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 with essential hypertension (high blood pressure). 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 blood pressure is not adequately controlled, the dose can be increased up to 80 mg or another medicine for hypertension, such as chlorthalidone or hydrochlorothiazide, can be added.
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 potent vasoconstrictor (a substance that restricts blood vessels. By blocking the receptors that angiotensin II normally attaches to, azilsartan medoxomil prevents the hormone from having an effect, allowing blood vessels to dilate. This allows blood pressure to drop to normal levels and reduces risks associated with high blood pressure, such as stroke.
How has Edarbi been studied - Azilsartan medoxomil?
The effects of Edarbi were first tested in experimental models before being studied in humans.
Eight main studies involving over 6,000 patients with essential hypertension have been carried out with Edarbi.
Five studies looked at the effects of Edarbi taken alone, comparing it with placebo (a dummy treatment) or with other antihypertensive medicines (ramipril, valsartan and olmesartan medoxomil). Patients who participated in these studies had mild to moderate hypertension.
Three studies looked at the effects of Edarbi in combination with other antihypertensive medicines (chlorthalidone, amlodipine and hydrochlorothiazide). Patients involved in the association studies had moderate to severe hypertension.
The duration of the studies ranged from six to 56 weeks. The main measure of effectiveness was the change in systolic blood pressure (blood pressure during the contraction of the heart).
What benefit has Edarbi - Azilsartan medoxomil shown during the studies?
Edarbi taken alone was more effective than placebo. In the two studies comparing Edarbi alone and placebo, patients showed an average reduction in systolic blood pressure of approximately 13.5 mmHg with Edarbi 40 mg and a decrease of approximately 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 studies comparing Edarbi alone with other medicines, the efficacy of Edarbi 80 mg in lowering blood pressure was superior to 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 can 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 usually mild or moderate; the most common is dizziness. For the full list of side effects reported with Edarbi, see the package leaflet.
Edarbi must 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 are more than three months pregnant. Its use is not recommended during the first three months of pregnancy.
Why has Edarbi - Azilsartan medoxomil been approved?
The CHMP concluded that Edarbi belongs to a class of medicines that are established in the treatment of hypertension and that its risks are similar to those of other medicines in this class. The Committee decided that Edarbi's benefits are greater than its risks in patients. with essential hypertension and recommended that the medicine be given a marketing authorization.
More information about Edarbi - Azilsartan medoxomil
On 7 December 2011, the European Commission issued a "Marketing Authorization" for Edarbi, valid throughout the European Union.
For more information about Edarbi therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 10-2011.
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