Aliskiren (Rasilez®) has been approved for use in the European Union according to a media release from the manufacturer. The Summary of Product Characteristics is now available via the Electronic Medicines Compendium.
This new antihypertensive is the first in a new class of drugs that work through direct renin inhibition. The drug has been approved based on data from 44 clinical studies involving over 7,800 patients.
Studies have shown greater blood pressure lowering when compared to ramipril or hydrochlorothiazide. Additional blood pressure lowering has been demonstrated in patients who were already taking angiotensin converting enzyme inhibitors (ACE-I), angiotensin receptor blockers (ARB), calcium channel blockers (CCB) and thiazide diuretics.
The drug has been shown to have a long duration of action and is the subject of ongoing studies in patients with high blood pressure and heart failure or kidney failure.
As with all new products, the evidence supporting use is limited in terms of restricted patient exposure and study endpoints focussing upon disease orientated outcomes (blood pressure in this case). These two factors combined mean that the risk-benefit profile of the drug is not yet fully understood. Increased usage will reveal more side effects and ongoing studies may provide more valuable patient orientated data (for example reduced risk of death or cardiovascular disease).
Action: Clinicians should be aware of the launch of this new antihypertensive agent. It is likely to be heavily marketed in the coming months. Initial use should be restricted to those patients already on maximal therapy, intolerant or contraindicated to established antihypertensive treatments.