Blood pressure lowering efficacy of renin inhibitors for primary hypertension

Cochrane Database of Systematic Reviews

Volumn 2017, Issue 4, 2017, Pages

  Musini, Vijaya M ^a   Lawrence, Kendra Ak ^a   Fortin, Patricia M ^b   Bassett, Ken ^a   Wright, James M ^a  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b JOHN RADCLIFFE HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALISKIREN; PLACEBO; RENIN INHIBITOR; AMIDE; ANTIHYPERTENSIVE AGENT; FUMARIC ACID DERIVATIVE; RENIN;

ANGIONEUROTIC EDEMA; ANKLE EDEMA; BLOOD PRESSURE MEASUREMENT; BLOOD PRESSURE REGULATION; BLOOD PRESSURE VARIABILITY; COLON CANCER; COUGHING; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DRUG EFFICACY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; HEADACHE; HEART MUSCLE ISCHEMIA; HEART RATE; HEMATURIA; HUMAN; HYPERTENSION; KIDNEY CARCINOMA; KIDNEY COLIC; MONOTHERAPY; MORTALITY; PERIORBITAL EDEMA; PERIPHERAL EDEMA; PRIMARY HYPERTENSION; PRIORITY JOURNAL; PULSE PRESSURE; RECTUM CANCER; RECTUM HEMORRHAGE; REVIEW; RHINOPHARYNGITIS; SEIZURE; SENSITIVITY ANALYSIS; SYSTEMATIC REVIEW; SYSTOLIC BLOOD PRESSURE; THORAX PAIN; TONIC CLONIC SEIZURE; TREATMENT DURATION; TREATMENT OUTCOME; URINE RETENTION; ANTAGONISTS AND INHIBITORS; BLOOD PRESSURE; CHEMICALLY INDUCED; DRUG EFFECTS; META ANALYSIS; MIDDLE AGED; RANDOMIZED CONTROLLED TRIAL (TOPIC);

AMIDES; ANTIHYPERTENSIVE AGENTS; BLOOD PRESSURE; DIARRHEA; FUMARATES; HUMANS; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RENIN;

EID: 85017103460     PISSN: 14651858     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD007066.pub3     Document Type: Review

References (115)

1. Novartis . Efficacy and safety of SPA100 (fixed-dose combination of aliskiren/amlodipine) in patients with essential hypertension. ClinicalTrials.gov identifier NCT01237223 May 11 2012:1-27. 3204134
2. Littlejohn TW 3rd, Jones SW, Zhang J, Hsu H, Keefe DL. Efficacy and safety of aliskiren and amlodipine combination therapy in patients with hypertension: a randomized, double-blind, multifactorial study. Journal of Human Hypertension 2013;27(5):321-7. 3204117
3. Novartis . An 8-week double-blind, multicenter, randomized, multifactorial, placebo-controlled, parallel group study to evaluate the efficacy and safety of aliskiren administered alone and in combination with amlodipine in patients with essential hypertension. Novartis Clinical Trial Results Database. 26th May 2010:1-16. [Little John]3204118
4. Kushiro T, Hiroshige I, Yoshihisa A, Hiromi G, Shinji T, Keefe D. Aliskiren, a novel oral renin inhibitor, provides dose-dependent efficacy and placebo-like tolerability in Japanese patients with hypertension. Hypertension Research - Clinical & Experimental 2006;29(12):997-1005. 3204120
5. Novartis . Dose-finding study of SPP100 in essential hypertension. Clinical Study Report. European Medicines Agency October 13th 2005:10531-665. 5372543
6. Novartis . A randomized, double-blind, placebo and active-controlled, multicenter, parallel-group study comparing SPP100 (Aliskiren) 150 mg to placebo and to Losartan 50 mg to evaluate efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension. Clinical Study Report. European Medicines Agency January 10, 2008:1-137. 4142377
7. Gradman A, Schmieder R, Lins R, Nussberger J, Chiang Y, Bedigian M. Aliskiren, a novel orally effective renin inhibitor, provides dose-dependent antihypertensive efficacy and placebo-like tolerability in hypertensive patients. Circulation 2005;111:1012-8. 3204122
8. Novartis . A multicentre, randomized, double blind, placebo-controlled, parallel-group study comparing aliskiren 150 mg, 300 mg, and 600 mg and Irbesartan 150 mg in patients with mild-to-moderate essential hypertension. Clinical Study Report. European Medicines Agency April 1st 2004:1-61. 5372544
9. Nussberger J, Gradman AH, Schmieder RE, Lins RL, Chiang Y, Prescott MF. Plasma renin and the antihypertensive effect of the orally active renin inhibitor aliskiren in clinical hypertension. International Journal of Clinical Practice 2007;61(9):1461-1468. 3204123
