|
E-mail this page to a friend!
Senior Citizen Health & Medicine
New Type Medicine Approved by FDA to Treat High
Blood Pressure
Tekturna is first of new class of drugs called
direct renin inhibitors
 March 7, 2007 - The United States yesterday became
the first country to approve Tekturna (aliskiren) tablets, the first new
type of medicine in more than a decade for treating high blood pressure
- a condition estimated to affect nearly one billion people worldwide
and remains uncontrolled in nearly 70% of patients. Hypertension affects
about 25 percent of Americans, mostly senior citizens, and causes
increased risk of stroke, heart attack, kidney failure, heart failure
and death, according to the U.S. Food and Drug Administration.
| |
Related Stories |
|
| |
Older Men Regularly Taking Over-the-Counter Pain
Relievers have Risk of High Blood Pressure
Previous studies of women have found similar
results
Feb. 26, 2007 –
Read more...
Senior Citizens Face Double Whammy When It Comes to
Body Fat
Aging, obesity results in bigger body, less
lean mass among elderly
Feb. 7, 2007 -
Read
more...
Men with High Blood Pressure Drinking Moderate
Amounts of Alcohol May Lower Risk of Heart Attack
Also found rates of stroke and death from heart
disease did not differ from non-drinkers
January 2, 2007 -
Read more...
Moderate Drinking May Help Older Women Live Longer,
Better
Women in 70's see significant
benefits in cardiovascular health
and overall quality of life
December 14, 2006
Hypertension Guidelines Fail to Improve Blood
Pressure Control in Diabetics
December 27, 2006
Senior Citizens See Decrease in Incidence of Stroke
in Last 50 Years
Death within 30 days decreased significantly in men
but not women
December 26, 2006
Death Risk Jumps for Heart Failure Patients with Low
Systolic Blood Pressure
Heart failure most common hospital discharge
diagnosis for seniors
November 7, 2006
Read the latest news on Senior
Health & Medicine |
|
The FDA approved Tekturna as the first in a new
class of drugs called direct renin inhibitors. A once-daily oral
therapy, Tekturna acts by targeting renin -- an enzyme responsible for
triggering a process that can contribute to high blood pressure. This
condition is a leading contributor to cardiovascular disease, considered
the world's leading cause of death.
"Renin angiotensin system activity contributes to
many of the complications associated with high blood pressure," said
Marc A. Pfeffer, M.D., PhD, Professor of Medicine, Harvard Medical
School and Cardiologist, at Brigham & Women's Hospital. "By inhibiting
this important system at its origin, renin production, a direct renin
inhibitor, such as Tekturna, offers an exciting therapeutic option for
treating hypertension."
Tekturna, a new molecular entity (NME), is the
first high blood pressure drug approved by FDA that inhibits renin, a
kidney enzyme associated with the regulation of blood pressure. Tekturna
acts at the beginning of the blood pressure regulation process, while
other available high blood pressure medications act at later stages.
"Hypertension is rightly called "the silent killer"
because it usually has no symptoms until it causes major damage to the
body organs," said Douglas C. Throckmorton, M.D., Deputy Director of
FDA"s Center for Drug Evaluation and Research. "Today"s approval adds a
new safe and effective treatment option for people who need help to
control their blood pressure."
The effectiveness of Tekturna in lowering blood
pressure has been demonstrated in six placebo-controlled eight-week
clinical trials, which studied more than 2,000 patients with mild to
moderate hypertension.
The effect was maintained for up to one year.
Tekturna was effective across all demographic subgroups, but African
American patients tended to have smaller reductions in blood pressure
than Caucasians and Asians, as is generally true for drugs that affect
the renin-angiotensin system, a component of blood pressure regulation.
When Tekturna was used in combination with
hydrochlorothiazide, a diuretic, further reductions in blood pressure
were achieved.
Tekturna was evaluated for safety in more than
6,460 patients, including 1,740 who were treated longer than six months,
and more than 1,250 for over one year. Side effects were usually mild
and brief. The most common side effect experienced by patients taking
Tekturna was diarrhea. Diarrhea was reported by approximately 2 percent
of patients on the higher of the two approved doses, compared with
approximately 1 percent on placebo. Rarely, patients taking Tekturna
developed an allergic reaction with swelling of the face, lips or tongue
and difficulty breathing, as has been seen with other drugs for high
blood pressure that act directly on the renin-angiotensin system.
Tekturna and other drugs that act directly on the
renin-angiotensin system should not be used during pregnancy because
they can cause injury and even death to the developing fetus.
Tekturna is manufactured by Novartis
Pharmaceuticals Corp., East Hanover, N.J.
Novartis said Tekturna is expected to be available
in March in pharmacies as 150 mg and 300 mg tablets.
Additional information about treatments for
hypertension can be found at
www.fda.gov/fdac/features/1999/499_hbp.html.
For information about hypertension, please visit
the National Heart Lung and Blood Institute"s Web site at
www.nhlbi.nih.gov/health/dci/Diseases/Hbp/HBP_WhatIs.html.
For more about Tekturna, visit
http://www.tekturna.com.
For more about Novartis visit
http://www.novartis.com/.
Click to More Senior News on the
Front Page
Copyright: SeniorJournal.com |
