Irbesartan: A review of its use in hypertension and diabetic nephropathy

Drugs

Volumn 68, Issue 11, 2008, Pages 1543-1569

  Croom, Katherine F ^a,b   Plosker, Greg L ^a,b  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

^b WOLTERS KLUWER HEALTH   (United States)

Author keywords

Adis Drug Evaluations; Diabetic nephropathies; Hypertension; Irbesartan, general

Indexed keywords

ALBUMIN; ALISKIREN; AMLODIPINE; ANGIOTENSIN 1 RECEPTOR; ANGIOTENSIN II; ANGIOTENSIN RECEPTOR ANTAGONIST; ANTIDIABETIC AGENT; ANTIHYPERTENSIVE AGENT; ATENOLOL; CALCIUM ANTAGONIST; CREATININE; CYTOCHROME P450 2C9; DIHYDROPYRIDINE DERIVATIVE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DOXAZOSIN; ENALAPRIL; IRBESARTAN; IRBETAN; LOSARTAN; NEPHRIN; OLMESARTAN; PLACEBO; RAMIPRIL; VALSARTAN;

ALBUMINURIA; AREA UNDER THE CURVE; ARTERIAL STIFFNESS; BLOOD PRESSURE REGULATION; CLINICAL TRIAL; COST CONTROL; COUGHING; CREATININE BLOOD LEVEL; DIABETIC NEPHROPATHY; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DISEASE MODEL; DIZZINESS; DOSE RESPONSE; DOWN REGULATION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE TITRATION; DRUG EFFECT; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG RESPONSE; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; ENDOTHELIAL DYSFUNCTION; EPIGASTRIC PAIN; ESSENTIAL HYPERTENSION; FATIGUE; GLOMERULUS FILTRATION RATE; HEADACHE; HEART LEFT VENTRICLE MASS; HEARTBURN; HUMAN; HYPERKALEMIA; HYPERTENSION; INFLAMMATION; LIFE EXPECTANCY; MAXIMUM PLASMA CONCENTRATION; MICROALBUMINURIA; MUSCULOSKELETAL PAIN; NAUSEA; NON INSULIN DEPENDENT DIABETES MELLITUS; ORTHOSTATIC HYPOTENSION; OXIDATIVE STRESS; PROBABILITY; PROTEINURIA; RENAL PROTECTION; REVIEW; SCREENING TEST; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; VASCULAR ENDOTHELIUM; VASODILATATION; VOMITING;

ADULT; ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS; BIPHENYL COMPOUNDS; DIABETES MELLITUS, TYPE 2; DIABETIC NEPHROPATHIES; HUMANS; HYPERTENSION; TETRAZOLES;

EID: 47349131866     PISSN: 00126667     EISSN: 00126667     Source Type: Journal    
DOI: 10.2165/00003495-200868110-00008     Document Type: Review

References (141)

1. Kearney PM, Whelton M, Reynolds K, et al. Global burden of hypertension: analysis of worldwide data. Lancet 2005 Jan 15; 365: 217-23
2. Wild S, Roglic G, Green A, et al. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004; 27: 1047-53
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 Dec; 42 (6): 1206-52
4. Beckman JA, Creager MA, Libby P. Diabetes and atherosclerosis: epidemiology, pathophysiology, and management. JAMA 2002; 287: 2570-81
5. Ritz E, Rychlik I, Locatelli F, et al. End-stage renal failure in type 2 diabetes: a medical catastrophe of worldwide dimensions. Am J Kidney Dis 1999 Nov; 34 (5): 795-808
6. 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 of Cardiology (ESC). Eur Heart J 2007 Jun; 28 (12): 1462-536
7. Croom KF, Curran MP, Goa KL, et al. Irbesartan: a review of its use in hypertension and in the management of diabetic nephropathy. Drugs 2004; 64 (9): 999-1028
8. Pohl MA, Blumenthal S, Cordonnier DJ, et al. Independent and additive impact of blood pressure control and angiotensin II receptor blockade on renal outcomes in the Irbesartan Diabetic Nephropathy Trial: clinical implications and limitations. J Am Soc Nephrol 2005 Oct; 16 (10): 3027-37
9. Nangaku M, Ohse T, Tanaka T, et al. Renoprotection with antihypertensives: reduction of proteinuria and improvement of oxygenation via inhibition of the renin-angiotensin system. Curr Hypertens Rev 2005; 1 (1): 67-76
10. Atkins RC, Briganti EM, Lewis JB, et al. Proteinuria reduction and progression to renal failure in patients with type 2 diabetes mellitus and overt nephropathy. Am J Kidney Dis 2005 Feb; 45 (2): 281-7
11. Wenzel RR. Renal protection in hypertensive patients: selection of antihypertensive therapy. Drugs 2005; 66 Suppl. 2: 29-39
