There was a dose-dependent decrease in blood pressure for aliskiren 75 mg , 150 mg and 300 mg .
Aliskiren had no effect on blood pressure variability .
Due to very limited information available regarding change in heart rate and pulse pressure , it was not possible to meta-analyze these outcomes .Mortality and non-fatal serious adverse events were not increased .
AUTHORS ' CONCLUSIONS Compared to placebo , aliskiren lowered BP and this effect is dose-dependent .
This magnitude of BP lowering effect is similar to that for angiotensin-converting enzyme ( ACE ) inhibitors and angiotensin receptor blockers ( ARBs ) .
There is no difference in mortality , nonfatal serious adverse events or withdrawal due to adverse effects with short term aliskiren monotherapy .
BACKGROUND Hypertension is a chronic condition associated with an increased risk of mortality and morbidity .
Renin is the enzyme responsible for converting angiotensinogen to angiotensin I , which is then converted to angiotensin II .
Renin inhibitors are a new class of drugs that decrease blood pressure ( BP ) by preventing the formation of both angiotensin I and angiotensin II .
OBJECTIVES To quantify the dose-related BP lowering efficacy of renin inhibitors compared to placebo in the treatment of primary hypertension .
To determine the change in BP variability , pulse pressure , and heart rate and to evaluate adverse events ( mortality , non-fatal serious adverse events , total adverse events , withdrawal due to adverse effects and specific adverse events such as dry cough , diarrhoea and angioedema ) .
Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: the ASTRONAUT randomized trial.
IMPORTANCE Hospitalizations for heart failure ( HHF ) represent a major health burden , with high rates of early postdischarge rehospitalization and mortality . OBJECTIVE To investigate whether aliskiren , a direct renin inhibitor , when added to st and ard therapy , would reduce the rate of cardiovascular ( CV ) death or HF rehospitalization among HHF patients . DESIGN , SETTING , AND PARTICIPANTS International , double-blind , placebo-controlled study that r and omized hemodynamically stable HHF patients a median 5 days after admission . Eligible patients were 18 years or older with left ventricular ejection fraction ( LVEF ) 40 % or less , elevated natriuretic peptides ( brain natriuretic peptide [ BNP ] ≥ 400 pg/mL or N -terminal pro-BNP [ NT-proBNP ] ≥ 1600 pg/mL ) , and signs and symptoms of fluid overload . Patients were recruited from 316 sites across North and South America , Europe , and Asia between May 2009 and December 2011 . The follow-up period ended in July 2012 . INTERVENTION All patients received 150 mg ( increased to 300 mg as tolerated ) of aliskiren or placebo daily , in addition to st and ard therapy . The study drug was continued after discharge for a median 11.3 months . MAIN OUTCOME MEASURES Cardiovascular death or HF rehospitalization at 6 months and 12 months . RESULTS In total , 1639 patients were r and omized , with 1615 patients included in the final efficacy analysis cohort ( 808  aliskiren  , 807  placebo ) . Mean age was 65 years ; mean LVEF , 28 % ; 41 % of patients had diabetes mellitus , mean estimated glomerular filtration rate , 67 mL/min/1.73 m2 . At admission and r and omization , median NT-proBNP levels were 4239 pg/mL and 2718 pg/mL , respectively . At r and omization , patients were receiving diuretics ( 95.9 % ) , β-blockers ( 82.5 % ) , angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers ( 84.2 % ) , and mineralocorticoid receptor antagonists ( 57.0 % ) . In total , 24.9 % of patients receiving aliskiren ( 77 CV deaths , 153 HF rehospitalizations ) and 26.5 % of patients receiving placebo ( 85 CV deaths , 166 HF rehospitalizations ) experienced the primary end point at 6 months ( hazard ratio [ HR ] , 0.92 ; 95 % CI , 0.76 - 1.12 ; P = .41 ) . At 12 months , the event rates were 35.0 % for the aliskiren group ( 126 CV deaths , 212 HF rehospitalizations ) and 37.3 % for the placebo group ( 137 CV deaths , 224 HF rehospitalizations ; HR , 0.93 ; 95 % CI , 0.79 - 1.09 ; P = .36 ) . The rates of hyperkalemia , hypotension , and renal impairment/renal failure were higher in the aliskiren group compared with placebo . CONCLUSION AND RELEVANCE Among patients hospitalized for HF with reduced LVEF , initiation of aliskiren in addition to st and ard therapy did not reduce CV death or HF rehospitalization at 6 months or 12 months after discharge . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00894387
There was a dose-dependent decrease in blood pressure for aliskiren 75 mg , 150 mg and 300 mg .
Aliskiren had no effect on blood pressure variability .
Due to very limited information available regarding change in heart rate and pulse pressure , it was not possible to meta-analyze these outcomes .Mortality and non-fatal serious adverse events were not increased .
AUTHORS ' CONCLUSIONS Compared to placebo , aliskiren lowered BP and this effect is dose-dependent .
This magnitude of BP lowering effect is similar to that for angiotensin-converting enzyme ( ACE ) inhibitors and angiotensin receptor blockers ( ARBs ) .
There is no difference in mortality , nonfatal serious adverse events or withdrawal due to adverse effects with short term aliskiren monotherapy .
BACKGROUND Hypertension is a chronic condition associated with an increased risk of mortality and morbidity .
Renin is the enzyme responsible for converting angiotensinogen to angiotensin I , which is then converted to angiotensin II .
Renin inhibitors are a new class of drugs that decrease blood pressure ( BP ) by preventing the formation of both angiotensin I and angiotensin II .
OBJECTIVES To quantify the dose-related BP lowering efficacy of renin inhibitors compared to placebo in the treatment of primary hypertension .
To determine the change in BP variability , pulse pressure , and heart rate and to evaluate adverse events ( mortality , non-fatal serious adverse events , total adverse events , withdrawal due to adverse effects and specific adverse events such as dry cough , diarrhoea and angioedema ) .