Edarbi - Azilsartan medoxomil

What is Edarbi - Azilsartan medoxomil?

Edarbi is a medicine that contains the active substance azilsartan medoxomil. It is available as tablets (20 mg, 40 mg and 80 mg).

What is Edarbi - Azilsartan medoxomil used for?

Edarbi is used in adults suffering from hypertension (high blood pressure) essential. The term "essential" means that hypertension has no obvious cause.

The medicine can only be obtained with a prescription.

How is Edarbi used - Azilsartan medoxomil?

Edarbi is taken by mouth; the usual recommended dose is 40 mg once a day. If your blood pressure is not adequately controlled, you can increase the dose to 80 mg or add another medicine for hypertension, such as chlorthalidone or hydrochlorothiazide.

How does Edarbi - Azilsartan medoxomil work?

The active substance in Edarbi, azilsartan medoxomil, is an "angiotensin II receptor antagonist", which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels. By blocking the receptors to which angiotensin II normally attaches, azilsartan medoxomil prevents the hormone from producing an effect, allowing the blood vessels to dilate. This allows to lower blood pressure to normal levels and reduce the risks associated with high blood pressure, such as stroke.

How has Edarbi - Azilsartan medoxomil been studied?

The effects of Edarbi were first tested in experimental models before being studied in humans.

With Edarbi, eight main studies were carried out on over 6000 patients with essential hypertension.

Five studies analyzed the effects of Edarbi taken alone, comparing it with a placebo (a dummy treatment) or with other antihypertensive drugs (ramipril, valsartan and olmesartan medoxomil). Patients who participated in these studies had mild to moderate hypertension.

Three studies have examined the effects of Edarbi in combination with other antihypertensive medicinal products (chlorthalidone, amlodipine and hydrochlorothiazide). Patients involved in the association studies had moderate to severe hypertension.

The duration of the studies was between six and 56 weeks. The main measure of effectiveness was the change in systolic blood pressure (blood pressure during heart contraction).

What benefit has Edarbi - Azilsartan medoxomil shown during the studies?

Edarbi taken alone was more effective than placebo. In the two comparative studies of Edarbi taken alone and placebo, patients showed an average reduction in systolic blood pressure of about 13.5 mmHg with Edarbi 40 mg and a drop of about 14.5 mmHg with Edarbi 80 mg after six weeks, compared with a decrease of 0.3-1.4 mmHg in patients treated with placebo.

In comparative studies of Edarbi taken alone and other medicines, the effectiveness of 80 mg of Edarbi in reducing blood pressure was higher than that of the highest approved dose of valsartan (320 mg) and olmesartan medoxomil (40 mg) . Edarbi 40 and 80 mg was also more effective than ramipril (10 mg).

Studies have also shown that Edarbi taken in combination with other medicines may lead to additional reductions in blood pressure compared to these same medicines taken without Edarbi.

What is the risk associated with Edarbi - Azilsartan medoxomil?

The side effects of Edarbi are generally mild or moderate; the most common is dizziness. For the full list of all side effects reported with Edarbi, see the package leaflet.

Edarbi should not be used in people who may be hypersensitive (allergic) to azilsartan medoxomil or any of the other ingredients. It must not be used in women who have been pregnant for more than three months. Not recommended for use during the first three months of pregnancy.

Why has Edarbi - Azilsartan medoxomil been approved?

The CHMP concluded that Edarbi belongs to an established class of medicines in the treatment of hypertension and that its risks are similar to those of other medicines of that class. The Committee decided that Edarbi's benefits are greater than its risks in patients with essential hypertension and recommended that it be given marketing authorization.