12. Parving HH, Lehnert H, Bröchner-Mortensen J, et al. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med 2001 Sep 20; 345 (12): 870-8
13. Koh KK, Han SH, Chung WJ, et al. Comparison of effects of losartan, irbesartan, and candesartan on flow-mediated brachial artery dilation and on inflammatory and thrombolytic markers in patients with systemic hypertension. Am J Cardiol 2004 Jun 1; 93 (11): 1432-5
14. Persson F, Rossing P, Hovind P, et al. Irbesartan treatment reduces biomarkers of inflammatory activity in patients with type 2 diabetes and microalbuminuria: an IRMA 2 substudy. Diabetes 2006 Dec; 55 (12): 3550-5
15. Ceriello A, Assaloni R, Da Ros R, et al. Effect of atorvastatin and irbesartan, alone and in combination, on postprandial endothelial dysfunction, oxidative stress, and inflammation in type 2 diabetic patients. Circulation 2005 May 17; 111 (19): 2518-24
16. Ceriello A, Assaloni R, Da Ros R, et al. Effect of irbesartan on nitrotyrosine generation in non-hypertensive diabetic patients. Diabetologia 2004 Sep; 47 (9): 1535-40
17. Sola S, Mir MQ, Cheema FA, et al. Irbesartan and lipoic acid improve endothelial function and reduce markers of inflammation in the metabolic syndrome: results of the Irbesartan and Lipoic Acid in Endothelial Dysfunction (ISLAND) study. Circulation 2005 Jan 25; 111 (3): 343-8
18. Koylan N, Oflaz H, Meric M. The effects of irbesartan versus atenolol on endothelial dysfunction in patients with type II diabetes and hypertenion [abstract no. P107]. J Clin Hypertens 2007 May; 9 (5 Suppl. A): 49
19. Burnier M, Hagman M, Nussberger J, et al. Short-term and sustained renal effects of angiotensin II receptor blockade in healthy subjects. Hypertension 1995 Apr; 25 (4 Pt 1): 602-9
20. Schmitt F, Martinez F, Brillet G, et al. Acute renal effects of AT1-receptor blockade after exogenous angiotensin II infusion in healthy subjects. J Cardiovasc Pharmacol 1998 Feb; 31 (2): 314-21
21. Pechère-Bertschi A, Nussberger J, Decosterd L, et al. Renal response to the angiotensin II receptor subtype 1 antagonist irbesartan versus enalapril in hypertensive patients. J Hypertens 1998 Mar; 16 (3): 385-93
22. Bonnet F, Cooper ME, Kawachi H, et al. Irbesartan normalises the deficiency in glomerular nephrin expression in a model of diabetes and hypertension. Diabetologica 2001; 44: 874-7
23. Marino MR, Langenbacher K, Ford NF, et al. Pharmacokinetics and pharmacodynamics of irbesartan in healthy subjects. J Clin Pharmacol 1998 Mar; 38 (3): 246-55
24. Ribstein J, Picard A, Armagnac C, et al. Inhibition of the acute effects of angiotensin II by the receptor antagonist irbesartan in normotensive men. J Cardiovasc Pharmacol 2001 Apr; 37 (4): 449-60
25. Sica DA, Marino MR, Hammett JL, et al. The pharmacokinetics of irbesartan in renal failure and maintenance hemodialysis. Clin Pharmacol Ther 1997 Dec; 62 (6): 610-8
26. Mazzolai L, Maillard M, Rossat J, et al. Angiotensin II receptor blockade in normotensive subjects: a direct comparison of three AT1 receptor antagonists. Hypertension 1999 Mar; 33 (3): 850-5
27. Belz GG, Butzer R, Kober S, et al. Time course and extent of angiotensin II antagonism after irbesartan, losartan, and valsartan in humans assessed by angiotensin II dose response and radioligand receptor assay. Clin Pharmacol Ther 1999 Oct; 66 (4): 367-73
28. Schindler C, Brosnihan KB, Ferrario CM, et al. Comparison of inhibitory effects of irbesartan and atorvastatin treatment on the renin angiotensin system (RAS) in veins: a randomized double-blind crossover trial in healthy subjects. J Clin Pharmacol 2007 Jan; 47 (1): 112-20
29. Kober S, Butzer R, Langguth P, et al. Extent and duration of angiotensin II antagonistic activity of irbesartan and candesartan cilexetil [abstract no. A105]. Am J Hypertension 2000 Apr; 13 (4 Pt 2): 150A
30. Belz GG, Butzer R, Kober S, et al. Irbesartan results in more complete blockade of human renal AT1-receptor mediated effects than does candesartan cilexetil as evidenced by higher plasma renin levels [abstract no. A106]. Am J Hypertens 2000 Apr; 13 (4 Pt 2): 151A
