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 ) .
Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension: a randomised, double-blind trial
BACKGROUND The aim of this study was to assess dual renin system intervention with the maximum recommended doses of aliskiren and valsartan , compared with each drug alone in patients with hypertension . METHODS In this double-blind study , 1797 patients with hypertension ( mean sitting diastolic blood pressure 95 - 109 mm Hg and 8-h daytime ambulatory diastolic blood pressure > or = 90 mm Hg ) were r and omly assigned to receive once-daily aliskiren 150 mg ( n=437 ) , valsartan 160 mg ( 455 ) , a combination of aliskiren 150 mg and valsartan 160 mg ( 446 ) , or placebo ( 459 ) for 4 weeks , followed by forced titration to double the dose to the maximum recommended dose for another 4 weeks . The primary endpoint was change in mean sitting diastolic blood pressure from baseline to week 8 endpoint . Analyses were done by intention to treat . This trial is registered at Clinical Trials.gov with the number NCT00219180 . FINDINGS 196 ( 11 % ) patients discontinued study treatment before the end of the trial ( 63 in the placebo group , 53 in the aliskiren group , 43 in the valsartan group , and 37 in the aliskiren/valsartan group ) , mainly due to lack of therapeutic effect . At week 8 endpoint , the combination of aliskiren 300 mg and valsartan 320 mg lowered mean sitting diastolic blood pressure from baseline by 12.2 mm Hg , significantly more than either monotherapy ( aliskiren 300 mg 9.0 mm Hg decrease , p<0.0001 ; valsartan 320 mg , 9.7 mm Hg decrease , p<0.0001 ) , or with placebo ( 4.1 mm Hg decrease , p<0.0001 ) . Rates of adverse events and laboratory abnormalities were similar in all groups . INTERPRETATION The combination of aliskiren and valsartan at maximum recommended doses provides significantly greater reductions in blood pressure than does monotherapy with either agent in patients with hypertension , with a tolerability profile similar to that with aliskiren and valsartan alone
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 ) .