoto M, Deng YB, Munehira J, et al. Effects of nitrendipine on left ventricular structure and function and aortic distensibility in elderly patients with isolated systolic hypertension. Curr Ther Res Clin Exp 1997 Feb; 58 (2): 117-26
19. Modena MG, Mattioli AV, Parato VM, et al. Effect of antihypertensive treatment with nitrendipine on left ventricular mass and diastolic filling in patients with mild to moderate hypertension. J Cardiovasc Pharmacol 1992 Jan; 19 (1): 148-53
20. Gerritsen TA, Bak AAA, Stolk RP, et al. Effects of nitrendipine and enalapril on left ventricular mass in patients with non-insulin-dependent diabetes mellitus and hypertension. J Hypertens 1998 May; 16 (5): 689-96
21. Mosconi L, Ruggenenti P, Perna A, et al. Nitrendipine and enalapril improve albuminuria and glomerular filtration rate in non-insulin dependent diabetes. Kidney Int 1996 Jun; 49 Suppl. 55: S91-3
22. Ross SA, Josefsberg Z, Fick GH, et al. Effects of nitrendipine and enalapril in hypertensive type II diabetic subjects with microalbuminuria. J Hypertens 1992 Jun; 10 Suppl. 4: 310
23. Estacio RO, Jeffers BW, Gifford N, et al. Effect of blood pressure control on diabetic microvascular complications in patients with hypertension and type 2 diabetes. Diabetes Care 2000; 23 Suppl. 2: B54-64
24. Scaglione R, Indovina A, Parrinello G, et al. Antihypertensive efficacy and effects of nitrendipine on cardiac and renal hemodynamics in mild to moderate hypertensive patients: randomized controlled trial versus hydrochlorothiazide. Cardiovasc Drugs Ther 1992 Apr; 6 (2): 141-6
25. Pinol C, Cobos A, Cases A, et al. Nitrendipine and enalapril in the treatment of diabetic hypertensive patients with microalbuminuria. Kidney Int 1996 Jun; 49 Suppl. 55: S85-7
26. Ruggenenti P, Mosconi L, Bianchi L, et al. Long-term treatment with either enalapril or nitrendipine stabilizes albuminuria and increases glomerular filtration rate in non-insulin-dependent diabetic patients. Am J Kidney Dis 1994 Nov; 24 (5): 753-61
27. Lender D, Arauz-Pacheco C, Breen L, et al. A double blind comparison of the effects of amlodipine and enalapril on insulin sensitivity in hypertensive patients. Am J Hypertens 1999; 12 (3): 298-303
28. Kazda S, Hirth C, Stasch JP. Diuretic effect of nitrendipine contributes to its antihypertensive efficacy: a review. J Cardiovasc Pharmacol 1988; 12 Suppl. 4: S1-5
29. Ruilope LM. Renal effects of nitrendipine. J Cardiovasc Pharmacol 1991; 18 Suppl. 5: S10-3
30. Paolisso G, Aceto E, Cennamo G, et al. Metabolic effects of nitrendipine. Clin Ther 1991; 13 (6): 695-8
31. Mancini M, Marotta T, Ferrara LA. Metabolic neutrality in nitrendipine therapy. J Cardiovasc Pharmacol 1991; 18 Suppl. 1: S30-3
32. Frontera G, Delgadillo J, Calvo G, et al. Pharmacokinetic interaction study between enalapril and nitrendipine in healthy subjects [abstract no. 395]. Eur J Clin Pharmacol 1997; 52 Suppl.: A131
33. Todd PA, Goa KL. Enalapril: an update of its pharmacological properties and therapeutic use in congestive heart failure. Drugs 1989 Feb; 37 (2): 141-61
34. Grupo-Vita. Development of a fixed dose combination of enalapril/nitrendipine for the treatment of arterial hypertension. Barcelona: Grupo-Vita, 2003. (Data on file)
35. Committee for Proprietary Medicinal Products. Note for guidance on the investigation of bioavailability and bioequivalence of the European Agency for the Evaluation of Medicinal Products (CPMP/EWP/QWP/1401/98) [online]. Available from URL: http://www.emea.eu.int/ [Accessed 2004 Apr 15]
36. Roca-Cusachs Aygrupoespañoldeestudioenalapril/nitrendipino. Evaluación de la eficacia de la asociación de Enalapril 10/Nitrendipino 20 en pacientes que no se controlan con monoterapia de enalapril o nitrendipino [in Spanish; abstract no. 85T]. Hipertensión 2002; 19 Suppl. 2: 175. Plus poster presented at the 7a Reuníón Nacíonal Socíedad Española de Hípertensión Líga Española para la Lucha contra la Hipertensíón Arteríal; 2002 Mar 12-15; Madrid
37. Forette F, Seux ML, Staessen JA, et al. Prevention of dementia in randomised double-blind placebo-controlled systolic hypertension in Europe (Syst-Eur) trial. Lancet 1998; 352 (9137): 1347-51.
