Ipreziv - Azilsartan medoxomil

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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 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 Ipreziv - Azilsartan medoxomil used?

Ipreziv 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 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 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 a drop in blood pressure 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.

With Ipreziv, eight main studies were performed on over 6, 000 patients with essential hypertension.

Five studies analyzed the effects of Ipreziv 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 Ipreziv 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 Ipreziv - Azilsartan medoxomil shown during the studies?

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

In studies comparing Ipreziv taken alone and other medicines, the efficacy of 80 mg of Ipreziv in lowering blood pressure was higher than 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 may 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 generally mild or moderate; the most common is dizziness. For the full list of all side effects reported with Ipreziv, see the package leaflet.

Ipreziv 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 Ipreziv - Azilsartan medoxomil been approved?

The CHMP concluded that Ipreziv 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 Ipreziv's benefits are greater than its risks in patients with essential hypertension and recommended that it be given marketing authorization.