Cholestagel - colesevelam

What is Cholestagel?

Cholestagel is a medicine that contains the active substance colesevelam. It comes in the form of white capsules (625 mg).

What is Cholestagel used for?

Cholestagel is used to lower cholesterol in adults with primary hypercholesterolemia (high blood cholesterol levels). "Primary" means that there are no diseases that cause the high cholesterol levels.

  1. Cholestagel is used, in addition to a cholesterol-lowering diet, to lower total cholesterol and "bad" or LDL (low-density-lipoprotein) cholesterol levels when statins (another cholesterol-lowering medicine) they are not indicated or are not well tolerated;
  2. Cholestagel is also used, in addition to a statin and a cholesterol-lowering diet, to further lower LDL cholesterol levels in patients who are not adequately controlled on a statin alone.

The medicine can only be obtained with a prescription.

How is Cholestagel used?

The recommended dose of Cholestagel is four to six tablets a day, to be taken with food and drink. The tablets can be taken all at once or in two divided doses throughout the day. The maximum dose is seven tablets per day if taken alone and six tablets per day if taken with a statin.
Prior to treatment, patients should start a cholesterol-lowering diet, which they should continue to follow during treatment. It is also necessary to measure blood cholesterol levels before and during treatment to check the patient's response.

How does Cholestagel work?

The active substance in Cholestagel, colesevelam, is not absorbed by the body, but remains in the intestine, where it binds to substances called bile acids, which it carries out of the body in the stool. Since bile acids cannot be absorbed into the body. blood, the liver has to make more bile acids. Since the liver uses cholesterol to make bile acids, this lowers cholesterol levels in the blood. Lowering cholesterol, especially LDL cholesterol, decreases the risk of heart disease.

How has Cholestagel been studied?

Cholestagel has been compared with placebo (a dummy treatment) in five main studies. Two of these studies looked at Cholestagel taken alone in 592 adults and three looked at Cholestagel taken in combination with a statin (lovastatin, simvastatin or atorvastatin) in 491 adults. The main measure of effectiveness was the decrease in LDL cholesterol levels at the end of the studies. All studies lasted four to six weeks, except for one study on Cholestagel alone which lasted six months.

What benefit has Cholestagel shown during the studies?

In studies of Cholestagen alone, more than half of patients treated with 3.8 or 4.5 g of Cholestagel (approximately six to seven tablets) reported a 15-18% decrease in LDL cholesterol levels after six weeks . In the six-month study, the decrease recorded at six weeks with 3.8 g of Cholestagel (approximately six tablets) was maintained for six months. Conversely, placebo-treated patients reported no changes in LDL cholesterol levels. The effectiveness of Cholestagel was independent of whether the medicine was taken in the morning, in the evening or twice a day.
The results of the three studies in which Cholestagel was administered together with a statin show a "further 8% reduction in LDL cholesterol levels with 2.3 g of Cholestagel (approximately four tablets) and 16% with 3.8 g. of Cholestagel (about six tablets).

What is the risk associated with Cholestagel?

In studies, the most common side effects with Cholestagel (seen in more than 1 in 10 patients) were flatulence (gas) and constipation. For the full list of side effects reported with Cholestagel, see the package leaflet.
Cholestagel should not be used in people who may be hypersensitive (allergic) to colesevelam or any of the other ingredients. It must not be administered to patients with intestinal or biliary obstruction.

Why has Cholestagel been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Cholestagel outweigh its risks as an adjunct therapy in addition to diet to provide additional reductions in LDL cholesterol levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin only and as adjunct therapy in addition to diet to reduce elevated total cholesterol and LDL cholesterol levels in adult patients with primary hypercholesterolaemia for whom statins are considered inadequate or poorly tolerated. The committee recommended the granting of a marketing authorization for Cholestagel.

More information about Cholestagel

On 10 March 2004, the European Commission issued to Genzyme Europe B.V. a "Marketing Authorization" for Cholestagel, valid throughout the European Union. The "Marketing Authorization" was renewed on 10 March 2009.
For the full version of Cholestagel's EPAR, click here.

Last update of this summary: 03-2009.

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