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EDARBYCLOR (azilsartan medoxomil and chlorthalidone) Now Available in
U.S. Pharmacies for Patients with Hypertension
DEERFIELD, Ill., and OSAKA, Japan, Feb. 6, 2012 /PRNewswire/ -- Takeda
Pharmaceutical Company Limited (Takeda) and its wholly-owned
subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced
EDARBYCLOR (azilsartan medoxomil and chlorthalidone) is now available
by prescription in U.S. pharmacies for the treatment of hypertension
to lower blood pressure in adults. It is the only fixed-dose therapy
in the U.S. to combine an angiotensin II receptor blocker (ARB) with
chlorthalidone in a once-daily, single tablet. In a phase 3 clinical
trial, the systolic blood pressure reductions of the maximum dose of
EDARBYCLOR (40/25 mg), by both clinic and trough 24-hour ambulatory
blood pressure monitoring, were shown to be statistically superior to
those of the fixed-dose combination of olmesartan
medoxomil-hydrochlorothiazide at its maximum dose (40/25 mg).
Additionally, similar blood pressure lowering effects of EDARBYCLOR
were observed in a sub-group analysis of black patients.
EDARBYCLOR is a fixed-dose combination of two medications: azilsartan
medoxomil, an ARB, and chlorthalidone, a long-acting diuretic used in
the treatment of hypertension. Azilsartan medoxomil is approved under
the trade name EDARBI in the U.S., Europe and Mexico. The two
medications work to help lower blood pressure levels in patients with
hypertension. EDARBYCLOR was approved by the U.S. Food and Drug
Administration on December 20, 2011, at a recommended starting dose of
40/12.5 mg and a maximal dose of 40/25 mg.
Lowering blood pressure reduces the risk of fatal and nonfatal
cardiovascular events, primarily strokes and heart attacks. There are
no controlled trials of EDARBYCLOR demonstrating reductions in
cardiovascular risk in patients with hypertension; however, trials
with chlorthalidone and at least one drug similar to azilsartan
medoxomil have demonstrated such benefits.
"February is American Heart Month and it's important to recognize that
nearly 40 percent of hypertension patients are not at their blood
pressure targets, putting them at increased cardiovascular risk," said
Douglas Cole, president, Takeda Pharmaceuticals U.S.A., Inc. "We're
pleased to bring EDARBYCLOR to market and expand the EDARBI family of
products to help appropriate patients with hypertension work towards
reaching their blood pressure goals."
About Hypertension Hypertension, or high blood pressure, is a chronic
medical condition in which blood pressure is elevated to levels of 140
mm Hg or greater systolic and/or 90 mm Hg or greater diastolic.
Elevated systolic or diastolic pressure causes increased
cardiovascular risk, and the absolute risk increase per mm Hg is
greater at higher blood pressures, so that even modest reductions of
severe hypertension can provide substantial benefit. Control of high
blood pressure should be part of comprehensive cardiovascular risk
management including, as appropriate, lipid control, management of
diabetes, prevention of blood clots, smoking cessation, exercise and
limited sodium intake.
Hypertension impacts approximately 76 million Americans, or nearly one
in three adults. It is estimated that nearly one billion people are
affected by hypertension worldwide, and this figure is predicted to
increase to 1.5 billion by 2025. Hypertension typically has no
symptoms. Adults of all ages and backgrounds can develop hypertension;
however, the risk of developing the condition increases with age, with
more than half of people over age 60 affected. Hypertension is also
costly to the nation's health care system. The American Heart
Association recently estimated that direct and indirect expenses
associated with hypertension cost the nation more than $73 billion in
About EDARBI and EDARBYCLOR EDARBI (azilsartan medoxomil) is an
angiotensin II receptor blocker (ARB) developed by Takeda for the
treatment of hypertension to lower blood pressure in adults. EDARBI
lowers blood pressure by blocking the action of angiotensin II, a
vasopressor hormone, which naturally exists within the body. When
EDARBI blocks the angiotensin II receptor, blood vessels can stay
relaxed and open, and blood pressure can be reduced. EDARBI is
indicated for the treatment of hypertension to lower blood pressure in
adults, either alone or in combination with other antihypertensive
agents. The recommended dose of EDARBI in adults is 80 mg taken once
daily. A starting dose of 40 mg may be appropriate for patients on
high doses of diuretics. EDARBI is approved in the United States,
Europe and Mexico.
EDARBYCLOR (azilsartan medoxomil and chlorthalidone) is a fixed-dose
combination therapy for the treatment of hypertension that combines
azilsartan medoxomil and chlorthalidone in a single tablet.
