Rasilez (aliskiren) has been approved for the treatment of essential hypertension. The drug represents a new mechanism of action, namely inhibition of rennin, which is the first and rate limited step for the renin-angiotensin system. On beforehand we know ACE-inhibitors and ATII-antagonists, which inhibit other steps in the same system.
Aliskiren has in doses of 150-300 mg a significant reducing effect on blood pressure compared to placebo and an equal effect with thiazid, AT-II-agonists and ramipril. It has an additive effect combined with thiazide, AT-II-antagonists, ramipril and amlopidin.
The studies duration is mostly 4 to 12 weeks and the primary endpoints have in general been reduction of middlediastolic blood pressure. Aliskiren has not been studied in patients with severely increased blood pressure, in patients with cardiovascular diseases and only to a lesser extent in patients with well regulated diabetes mellitus.
The effect of clinical significant endpoints (reduction in cardiovascular morbidity and mortality and rhenoprotective effect) has not been studied.
There are few side effects – at placebo level – consisting of headache, gastrointestinal genes and nasopharyngitis.
The price level is the same as the AT-II-antagonists and is significantly more expensive than other antihypertensives.
Aliskiren is appropriate in treatment of hypertension and must until further notice be reserved to patients with mild to medium uncomplicated hypertension, where the purpose of treatment can not be achieved with other antihypertensives.
Rasilez was marketed the 31 of December 2007.