10. Novartis . A randomized, double blind, multicentre, multifactorial, placebo-controlled, parallel-group study to confirm the efficacy and safety of aliskiren monotherapy, and evaluate efficacy and safety of combinations of aliskiren and valsartan in hypertensive patients. Clinical Study Report. European Medicines Agency June 8th 2005:1547-1634. 5372545
11. Pool J, Roland E, Schmieder M, Aldigier JC, Januszewicz A, Zidek W, Chiang Y, Satlin A. Aliskiren, an orally effective renin inhibitor, provides antihypertensive efficacy alone and in combination with valsartan. American Journal of Hypertension 2007;20(1):11-20. 3204125
12. Novartis . An 8 week, double-blind, multicenter, randomized, multifactorial, placebo-controlled, parallel group, study to evaluate the efficacy and safety of aliskiren administered alone and in combination with hydrochlorothiazide in patients with essential hypertension. Clinical Study Report. European Medicines Agency October 25th 2005:3354-3454. 5372546
13. Villamil A, Chrysant S, Calhoun D, Schober B, Hsu H, Matrisciano-Dimichino L, Zhang J. Renin inhibition with aliskiren provides additive antihypertensive efficacy when used in combination with hydrochlorothiazide. Journal of hypertension 2007;25(1):217-226. 3204127
14. Novartis . An 8 week, randomized, double-blind, placebo-controlled, parallel group, multicenter, study comparing aliskiren 150 mg, 300 mg, and 600 mg to placebo in patients with essential hypertension. Clinical Study Report. European Medicines Agency November 1st 2005:8458-543. 5372547
15. Oh B, Mitchell J, Herron J, Chung J, Khan Ml, Keefe D. Aliskiren, an oral renin inhibitor, provides dose-dependent efficacy and sustained 24-hour blood pressure control in patients with hypertension. Journal of the Amarican College of Cardiology 2007;49(11):1157-63. 3204129
16. Novartis . A twenty six-week, randomized, double-blind, parallel group, multicenter, active-controlled, dose titration study to evaluate the efficacy and safety of aliskiren compared to HCTZ with the optional addition of amlodipine, followed by a second twenty six weeks of blinded treatment, in patients with essential hypertension. Clinical Study Report. European Medicines Agency May 16th 2006:28012-9161. 5372548
17. Schmieder RE, Philipp T, Guerediaga J, Gorostidi M, Smith B, Weissbach N, et. al. Long-term antihypertensive efficacy and safety of the Oral direct renin Inhibitor aliskiren. Circulation 2009;119:417-25. 3204140
18. Novartis . An eight-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study comparing aliskiren 150 mg, 300 mg, and 600 mg to placebo in patients with essential hypertension. Clinical Study Report. European Medicines Agency September 2006:17604-20246. 5372549
19. Oparil S, Yarrows S, Patel SF, Ang H, Zhang J, Satlin A. 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. 3204136
20. Novartis . A randomized, double-blind, placebo-controlled, parallel-group, multicenter study comparing an eight-week treatment of aliskiren 75 mg, 150 mg and 300 mg to placebo in patients with essential hypertension. Novartis Clinical Trials Results Database November 4th 2009:1-14. 5372550
21. Puig JG, Schunkert H, Taylor AA, Boye S, Jin J, Keefe DL. Evaluation of the dose-response relationship of aliskiren, a direct renin inhibitor in an 8-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled study in adult patients with stage 1 or 2 essential hypertension. Clinical Therapeutics 2009;31(12):2839-50. 3204138
22. Novartis . An eight-week double-blind, multi-center, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren 75 mg, 150 mg and 300 mg in elderly patients with essential hypertension when given with a light meal. Clinical Study Report. European Medicines Agency. Date not reported:1-100. 3204131
23. Villa G, Le Breton S, Ibram G, Keefe D. 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. Journal of Clinical Pharmacology 2012;52:1901-11. 3204132
