What is Irbesartan Winthrop?
Irbesartan Winthrop is a medicine that contains the active substance irbesartan, available as white, oval-shaped tablets (75, 150 and 300 mg).
The medicine is similar to Aprovel, which is already authorized in the European Union (EU). The company that makes Aprovel has agreed that its scientific data are used for Irbesartan Winthrop.
What is Irbesartan Winthrop used for?
Irbesartan Winthrop is used in patients with essential hypertension (high blood pressure). The term "essential" indicates that hypertension has no obvious cause. Irbesartan Winthrop is also used to treat kidney disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes). The use of Irbesartan Winthrop is not recommended for patients under 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 Irbesartan Winthrop used?
Irbesartan Winthrop is to be taken by mouth, with or without meals. The usually recommended dose is 150 mg once a day. If blood pressure is not sufficiently 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, Irbesartan Winthrop is combined with other treatments for hypertension. Treatment starts with a dose of 150 mg once daily, which is usually increased to 300 mg once daily. day.
How does Irbesartan Winthrop work?
The active substance in Irbesartan Winthrop, 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 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 Irbesartan Winthrop been studied?
Irbesartan Winthrop was initially studied in 11 trials to evaluate its efficacy on blood pressure. Irbesartan Winthrop was compared with placebo (a dummy treatment) in a group of 712 patients and with other medicines for hypertension (atenol, 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 (blood pressure measured in the interval between two heartbeats).
For the treatment of kidney disease, Irbesartan Winthrop has been studied in two large studies involving a total of 2,326 patients with type 2 diabetes. Irbesartan Winthrop 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 investigating whether Irbesartan Winthrop contributed to lengthening the time it takes for patients' blood creatinine levels (a marker of kidney disease) to double, until the need arose for dialysis or kidney transplant or until death In this study, Irbesartan Winthrop was compared with placebo and amlodipine.
What benefit has Irbesartan Winthrop shown during the studies?
In blood pressure studies, Irbesartan Winthrop was more effective than placebo in lowering 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, Irbesartan Winthrop was more effective than placebo in reducing the risk of kidney damage as measured by protein excretion. In the second kidney disease study, Irbesartan Winthrop reduced the risk of doubling blood creatinine levels, having to have a kidney transplant or dialysis, 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 Irbesartan Winthrop?
The most common side effects with Irbesartan Winthrop (seen in 1 to 10 patients in 100) are dizziness, nausea or vomiting, fatigue (tiredness) and increases in blood creatine kinase (an enzyme found in 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), orthostatic hypotension (low blood pressure when standing standing) and musculoskeletal (joint) pain. For the full list of side effects reported with Irbesartan Winthrop, see the Package Leaflet.
Irbesartan Winthrop 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 are more than three months pregnant. Its use is not recommended during the first three months of pregnancy.
Why has Irbesartan Winthrop been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan Winthrop's benefits are greater than its risks for the treatment of hypertension and kidney disease in patients with hypertension and type 2 diabetes mellitus. recommended the granting of the marketing authorization for Irbesartan Winthrop.
Other information about Irbesartan Winthrop:
On January 19, 2007, the European Commission granted Sanofi Pharma Bristol-Myers Squibb SNC an EU-wide "Marketing Authorization" for Irbesartan Winthrop.
For the full version of Irbesartan Winthrop's EPAR, click here.
Last update of this summary: 03-2009.
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