The first in a new class of antihypertensives in over a decade can lower blood pressure by up to 50% when combined with other treatments, and may have key advantages for heart failure patients, according to new research.
Data presented at the European Society of Cardiology congress in Vienna suggests that Novartis's Rasilez (aliskiren) produces an additional reduction in blood pressure of 30% - 50% when added to commonly prescribed hypertension medications. The new combined data from three major trials also suggests Rasilez is as effective as standard drugs when used alone.
The drug was approved by EU regulators last week, five months after authorities in the USA gave the go-ahead for the drug there, where it is sold as Tekturna.
Rasilez is the first in a new class of medicines that treat high blood pressure by inhibiting renin (an enzyme secreted by the kidney) at the 'source' of the renin system. Excess levels of renin can lead to hypertension.
Leading hypertension expert, Peter Sever of Imperial College, London, said that blocking the renin-angiotensin system by direct inhibition of renin has been a long standing goal for scientists involved in developing antihypertensive therapy. "I believe Rasilez is a drug that could help many people whose blood pressure is not currently at target levels," he added.
The data presented at ESC showed that Rasilez lowered blood pressure consistently over 24 hours. When it was added to the ACE inhibitor ramipril, an additional 4mmHg to 5mmHg reduction in systolic blood pressure was seen, and when added to a calcium channel blocker, Razilez doubled the reduction in systolic blood pressure to -6mmHg.
In addition, results of another study revealed at the Vienna meeting suggest that Rasilez might have specific benefits for heart failure patients. The ALOFT (ALiskiren Observation of Heart Failure Treatment) study results are the first to highlight the potential benefits of the drug beyond blood pressure lowering.
Unlike some other blood pressure medicines, such as calcium channel blockers and some beta blockers that can exacerbate heart failure, Rasilez showed a safety profile similar to placebo when used in this hard-to-treat patient population. The 12-week trial found that the addition of Rasilez to standard heart failure treatments resulted in reductions in BNP (brain natriuretic peptide) nearly five times greater than the standard therapy alone.
The level of BNP in the bloodstream increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. Study leader John McMurray, of the British Heart Foundation Cardiovascular Research Centre, University of Glasgow, noted, however, that "further research is needed to tell us whether this reduction in BNP might be associated with improvements in clinical outcomes."