Ipreziv - Azilsartan medoxomil

PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED

What is Ipreziv - Azilsartan medoxomil?

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

What is Ipreziv - Azilsartan medoxomil used for?

Ipreziv 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 Ipreziv used?

Ipreziv 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 Ipreziv - Azilsartan medoxomil work?

The active substance in Ipreziv, 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 widen. This allows blood pressure to drop to normal levels and reduces the risks associated with high blood pressure, such as stroke.

How has Ipreziv - Azilsartan medoxomil been studied?

The effects of Ipreziv 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 Ipreziv.
Five studies looked at the effects of Ipreziv 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 Ipreziv 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 Ipreziv - Azilsartan medoxomil shown during the studies?

Ipreziv taken alone was more effective than placebo. In the two studies comparing Ipreziv alone and placebo, patients showed an average reduction in systolic blood pressure of approximately 13.5 mmHg with Ipreziv 40 mg and a decrease of approximately 14.5 mmHg with Ipreziv 80 mg after six weeks, compared with a decrease of 0.3 - 1.4 mmHg in patients treated with placebo.
In studies comparing Ipreziv alone to other medicines, the efficacy of Ipreziv 80 mg in lowering blood pressure was superior to that of the highest approved dose of valsartan (320 mg) and olmesartan medoxomil (40 mg). Ipreziv 40 and 80 mg was also more effective than ramipril (10 mg).
Studies have also shown that Ipreziv taken in combination with other medicines can lead to additional reductions in blood pressure compared to these same medicines taken without Ipreziv.

What is the risk associated with Ipreziv - Azilsartan medoxomil?

The side effects of Ipreziv are usually mild or moderate; the most common is dizziness. For the full list of side effects reported with Ipreziv, see the package leaflet.
Ipreziv 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 Ipreziv - Azilsartan medoxomil been approved?

The CHMP concluded that Ipreziv 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 Ipreziv'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 Ipreziv - Azilsartan medoxomil

On 7 December 2011, the European Commission issued a "Marketing Authorization" for Ipreziv, valid throughout the European Union.
For more information about Ipreziv 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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