Safety and efficacy of aliskiren in the treatment of hypertension: a systematic overview

Bibliography

• Brown MJ. Aliskiren. Circulation 2008;118(7):773-84
   PubMed Web of Science ®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(4):698-705
   PubMed Web of Science ®Google Scholar
• Jacoby DS, Rader DJ. Renin-angiotensin system and atherothrombotic disease: from genes to treatment. Arch Intern Med 2003;163(10):1155-64
   PubMed Web of Science ®Google Scholar
• Schmidt-Ott KM, Kagiyama S, Phillips MI. The multiple actions of angiotensin II in atherosclerosis. Regul Pept 2000;93(1-3):65-77
   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(5):971-81
   PubMedGoogle Scholar
• Schweda F, Kurtz A. Regulation of renin release by local and systemic factors. Rev Physiol Biochem Pharmacol 2012;161:1-44
   Web of Science ®Google Scholar
• Nishiyama A, Kim-Mitsuyama S. New approaches to blockade of the renin-angiotensin-aldosterone system: overview of regulation of the renin-angiotensin-aldosterone system. J Pharmacol Sci 2010;113(4):289-91
   PubMed Web of Science ®Google 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(2):417-26
   PubMed Web of Science ®Google Scholar
• Azizi M, Frank M, Steichen O, Blanchard A. Advantages and limitations of renin inhibition with aliskiren. Ann Pharm Fr 2011;69(3):142-50
   PubMedGoogle Scholar
• Musini VM, Fortin PM, Bassett K, Wright JM. Blood pressure lowering efficacy of renin inhibitors for primary hypertension. Cochrane Database Syst Rev 2008(4):CD007066
   PubMed Web of Science ®Google Scholar
• Verdecchia P, Angeli F, Mazzotta G, Aliskiren versus ramipril in hypertension. Ther Adv Cardiovasc Dis 2010;4(3):193-200
   PubMedGoogle Scholar
• Zhu JR, Sun NL, Yang K, Efficacy and safety of aliskiren, a direct renin inhibitor, compared with ramipril in Asian patients with mild to moderate hypertension. Hypertens Res 2012;35(1):28-33
   PubMed Web of Science ®Google Scholar
• Parving HH, Brenner BM, McMurray JJ, Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE): rationale and study design. Nephrol Dial Transplant 2009;24(5):1663-71
   PubMed Web of Science ®Google Scholar
• ALTITUDE halted: Adverse events when aliskiren added to ACE, ARB therapy. Available from: http://www.theheart.org/article/1331173.do [Updated 20 December 2011]
   Google Scholar
• Haynes RB, Wilczynski N, McKibbon KA, Developing optimal search strategies for detecting clinically sound studies in MEDLINE. J Am Med Inform Assoc 1994;1(6):447-58
   PubMed Web of Science ®Google Scholar
• McAuley L, Pham B, Tugwell P, Moher D. Does the inclusion of grey literature influence estimates of intervention effectiveness reported in meta-analyses? Lancet 2000;356(9237):1228-31
   PubMed Web of Science ®Google Scholar
• Gregoire G, Derderian F, Le Lorier J. Selecting the language of the publications included in a meta-analysis: is there a tower of babel bias? J Clin Epidemiol 1995;48:159-63
   PubMed Web of Science ®Google Scholar
• Wood JM, Baum HP, Jobber RA, Neisius D. Sustained reduction in blood pressure during chronic administration of a renin inhibitor to normotensive marmosets. J Cardiovasc Pharmacol 1987;10(Suppl 7):S96-8
   PubMedGoogle Scholar
• James MN, Sielecki AR. Stereochemical analysis of peptide bond hydrolysis catalyzed by the aspartic proteinase penicillopepsin. Biochemistry 1985;24(14):3701-13
   PubMed Web of Science ®Google Scholar
• Azizi M, Webb R, Nussberger J, Hollenberg NK. Renin inhibition with aliskiren: where are we now, and where are we going? J Hypertens 2006;24(2):243-56
   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(16):1098-104
   PubMed Web of Science ®Google 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(1):110-16
   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(6):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(3):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(36):22348-57
   PubMed Web of Science ®Google Scholar
• Roig E, Perez-Villa F, Morales M, Clinical implications of increased plasma angiotensin II despite ACE inhibitor therapy in patients with congestive heart failure. Eur Heart J 2000;21(1):53-7
   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(8):1418-28
   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(4):433-6
   PubMed Web of Science ®Google Scholar