24. Andersen K, Weinberger MH, Egan B, Constance CM, Ali MA, Jin J, et al. Comparative efficacy and safety of aliskiren, an oral direct renin inhibitor, and ramipril in hypertension: A 6-month, randomized, double-blind trial. Journal of Hypertension 2008;3:589-92. 3204142
25. Dorresteijn JA, Schrover IM, Visseren FL, Scheffer PG, Oey PL, Danser AH, et al. Differential effects of renin-angiotensin-aldosterone system inhibition, sympathoinhibition and diuretic therapy on endothelial function and blood pressure in obesity-related hypertension: a double-blind, placebo-controlled cross-over trial. Journal of Hypertension 2013;31(2):393-403. 3204144
26. Frandsen E, Persson F, Boomsma F, Prescott M, Dole WP, Rossing P, et al. The effect of direct renin inhibition alone or in combination with angiotensin II receptor blockade on markers of the renin-angiotension aldosterone system. Diabetologica 2008;51(Suppl 1):S 491. 3204146
27. Gheorghiade M, Bohm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, et al. ASTRONAUT Investigators and Coordinators. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA 2013 March 20;309(11):1125-35. 3204148
28. Jordan J, Engeli S, Boye SW, Le Breton S, Keefe DL. Direct Renin inhibition with aliskiren in obese patients with arterial hypertension. Hypertension 2007;49(5):1047-55. 3204150
29. Jumar A, Ott C, Kistner I, Friedrich S, Schmidt S, Harazny, JM, et al. Effect of aliskiren on vascular remodelling in small retinal circulation. Journal of Hypertension 2015;33(12):2491-9. 3204152
30. Maser RE, Lenhard MJ, Kolm P, Edwards DG. Direct renin inhibition improves parasympathetic function in diabetes. Diabetes, Obesity and Metabolism 2013;15:28-34. 3204154
31. Mihai G, Varghese J, Kampfrath T, Gushchina L, Hafer L, Deiuliis, et al. Aliskiren effect on plaque progression in established atherosclerosis using high resolution 3D MRI (ALPINE): a double-blind placebo-controlled trial. Journal of the American Heart Association 2013 June;2(3):e004879. 3204157
32. Novartis . Aliskiren in combination with losartan compared to losartan on the regression of left ventricular hypertrophy in overweight patients with essential hypertension (ALLAY). ClinicalTrials.gov identifier NCT00219141 May 2011:1-31. 3204162
33. Novartis . Comparison of aliskiren and amlodipine on insulin resistance and endothelial dysfunction in patients with hypertension and metabolic syndrome. ClinicalTrials.gov Identifier NCT00417170 September 2011:1-14. 3204166
34. Novartis NCT00654875. Efficacy and safety of once daily dosing of aliskiren (300 mg (qd) once a day) to twice daily dosing of aliskiren (150 mg (bid) twice a day) in treating moderate hypertension. ClinicalTrials.gov Identifier NCT00654875 June 2011:1-18. 3204168
35. Novartis . Study to evaluate the efficacy and safety of combination aliskiren/amlodipine in patients not adequately responding to aliskiren alone. ClinicalTrials.gov Identifier NCT00777946 June 2011:1-18. 3204170
36. Novartis . Efficacy and safety of aliskiren in patients with mild to moderate hypertension during exercise. ClinicalTrials.gov identifier NCT00819767 January 2009:1-13. 3204172
37. Novartis . Efficacy and safety of aliskiren 300 mg compared to telmisartan 80 mg after 1 week of treatment withdrawal (ASSERTIVE). ClinicalTrials.gov Identifier NCT00865020 June 2011:1-17. 3204174
38. Novartis . Aliskiren and valsartan vs valsartan alone in patients with stage ii systolic hypertension and type ii diabetes mellitus. ClinicalTrials.gov Identifier NCT00927394 December 2012:1-29. 3204176
39. Novartis . Efficacy of aliskiren compared to ramipril in the treatment of moderate systolic hypertensive patients (ALIAS). ClinicalTrials.gov Identifier NCT01042392 March 2012:1-26. 3204178
40. Novartis . Treatment of Adiposity Related hypErTension (TARGET). ClinicalTrials.gov Identifier NCT01138423 February 2012. 3204180
