Pharmacokinetic, pharmacodynamic and clinical evaluation of aliskiren for hypertension treatment

Bibliography

• Brown MJ. Aliskiren. Circulation 2008;118:773-84
   PubMed Web of Science ®Google Scholar
• Lawes CM, Vander Hoorn S, Rodgers A. Global burden of blood-pressure-related disease, 2001. Lancet 2008;371:1513-18
   PubMed Web of Science ®Google Scholar
• Wood JM, Stanton JL, Hofbauer KG. Inhibitors of renin as potential therapeutic agents. J Enzyme Inhib 1987;1:169-85
   PubMedGoogle Scholar
• Wood JM, Schnell CR, Cumin F, Aliskiren, a novel, orally effective renin inhibitor, lowers blood pressure in marmosets and spontaneously hypertensive rats. J Hypertens 2005;23:417-26
   PubMed Web of Science ®Google Scholar
• James MN, Sielecki AR. Stereochemical analysis of peptide bond hydrolysis catalyzed by the aspartic proteinase penicillopepsin. Biochemistry 1985;24:3701-13
   PubMed Web of Science ®Google Scholar
• Azizi M, Webb R, Nussberger J, Renin inhibition with aliskiren: where are we now, and where are we going? J Hypertens 2006;24:243-56
   PubMed Web of Science ®Google Scholar
• Verdecchia P, Angeli F, Mazzotta G, The renin angiotensin system in the development of cardiovascular disease: role of aliskiren in risk reduction. Vasc Health Risk Manag 2008;4:971-81
   PubMedGoogle Scholar
• Campbell DJ, Woodward M, Chalmers JP, Prediction of myocardial infarction by N-terminal-pro-B-type natriuretic peptide, C-reactive protein, and renin in subjects with cerebrovascular disease. Circulation 2005;112:110-16
   PubMed Web of Science ®Google Scholar
• Alderman MH, Madhavan S, Ooi WL, Association of the renin-sodium profile with the risk of myocardial infarction in patients with hypertension. N Engl J Med 1991;324:1098-104
   PubMed Web of Science ®Google Scholar
• Muhlestein JB, May HT, Bair TL, Relation of elevated plasma renin activity at baseline to cardiac events in patients with angiographically proven coronary artery disease. Am J Cardiol 2010;106:764-9
   PubMed Web of Science ®Google Scholar
• Van de Wal RM, Plokker HW, Lok DJ, Determinants of increased angiotensin II levels in severe chronic heart failure patients despite ACE inhibition. Int J Cardiol 2006;106:367-72
   PubMed Web of Science ®Google Scholar
• Urata H, Kinoshita A, Misono KS, Identification of a highly specific chymase as the major angiotensin II-forming enzyme in the human heart. J Biol Chem 1990;265:22348-57
   PubMed Web of Science ®Google Scholar
• Stanton AV, Dicker P, O'Brien ET. Aliskiren monotherapy results in the greatest and the least blood pressure lowering in patients with high- and low-baseline PRA levels, respectively. Am J Hypertens 2009;22:954-7
   PubMed Web of Science ®Google Scholar
• Sealey JE, Laragh JH. Aliskiren, the first renin inhibitor for treating hypertension: reactive renin secretion may limit its effectiveness. Am J Hypertens 2007;20:587-97
   PubMed Web of Science ®Google Scholar
• Sealey JE, Laragh JH. Aliskiren fails to lower blood pressure in patients who have either low PRA levels or whose PRA falls insufficiently or reactively rises. Am J Hypertens 2009;22:112-21
   PubMed Web of Science ®Google Scholar
• Stanton AV, Gradman AH, Schmieder RE, Aliskiren monotherapy does not cause paradoxical blood pressure rises: meta-analysis of data from 8 clinical trials. Hypertension 2010;55:54-60
   PubMed Web of Science ®Google Scholar