31. McIntyre M, MacFadyen RJ, Meredith PA, et al. Dose-ranging study of the angiotensin II receptor antagonist irbesartan (SR 47436/BMS-186295) on blood pressure and neurohormonal effects in salt-deplete men. J Cardiovasc Pharmacol 1996 Jul; 28 (1): 101-6
32. Azizi M, Bissery A, Bura-Rivière A, et al. Dual renin-angiotensin system blockade restores blood pressure-renin dependency in individuals with low renin concentrations. J Hypertens 2003 Oct; 21 (10): 1887-95
33. Schneider MP, Klingbeil AU, Delles C, et al. Effects of irbesartan versus atenolol on vascular stiffness and aortic blood pressure in essential hypertension [abstract no. 2B.1]. J Hypertens 2005 Jun; 23 Suppl. 2: 13
34. Park CG, Ahn JC, Hong SJ, et al. Efficacy of irbesartan on left ventricular mass and arterial stiffness in hypertensive patients. Korean J Intern Med 2006 Jun; 21 (2): 103-8
35. Casanova AV, Vicente JA, Mas JR. Evaluation of arterial distensibility in hypertensive patients treated with irbesartan [absus stract no. P3.202]. J Hypertens 2006; 24 Suppl. 4: S66
36. Mörtsell D, Malmqvist K, Held C, et al. Irbesartan reduces common carotid artery intima-media thickness in hypertensive patients when compared with atenolol: the Swedish Irbesartan Left Ventricular Hypertrophy Investigation versus Atenolol (SILVHIA) study. J Intern Med 2007 May; 261 (5): 472-9
37. Navalkar S, Parthasarathy S, Santanam N, et al. Irbesartan, an angiotensin type 1 receptor inhibitor, regulates markers of inflammation in patients with premature atherosclerosis. J Am Coll Cardiol 2001; 37 (2): 440-4
38. Khan BV, Navalkar S, Khan QA, et al. Irbesartan, an angiotensin type 1 receptor inhibitor, regulates the vascular oxidative state in patients with coronary artery disease. J Am Coll Cardiol 2001; 38 (6): 1662-7
39. Lauten WB, Khan QA, Rajagopalan S, et al. Usefulness of quinapril and irbesartan to improve the anti-inflammatory response of atorvastatin and aspirin in patients with coronary heart disease. Am J Cardiol 2003 May 1; 91: 1116-9
40. Cheng SM, Yang SP, Ho LJ, et al. Irbesartan inhibits human T-lymphocyte activation through downregulation of activator protein-1. Br J Pharmacol 2004 Jul; 142 (6): 933-42
41. Burnier M, Pechere-Bertschi A, Nussberger J, et al. Studies of the renal effects of angiotensin II receptor blockade: the confounding factor of acute water loading on the action of vasoactive systems. Am J Kidney Dis 1995 Jul; 26 (1): 108-15
42. Dang A, Zhang Y, Liu G, et al. Effects of losartan and irbesartan on serum uric acid in hypertensive patients with hyperuricaemia in Chinese population. J Hum Hypertens 2006 Jan; 20 (1): 45-50
43. Xiong XL, Jia RH, Yang DP, et al. Irbesartan attenuates contrast media-induced NRK-52E cells apoptosis. Pharmacol Res 2006; 54 (4): 253-60
44. Leehey DJ, Isreb MA, Marcic S, et al. Effect of high glucose on superoxide in human mesangial cells: role of angiotensin II. Nephron Exp Nephrol 2005; 100 (1): e46-53
45. Derosa G, Cicero AFG, Gaddi A, et al. Effects of doxazosin and irbesartan on blood pressure and metabolic control in patients with type 2 diabetes and hypertension. J Cardiovasc Pharmacol 2005 Jun; 45 (6): 599-604
46. Derosa G, Cicero AF, D'Angelo A, et al. Telmisartan and irbesartan therapy in type 2 diabetic patients treated with rosiglitazone: effects on insulin-resistance, leptin and tumor necrosis factor-alpha. Hypertens Res 2006 Nov; 29 (11): 849-56
47. Negro R, Formoso G, Hassan H. The effects of irbesartan and telmisartan on metabolic parameters and blood pressure in obese, insulin resistant, hypertensive patients. J Endocrinol Invest 2006 Dec; 29 (11): 957-61
48. Levy D, Garrison RJ, Savage DD, et al. Prognostic implications of echocardiographically determined left ventricular mass in the Framingham Heart Study. N Engl J Med 1990 May 31; 322 (22): 1561-6
