Karvea | European Medicines Agency (EMA)

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Overview

This is a summary of the European public assessment report (EPAR) for Karvea. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Karvea.

Karvea is a medicine that contains the active substance irbesartan. It is available as tablets (75, 150 and 300 mg).

Karvea is used in adults who have essential hypertension (high blood pressure). ‘Essential’ means that the hypertension has no obvious cause. Karvea is also used to treat kidney disease in adults with hypertension and type-2 diabetes (non?insulin-dependent diabetes).

The medicine can only be obtained with a prescription.

The usual recommended dose of Karvea is 150 mg once a day. If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide. A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.

In patients with hypertension and type-2 diabetes, Karvea is added to some other treatments for hypertension. Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.

The active substance in Karvea, 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 stops the hormone having an effect, allowing the blood vessels to widen. This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.

Karvea was originally studied in 11 trials for its effects on blood pressure. Karvea 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 in combination with hydrochlorothiazide was also examined in 1,736 patients. The main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).

For the treatment of kidney disease, Karvea was studied in two large studies involving a total of 2,326 patients with type-2 diabetes. Karvea was used for two years or more. One study looked at markers of kidney damage by measuring whether the kidneys were releasing the protein albumin into the urine. The second study looked at whether Karvea increased the time taken until the patients’ blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died. In this study, Karvea was compared with placebo and with amlodipine.

In the blood pressure studies, Karvea was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension. When used with hydrochlorothiazide, the effects of the two medicines were additive.

In the first kidney-disease study, Karvea was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion. In the second kidney-disease study, Karvea reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant, or death during the study by 20% in comparison with placebo. There was a 23% relative risk reduction compared with amlodipine. The main benefit was on the effect on blood creatinine levels.

The most common side effect with Karvea (seen in more than 1 patient in 10) is hyperkalaemia (high blood potassium levels). For the full list of all side effects reported with Karvea, see the package leaflet.

Karvea must not be used in people who are 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 during the first three months of pregnancy is not recommended. Karvea in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.

The CHMP decided that Karvea’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The European Commission granted a marketing authorisation valid throughout the European Union for Karvea on 27 August 1997.

For more information about treatment with Karvea, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

English (EN)
(74.27 KB – PDF)

First published: 06/05/2009Last updated: 23/09/2013

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Product information

English (EN)
(979.96 KB – PDF)

First published: 22/04/2009Last updated: 14/02/2025

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Latest procedure affecting product information:
VR/0000242076

11/02/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(18.1 KB – PDF)

First published: 17/04/2007Last updated: 17/04/2007

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Product details

Name of medicine: Karvea
Active substance: irbesartan
International non-proprietary name (INN) or common name: irbesartan
Therapeutic area (MeSH): Hypertension
Anatomical therapeutic chemical (ATC) code: C09CA04

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension.

Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal product regimen.

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