• Dieterle W, Corynen S, Vaidyanathan S, Mann J. Pharmacokinetic interactions of the oral renin inhibitor aliskiren with lovastatin, atenolol, celecoxib and cimetidine. Int J Clin Pharmacol Ther 2005;43(11):527-35
   PubMed Web of Science ®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(3):589-99
   PubMed Web of Science ®Google Scholar
• Berman N, Hostetter T. Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension. Am J Kidney Dis 2008;51(3):370-2
   PubMed Web of Science ®Google Scholar
• Black HR, Weinberger MH, Purkayastha D, Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension. J Clin Hypertens (Greenwich) 2011;13(8):571-81
   PubMed Web of Science ®Google Scholar
• Chrysant SG. The antihypertensive effectiveness and safety of dual RAAS blockade with aliskiren and valsartan. Drugs Today (Barc) 2010;46(3):151-62
   PubMed Web of Science ®Google Scholar
• Chrysant SG, Murray AV, Hoppe UC, Long-term safety, tolerability and efficacy of aliskiren in combination with valsartan in patients with hypertension: a 6-month interim analysis. Curr Med Res Opin 2008;24(4):1039-47
   PubMed Web of Science ®Google Scholar
• Chrysant SG, Murray AV, Hoppe UC, Long-term safety and efficacy of aliskiren and valsartan combination with or without the addition of HCT in patients with hypertension. Curr Med Res Opin 2010;26(12):2841-9
   PubMed Web of Science ®Google Scholar
• Ferdinand KC, Weitzman R, Israel M, Efficacy and safety of aliskiren-based dual and triple combination therapies in US minority patients with stage 2 hypertension. J Am Soc Hypertens 2011;5(2):102-13
   PubMed Web of Science ®Google Scholar
• Gradman AH, Weir MR, Wright M, Efficacy, safety and tolerability of aliskiren, a direct renin inhibitor, in women with hypertension: a pooled analysis of eight studies. J Hum Hypertens 2010;24(11):721-9
   PubMed Web of Science ®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(4):221-8
   PubMed Web of Science ®Google Scholar
• Ito S, Nakura N, Le Breton S, Keefe D. Efficacy and safety of aliskiren in Japanese hypertensive patients with renal dysfunction. Hypertens Res 2010;33(1):62-6
   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 2011;25(3):186-95
   PubMed Web of Science ®Google Scholar
• Kushiro T, Itakura H, Abo Y, Long-term safety, tolerability, and antihypertensive efficacy of aliskiren, an oral direct renin inhibitor, in Japanese patients with hypertension. Hypertens Res 2009;32(3):169-75
   PubMed Web of Science ®Google Scholar
• Littlejohn TW III, Trenkwalder P, Hollanders G, Long-term safety, tolerability and efficacy of combination therapy with aliskiren and amlodipine in patients with hypertension. Curr Med Res Opin 2009;25(4):951-9
   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(9583):221-9
   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;33(11):2304-9
   PubMed Web of Science ®Google Scholar
• Rashid H. Direct renin inhibition: an evaluation of the safety and tolerability of aliskiren. Curr Med Res Opin 2008;24(9):2627-37
   PubMed Web of Science ®Google Scholar
• Schmieder RE, Philipp T, Guerediaga J, Long-term antihypertensive efficacy and safety of the oral direct renin inhibitor aliskiren: a 12-month randomized, double-blind comparator trial with hydrochlorothiazide. Circulation 2009;119(3):417-25
   PubMed Web of Science ®Google Scholar
• Sica D, Gradman AH, Lederballe O, Long-term safety and tolerability of the oral direct renin inhibitor aliskiren with optional add-on hydrochlorothiazide in patients with hypertension: a randomized, open-label, parallel-group, multicentre, dose-escalation study with an extension phase. Clin Drug Investig 2011;31(12):825-37
   PubMed Web of Science ®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(4):190-8
   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(4):453-60
   PubMed Web of Science ®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(2):192-200
   PubMed Web of Science ®Google Scholar
• Villa G, Le Breton S, Ibram G, Keefe DL. Efficacy, safety, and tolerability of aliskiren monotherapy administered with a light meal in elderly hypertensive patients: a randomized, double-blind, placebo-controlled, dose-response evaluation study. J Clin Pharmacol 2011. [Epub ahead of print]
   PubMed Web of Science ®Google Scholar