49. Malmqvist K, Kahan T, Edner M, et al. Regression of left ventricular hypertrophy in human hypertension with irbesartan. J Hypertens 2001 Jun; 19 (6): 1167-76
50. Gaudio C, Ferri FM, Giovannini M, et al. Comparative effects of irbesartan versus amlodipine on left ventricular mass index in hypertensive patients with left ventricular hypertrophy. J Cardiovasc Pharmacol 2003 Nov; 42 (5): 622-8
51. Malmqvist K, Kahan T, Edner M, et al. Comparison of actions of irbesartan versus atenolol on cardiac repolarization in hypertensive left ventricular hypertrophy: results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation Versus Atenolol (SILVHIA). Am J Cardiol 2002 Nov 15; 90 (10): 1107-12
52. Müller-Brunotte R, Edner M, Malmqvist K, et al. Irbesartan and atenolol improve diastolic function in patients with hypertensive left ventricular hypertrophy. J Hypertens 2005 Mar; 23 (3): 633-40
53. Vachharajani NN, Shyu WC, Chando TJ, et al. Oral bioavailability and disposition characteristics of irbesartan, an angiotensin antagonist, in healthy volunteers. J Clin Pharmacol 1998 Aug; 38 (8): 702-7
54. Chando TJ, Everett DW, Kahle AD, et al. Biotransformation of irbesartan in man. Drug Metab Dispos 1998 May; 26 (5): 408-17
55. Vachharajani NN, Shyu WC, Smith RA, et al. The effects of age and gender on the pharmacokinetics of irbesartan. Br J Clin Pharmacol 1998 Dec; 46 (6): 611-3
56. Marino MR, Langenbacher KM, Raymond RH, et al. Pharmacokinetics and pharmacodynamics of irbesartan in patients with hepatic cirrhosis. J Clin Pharmacol 1998 Apr; 38 (4): 347-56
57. Kostis JB, Vachharajani NN, Hadjilambris OW, et al. The pharmacokinetics and pharmacodynamics of irbesartan in heart failure. J Clin Pharmacol 2001 Sep; 41 (9): 935-42
58. Vachharajani N, Shyu WC, Mantha S, et al. Lack of food effect on the oral bioavailability of irbesartan [abstract no. 60]. J Clin Pharmacology 1997 Sep; 37 (9): 872
59. Morsing P, Adler G, Brandt-Eliasson U, et al. Mechanistic differences of various AT1-receptor blockers in isolated vessels of different origin. Hypertension 1999 Jun; 33 (6): 1406-13
60. Ruilope L. Human pharmacokinetic/pharmacodynamic profile of irbesartan: a new potent angiotensin II receptor antagonist. J Hypertens 1997 Dec; 15 Suppl. 7: S15-20
61. Perrier L, Bourríe M, Marti E, et al. In vitro N-glucuronidation of SR 474346 (BMS 186295), a new AT1 nonpeptide angiotensin II receptor antagonist, by rat, monkey and human hepatic microsomal fractions. J Pharmacol Exp Ther 1994 Oct; 271 (1): 91-9
62. Bourrié M, Meunier V, Berger Y, et al. Role of cytochrome P-4502C9 in irbesartan oxidation by human liver microsomes. Drug Metab Dispos 1999 Feb; 27 (2): 288-96
63. Marino MR, Vachharajani NN. Drug interactions with irbesartan. Clin Pharmacokinet 2001; 40 (8): 605-14
64. Kovacs SJ, Wilton JH, Blum RA. Steady state (SS) pharmacokinetics (PK) of irbesartan alone and in combination with fluconazole (F) [abstract no. PI-59]. Clin Pharmacol Ther 1999 Feb; 65 (2): 132
65. Marino MR, Hammett JL, Ferreira I, et al. Effect of nifedipine on the steady-state pharmacokinetics and pharmacodynamics of irbesartan in healthy subjects. J Cardiovasc Pharmacol Ther 1998 Apr; 3 (2): 111-8
66. Mangold B, Gielsdorf W, Marino MR. Irbesartan does not affect the steady-state pharmacodynamics and pharmacokinetics of warfarin. Eur J Clin Pharmacol 1999 Oct; 55 (8): 593-8
67. Marino MR, Vachharajani NN, Hadjilambris OW. Irbesartan does not affect the pharmacokinetics of simvastatin in healthy subjects. J Clin Pharmacol 2000 Aug; 40 (8): 875-9
68. Marino MR, Langenbacher KM, Mangold B, et al. Lack of drug interactions with irbesartan: a summary of five pharmacokinetic studies [abstract no. P31.096]. J Hypertens 1998 Jun; 16 Suppl. 2: S248
69. Marino MR, Langenbacher KM, Ford NF, et al. Effect of hydrochlorothiazide on the pharmacokinetics and pharmacodynamics of the angiotensin II blocker irbesartan. Clin Drug Invest 1997 Nov; 14 (5): 383-91