38. de la Sierra A, Gil-Extremera B, Calvo C, et al. Comparison of the antihypertensive effects of the fixed dose combination enalapril 10 mg / nitrendipine 20 mg versus losartan 50 mg / hydrochlorothiazide 12.5 mg, assessed by 24-hour ambulatory blood pressure monitoring, in essential hypertensive patients. J Hum Hypertens 2004; 18 (3): 215-22
39. Marin R, de la Sierra A, Roca-Cusachs A, et al. Comparison of a fixed-dose combination vs dose titration in second line therapy of hypertension [abstract no. P-436]. Am J Hypertens 2003 May; 16 (5 Pt 2): 195A. Plus poster presented at the 18th Annual Scientific Meeting of the American Society of Hypertension; 2003 May 14-17; New York
40. Anabile G, Bory M, Ledoux L, et al. Comparison of nitrendipine + enalapril and hydrochlorothiazide + enalapril in patients with enalapril resistant hypertension. J Hypertens 1992 Jun; 10 Suppl. 4: 177
41. Staessen JA, Fagard R, Thijs L, et al. Randomised double-blind comparison of placebo and active treatment for older patients with isolated systolic hypertension. Lancet 1997 Sep 13; 350 (9080): 757-64
42. Verkaaik R, Hoogewind R, Woittiez AJJ, et al. Effects of nitrendipine and enalapril in essential hypertension [abstract no. 123]. Neth J Med 1991 Dec; 39: A70
43. Gil-Extremera B, Spanish Group for Study of Enalapril/Nitrendipine. ABPM Study: efficacy of two fixed dose combinations, enalapril/nitrendipine vs. losartan/hidrochlorotiazide, in not controlled mild-moderate hypertensive patients [abstract no. P-213]. Am J Hypertens 2003 May; 16 (5 Pt 2): 116. Plus poster presented at the 18th Annual Scientific Meeting of the American Society of Hypertension; 2003 May 14-17; New York
44. Roca-Cusachs A, Torres F, Horas M, et al. Nitrendipine and enalapril combination therapy in mild to moderate hypertension: assessment of dose-response relationship by a clinical trial of factorial design. J Cardiovasc Pharmacol 2001 Dec; 38 (6): 840-9
45. Joint National Committee on Prevention DEaToHBP. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure. Arch Intern Med 1997; 157 (21): 2413-46
46. Roca-Cusachs A, Spanish Group for Study of enalapril/Nitrendipine. Efficacy of a fixed dose combination of enalapril/nitrendipine in patients not controlled with enalapril or nitrendipine monotherapy, results of pooled analysis of two studies: ENEAS-1 and ENEAS-2 [abstract no. P-41]. Am J Hypertens 2002 Apr; 15 (4 Pt 2): 48
47. Roca-Cusachs A, Pontes C, Combalia J, et al. Reduced incidence of oedema with the enalapril/nitrendipine fixed dose combination [abstract no. P2.205]. J Hypertension 2003; 21 Suppl. 4: S180. Plus poster presented at the 13th European Meeting on Hypertension; 2003 June 13-17; Milan
48. Grupo-Vita. Product information: Eneas® (enalapril maleate/nitrendipine) tablets, 10/20mg. Barcelona: Grupo-Vita, 2003
49. Joint Formulary Committee. British National Formulary. 47th ed. London: British Medical Association and Royal Pharmaceutical Society of Great Britain [online]. Available from URL: http://www.bnf.org/ [Accessed 2004 Apr 15]
