Tekturna (Aliskiren) tabiliti dep atalghan yuquri qan bisimining
yingi dorisi FDA teripidin testiqlanghan bolup, qan bisimini
towenlitish roli burunqi herqandaq dorilar bilen silishturghanda hem
tiz hem unumluk iken. Bu dorini ishletkende bashqa qan bisimini
towenlitidighan dorilarni qoshumche qilip ishletmisimu bolidiken.

FDA Approves New Drug Treatment for High Blood Pressure

FDA News http://www.fda.gov/bbs/topics/NEWS/2007/NEW01580.html

The U.S. Food and Drug Administration (FDA) today announced the
approval of Tekturna (aliskiren) tablets for the treatment of high
blood pressure, or hypertension, which affects an estimated 25
percent of Americans and causes increased risk of stroke, heart
attack, kidney failure, heart failure and death.

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.