41. Novartis . Randomized, double blind, active-controlled, parallel study to analyse effects of the combination of aliskiren and valsartan on the vascular structure and function of retinal vessels. ClinicalTrials.gov Identifier NCT01318395 June 2014. 3204182
42. Nicholls SJ, Bakris GL, Kastelein JJ, Menon V, Williams B, Armbrecht J, et al. Effect of aliskiren on progression of coronary disease in patients with prehypertension: the AQUARIUS randomized clinical trial. JAMA 2013 September 18.;310(11):1135-44. 3204184
43. Nussberger J, Gradman AH, Schmieder RE, LinsRL, Chiang Y, Prescott MF. Plasma renin and the antihypertensive effect of the orally active renin inhibitor aliskiren in clinical hypertension. International Journal ofClinical Practice 2007;61(9):1461-8. 3204186
44. O'Brien E, Barton J, Nussberger J, Mulcahy D, Jensen C, Dicker P, et al. Aliskiren reduces blood pressure and suppresses plasma renin activity in combination with a thiazide diuretic, an angiotensin-converting enzyme inhibitor, or an angiotensin receptor blocker. Hypertension 2007;49(2):276-84. 3204188
45. Novartis . Study to assess the optimal renoprotective dose of aliskiren in hypertensive patients with type 2 diabetes and incipient or overt nephropathy. ClinicalTrials.gov identifier NCT00464776 April 2007. 3204190
46. Persson F, Rossing P, Reinhard H, Juhl T, Stehouwer CDA, Schalkwijk C, et al. Renal effects of aliskiren compared with and in combination with irbesartan in patients with type 2 diabetes, hypertension, and albuminuria. Diabetes Care 2009;10(32):1873-9. 3204191
47. Pitt B, McMurray JJ, Latini R, Maggioni A, Solomon SD, Smith BA, et al. Neurohumoral effects of a new oral direct renin inhibitor in stable heart failure: The Aliskiren Observation of Heart Failure Treatment study (ALOFT. Circulation 2007;116(16 Suppl):S. 3204193
48. Scirica BM, Morrow DA, Bode C, Ruzyllo W, Ruda M, Oude Ophuis AJ, et al. Patients with acute coronary syndromes and elevated levels of natriuretic peptides: the results of the AVANT GARDE-TIMI 43 Trial. European Heart Journal 2010 August;31(16):1993-2005. 3204195
49. Shah AM, Shin SH, Takeuchi M, Skali H, Desai AS, Kober L, et al. Left ventricular systolic and diastolic function, remodelling, and clinical outcomes among patients with diabetes following myocardial infarction and the influence of direct renin inhibition with aliskiren. European Journal of Heart Failure 2012, February;142(2):185-92. 3204197
50. Solomon SD, Shin SH, Shah A, Skali H, Desai A, Kober L, et al. Effect of the direct renin inhibitor aliskiren on left ventricular remodelling following myocardial infarction with systolic dysfunction. European Heart Journal 2011;32(10):1227-34. 3204199
51. 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. 3204201
52. Strasser RH, Puig JG, Farsang C, Croket M, Li J, van Ingen H. A comparison of the tolerability of the direct renin inhibitor aliskiren and lisinopril in patients with severe hypertension. Journal of Human Hypertension 2007;21(10):780-7. 3204203
53. Teo KK, Pfeffer M, Mancia G, O'Donnell M, Dagenais G, Diaz R, et al. Aliskiren Prevention of Later Life Outcomes trial Investigators. Aliskiren alone or with other antihypertensives in the elderly with borderline and stage 1 hypertension: the APOLLO trial. European Heart Journal 2014;35(26):1743-51. 3204205
54. Uresin Y, Taylor AA, Kilo C, Tschope D, Santonastaso M, Ibram G, et al. Efficacy and safety of the direct renin inhibitor aliskiren and ramipril alone or in combination in patients with diabetes and hypertension. Journal of the Renin-Angiotensin-Aldosterone System 2007;8(4)(4):190-8. 3204207
55. Verdecchia P, Calvo C, Mockel V, Keeling L, Satlin A. Safety and efficacy of the oral direct renin inhibitor aliskiren in elderly patients with hypertension. Blood Pressure 2007;16(6):381-91. 3204209
56. Parving HH, Brenner BM, McMurray JH, Zeeuw D, Haffner SM, Solomon, et al. ALTITUDE Investigators. Cardiorenal end points in a trial of aliskiren for type 2 diabetes. New England Journal of Medicine 2012;367:2204-13.
