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 ) .
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.
BACKGROUND Aliskiren is approved for the treatment of hypertension at once-daily doses of 150 or 300 mg by the US Food and Drug Administration and the European Commission . It is generally well tolerated and provides 24-hour , dose-dependent blood pressure ( BP ) reduction ; however , the effect of the 75-mg dose has been inconsistent in previous trials . OBJECTIVES This study was design ed to assess the efficacy and tolerability of once-daily administration of aliskiren 75 mg and to evaluate the dose-response relationship across all 3 doses of aliskiren ( 75 , 150 , and 300 mg ) . METHODS In this 8-week , multicenter , r and omized , double-blind , parallel-group , placebo-controlled study , patients aged > or = 18 years with stage 1 or 2 essential hypertension entered a 3- to 4-week , single-blind , placebo run-in period . Eligible patients were r and omized ( 1:1:1:1 ) to receive oral , once-daily doses of aliskiren 75 , 150 , or 300 mg or placebo . The primary efficacy variable was the change from baseline in mean sitting diastolic BP ( msDBP ) at the week-8 end point . Tolerability was assessed by monitoring and recording all adverse events ( AEs ) . RESULTS A total of 642 patients ( mean [ SD ] age , 52.0 [ 10.73 ] years ; 60.0 % male ; 80.8 % white ; mean body weight , 89.2 [ 18.4 ] kg [ range , 50 - 160 kg ] ) were included in the study . Overall , 576 patients ( 89.7 % ) completed the double-blind treatment period . The most frequent reasons for discontinuation were unsatisfactory therapeutic effect ( 27/642 r and omized patients [ 4.2 % ] ) and AEs ( 17/642 [ 2.6 % ] ) . At end point , aliskiren 150 and 300 mg significantly reduced msDBP ( both , P < 0.001 ) and mean sitting systolic CONCLUSIONS This study found a positive linear dose-response relationship in BP reduction with aliskiren 75 , 150 , and 300 mg dosed once daily , but only aliskiren 150 and 300 mg provided statistically significant reductions from baseline compared with placebo . All 3 doses of aliskiren were generally well tolerated
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 ) .