Chlorthalidone reduces the amount of water in the body by increasing
the flow of urine, which helps lower blood pressure. EDARBYCLOR is
indicated for the treatment of hypertension to lower blood pressure;
it may be used in patients not adequately controlled with monotherapy
and as an initial therapy if a patient is likely to need multiple
drugs to achieve blood pressure goals. The recommended starting dose
of EDARBYCLOR in adults is 40/12.5 mg taken orally once daily. The
maximal dose is 40/25 mg.
Important Safety Information Boxed Warning for FETAL TOXICITY
When pregnancy is detected, patients should discontinue EDARBI or
EDARBYCLOR as soon as possible. Drugs that act directly on the
renin-angiotensin system can cause injury and death to the developing
EDARBYCLOR is contraindicated in patients with anuria.
Use of drugs that act on the renin-angiotensin system during the
second and third trimesters of pregnancy reduces fetal renal function
and increases fetal and neonatal morbidity and death. When pregnancy
is detected, patients should discontinue EDARBI or EDARBYCLOR as soon
as possible. Thiazides cross the placental barrier and appear in cord
blood and may be associated with adverse reactions, including fetal or
neonatal jaundice and thrombocytopenia.
In patients with an activated renin-angiotensin-aldosterone system
(RAAS), such as volume- and/or salt-depleted patients, EDARBI and
EDARBYCLOR can cause excessive hypotension. Correct volume or salt
depletion prior to administration of EDARBI or EDARBYCLOR.
Patients with renal impairment should be monitored for worsening renal
function. In patients whose renal function may depend on the activity
of the renin-angiotensin system, treatment with ACE inhibitors and
ARBs has been associated with oliguria or progressive azotemia and
rarely with acute renal failure and death. In patients with renal
artery stenosis, EDARBI and EDARBYCLOR may cause renal failure. In
patients with renal disease, chlorthalidone may precipitate azotemia.
Consider withholding or discontinuing EDARBI or EDARBYCLOR if
progressive renal impairment becomes evident.
Hypokalemia is a dose-dependent adverse reaction that may develop with
chlorthalidone. Coadministration of digitalis may exacerbate the
adverse effects of hypokalemia. EDARBYCLOR attenuates
Hyperuricemia may occur or frank gout may be precipitated in certain
patients receiving chlorthalidone or other thiazide diuretics.
The most common adverse reaction that occurred more frequently with
EDARBI than placebo in adults was diarrhea (2 percent versus 0.5
percent). The adverse reactions that occurred at an incidence of
greater than or equal to 2 percent of EDARBYCLOR-treated patients, and
greater than azilsartan medoxomil or chlorthalidone, were dizziness
(8.9 percent) and fatigue (2.0 percent). The incidence of consecutive
elevations of creatinine with EDARBYCLOR (greater than or equal to 50
percent from baseline and greater than the upper limit of normal) was
2 percent; elevations were typically transient, or nonprogressive and
reversible, and associated with large blood pressure reductions. With
EDARBI 80 mg, small reversible increases were seen.
Renal clearance of lithium is reduced by diuretics, such as
chlorthalidone, increasing the risk of lithium toxicity. Patients
receiving EDARBI or EDARBYCLOR and nonsteroidal anti-inflammatory
drugs (NSAIDs) who are also elderly, volume-depleted (including those
on diuretics), or who have compromised renal function due to potential
reversible deterioration of renal function should have their renal
function monitored periodically. NSAIDs may interfere with
For further information:
Please click here for complete EDARBI Prescribing Information or here
for complete EDARBYCLOR Prescribing Information.
Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research &
Development Center, Inc. Based in Deerfield, Ill., Takeda
Pharmaceuticals U.S.A., Inc. and Takeda Global Research & Development
Center, Inc. are subsidiaries of Takeda Pharmaceutical Company
Limited, the largest pharmaceutical company in Japan. The respective
companies currently market oral diabetes, insomnia, rheumatology, and
gastroenterology and cardiovascular treatments and seek to bring
innovative products to patients through a pipeline that includes
compounds in development for metabolic and cardiovascular disease,
gastroenterology, neurology and other conditions. To learn more about
these Takeda companies, visit www.tpna.com.
About Takeda Pharmaceutical Company Limited Located in Osaka, Japan,
Takeda is a research-based global company with its main focus on
pharmaceuticals. As the largest pharmaceutical company in Japan and
one of the global leaders of the industry, Takeda is committed to
strive towards better health for patients worldwide through leading
innovation in medicine. Additional information about Takeda is
available through its corporate website, www.takeda.com.
Ashleigh Duchene GolinHarris 312-729-4428 email@example.com
Jocelyn Gerst Takeda Pharmaceuticals U.S.A., Inc. 224-554-5542
Corporate Communications Dept. Takeda Pharmaceutical Company Limited
SOURCE Takeda Pharmaceutical Company Limited
/Web Site: http://www.takeda.com
CO: Takeda Pharmaceutical Company Limited; Takeda Pharmaceuticals U.S.A., Inc.
ST: Illinois Japan
IN: HEA PHA MTC
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