57. Nicholls SJ, Bakris GL, Kastelein JP, et al. Effect of Aliskiren on Progression of Coronary Disease in Patients With PrehypertensionThe AQUARIUS Randomized Clinical Trial. JAMA 2013;310(11):1135-44.
58. Solomon SD, Shin SH, Shah A, Skali H, Desai A, Kober L, Maggioni AP, Rouleau JL, Kelly RY, Hester A, McMurray JJ, Pfeffer MA. Aliskiren Study in Post-MI Patients to Reduce Remodeling (ASPIRE) Investigators. European Heart Journal May 2011;32:1227-34.
59. Gheorghiade M, Böhm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, Solomon SD, Baschiera F, Botha J, Hua TA, Gimpelewicz CR, Jaumont X, Lesogor A, Maggioni AP, ASTRONAUT Investigators and Coordinators. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial. JAMA March 20 2013;309(11):1125-35.
60. Scirica BM, Morrow DA, Bode C, Ruzyllo W, Ruda M, Oude Ophuis AJ, Lopez-Sendon J, Swedberg K, Ogorek M, Rifai N, Lukashevich V, Maboudian M, Cannon CP, McCabe CH, Braunwald E. Patients with acute coronary syndromes and elevated levels of natriuretic peptides: the results of the AVANT GARDE-TIMI 43 Trial. European Heart Journal 2010;31(16):1993-2005.
61. Persson F, Lewis JB, Lewis EJ, Rossing P, Hollenberg NK, Parving HH. Aliskiren in combination with losartan reduces albuminuria independent of baseline blood pressure in patients with type 2 diabetes and nephropathy. Clin J Am Soc Nephrol May 2011;6(5):1025-31. [DOI: 10.2215/CJN.07590810]
62. Chalmers I. Underreporting research is scientific misconduct. JAMA 1990;263(10):1405-8.
63. Chen Y, Meng L, Shao H, Feng Yu. Aliskiren vs. other antihypertensive drugs in the treatment of hypertension: a meta-analysis. Hypertension Research 2013;36:252-61.
64. Doshi P, Jefferson T, Del Mar C. The imperative to share clinical study reports: recommendations from the Tamiflu experience. PLoS Medicine 2012;9(4):1-6.
65. Doshi P, Jefferson T. Open data 5 years on: a case series of 12 freedom of information requests for regulatory data to the European Medicines Agency. Trials 2016;17(78):1-7.
66. Duprez D. Role of the renin-angiotensin-aldosterone system in vascular remodeling and inflammation: a clinical review. Journal of Hypertension 2006;24:983-91.
67. Dwan K, Gamble C, Williamson PR, Kirkham JJ, for the Reporting Bias Group. Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review. PloS One 2013;8(7):1-38.
68. Eyding D, Lelgemann M, Grouven U, Harter M, Kromp M, Kaiser T, et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ 2010;341:816.
69. Center for drug evaluation and research. Tekturna (Aliskiren) Medical Review. FDA database March 5th 2007, issue Application number 21-985:1-283.
70. Frishman WH, Fozailoff A, Lin C, Dike C. Renin inhibition: a new approach to cardiovascular therapy. Journal of Clinical Pharmacology 1994;34:873-80.
71. Gotzsche P, Jorgenson AW. Opening up data at the European Medicines Agency. BMJ 2011;343:1184-6.
72. Gradman A, Schmieder R, Lins R, Nussberger J, Chiang Y, Bedigian M. Aliskiren, a novel orally effective renin inhibitor, provides dose-dependent antihypertensive efficacy and placebo-like tolerability in hypertensive patients. Circulation 2005;111:1012-8. 3204122
73. Gradman AH, Weir MR, Wright M, Bush CA, Keefe DL. Efficacy, safety and tolerability of aliskiren, a direct renin inhibitor, in women with hypertension: a pooled analysis of eight studies. Journal of Human Hypertension 2010;24:721-9.
