Aliskiren and valsartan combination reduces BP
David Kneafsey/istockphoto.com
Sitting diastolic blood pressure lowered |
Aliskiren — developed by Novartis — has been shown to reduce blood pressure when used in combination with valsartan better than either agent used alone, according to a Lancet study (2007;370:221).
Researchers randomised 1,797 patients with hypertension to receive, once
a day, aliskiren 150mg, valsartan 160mg, a combination of the two drugs,
or placebo for four weeks, followed by a forced doubling to maximum doses
for a further four weeks.
At the end of eight weeks, the combination therapy lowered patients’ mean
sitting diastolic blood pressure more than the individual therapies (reduction
from baseline, aliskiren/valsartan 12.2mmHg, aliskiren 9.0mmHg, valsartan
9.7mmHg; P<0.0001 for both) and more than placebo (4.1mmHg; P<0.0001).
Aliskiren, a first-in-class orally active renin inhibitor, exerts its
effect at the renin system’s point of activation, directly inhibiting
plasma renin activity. In an accompanying editorial (ibid p195), Willem
Birkenäger, of Erasmus University, Rotterdam, the Netherlands, and
Jan Staessen, of the University of Leuven, Belgium, point out that dual
inhibition of the renin system, using renin inhibitors combined with
angiotensin-converting enzyme inhibitors or angiotensin receptor blockers
(such as valsartan), inhibits plasma renin activity, even in the presence
of the reactive rise in renin that occurs with chronic inhibition.
However, they say: “No new class of antihypertensive agents should
make it to routine use without hard outcome data. That necessity applies
even more to dual inhibition of the renin system, which exposes patients
to hyperkalaemia and renal insufficiency.”
The EU’s Committee for Medicinal Products for Human Use has given
a “positive opinion” to grant a marketing authorisation for
alskiren (Rasilez) for treatment of essential hypertension. This is subject
to European Commission approval.
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