• Weinberger MH, Izzo JL Jr, Purkayastha D, Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension and obesity or metabolic syndrome. J Am Soc Hypertens 2011;5(6):489-97
   PubMed Web of Science ®Google Scholar
• Weir MR, Bush C, Anderson DR, Antihypertensive efficacy, safety, and tolerability of the oral direct renin inhibitor aliskiren in patients with hypertension: a pooled analysis. J Am Soc Hypertens 2007;1(4):264-77
   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(10):780-7
   PubMed Web of Science ®Google Scholar
• FDA. Food and Drug Administration. Drug product label. Tekturna, NDA no. 021985. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021985s019lbl.pdf 2010
   Google Scholar
• Musini VM, Fortin PM, Bassett K, Wright JM. Blood pressure lowering efficacy of renin inhibitors for primary hypertension: a Cochrane systematic review. J Hum Hypertens 2009;23(8):495-502
   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(12):997-1005
   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(5):1047-55
   PubMed Web of Science ®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(11):1157-63
   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(1):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(1):217-26
   PubMed Web of Science ®Google Scholar
• Dahlof B, Anderson D, 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
• 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(8):1012-18
   PubMed Web of Science ®Google Scholar
• Stanton A, Jensen C, Nussberger J, O'Brien E. Blood pressure lowering in essential hypertension with an oral renin inhibitor, aliskiren. Hypertension 2003;42(6):1137-43
   PubMed Web of Science ®Google Scholar
• Anderson VR, Perry CM, Robinson DM. Ramipril: a review of its use in preventing cardiovascular outcomes in high-risk patients. Am J Cardiovasc Drugs 2006;6(6):417-32
   PubMedGoogle Scholar
• Yusuf S, Sleight P, Pogue J, Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. N Engl J Med 2000;342(3):145-53
   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(6):1076-83
   PubMed Web of Science ®Google Scholar
• Brown MJ, McInnes GT, Papst CC, Aliskiren and the calcium channel blocker amlodipine combination as an initial treatment strategy for hypertension control (ACCELERATE): a randomised, parallel-group trial. Lancet 2011;377(9762):312-20
   PubMed Web of Science ®Google Scholar
• White WB, Bresalier R, Kaplan AP, Safety and tolerability of the direct renin inhibitor aliskiren in combination with angiotensin receptor blockers and thiazide diuretics: a pooled analysis of clinical experience of 12,942 patients. J Clin Hypertens (Greenwich) 2011;13(7):506-16
   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(23):2433-46
   PubMed Web of Science ®Google Scholar
• Mervaala E, Muller DN, Schmidt F, Blood pressure-independent effects in rats with human renin and angiotensinogen genes. Hypertension 2000;35(2):587-94
   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(5):1306-11
   PubMed Web of Science ®Google Scholar
• Kelly DJ, Zhang Y, Moe G, Aliskiren, a novel renin inhibitor, is renoprotective in a model of advanced diabetic nephropathy in rats. Diabetologia 2007;50(11):2398-404
   PubMed Web of Science ®Google Scholar
• Solomon SD, Appelbaum E, Manning WJ, Effect of the direct renin inhibitor aliskiren, the Angiotensin receptor blocker losartan, or both on left ventricular mass in patients with hypertension and left ventricular hypertrophy. Circulation 2009;119(4):530-7
   PubMed Web of Science ®Google Scholar
• Fischer MA, Avorn J. Economic implications of evidence-based prescribing for hypertension: can better care cost less? JAMA 2004;291(15):1850-6
   PubMed Web of Science ®Google Scholar
• Novartis Pharmaceuticals UK Ltd. Form B: detailed appraisal information. Rasilez.. 2008. Available from: http://www.wales.nhs.uk/sites3/Documents/371/Aliskiren%20Rasilez%20FAR.pdf [Updated June 2008]
   Google Scholar
• Delea TE, Sofrygin O, Palmer JL, Cost-effectiveness of aliskiren in type 2 diabetes, hypertension, and albuminuria. J Am Soc Nephrol 2009;20(10):2205-13
   PubMed Web of Science ®Google Scholar
• Angeli F, Reboldi G, Verdecchia P. Finding a place for aliskiren in the wide spectrum of blood pressure lowering agents. Hypertens Res 2012;35(1):17-19
   PubMed Web of Science ®Google Scholar