74. Harel Z, Gilbert C, Wald R, Bell C, Perl J, Juurlink D, et al. The effect of combination treatment with aliskiren and blockers of the renin-angiotensin system on hyperkalaemia and acute kidney injury: systematic review and meta-analysis. BMJ 2012;344(e42):1-13. [DOI: 10.1136/bmj.e42]
75. Hart 2012. Effect of reporting bias on meta-analyses of drug trials reanalysis of meta-analyses. BMJ 2012;344:13.
76. Helmer OM. Studies on renin antibodies. Circulation 1958;17(4 part 2):648-52.
77. Heran BS, Wong MMY, Heran IK, Wright JM. Dose-related blood pressure lowering efficacy of angiotensin converting enzyme (ACE) inhibitors in the treatment of primary hypertension. Cochrane Database of Systematic Reviews 2008, Issue 4. [DOI: 10.1002/14651858.CD003823]
78. Heran BS, Wong MMY, Heran IK, Wright JM. Blood pressure lowering efficacy of angiotensin receptor blockers for primary hypertension. Cochrane Database of Systematic Reviews 2008, Issue 4. [DOI: 10.1002/14651858.CD003822.pub2]
79. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.10 [updated March 2011]. Available from www.cochrane-handbook.org: The Cochrane Collaboration, 2011.
80. Hodkinson A, Kirkham J, Tudur-Smith C, Gamble C. Reporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension. BMJ 2013;3:1-9.
81. Hodkinson A, Gamble C, Smith CT. Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials. Trials 2016;17(1):1-11.
82. Jefferson T, Jones MA, Doshi P, Del Mar CB, Hama R, Thompson MJ, et al. Neuraminidase inhibitors for preventing and treating influenza in adults and children. Cochrane Database of Systematic Reviews 2014, Issue 4. [DOI: 10.1002/14651858.CD008965.pub4]
83. Jefferson T. Facing the unreliability of clinical trials literature. Drug and Therapeutics Bulletin of Navarre, Spain 2015;22(2):1-11.
84. Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R, et al. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ 2010;340:637-40.
85. Krum H, Gilbert RE. Novel therapies blocking the renin-angiotensin-aldosterone system in the management of hypertension and related disorders. Journal of Hypertension 2007;25:25-35.
86. Kushiro T, Hiroshige I, Yoshihisa A, Hiromi G, Shinji T, Keefe D. Aliskiren, a novel oral renin inhibitor, provides dose-dependent efficacy and placebo-like tolerability in Japanese patients with hypertension. Hypertension Research - Clinical & Experimental 2006;29(12):997-1005. 3204120
87. Law MR, Wald NJ, Morris JK, Jordan RE. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ 2003;326(7404):1427. [PUBMED: 12829555]
88. Littlejohn TW 3rd, Jones SW, Zhang J, Hsu H, Keefe DL. Efficacy and safety of aliskiren and amlodipine combination therapy in patients with hypertension: a randomized, double-blind, multifactorial study. Journal of Human Hypertension 2013;27(5):321-7. 3204117
89. Makani H, Bangalore S, Desouza K, Shah A, Messerli F. Efficacy and safety of dual blockade of the renin-angiotensin system: meta-analysis of randomised trials. BMJ 2013;346(f360):1-15. [DOI: 10.1136/bmj.f360]
90. Maund E, Tendal B, Hrobjartsson A, Jorgenson K, Lundh A, Schroll J, et al. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications. BMJ 2014;348:1-9.
91. McGauran N, Wieseler B, Kreis J, Schuler YB, Kolsch H, Kaiser T. Reporting bias in medical research - a narrative review. Trials 2010;11:1-15.
92. Musini VM, Wright JM. Factors affecting blood pressure variability: lessons learned from two systematic reviews of randomized controlled trials. PLoS One 2009;4(5):e5673. [DOI: 10.1371/journal.pone.0005673]
93. Novartis. Novartis Clinical Trials Database https://www.novartisclinicaltrials.com/TrialConnectWeb/home.nov.
94. Oh B, Mitchell J, Herron J, Chung J, Khan Ml, Keefe D. Aliskiren, an oral renin inhibitor, provides dose-dependent efficacy and sustained 24-hour blood pressure control in patients with hypertension. Journal of the Amarican College of Cardiology 2007;49(11):1157-63. 3204129
95. Oparil S, Yarrows S, Patel SF, Ang H, Zhang J, Satlin A. 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. 3204136
96. Pool J, Roland E, Schmieder M, Aldigier JC, Januszewicz A, Zidek W, Chiang Y, Satlin A. Aliskiren, an orally effective renin inhibitor, provides antihypertensive efficacy alone and in combination with valsartan. American Journal of Hypertension 2007;20(1):11-20. 3204125
97. Poulter NR, Prabhakaran D, Caulfield M. Hypertension. Lancet 22nd August 2015;386(9995):801-12.
98. Powers B, Greene L, Balfe LM. Updates on the treatment of essential hypertension: a summary of AHRQ's comparativeeffectiveness review of angiotensin-converting enzyme inhibitors, angiotensin II receptorblockers, and direct renin inhibitors. Journal of Managed Care Pharmacy October 2011;17(8):Supplement S1-S14.