70. Escolar M, López de Ocariz A, Simón M, et al. Effects of antacids on irbesartan pharmacokinetics [abstract no. FC-9]. Meth Find Exp Clin Pharmacol 1998; 20 Suppl. A: 53
71. Marino MR, Hammett JL, Ferreira I, et al. Effect of irbesartan on the steady-state pharmacokinetics of digoxin in healthy male subjects [abstract no. P-278E]. ASHP Midyear Clinical Meeting 1998; 33: 2301
72. Fogari R, Ambrosoli S, Corradi L, et al. 24-Hour blood pressure control by once-daily administration of irbesartan assessed by ambulatory blood pressure monitoring. Irbesartan Multicenter Investigators' Group. J Hypertens 1997 Dec; 15 (12 Pt 1): 1511-8
73. Pool JL, Guthrie RM, Littlejohn III TW, et al. Dose-related antihypertensive effects of irbesartan in patients with mild-to-moderate hypertension. Am J Hypertens 1998 Apr; 11 (4 Pt 1): 462-70
74. Guthrie R, Saini R, Herman T, et al. Efficacy and tolerability of irbesartan, an angiotensin II receptor antagonist, in primary hypertension: a double-blind, placebo-controlled, dose-titration study. Clin Drug Invest 1998 Mar; 15 (3): 217-27
75. Reeves RA, Lin C-S, Kassler-Taub K, et al. Dose-related efficacy of irbesartan for hypertension: an integrated analysis. Hypertension 1998 Jun; 31 (6): 1311-6
76. Lacourcière Y. A multicenter, randomized, double-blind study of the antihypertensive efficacy and tolerability of irbesartan in patients aged ≥65 years with mild to moderate hypertension. Clin Ther 2000 Oct; 22 (10): 1213-24
77. Mimran A, Ruilope L, Kerwin L, et al. A randomised, double-blind comparison of the angiotensin II receptor antagonist, irbesartan, with the full dose range of enalapril for the treatment of mild-to-moderate hypertension. J Hum Hypertens 1998 Mar; 12 (3): 203-8
78. Coca A, Calvo C, Garcia-Puig J, et al. A multicenter, randomized, double-blind comparison of the efficacy and safety of irbesartan and enalapril in adults with mild to moderate essential hypertension as assessed by ambulatory blood pressure monitoring: the MAPAVEL study. Clin Ther 2002 Jan; 24 (1): 126-38
79. Chiou K-R, Chen C-H, Ding PY-A, et al. Randomized, double-blind comparison of irbesartan and enalapril for treatment of mild to moderate hypertension. Chin Med J (Taipei) 2000 May; 63 (5): 368-76
80. Mancia G, Korlipara K, van Rossum P, et al. An ambulatory blood pressure monitoring study of the comparative antihypertensive efficacy of two angiotensin II receptor antagonists, irbesartan and valsartan. Blood Press Monit 2002 Apr; 7 (2): 135-42
81. Kassler-Taub K, Littlejohn T, Elliott W, et al. Comparative efficacy of two angiotensin II receptor antagonists, irbesartan and losartan, in mild-to-moderate hypertension. Irbesartan/ Losartan Study Investigators [published erratum appears in Am J Hypertension 1998 Jun; 11 (6 Pt 1): 736]. Am J Hypertens 1998; 11 (4 Pt 1): 445-53
82. Oparil S, Guthrie R, Lewin AJ, et al. An elective-titration study of the comparative effectiveness of two angiotensin II-receptor blockers, irbesartan and losartan. Irbesartan/Losartan Study Investigators. Clin Ther 1998; 20 (3): 398-409
83. Oparil S, Williams D, Chrysant SG, et al. Comparative efficacy of olmesartan, losartan, valsartan, and irbesartan in the control of essential hypertension [published erratum appears in J Clin Hypertens 2001 Nov-Dec; 3 (6): 395]. J Clin Hypertens 2001; 3 (5): 283-91, 318
84. Stumpe KO, Haworth D, Hoglund C, et al. Comparison of the angiotensin II receptor antagonist irbesartan with atenolol for treatment of hypertension. Blood Press 1998 Jan; 7 (1): 31-7
85. Neutel JM, Germino FW, Smith D. Comparison of monotherapy with irbesartan 150 mg or amlodipine 5 mg for treatment of mild-to-moderate hypertension. J Renin Angiotensin Aldosterone Syst 2005 Sep; 6 (2): 84-9
86. Yoshinaga K. A phase III clinical study of irbesartan, an angiotensin II receptor antagonist, in patients with essential hypertension: a double-blind, intergroup, comparative trial using enalapril maleate as the comparator [in Japanese]. Rinsho Iyaku 2008; 24 (6): 507-42
