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Aliskiren-HCT cleared for treatment of hypertension
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The FDA approved a new direct renin inhibitor antihypertensive drug.
The new drug combines two common hypertension medications into a single pill known as aliskiren-hydrochlorothiazide (Tekturna HCT, Novartis). The drug is the first approved hypertension medication to combine the two therapies into a single dose.
Mechanisms and trial data
Individually, aliskiren and the diuretic HCT are known as effective hypertension drugs when used in combination with each other or with other drug therapies. Aliskiren-HCT as a direct renin inhibitor works by inhibiting the plasma renin activity and preventing the conversion of angiotensinogen to angiotensin I. The HCT component decreases plasma volume while increasing sodium and chloride excretion.
Results from clinical safety and efficacy trials involving 2,762 patients suggested that patients given aliskiren-HCT (2.7%) had fewer adverse clinical events than patients given placebo (3.6%). The eight-week clinical efficacy and safety trial for aliskiren-HCT was a randomized, placebo-controlled, double blind, 15-arm factorial, parallel-group trial. Researchers randomly assigned patients into groups receiving combinations of aliskiren and HCT doses and followed them for BP responses. The highest reductions in systolic and diastolic BP occurred with the highest doses of aliskerin (300 mg) and HCT (25 mg), with a 13.7% reduction in the treated group vs. 7.3% in the placebo group.
According to the drug label, the most common adverse reactions to aliskiren-HCT are dizziness and diarrhea. - by Eric Raible
It is going to be interesting to see how this drug performs. Obviously, the studies’ results showed that you potentiated BP reduction, and the notion before was that you gave a diuretic to stimulate the renin angiotensin system and further get an enhancement of the ACE inhibitor or angiotensin receptor blocker. Here, you shut the whole system off by blocking the rate-limiting enzyme, so it is interesting that you are still getting an effect, which is probably related to volume rather than the stimulating of the system. So it works, and it certainly is useful as an alternative, especially in people who have high renin states, to not further exacerbate it. For people with renal artery disease or in situations where you have higher renin, it is a useful adjunct. Is it earth-shattering or dramatically new? No, it is not.
– George L. Bakris, MD
Cardiology Today Editorial Board member