99. Puig JG, Schunkert H, Taylor AA, Boye S, Jin J, Keefe DL. Evaluation of the dose-response relationship of aliskiren, a direct renin inhibitor in an 8-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled study in adult patients with stage 1 or 2 essential hypertension. Clinical Therapeutics 2009;31(12):2839-50. 3204138
100. Rising K, Bacchett P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Medicine 2008;5(11):1561-70.
101. Schmieder RE, Philipp T, Guerediaga J, Gorostidi M, Smith B, Weissbach N, et. al. Long-term antihypertensive efficacy and safety of the Oral direct renin Inhibitor aliskiren. Circulation 2009;119:417-25. 3204140
102. Schünemann HJ, Oxman AD, Vist GE, Higgins JPT, Deeks Jj, Glasziou P, et al. Chapter 12: Interpreting results and drawing conclusions. In: Higgins JPT, Green S editor(s). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0 (updated March 2011). Available from www.cochrane-handbook.org: The Cochrane Collaboration, 2011.
103. Sharma T, Guski LS, Freund N, Gøtzsche P. Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports. BMJ 2016;352(65):1-10.
104. FDA Drug Safety Communication: New Warning and Contraindication for blood pressure medicines containing aliskiren (Tekturna). http://www.fda.gov/Drugs/DrugSafety/ucm300889.htm#data Last updated on19th January 2016.
105. Villa G, Le Breton S, Ibram G, Keefe D. 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. Journal of Clinical Pharmacology 2012;52:1901-11. 3204132
106. Villamil A, Chrysant S, Calhoun D, Schober B, Hsu H, Matrisciano-Dimichino L, Zhang J. Renin inhibition with aliskiren provides additive antihypertensive efficacy when used in combination with hydrochlorothiazide. Journal of hypertension 2007;25(1):217-226. 3204127
107. Weir MR, Bush C, Anderson DR, Zhang J, Keefe D, Satlin A. Antihypertensive efficacy, safety, and tolerability of the oral direct renin inhibitor aliskiren in patients with hypertension: a pooled analysis. Journal of the American Society of Hypertension 2007;1(4):264-77.
108. White WB, Bresalier R, Kaplan AP, Palmer BF, Riddell RH, Lesogor A, et al. Safety and tolerability of the direct renin Inhibitor Aliskiren: A pooled analysis of clinical experience in more than 12, 000 patients with hypertension. Journal of Clinical Hypertension 2010;12(10):765-75.
109. Wieseler B, Chrysant SG, Calhoun D, Schober B, Hsu H, Matrisciano-Dimichino L, et al. Impact of document type on reporting ality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications. BMJ 2012;344:1-11.
110. Wright JM, Musini VM. First-line drugs for hypertension. Cochrane Database of Systematic Reviews 2009, Issue 3. [DOI: 10.1002/14651858.CD001841.pub2]
111. Zhang Jing-Tao, Chen Ke-Ping, Guan Ting, Zhang Shu. Effect of aliskiren on cardiovascular outcomes in patients with pre -hypertension: a meta-analysis of randomized controlled trials. Drug Design, Development and Therapy 2015;9:1963-71.
112. Musini VM, Fortin PM, Bassett K, Wright JM. Blood pressure lowering efficacy of renin inhibitors for primary hypertension:a Cochrane systematic review. Journal of Human Hypertension 2009;23(8):495-502.
113. Musini VM, Fortin PM, Bassett K, Wright JM. Blood pressure lowering efficacy of renin inhibitors for primary hypertension. Cochrane Database of Systematic Reviews 2008, Issue 2. [DOI: 10.1002/14651858.CD007066]
114. Musini VM, Fortin PM, Bassett K, Wright JM. Blood pressure lowering efficacy of renin inhibitors for primary hypertension. Cochrane Database of Systematic Reviews 2008, Issue 4. [DOI: 10.1002/14651858.CD007066.pub2]
115. Musini VM, Fortin PM, Bassett K, Wright JM. Blood pressure lowering efficacy of renin inhibitors for primary hypertension. Cochrane Database of Systematic Reviews 2011, Issue 9. [DOI: 10.1002/14651858.CD007066.pub2]