87. Yoshinaga K. A phase III clinical study of irbesartan, an angiotensin II receptor antagonist, in patients with essential hypertension: a double-blind, intergroup, comparative trial using losartan potassium as the comparator [in Japanese]. Rinsho Iyaku 2008; 24 (6): 543-73
88. Gradman AH, Schmieder RE, Lins RL, et al. Aliskiren, a novel orally effective renin inhibitor, provides dose-dependent antihypertensive efficacy and placebo-like tolerability in hypertensive patients. Circulation 2005; 111: 1012-8
89. Littlejohn III T, Saini R, Kassler-Taub K, et al. Long-term safety and antihypertensive efficacy of irbesartan; pooled results of five open-label studies. Clin Exper Hypertension 1999 Nov; 21 (8): 1273-95
90. Grimbert P, Grenier O, Thuillez C. Dose-related efficacy of irbesartan in patients with mild-to-moderate essential hypertension. Thérapie 2005 Dec; 60 (6): 577-82
91. Strutz F, Bramlage P, Paar WD. Effect of three months' treatment with irbesartan on blood and pulse pressure of hypertensive type 2 diabetic patients: open, observational study in 31,793 patients. Curr Med Res Opin 2005 Sep; 21 (9): 1433-40
92. Kintscher U, Bramlage P, Paar WD, et al. Irbesartan for the treatment of hypertension in patients with the metabolic syndrome: a sub analysis of the Treat to Target post authorization survey. Prospective observational, two armed study in 14,200 patients. Cardiovasc Diabetol. Epub 2007 Apr 3
93. Parhofer KG, Muenzel F, Krekler M. Effect of the angiotensin receptor blocker irbesartan on metabolic parameters in clinical practice: the DO-IT prospective observational study. Cardiovasc Diabetol. Epub 2007 Nov 27
94. Smith DH, Dubiel R, Jones M. Use of 24-hour ambulatory blood pressure monitoring to assess antihypertensive efficacy: a comparison of olmesartan medoxomil, losartan potassium, valsartan, and irbesartan. Am J Cardiovasc Drugs 2005; 5 (1): 41-50
95. 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
96. Ravera M, Ratto E, Vettoretti S, et al. Prevention and treatment of diabetic nephropathy: the program for irbesartan mortality and morbidity evaluation. J Am Soc Nephrol 2005 Mar; 16 Suppl. 1: S48-52
97. Sasso FC, Carbonara O, Persico M, et al. Irbesartan reduces the albumin excretion rate in microalbuminuric type 2 diabetic patients independently of hypertension: a randomized double-blind placebo-controlled crossover study. Diabetes Care 2002 Nov; 25 (11): 1909-13
98. Bakris GL, Ruilope L, Locatelli F, et al. Treatment of microalbuminuria in hypertensive subjects with elevated cardio-vascular risk: results of the IMPROVE trial. Kidney Int 2007 Aug 1; 72: 879-85
99. Lehnert H, Bramlage P, Pittrow D, et al. Regression of microalbuminuria in type 2 diabetics after switch to irbesartan treatment: an observational study in 38 016 patients in primary care. Clin Drug Investig 2004; 24 (4): 217-25
100. de Álvaro F, Velasco O, Honorato J, et al. Microalbuminuria in hypertensive patients: evaluation of one-year treatment with irbesartan. Kidney Int Suppl 2005 Jan; 67 (93): S29-34
101. Bertomeu V, Alegria E, Honorato J, et al. Microalbuminuria and cardiovascular morbidity: effect of treatment with irbesartan in clinical settings. 1 year-interim results. Koral-Cardio study [abstract no. P-84]. J Clin Hypertens 2006 May; 8 Suppl. A (5): A42
102. Rossing K, Christensen PK, Andersen S, et al. Comparative effects of irbesartan on ambulatory and office blood pressure: a substudy of ambulatory blood pressure from the Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria Study. Diabetes Care 2003 Mar; 26 (3): 569-74
103. Andersen S, Bröchner-Mortensen J, Parving H-H. Kidney function during and after withdrawal of long-term irbesartan treatment in patients with type 2 diabetes and microalbuminuria: irbesartan in patients with type 2 diabetes and microalbuminuria Study Group. Diabetes Care 2003 Dec; 26 (12): 3296-302
