Aliskiren can possibly be the latest method of treating patients suffering from hypertension.
Data emerging from early studies of aliskiren indicate that the new drug is effective as a single treatment for patients with mild-to-moderate uncomplicated essential high blood pressure. Results of initial randomized controlled clinical trials also suggest that the new medication is well tolerated and that patients exhibit good adherence to the once-a-day oral medication.
The evaluation appears in the premier issue of the journal Core Evidence, the first international peer-reviewed publication to assess medications by critically evaluating evidence on clinical effectiveness and outcomes.
Despite the availability of many effective, well-tolerated drugs, a significant portion of treated hypertensive patients remain uncontrolled and face serious morbidity and mortality as a consequence, said the researchers.
Current drug therapies for hypertension include diuretics, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, aldosterone receptor blockers (ARBs), calcium channel blockers, and alpha-1 blockers, used individually and in various combinations.
Aliskiren, under development by Novartis, is the first in a new class of antihypertensive drugs called renin inhibitors. Renin is an enzyme that controls the formation of a substance called angiotensin II, the key mediator in the regulation of body fluid volume and blood pressure.
Aliskiren, which has not yet been approved by the US Food and Drug Administration, currently is in phase III trials as a stand-alone therapy and in phase II as combination therapy in patients with mild-to-moderate hypertension, and in phase II trials in patients with diabetic nephropathy.
The Core Evidence review of available phase II data concludes that there is now good evidence that as a stand-alone therapy aliskiren reduces blood pressure significantly compared with placebo and is as effective as two commonly prescribed ARBs with a similar tolerability profile. The article also noted that, although further examination is needed, there is preliminary evidence from one study that adherence to aliskiren therapy is high, averaging more than 95%.