50. Merck Sharp & Dohme Limited. Product information: Innovace (enalapril) tablets, 2.5, 5, 10 and 20 mg [online]. Available from URL: http://emc.medicines.org.uk [Accessed 2004 Apr 15]
51. Kirch W, Hutt HJ, Heidemann H, et al. Drug interactions with nitrendipine. J Cardiovasc Pharmacol 1984; 6 Suppl. 7: S982-5
52. 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
53. Guidelines Committee. 2003 European Society of Hypertension - European Society of Cardiology guidelines for the managment of arterial hypertension. J Hypertens 2003; 21 (6): 1011-53
54. Williams B, Poulter NR, Brown MJ, et al. Guidelines for management of hypertension: report of the fourth working party of the British Hypertension Society, 2004 - BHS IV. J Hum Hypertens 2004; 18 (3): 139-85
55. World Health Organization- International Society of Hypertension Writing Group. 2003 World Health Organization (WHO)/International Society of Hypertension (ISH) statement on management of hypertension. J Hypertens 2003; 21 (11): 1983-92
56. The World Health Report 2002. Reducing Risks, Promoting Healthy Life. Geneva: The World Health Organization [online]. Available from URL: http://www.who.int [Accessed 2004 Jan 26]
57. Carretero O, Oparil S. Essential hypertension, part II: treatment. Circulation 2000; 101 (4): 446-53
58. Zanchetti A. Contribution of fixed low-dose combinations to initial therapy in hypertension. Eur Heart J Suppl 1999; 1 Suppl. L: L5-9
59. Law MR, Wald NJ, Morris JK, et al. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ 2003; 326 (7404): 1427
60. Sica DA. Rationale for fixed-dose combinations in the treatment of hypertension: the cycle repeats. Drugs 2002; 62 (3): 443-62
61. Epstein M, Bakris G. Newer approaches to antihypertensive therapy. Use of fixed-dose combination therapy. Arch Int Med 1996; 156 (17): 1969-78
62. Hosie J, Wiklund I. Managing hypertension in general practice: can we do better? J Hum Hypertens 1995; 9 Suppl. 2: S15-8
63. Graves JW. Management of difficult to control hypertension. Mayo Clin Proc 2000; 75 (3): 278-84
64. Guidelines Subcommittee. 1999 World Health Organization - International Society of Hypertension Guidelines for the Management of Hypertension. Blood Press 1999; 8 Suppl. 1: 9-43
65. Berlowitz DR, Ash AS, Hickey EC, et al. Inadequate management of blood pressure in a hypertensive population. New Eng J Med 1998; 339 (27): 1957-63
66. Carvajal A, Jabary N, Garcia Del Pozo J, et al. Fixed-dose combination vs monotherapy in first-line treatment of hypertension: a meta analysis [abstract no. P1030]. J Hypertension 2002; 20 Suppl. 4: S244. Plus poster presented at the Joint Meeting of the 19th Scientific Meeting of the International Society of Hypertension and the 12th Meeting of the European Society of Hypertension; 2002 June 23-27; Prague
67. Anton̄anzas F, Velasco M, Abbas I, et al. Modelo teörico de análisis coste-efectividad de la terapia combinada de enalapril-nitrendipino en el tratamiento de la hipertensión arterial [in Spanish]. Aten Primaria 2003; 31 (6): 366-71