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New Type of Hypertension Drug Shows Promise
Aug. 22, 2005 - Data emerging from early studies of
aliskiren, a new type of treatment for hypertension, 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.
Hypertension affects approximately 50 million
people in the USA and about 1 billion people worldwide, and the World
Health Organization (WHO) estimates that there are 7.1 million deaths
each year (13% of all mortality) due to complications of hypertension.
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, wrote Doris Peter, PhD, the journals Editor for North
America, who authored the review. The current challenges in the drug
treatment of hypertension include adherence to therapy and the need for
most patients to take more than one drug to control their hypertension,
Dr Peter said.
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.
A recent study shows that while the rate of high blood
pressure increased with age, numbers of people receiving treatment for
the condition did not. Seventy-four percent of people age 80 and older
had high blood pressure, compared with 63 percent of senior citizens age 60 to 79
and 27 percent of those under the age of 60. However, less than two
thirds of hypertensive patients in the two older age groups received
treatment.
Aliskiren, under development by Novartis, is the
first in a new class of antihypertensive drugs called renin inhibitors.
Renin is an enzyme which 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. For patients whose blood pressure can be
controlled with single-agent therapy, aliskiren may offer another
well-tolerated, effective alternative, the review concluded.
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%. The
article observed that, A good tolerability profile together with
once-daily administration may be expected to positively influence
adherence and quality of life, both of which can be significant barriers
to effective disease management in patients with hypertension.
However, the review also noted that, most patients
with hypertension eventually need a second antihypertensive drug and
although there is some evidence that aliskiren combined with an ARB is
effective in reducing blood pressure, the use of aliskiren in
combination therapy cannot be recommended without further study.
Published by Core Medical Publishing Ltd (http://www.coremedicalpublishing.com),
a new company with offices in Manchester, UK and New York, Core Evidence
is the first international peer-reviewed journal to rigorously evaluate
the evidence for rational drug selection based on outcomes central to
informed medical decision-making, with the goal of improved quality of
care. Core Evidence is available in print and/or online formats. For
subscription information, call toll-free 866-246-3817 or email
custserv@coreevidence.com.
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