What is Aprovel?
Aprovel is a medicine that contains the active substance irbesartan, available as white, oval-shaped tablets (75, 150 and 300 mg).
What is Aprovel used for?
Aprovel is used in patients with essential hypertension (high blood pressure). The term "essential" means that hypertension has no obvious cause. Aprovel is also used to treat kidney disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes). Aprovel is not used for use. it is recommended in patients under 18 years because there is no information on safety and efficacy for this age group.
The medicine can only be obtained with a prescription.
How is Aproval used?
Aprovel is taken by mouth, with or without meals. The usually recommended dose is 150 mg once a day. If blood pressure is not adequately controlled, the dose can be increased to 300 mg per day or other medicines for hypertension, such as hydrochlorothiazide, can be added. A starting dose of 75 mg can be used in patients undergoing hemodialysis (a blood purification technique) or in patients over 75 years of age.
In patients with hypertension and type 2 diabetes, Aprovel is combined with other treatments for hypertension. Treatment starts with a dose of 150 mg once daily, which is usually increased up to 300 mg once daily. .
How does Aprovel work?
The active substance in Aprovel, irbesartan, 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 constricts blood vessels By blocking the receptors that angiotensin II normally attaches to, irbesartan blocks the hormone's effect, allowing the blood vessels to widen. This results in a drop in blood pressure and reduces the risks associated with high blood pressure, such as stroke.
How has Aprovel been studied?
Aprovel was initially studied in 11 trials to evaluate its effects on blood pressure. Aprovel was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients. Its use was also tested in combination with hydrochlorothiazide in 1,736. patients. The main measure of effectiveness was based on the reduction in diastolic blood pressure (the blood pressure measured in the interval between two heartbeats).
For the treatment of kidney disease, Aprovel has been studied in two large studies involving 2,326 patients with type 2 diabetes. Aprovel has been used for at least two years. One study looked at markers of kidney damage by measuring the eventual release of albumin protein in the urine by the kidneys. The second study was aimed at verifying whether Aprovel contributed to lengthening the length of time needed for the patients' blood creatinine levels (a marker of kidney disease) to double, until the need arose for dialysis or kidney transplantation or until to death of the patient In this study, Aprovel was compared with placebo and amlodipine.
What benefit has Aprovel shown during the studies?
In blood pressure studies, Aprovel was more effective than placebo in lowering diastolic blood pressure and had similar effects to other medicines for hypertension. Used in combination with hydrochlorothiazide, the two medicines showed an additional effect.
In the first kidney disease study, Aprovel was more effective than placebo in reducing the risk of kidney damage as measured by protein excretion. In the second kidney disease study, Aprovel reduced the relative risk by 20% compared to placebo. doubling blood creatinine levels, having to resort to dialysis or kidney transplantation or the risk of death during the study. Compared to amlodipine there was a 23% relative risk reduction. The main benefit was the effect on blood creatinine levels.
What is the risk associated with Aprovel?
The most common side effects with Aprovel (seen in 1 to 10 patients in 100) are dizziness, nausea or vomiting, fatigue (tiredness) and increased levels of creatine kinase in the blood (an enzyme found in the muscles). In addition, more than one in 100 patients with type 2 diabetes and kidney disease have reported the following side effects: hyperkalemia (high levels of potassium in the blood), orthostatic dizziness (when standing), musculoskeletal (joint) pain and orthostatic hypotension ( low blood pressure when standing). For the full list of side effects reported with Aprovel, see the package leaflet.
Aprovel must not be used in people who may be hypersensitive (allergic) to irbesartan 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 Aprovel been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Aprovel's benefits are greater than its risks for the treatment of essential hypertension and kidney disease in patients with hypertension and type 2 diabetes mellitus. release of the marketing authorization for Aprovel.
Other information about Aprovel:
On 27 August 1997 the European Commission granted Sanofi Pharma Bristol-Myers Squibb SNC a "marketing authorization" for Aprovel, valid throughout the European Union. The "marketing authorization" was renewed on 27 August. 2002 and August 27, 2007.
For the full version of Aprovel's EPAR, click here.
Last update of this summary: 03-2009.
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