• Krop M, Garrelds IM, de Bruin RJ, Aliskiren accumulates in Renin secretory granules and binds plasma prorenin. Hypertension 2008;52:1076-83
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration (FDA) SG. Drug product label. Tekturna, NDA no. 021985. Available from: http://wwwaccessdatafdagov/drugsatfda_docs/label/2010/021985s012lblpdf. 2010
   Google Scholar
• Wood JM, Maibaum J, Rahuel J, Structure-based design of aliskiren, a novel orally effective renin inhibitor. Biochem Biophys Res Commun 2003;308:698-705
   PubMed Web of Science ®Google Scholar
• Rahuel J, Rasetti V, Maibaum J, Structure-based drug design: the discovery of novel nonpeptide orally active inhibitors of human renin. Chem Biol 2000;7:493-504
   PubMed Web of Science ®Google Scholar
• Tapaninen T, Neuvonen PJ, Niemi M. Grapefruit juice greatly reduces the plasma concentrations of the OATP2B1 and CYP3A4 substrate aliskiren. Clin Pharmacol Ther 2010;88:339-42
   PubMed Web of Science ®Google Scholar
• Limoges D, Dieterich HA, Yeh CM, A study of dose-proportionality in the pharmacokinetics of the oral direct renin inhibitor aliskiren in healthy subjects. Int J Clin Pharmacol Ther 2008;46:252-8
   PubMed Web of Science ®Google Scholar
• Staessen JA, Li Y, Richart T. Oral renin inhibitors. Lancet 2006;368:1449-56
   PubMed Web of Science ®Google Scholar
• Cvetkovic M, Leake B, Fromm MF, OATP and P-glycoprotein transporters mediate the cellular uptake and excretion of fexofenadine. Drug Metab Dispos 1999;27:866-71
   PubMed Web of Science ®Google Scholar
• Chen J, Raymond H. The role of CYP3A4 and p-glycoprotein in food-drug and herb-drug interactions. Aust Pharmacist 2006;25:732-8
   Google Scholar
• Cascorbi I. Role of pharmacogenetics of ATP-binding cassette transporters in the pharmacokinetics of drugs. Pharmacol Ther 2006;112:457-73
   PubMed Web of Science ®Google Scholar
• Tapaninen T, Neuvonen PJ, Niemi M. Effect of ABCB1 haplotypes on the pharmacokinetics and renin-inhibiting effect of aliskiren. Eur J Clin Pharmacol 2010;66:865-70
   PubMed Web of Science ®Google Scholar
• Waldmeier F, Glaenzel U, Wirz B, Absorption, distribution, metabolism, and elimination of the direct renin inhibitor aliskiren in healthy volunteers. Drug Metab Dispos 2007;35:1418-28
   PubMed Web of Science ®Google Scholar
• Vaidyanathan S, Camenisch G, Schuetz H, Pharmacokinetics of the oral direct renin inhibitor Aliskiren in combination with digoxin, atorvastatin, and detoconazole in healthy subjects: the role of P-glycoprotein in the disposition of Aliskiren. J Clin Pharmacol 2008;48:1323-38
   PubMed Web of Science ®Google Scholar
• Dieterle W, Corynen S, Mann J. Effect of the oral renin inhibitor aliskiren on the pharmacokinetics and pharmacodynamics of a single dose of warfarin in healthy subjects. Br J Clin Pharmacol 2004;58:433-6
   PubMed Web of Science ®Google Scholar
• Dieterle W, Corynen S, Vaidyanathan S, Pharmacokinetic interactions of the oral renin inhibitor aliskiren with lovastatin, atenolol, celecoxib and cimetidine. Int J Clin Pharmacol Ther 2005;43:527-35
   PubMed Web of Science ®Google Scholar
• Vaidyanathan S, Valencia J, Kemp C, Lack of pharmacokinetic interactions of aliskiren, a novel direct renin inhibitor for the treatment of hypertension, with the antihypertensives amlodipine, valsartan, hydrochlorothiazide (HCTZ) and ramipril in healthy volunteers. Int J Clin Pract 2006;60:1343-56
   PubMed Web of Science ®Google Scholar
• Nussberger J, Wuerzner G, Jensen C, Angiotensin II suppression in humans by the orally active renin inhibitor Aliskiren (SPP100): comparison with enalapril. Hypertension 2002;39:E1-8
   PubMed Web of Science ®Google Scholar
• Tapaninen T, Backman JT, Kurkinen K, Itraconazole, a P-Glycoprotein and CYP3A4 Inhibitor, Markedly Raises the Plasma Concentrations and Enhances the Renin-Inhibiting Effect of Aliskiren. J Clin Pharmacol 2010: published online before print April 16, 2010, doi: 10.1177/0091270010365885
   Google Scholar
• Tapaninen T, Neuvonen PJ, Niemi M. Rifampicin reduces the plasma concentrations and the renin-inhibiting effect of aliskiren. Eur J Clin Pharmacol 2010;66:497-502
   PubMed Web of Science ®Google Scholar
• Jarugula V, Yeh CM, Howard D, Influence of body weight and gender on the pharmacokinetics, pharmacodynamics, and antihypertensive efficacy of Aliskiren. J Clin Pharmacol 2010: published online before print February 11, 2010, doi: 10.1177/0091270009359525
   Google Scholar
• Hu P, Bartlett M, Karan RS, Pharmacokinetics, safety and tolerability of single and multiple oral doses of aliskiren in healthy Chinese subjects: a randomized, single-blind, parallel-group, placebo-controlled study. Clin Drug Investig 2010;30:221-8
   PubMed Web of Science ®Google Scholar
• Vaidyanathan S, Reynolds C, Yeh CM, Pharmacokinetics, safety, and tolerability of the novel oral direct renin inhibitor aliskiren in elderly healthy subjects. J Clin Pharmacol 2007;47:453-60
   PubMed Web of Science ®Google Scholar
• Levey AS, Bosch JP, Lewis JB, A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of diet in renal disease Study Group. Ann Intern Med 1999;130:461-70
   PubMed Web of Science ®Google Scholar
• Vaidyanathan S, Limoges D, Yeh C, PIII-23. Aliskiren, an orally effective renin inhibitor, shows dose-linear pharmacokinetics in healthy volunteers. Clin Pharmacol Ther 2006;79: abstract P64
   Web of Science ®Google Scholar
• Duprez DA, Munger MA, Botha J, Aliskiren for geriatric lowering of systolic hypertension: a randomized controlled trial. J Hum Hypertens 2010;24:600-8
   PubMed Web of Science ®Google Scholar
• Aliskiren pregnancy and breastfeeding warnings. Available from: http://wwwdrugscom/pregnancy/aliskirenhtml. [Accessed 11 September 2010]
   Google Scholar
• Vaidyanathan S, Warren V, Yeh C, Pharmacokinetics, safety, and tolerability of the oral Renin inhibitor aliskiren in patients with hepatic impairment. J Clin Pharmacol 2007;47:192-200
   PubMed Web of Science ®Google Scholar
• Kelly JG, O'Malley K. Clinical pharmacokinetics of calcium antagonists. An update. Clin Pharmacokinet 1992;22:416-33
   PubMed Web of Science ®Google Scholar
• Vaidyanathan S, Bigler H, Yeh C, Pharmacokinetics of the oral direct renin inhibitor aliskiren alone and in combination with irbesartan in renal impairment. Clin Pharmacokinet 2007;46:661-75
   PubMed Web of Science ®Google Scholar
• Ganten D, Wagner J, Zeh K, Species specificity of renin kinetics in transgenic rats harboring the human renin and angiotensinogen genes. Proc Natl Acad Sci USA 1992;89:7806-10
   PubMed Web of Science ®Google Scholar
• Fukamizu A, Sugimura K, Takimoto E, Chimeric renin-angiotensin system demonstrates sustained increase in blood pressure of transgenic mice carrying both human renin and human angiotensinogen genes. J Biol Chem 1993;268:11617-21
   PubMed Web of Science ®Google Scholar
• Pilz B, Shagdarsuren E, Wellner M, Aliskiren, a human renin inhibitor, ameliorates cardiac and renal damage in double-transgenic rats. Hypertension 2005;46:569-76
   PubMed Web of Science ®Google Scholar
• Azizi M, Menard J, Bissery A, Pharmacologic demonstration of the synergistic effects of a combination of the renin inhibitor aliskiren and the AT1 receptor antagonist valsartan on the angiotensin II-renin feedback interruption. J Am Soc Nephrol 2004;15:3126-33
   PubMed Web of Science ®Google Scholar
• Kushiro T, Itakura H, Abo Y, Aliskiren, a novel oral renin inhibitor, provides dose-dependent efficacy and placebo-like tolerability in Japanese patients with hypertension. Hypertens Res 2006;29:997-1005
   PubMed Web of Science ®Google Scholar
• Mitchell J, Oh B, Herron J, Once-daily aliskiren provides effective, smooth 24-h blood pressure control in patients with hypertension. J Clin Hypertens 2006;8(Suppl A):A93
   Google Scholar
• Oh BH, Mitchell J, Herron JR, Aliskiren, an oral renin inhibitor, provides dose-dependent efficacy and sustained 24-hour blood pressure control in patients with hypertension. J Am Coll Cardiol 2007;49:1157-63
   PubMed Web of Science ®Google Scholar
• Oparil S, Yarows SA, Patel S, Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension: a randomised, double-blind trial. Lancet 2007;370:221-9
   PubMed Web of Science ®Google Scholar
• Pool JL, Schmieder RE, Azizi M, Aliskiren, an orally effective renin inhibitor, provides antihypertensive efficacy alone and in combination with valsartan. Am J Hypertens 2007;20:11-20
   PubMed Web of Science ®Google Scholar
• Villamil A, Chrysant SG, Calhoun D, Renin inhibition with aliskiren provides additive antihypertensive efficacy when used in combination with hydrochlorothiazide. J Hypertens 2007;25:217-26
   PubMed Web of Science ®Google Scholar
• Jordan J, Engeli S, Boye SW, Direct Renin inhibition with aliskiren in obese patients with arterial hypertension. Hypertension 2007;49:1047-55
   PubMed Web of Science ®Google Scholar
• Dahlof B, Anderson DR, Arora V, Aliskiren, a direct renin inhibitor, provides antihypertensive efficacy and excellent tolerability independent of age or gender in patients with hypertension. J Clin Hypertens 2007;9(Suppl A):A157
   Google Scholar
• Stanton A, Jensen C, Nussberger J, Blood pressure lowering in essential hypertension with an oral renin inhibitor, aliskiren. Hypertension 2003;42:1137-43
   PubMed Web of Science ®Google Scholar
• Gradman AH, Schmieder RE, Lins RL, Aliskiren, a novel orally effective renin inhibitor, provides dose-dependent antihypertensive efficacy and placebo-like tolerability in hypertensive patients. Circulation 2005;111:1012-18
   PubMed Web of Science ®Google Scholar
• Strasser RH, Puig JG, Farsang C, A comparison of the tolerability of the direct renin inhibitor aliskiren and lisinopril in patients with severe hypertension. J Hum Hypertens 2007;21:780-7
   PubMed Web of Science ®Google Scholar
• Andersen K, Weinberger MH, Egan B, Aliskiren-based therapy lowers blood pressure more effectively than ramipril-based therapy in patients with hypertension: a 6-month, randomized, double-blind trial. J Am Coll Cardiol 2007;49(Suppl A):A371
   Google Scholar
• Andersen K, Weinberger MH, Egan B, Comparative efficacy and safety of aliskiren, an oral direct renin inhibitor, and ramipril in hypertension: a 6-month, randomized, double-blind trial. J Hypertens 2008;26:589-99
   PubMed Web of Science ®Google Scholar
• Duprez DA, Davis P, Botha J. The AGELESS Study: The effect of aliskiren vs ramipril alone or in combination with hydrochlorothiazide and amlodipine in patients 65 years of age with systolic hypertension (abstract 4423). Circulation 2008;118:886-7
   Web of Science ®Google Scholar
• National Cholesterol Education Program SG. Executive summary of the third report of The National Cholesterol Education Program (NCEP) Expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 2001;285:2486-97
   PubMed Web of Science ®Google Scholar
• Prasad A, Quyyumi AA. Renin-angiotensin system and angiotensin receptor blockers in the metabolic syndrome. Circulation 2004;110:1507-12
   PubMed Web of Science ®Google Scholar
• Krone W, Hanefeld M, Meyer HF, Comparative efficacy and safety of aliskiren and irbesartan in patients with hypertension and metabolic syndrome. J Hum Hypertens 2010: published online before print 8 April 2010; doi: 10.1038/jhh.2010.38
   Google Scholar
• Uresin Y, Taylor AA, Kilo C, Efficacy and safety of the direct renin inhibitor aliskiren and ramipril alone or in combination in patients with diabetes and hypertension. J Renin Angiotensin Aldosterone Syst 2007;8:190-8
   PubMed Web of Science ®Google Scholar
• Ito S, Nakura N, Le Breton S, Efficacy and safety of aliskiren in Japanese hypertensive patients with renal dysfunction. Hypertens Res 2010;33:62-6
   PubMed Web of Science ®Google Scholar
• McMurray JJ, Pitt B, Latini R, Effects of the oral direct renin inhibitor aliskiren in patients with symptomatic heart failure. Circ Heart Fail 2008;1:17-24
   PubMed Web of Science ®Google Scholar
• Parving HH, Persson F, Lewis JB, Aliskiren combined with losartan in type 2 diabetes and nephropathy. N Engl J Med 2008; 358:2433-46
   PubMed Web of Science ®Google Scholar
• Keane WF, Eknoyan G. Proteinuria, albuminuria, risk, assessment, detection, elimination (PARADE): a position paper of the National Kidney Foundation. Am J Kidney Dis 1999;33:1004-10
   PubMed Web of Science ®Google Scholar
• Feldman DL, Jin L, Xuan H, Effects of aliskiren on blood pressure, albuminuria, and (pro)renin receptor expression in diabetic TG(mRen-2)27 rats. Hypertension 2008;52:130-6
   PubMed Web of Science ®Google Scholar
• Persson F, Lewis JB, Lewis EJ, Impact of baseline renal function on the efficacy and safety of aliskiren added to losartan in patients with type 2 diabetes and nephropathy. Diabetes Care 2010: Published online before print August 6, 2010, doi: 10.2337/dc10-0833
   Google Scholar
• Persson F, Rossing P, Reinhard H, Optimal antiproteinuric dose of aliskiren in type 2 diabetes mellitus: a randomised crossover trial. Diabetologia 2010;53:1576-80
   PubMed Web of Science ®Google Scholar
• Solomon SD. Effect of the direct renin inhibitor aliskiren, either alone or in combination with losartan, compared to losartan, on left ventricular mass in patients with hypertension and left ventricular hypertrophy: the Aliskiren Left Ventricular Assessment of Hypertrophy (ALLAY) Trial. SCAI-ACC i2 Summit/American College of Cardiology Annual Scientific Session, Chicago, IL; 2008
   Google Scholar
• McInnes GT. Renin inhibition: the holy grail of renin-angiotensin system blockade? J Hum Hypertens 2007;21:766-9
   PubMed Web of Science ®Google Scholar
• Schefe JH, Neumann C, Goebel M, Prorenin engages the (pro)renin receptor like renin and both ligand activities are unopposed by aliskiren. J Hypertens 2008;26:1787-94
   PubMed Web of Science ®Google Scholar