104. Berl T, Hunsicker LG, Lewis JB, et al. Cardiovascular outcomes in the Irbesartan Diabetic Nephropathy Trial of patients with type 2 diabetes and overt nephropathy. Ann Intern Med 2003 Apr 1; 138 (7): 542-9
105. Simon TA, Gelarden RT, Freitag SA, et al. Safety of irbesartan hyperin the treatment of mild to moderate systemic hypertension. Am J Cardiol 1998 Jul; 82 (2): 179-82
106. Bristol-Myers Squibb Sanofi-Synthelabo Partnership. Avapro® (irbesartan) tablets: prescribing information [online]. Available from URL: http://www.bms.com [Accessed 2008 Feb 25]
107. Morales-Olivas FJ, Aristegui I, Estañ L, et al. The KARTAN study: a postmarketing assessment of irbesartan in patients with hypertension. Clin Ther 2004 Feb; 26 (2): 232-44
108. Palmer AJ, Annemans L, Roze S, et al. An economic evaluation of the Irbesartan in Diabetic Nephropathy Trial (IDNT) in a UK setting. J Hum Hypertens 2004 Oct; 18 (10): 733-8
109. Palmer AJ, Annemans L, Roze S, et al. An economic evaluation of irbesartan in the treatment of patients with type 2 diabetes, hypertension and nephropathy: cost-effectiveness of Irbesartan in Diabetic Nephropathy Trial (IDNT) in the Belgian and French settings. Nephrol Dial Transplant 2003 Oct; 18 (10): 2059-66
110. Palmer AJ, Annemans L, Roze S, et al. Cost-effectiveness analysis of irbesartan in patients with type 2 diabetes, hypertension and nephropathy: the Italian perspective [in Italian]. Pharmacoeconomics - Italian Research Articles 2005; 7 (1): 43-57
111. Palmer AJ, Annemans L, Roze S, et al. Irbesartan is projected to be cost and life saving in a Spanish setting for treatment of patients with type 2 diabetes, hypertension, and microalbuminuria. Kidney Int Suppl 2005 Jan; 67 (93): S52-4
112. Rodby RA, Chiou C-F, Borenstein J, et al. The cost-effectiveness of irbesartan in the treatment of hypertensive patients with type 2 diabetic nephropathy. Clin Ther 2003; 25 (7): 2102-19
113. Coyle D, Rodby RA. Economic evaluation of the use of irbesartan and amlodipine in the treatment of diabetic nephropathy in patients with hypertension in Canada. Can J Cardiol 2004 Jan; 20 (1): 71-9
114. Palmer AJ, Annemans L, Roze S, et al. Cost-effectiveness of early irbesartan treatment versus control (standard antihypertensive medications excluding ACE inhibitors, other angiotensin-2 receptor antagonists, and dihydropyridine calcium channel blockers) or late irbesartan treatment in patients with type 2 diabetes, hypertension, and renal disease. Diabetes Care 2004 Aug; 27 (8): 1897-903
115. Palmer AJ, Valentine WJ, Tucker DM, et al. A French cost-consequence analysis of the renoprotective benefits of irbesartan in patients with type 2 diabetes and hypertension. Curr Med Res Opin 2006 Nov; 22 (11): 2095-100
116. Annemans L, Demarteau N, Hu S, et al. An Asian regional analysis of cost-effectiveness of early irbesartan treatment versus conventional antihypertensive, late amlodipine and late irbesartan treatments in patients with type 2 diabetes, hypertension, and nephropathy. Value Health 2008 May-Jun; 11 (3): 354-64
117. Palmer AJ, Chen R, Valentine WJ, et al. Cost-consequence analysis in a French setting of screening and optimal treatment of nephropathy in hypertensive patients with type 2 diabetes. Diabetes Metab 2006 Feb; 32 (1): 69-76
118. Sanofi Pharma Bristol, Myers Squibb SNC. Aprovel 75mg tablets; aprovel 150mg tablets; aprovel 300mg tablets: summary of product characteristics. Paris: Sanofi Pharma, Bristol-Myers Squibb SNC, 2007 Oct
119. Cooper WO, Hernandez-Diaz S, Arbogast PG, et al. Major congenital malformations after first-trimester exposure to ACE inhibitors. N Engl J Med 2006 Jun 8; 354 (23): 2443-51
120. Sealey JE, Itskovitz-Eldor J. ACE inhibitors and major congenital malformations [letter]. N Engl J Med 2006 Sep 21; 355 (12): 1280-1
