2014

Edarbyclor (azilsartan medoxomil and chlorthalidone) Head-to-Head Data Published in Hypertension Blood pressure reductions statistically superior to olmesartan medoxomil-hydrochlorothiazide

DEERFIELD, Ill., June 19, 2012 /PRNewswire/ -- Results of a 12-week, head-to-head, phase 3 study published online in the American Heart Association journal Hypertension found systolic blood pressure (SBP) reductions of a fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg were statistically superior to those of the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg. This fixed-dose combination (azilsartan medoxomil and chlorthalidone) is currently marketed as Edarbyclor in the United States. It is the first and only hypertension medication to combine an angiotensin II receptor blocker (ARB) with chlorthalidone, a diuretic, in a once-daily, single tablet.

"Hypertension and its impact on cardiovascular health have long been studied; the goal of this particular study was to determine whether a fixed-dose combination of a well-established yet underutilized diuretic paired with a new angiotensin II receptor blocker would provide an effective option to help control hypertension," said study co-author Michael Weber, M.D., professor of medicine, State University of New York, Downstate College of Medicine, Brooklyn, N.Y. "The data showed that Edarbyclor exhibited superior blood pressure reductions compared to a commonly used combination treatment."

Results after 12 weeks of treatment showed that the fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg reduced clinic SBP by 42.5 mm Hg from baseline. The reductions were statistically significantly (P<0.001) greater than that of the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg (37.1 mm Hg). Similar results were observed across patient subgroups, including age, gender or race. Edarbyclor was approved by the U.S. Food and Drug Administration in December 2011 for the treatment of hypertension to lower blood pressure in adults.

"Takeda has a long history in exploring new approaches for the management of chronic diseases," said Ali Hariri, M.D., medical director of medical & scientific affairs at Takeda. "Edarbyclor is a good example of rethinking existing therapies in an effort to create a new treatment option for patients."

The published data was a 12-week, randomized, double-blind study that compared blood pressure reductions of azilsartan medoxomil and chlorthalidone to olmesartan medoxomil-hydrochlorothiazide among 1,071 patients with mean baseline clinic SBPs ranging from 160 to 190 mm Hg and diastolic blood pressures equal to or lower than 119 mm Hg. Two azilsartan medoxomil and chlorthalidone fixed-dose combination groups were force titrated from 20/12.5 mg and 40/12.5 mg to 40/25 mg and 80/25 mg, respectively. In the olmesartan medoxomil-hydrochlorothiazide fixed-dose combination group, patients were force titrated from 20/12.5 mg to 40/25 mg, the highest approved dose. The primary endpoint was change from baseline to week 12 in trough (measured about 24 hours after the last treatment dose) clinic SBP with changes in 24-hour ambulatory blood pressure monitoring as secondary endpoints.

After 12 weeks, azilsartan medoxomil and chlorthalidone lowered blood pressure more effectively than olmesartan medoxomil-hydrochlorothiazide at each hour of the 24-hour period between doses. Adverse events leading to permanent drug discontinuation occurred in 7.9 percent of patients taking azilsartan medoxomil and chlorthalidone 40/25 mg and 7.1 percent of patients taking olmesartan medoxomil-hydrochlorothiazide 40/25 mg.

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. 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 in the U.S.

Elevated systolic or diastolic pressure increases cardiovascular risk, and lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks. 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.

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 2009.

About Edarbyclor

Azilsartan medoxomil and chlorthalidone (currently marketed as Edarbyclor) is a fixed-dose combination therapy in a single tablet for the treatment of hypertension. Edarbyclor is indicated for the treatment of hypertension to lower blood pressure and 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 help achieve blood pressure goals. The recommended starting dose in adults is 40/12.5 mg taken orally once daily. The maximum recommended dose is 40/25 mg. Chlorthalidone is a diuretic that reduces the amount of salt and water in the body by increasing the flow of urine, which helps lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks. There are no controlled trials demonstrating risk reduction with Edarbyclor, but trials with chlorthalidone and at least one pharmacologically similar drug to azilsartan medoxomil have demonstrated such benefits.

Important Safety Information
WARNING: FETAL TOXICITY See full Prescribing Information for complete boxed warning.
When pregnancy is detected, discontinue EDARBYCLOR as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

EDARBYCLOR is contraindicated in patients with anuria.

Fetal Toxicity: 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, discontinue 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, EDARBYCLOR can cause excessive hypotension. Correct volume or salt depletion prior to administration of EDARBYCLOR.

Monitor for worsening renal function in patients with renal impairment. 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, EDARBYCLOR may cause renal failure. In patients with renal disease, chlorthalidone may precipitate azotemia. Consider withholding or discontinuing 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 chlorthalidone-associated hypokalemia.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving chlorthalidone or other thiazide diuretics.

Adverse Reactions (AEs): AEs that occurred at an incidence of ≥2% of EDARBYCLOR-treated patients and greater than azilsartan medoxomil or chlorthalidone were dizziness (8.9%) and fatigue (2.0%). Incidence of consecutive elevations of creatinine (≥50% from baseline and >ULN) was 2% and were typically transient, or nonprogressive and reversible, and associated with large blood pressure reductions.

Drug Interactions: Renal clearance of lithium is reduced by diuretics, such as chlorthalidone, increasing the risk of lithium toxicity. Monitor renal function periodically in patients receiving EDARBYCLOR and 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. NSAIDs may interfere with antihypertensive effect.

For further information, please click here for complete Edarbyclor Prescribing Information.

Indication and Usage

EDARBYCLOR is an angiotensin II receptor blocker (ARB) and a thiazide-like diuretic combination product indicated for the treatment of hypertension to lower blood pressure. EDARBYCLOR may be used if a patient is not adequately controlled on monotherapy or as initial therapy if multiple drugs are needed to help achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. There are no controlled trials demonstrating risk reduction with EDARBYCLOR, but trials with chlorthalidone and at least one pharmacologically similar drug to azilsartan medoxomil have demonstrated such benefits. 

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.

EDARBYCLOR may be used with other antihypertensive agents.

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, 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.

Contacts:
Jocelyn Gerst
Corporate Communications
Takeda Pharmaceuticals U.S.A., Inc.
224-554-5542
jocelyn.gerst@takeda.com

Ashleigh Duchene
GolinHarris
312-729-4428
aduchene@golinharris.com

SOURCE Takeda Pharmaceuticals U.S.A., Inc.



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