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 progression of coronary disease in patients with prehypertension: the AQUARIUS randomized clinical trial.
IMPORTANCE Blood pressure reduction and renin-angiotensin-aldosterone system inhibition are targets for treatment of atherosclerosis . The effect of renin inhibition on coronary disease progression has not been investigated . OBJECTIVE To determine the effects of renin inhibition with aliskiren on progression of coronary atherosclerosis . DESIGN , SETTING , AND PARTICIPANTS A double-blind , r and omized , multicenter trial ( Aliskiren Quantitative Atherosclerosis Regression Intravascular Ultrasound Study ) comparing aliskiren with placebo in 613 participants with coronary artery disease , systolic blood pressure between 125 and 139 mm Hg ( prehypertension range ) , and 2 additional cardiovascular risk factors conducted at 103 academic and community hospitals in Europe , Australia , and North and South America ( enrollment from March 2009 to February 2011 ; end of follow-up : January 31 , 2013 ) . INTERVENTIONS Participants underwent coronary intravascular ultrasound ( IVUS ) imaging and were r and omized to receive 300 mg of aliskiren ( n = 305 ) or placebo ( n = 308 ) taken orally daily for 104 weeks . Disease progression was measured by repeat IVUS examination after at least 72 weeks of treatment . MAIN OUTCOMES AND MEASURES The primary efficacy parameter was the change in percent atheroma volume ( PAV ) from baseline to study completion . Secondary efficacy parameters included the change in normalized total atheroma volume ( TAV ) and the percentage of participants with atheroma regression . Safety and tolerability were also assessed . RESULTS Evaluable imaging data were available at baseline and follow-up for 458 participants ( 74.7 % ) . The primary IVUS efficacy parameter , PAV , did not differ between participants treated with aliskiren ( -0.33 % ; 95 % CI , -0.68 % to 0.02 % ) and placebo ( 0.11 % ; 95 % CI , -0.24 % to 0.45 % ) ( between-group difference , -0.43 % [ 95 % CI , -0.92 % to 0.05 % ] ; P = .08 ) . The secondary IVUS efficacy parameter , TAV , did not differ between participants treated with aliskiren ( -4.1 mm3 ; 95 % CI , -6.27 to -1.94 mm3 ) and placebo ( -2.1 mm3 ; 95 % CI , -4.21 to 0.07 mm3 ) ( between-group difference , -2.04 mm3 [ 95 % CI , -5.03 to 0.95 mm3 ] ; P = .18 ) . There were no significant differences in the proportion of participants who demonstrated regression of PAV ( 56.9 % vs 48.9 % ; P = .08 ) and TAV ( 64.4 % vs 57.5 % ; P = .13 ) in the aliskiren and placebo groups , respectively . CONCLUSIONS AND RELEVANCE Among participants with prehypertension and coronary artery disease , the use of aliskiren compared with placebo did not result in improvement or slowing of progression of coronary atherosclerosis . These findings do not support the use of aliskiren for regression or prevention of progression of coronary atherosclerosis . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00853827
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 ) .