121. Tozawa M, Iseki K, Iseki C, et al. Blood pressure predicts risk of developing end-stage renal disease in men and women. Hypertension 2003; 41: 1341-5
122. Whitworth JA, World Health Organisation-International Society of Hypertension Writing Group. 2003 World Health Organisation (WHO)/International Society of Hypertension (ISH) statement on management of hypertension. J Hypertens 2003; 21 (11): 1983-92
123. Dahlöf B, Devereux RB, Kjeldsen SE, et al. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet 2002 Mar 23; 359 (9311): 995-1003
124. Croxtall JD, Keating GM. Irbesartan/hydrochlorothiazide: in moderate to severe hypertension. Drugs 2008; 68 (10): 1465-72
125. Sanofi Pharma Bristol, Myers Squibb SNC. CoAprovel 150/ 12.5mg, 300/12.5mg and 300/25mg film-coated tablet (Sanofi-Aventis Bristol-Myers Squibb SNC). Paris: Sanofi Pharma Bristol-Myers Squibb SNC, 2007 Jan
126. Sarafidis PA, Bakris GL. Microalbuminuria and chronic kidney disease as risk factors for cardiovascular disease. Nephrol Dial Transplant 2006; 21: 2366-74
127. Anavekar NS, Gans DJ, Berl T, et al. Predictors of cardiovascular events in patients with type 2 diabetic nephropathy and hypertension: a case for albuminuria. Kidney Int Suppl 2004 Nov; 66 (92): S50-5
128. Ribeiro AB. Angiotensin II antagonists: therapeutic benefits spanning the cardiovascular disease continuum from hypertension to heart failure and diabetic nephropathy. Curr Med Res Opin 2006 Jan; 22 (1): 1-16
129. Karalliedde J, Viberti G. Evidence for renoprotection by blockade of the renin-angiotensin-aldosterone system in hypertension and diabetes. J Hum Hypertens 2006; 20: 239-53
130. IDF Clinical Guidelines Task Force. Global guideline for type 2 diabetes. Brussels: International Diabetes Federation, 2005
131. American Diabetes Association. Standards of medical care in diabetes: 2008. Diabetes Care 2008; 31 Suppl. 1: S12-54
132. Mogensen CE, Neldam S, Tikkanen I, et al. Randomised controlled trial of dual blockade of renin-angiotensin system in patients with hypertension, microalbuminuria, and non-insulin dependent diabetes: the candesartan and lisinopril microalbuminuria (CALM) study. BMJ 2000 Dec 9; 321 (7274): 1440-4
133. Viberti G, Wheeldon NM, Microalbuminuria Reduction With VALsartan (MARVAL) Study investigators. Microalbumin-uria reduction with valsartan in patients with type 2 diabetes mellitus: a blood pressure-independent effect. Circulation 2002; 106: 672-8
134. 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
135. Toto R. Angiotensin II subtype 1 receptor blockers and renal function. Arch Intern Med 2001 Jun 25; 161 (12): 1492-9
136. Kum LC, Yip GW, Lee PW, et al. Comparison of angiotensin-converting enzyme inhibitor alone and in combination with irbesartan for the treatment of heart failure. Int J Cardiol 2008; 125: 16-21
137. Tonkon M, Awan N, Niazi I, et al. A study of the efficacy and safety of irbesartan in combination with conventional therapy, including ACE inhibitors, in heart failure. Irbesartan Heart Failure Group. Int J Clin Pract 2000; 54 (1): 11-4, 16-8
138. Yusuf S, Pfeffer MA, Swedberg K, et al. Effects of candesartan in patients with chronic heart failure and preserved left-ventricular ejection fraction: the CHARM-Preserved Trial. Lancet 2003 Sep 6; 362: 777-81
139. Yip GWK, Wang M, Wang T, et al. The Hong Kong Diastolic Heart Failure Study: a randomized control trial of diuretics, irbesartan and ramipril on quality of life, exercise capacity, left ventricular global and regional function in heart failure with a normal ejection fraction. Heart 2008 May; 94 (5): 573-80
140. Carson P, Massie BM, McKelvie R, et al. The irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial: rationale and design. J Card Fail 2005 Oct; 11 (8): 576-85
141. ACTIVE Steering Committee. Rationale and design of ACTIVE: the atrial fibrillation clopidogrel trial with irbesartan for prevention of vascular events. Am Heart J 2006; 151 (6): 1187-93