Azilsartan is superior to olmesartan (Diovan) and valsartan (Benicar) in controlling blood pressure, claims Takeda

Azilsartan medoxomil, an experimental drug to treat hypertension being developed by Takeda Pharmaceuticals, have been found showing superior efficacy to the commonly used olmesartan (Diovan) and valsartan (Benicar).

The efficacy of azilsartan has been compared in two clinical studies.

One study involving 1,291 patients compared the Takeda azilsartan at 40 milligrams or 80 mg with a 40 mg dose of valsartan (Benicar) or 320 mg of olmesartan (Diovan).

Azilsartan at 80 mg lowered systolic blood pressure by 14.5 mmHg, while the 40 mg dose took the number down by 13.4 mmHg. Diovan patients saw an average reduction of 10.2 mmHg, while Benicar led to a 12 mmHg reduction.

The study data, when analysed, found that the difference in reduction between the high dose azilsartan and both valsartan and olmesartan was considered to be statistically significant.

The second study in 1,272 patients tested azilsartan at three doses — 20 mg, 40 mg and 80 mg — against 40 mg of Benicar.

Azilsartan 80 mg dose lowered systolic blood pressure by 13.2 mmHg, while it went down by 12.1 points at 40 mg and 10.8 at 20 mg compared to a reduction of 11.2 seen with valsartan (Benicar).

The difference between the highest dose of azilsartan and valsartan (Benicar) was considered statistically significant, again.

The blood pressure reduction was also statistically significant between 80 mg of azilsartan and 40 mg of valsartan (Benicar).

Takeda Pharmaceutical Company Limited submitted a New Drug Application (NDA) to the United States Food and Drug Administration for azilsartan medoxomil.

Discovered by Takeda, azilsartan medoxomil is designed to lower blood pressure by blocking the action of a vasopressor hormone, angiotensin II.

“The NDA submission for azilsartan medoxomil is built upon a robust data package and is a significant milestone for Takeda,” said Nancy Joseph-Ridge, M.D., general manager of Takeda’s Pharmaceutical Development Division.

The NDA submission was supported by seven phase 3 clinical trials involving more than 5,900 patients. The safety and efficacy of azilsartan medoxomil was studied for initial therapy as a once-daily oral monotherapy or in combination with other antihypertensive medications, including chlorthalidone and amlodipine, besides olmesartan medoxomil, valsartan and ramipril.

Azilsartan medoxomil, also known as TAK-491, is currently in development for the treatment of hypertension, or high blood pressure, either used alone or in combination with other classes of antihypertensive agents.

Angiotensin II, a vasopressor, is a hormone that naturally exists within the body and plays a key role in cardiovascular function. The hormone induces contraction, or tightening, of blood vessels and thus plays an important role in mediating hypertension.

High blood pressure, or hypertension, impacts approximately 75 million Americans and is the second-leading preventable risk factor for death in the U.S. Hypertension is defined as elevated blood pressure 140 mm Hg or greater systolic or 90 mm Hg or greater diastolic.

Approximately 56 percent of all hypertension patients, or approximately 42 million Americans, still have uncontrolled hypertension despite current treatment options, or due to a lack of being diagnosed or treated.

Hypertension can lead to serious or fatal health problems. Earlier this year, the Institute of Medicine issued a report calling hypertension a “neglected disease” because it is treatable and yet widely prevalent.

High blood pressure often has no warning signs or symptoms, and many people don’t realize they have it.

People of all ages and backgrounds can develop hypertension, and the National Heart Lung and Blood Institute recommends blood pressure be checked every two years and that people with hypertension should check their blood pressure levels several times a year.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan.

Takeda currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and has a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions.

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals.