What is Karvea?
Karvea is a medicine that contains the active substance irbesartan, available as white, oval tablets (75, 150 and 300 mg).
What is Karvea used for?
Karvea is used in patients with essential hypertension (high blood pressure). The term "essential" indicates that hypertension has no obvious cause. Karvea is also used to treat kidney disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes). The use of Karvea is not recommended in patients below 18 years of age, because there is no information on safety and efficacy for this age group.
The medicine can only be obtained with a prescription.
How is Karvea used?
Karvea 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 hypertensive patients with type 2 diabetes, Karvea 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 Karvea work?
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 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.
What studies have been carried out on Karvea?
Karvea was initially studied in 11 trials to evaluate its efficacy in blood pressure. Karvea was compared with a placebo (a dummy treatment) in a group of 712 patients and with other medicines for hypertension (atenolol, enalapril 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, Karvea has been studied in two large studies involving a total of 2 326 patients with type 2 diabetes. Karvea 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 Karvea contributed to lengthening the period of time necessary for doubling the creatinine levels in patients' blood (creatinine is a marker of renal disease), up to the onset of the need for dialysis or transplantation kidney or until the patient's death. In this study, Karvea was compared with a placebo and with amlodipine.
What benefit has Karvea shown during the studies?
In blood pressure studies, Karvea was more effective than placebo in reducing the diastolic blood pressure and showed 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, Karvea was more effective than placebo in reducing the risk of kidney damage measured based on protein excretion. In the second kidney disease study, Karvea reduced the relative risk of doubling blood creatinine levels, having to resort to 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 Karvea?
The most common side effects of Karvea (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). In addition, 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 Karvea, see the Package Leaflet.
Karvea 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 was Karvea approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Karvea's benefits are greater than its risks for the treatment of essential hypertension and for the treatment of kidney disease in patients with hypertension and type 2 diabetes mellitus. recommended the granting of the marketing authorization for Karvea.
More information on Karvea:
On 27 August 1997, the European Commission granted Karvea a marketing authorization valid throughout the European Union to Bristol-Myers Squibb Pharma EEIG. The marketing authorization was renewed on 27 August 2002 and 27 August 2007.
For the full EPAR version of Karvea, click here.
Last update of this summary: 03-2009
