What is Aprovel?
Aprovel is a medicine that contains the active substance irbesartan, which is available as white, oval 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" indicates 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). The use of Aprovel is not recommended in patients under the age of 18 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 should be taken by mouth, with or without food. The usual recommended dose is 150 mg once a day. If blood pressure is not adequately controlled, the dose can be increased to 300 mg a day or other medicines can be added for hypertension, such as hydrochlorothiazide. 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 associated with other treatments for hypertension. Treatment begins with a dose of 150 mg once a day, which is usually increased up to 300 mg once a day.
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 powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, irbesartan blocks the effect of the hormone, allowing the blood vessels to dilate. This causes 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 assess its effects on blood pressure. Aprovel was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalaprile or amlodipine) in 823 patients. The use of the medicine was also analyzed in combination with hydrochlorothiazide in 1, 736 patients. The main efficacy index was based on the reduction of 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, measuring the eventual release of protein albumin in the urine by the kidneys. The second study was aimed at verifying whether Aprovel contributed to lengthening the period of time required to double the creatinine levels in the patients' blood (a marker of kidney disease), up to the onset of the need for dialysis or kidney transplant or up to at the death of the patient. In this study, Aprovel was compared with a placebo and with amlodipine.
What benefit has Aprovel shown during the studies?
In blood pressure studies, Aprovel was more effective than placebo in reducing 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 measured based on protein excretion. In the second kidney disease study, Aprovel reduced the relative risk of doubling blood creatinine levels, having to resort to dialysis or kidney transplantation or the risk of death during the study by 20% compared to placebo. There was a relative risk reduction of 23% compared to amlodipine. The main benefit was the effect on blood creatinine levels.
What is the risk associated with Aprovel?
The most common side effects of Aprovel (seen in between 1 and 10 patients in 100) are vertigo, nausea or vomiting, fatigue (tiredness) and increased levels of creatine kinase in the blood (an enzyme in the muscles). Furthermore, more than one in 100 patients with type 2 diabetes and kidney disease reported the following side effects: hyperkalemia (high levels of potassium in the blood), orthostatic vertigo (standing), musculoskeletal (joint) pain and orthostatic hypotension ( low blood pressure while standing). For the full list of all side effects reported with Aprovel, see the Package Leaflet.
Aprovel should 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 have been pregnant for more than three months. Not recommended for use 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. The committee recommended the granting of marketing authorization for Aprovel.
More information on Aprovel:
On 27 August 1997, the European Commission granted a marketing authorization for Aprovel, valid throughout the European Union, to Sanofi Pharma Bristol-Myers Squibb SNC. The marketing authorization was renewed on 27 August 2002 and 27 August 2007.
The full EPAR for Aprovel can be found here.
Last update of this summary: 03-2009.
