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 ) .
Aliskiren Effect on Plaque Progression in Established Atherosclerosis Using High Resolution 3D MRI (ALPINE): A Double-Blind Placebo-Controlled Trial
Background The renin – angiotensin system is well recognized as a mediator of pathophysiological events in atherosclerosis . The benefits of renin inhibition in atherosclerosis , especially when used in combination with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers ( ACEIs/ARBs ) are currently not known . We hypothesized that treatment with the renin inhibitor aliskiren in patients with established cardiovascular disease will prevent the progression of atherosclerosis as determined by high-resolution magnetic resonance imaging ( MRI ) measurements of arterial wall volume in the thoracic and abdominal aortas of high-risk patients with preexisting cardiovascular disease . Methods and Results This was a single-center , r and omized , double-blind , placebo-controlled trial in patients with established cardiovascular disease . After a 2-week single-blind placebo phase , patients were r and omized to receive either placebo ( n=37 , mean±SD age 64.5±8.9 years , 3 women )  or 150 mg of aliskiren ( n=34 , mean±SD age 63.9±11.5 years , 9 women ) . Treatment dose was escalated to 300 mg at 2 weeks and maintained during the remainder of the study . Patients underwent dark-blood , 3-dimensional MRI assessment of atherosclerotic plaque in the thoracic and abdominal segments at baseline and on study completion or termination ( up to 36 weeks of drug or matching placebo ) . Aliskiren use result ed in significant progression of aortic wall volume ( normalized total wall volume 5.31±6.57 vs 0.15±4.39 mm3 , P=0.03 , and percentage wall volume 3.37±2.96 % vs 0.97±2.02 % , P=0.04 ) compared with placebo . In a subgroup analysis of subjects receiving ACEI/ARB therapy , atherosclerosis progression was observed only in the aliskiren group , not in the placebo group . Conclusions MRI quantification of atheroma plaque burden demonstrated that aliskiren use in patients with preexisting cardiovascular disease result ed in an unexpected increase in aortic atherosclerosis compared with placebo . Although preliminary , these results may have implication s for the use of renin inhibition as a therapeutic strategy in patients with cardiovascular disease , especially in those receiving ACEI/ARB therapy . Clinical Trial Registration URL : http:// Clinical Trials.gov Unique identifier : NCT01417104
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 ) .