• Nussberger J, Aubert JF, Bouzourene K, Renin inhibition by aliskiren prevents atherosclerosis progression: comparison with irbesartan, atenolol, and amlodipine. Hypertension 2008;51:1306-11
   PubMed Web of Science ®Google Scholar
• Musini VM, Fortin PM, Bassett K, Blood pressure lowering efficacy of renin inhibitors for primary hypertension: a Cochrane systematic review. J Hum Hypertens 2009;23:495-502
   PubMed Web of Science ®Google Scholar
• Gradman AH, Schmieder RE, Lins RL, Aliskiren, a novel orally effective renin inhibitor, provides dose-dependent antihypertensive efficacy and placebo-like tolerability in hypertensive patients. Circulation 2005;111:1012-18
   PubMed Web of Science ®Google Scholar
• Uresin Y, Taylor A, Kilo C, Aliskiren, a novel renin inhibitor, has greater BP lowering than ramipril and additional BP lowering when combined with ramipril in patients with diabetes and hypertension. J Hypertens 2006;24(Suppl 4):82
   Google Scholar
• Weir M, Bush C, Zhang J, Antihypertensive efficacy and safety of the oral renin inhibitor aliskiren in patients with hypertension: a pooled analysis. Eur Heart J 2006;27(Suppl):299
   Google Scholar
• Parving H-H, Brenner BM, McMurray JJV, Aliskiren Trial in type 2 diabetes using cardio-renal endpoints (ALTITUDE): rationale and study design. Nephrol Dial Transplant 2009;24:1663-71
   PubMed Web of Science ®Google Scholar
• AliSkiren TRial ON Acute heart failure oUTcomes SG. Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure (ASTRONAUT). Available from: http://clinicaltrialsgov/ct2/show/NCT00894387?term=astronaut+aliskiren&rank=1. 2010
   Google Scholar
• Aliskiren Trial to Mediate Outcome Prevention in Heart FailuRE SG. Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbi-mortality in Patients With Chronic Heart Failure (ATMOSPHERE). Available from: http://clinicaltrialsgov/ct2/show/NCT00853658?term=atmosphere+aliskiren&rank=1. 2010
   Google Scholar
• Sever PS, Gradman AH, Azizi M. Managing cardiovascular and renal risk: the potential of direct renin inhibition. J Renin Angiotensin Aldosterone Syst 2009;10:65-76
   PubMed Web of Science ®Google Scholar
• Mohamed Saleem T, Jain A, Tarani P, Aliskiren: a novel, orally active renin inhibitor. Syst Rev Pharm 2010;1:93-8
   Google Scholar
• Solomon S. Effect of the direct renin inhibitor aliskiren on left ventricular remodelling following myocardial infarction with left ventricular dysfunction: ASPIRE. American College of Cardiology, 59th Annual Scientific Sessions. 2010
   Google Scholar
• Nickenig G, Simanenkov V, Lembo G, Efficacy of aliskiren/hydrochlorothiazide single-pill combinations in aliskiren non-responders. Blood Press Suppl 2008;2:31-40
   PubMedGoogle Scholar
• Geiger H, Barranco E, Gorostidi M, Combination therapy with various combinations of aliskiren, valsartan, and hydrochlorothiazide in hypertensive patients not adequately responsive to hydrochlorothiazide alone. J Clin Hypertens (Greenwich) 2009;11:324-32
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration (FDA) SG. Drug product label. Tekamlo, NDA no. 022545 Available from: http://wwwaccessdatafdagov/drugsatfda_docs/label/2010/022545s000lblpdf. 2010
   Google Scholar
• Bakris GL, Sarafidis PA, Weir MR, Renal outcomes with different fixed-dose combination therapies in patients with hypertension at high risk for cardiovascular events (ACCOMPLISH): a prespecified secondary analysis of a randomised controlled trial. Lancet 2010;375:1173-81
   PubMed Web of Science ®Google Scholar