The US Food and Drug Administration (FDA) has approved Takeda Pharmaceutical's Edarbyclor (azilsartan medoxomil and chlorthalidone) for the treatment of hypertension to lower blood pressure in adults.
Edarbyclor is the only fixed-dose therapy in the US to combine an angiotensin II receptor blocker (ARB) with the diuretic chlorthalidone in a once-daily, single tablet. The recommended starting dose of Edarbyclor is 40/12.5 mg and the maximum dose is 40/25 mg.
The two medications in Edarbyclor work to help lower blood pressure in patients with hypertension. Azilsartan medoxomil, marketed as Edarbi in the US, reduces blood pressure by blocking the action of angiotensin II, a vasopressor hormone that 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. Chlorthalidone reduces the amount of water in the body by increasing the flow of urine, which helps to lower blood pressure. Prior landmark clinical outcomes trials have demonstrated that chlorthalidone is effective in reducing blood pressure in patients with hypertension and that long-term use is associated with reductions in serious hypertension-related complications.
“Hypertension is a complex disease that affects one in three Americans. It is critical to control hypertension because lowering blood pressure has been shown to reduce the risk of serious health consequences, including stroke and heart attack,” said Domenic Sica, MD, professor of internal medicine and nephrology at Virginia Commonwealth University Medical Centre. “The approval of Edarbyclor provides an effective treatment option to lower blood pressure for appropriate patients with hypertension who may require a combination of drugs to help achieve blood pressure goals.”
Takeda Global Research & Development Centre, Inc. US submitted the new drug application for Edarbyclor in February 2011. The overall clinical program consisted of five phase III clinical studies involving more than 5,000 patients with hypertension. The studies, evaluating the safety and efficacy of Edarbyclor, ranged from eight weeks to 52 weeks in duration, with doses of azilsartan medoxomil/chlorthalidone ranging from 20/12.5 to 80/25 mg once daily.
The studies demonstrated Edarbyclor: lowered mean trough (22-24 hours) systolic blood pressure (SBP) by Ambulatory Blood Pressure Monitoring significantly more than either azilsartan medoxomil or chlorthalidone alone; lowered blood pressure in black and non-black patients at similar levels; lowered clinic SBP significantly more than the fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide at its highest approved dose (40/25 mg doses for both medications). The most common adverse reactions seen in clinical studies were dizziness and fatigue.
“In clinical studies, Edarbyclor demonstrated statistically significant blood pressure reductions compared to its respective monotherapies and was shown to be superior to the fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide at maximum respective doses,” said Paulos Berhanu, MD, executive medical director of medical & scientific affairs at Takeda. “It is our belief this innovative treatment helps reinforce Takeda's family of cardiovascular therapies by providing a new option to help appropriate patients, regardless of age, gender or race, work toward reaching their blood pressure goals.”
EDARBI (azilsartan medoxomil) is an angiotensin II receptor blocker (ARB) developed by Takeda for the treatment of hypertension to lower blood pressure in adults. It 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. It is indicated for the treatment of hypertension to lower blood pressure in adults, either alone or in combination with other anti-hypertensive 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. It has recently received Marketing Authorization in Europe and is currently available in the United States 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 and may be used as an initial therapy if a patient is likely to need multiple drugs to achieve blood pressure control. The recommended starting dose of Edarbyclor in adults is 40/12.5 mg taken orally once daily. The maximum recommended dose is 40/25 mg.
Edarbi and Edarbyclor are indicated for the treatment of hypertension to lower blood pressure. Edarbi is an angiotensin II receptor blocker (ARB) and Edarbyclor is an ARB and a thiazide-like diuretic combination. Edarbyclor may be used if not adequately controlled on monotherapy or as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. There are no controlled trials demonstrating risk reduction with Edarbi or Edarbyclor, but trials with chlorthalidone and at least one pharmacologically similar drug to azilsartan medoxomil have demonstrated such benefits.