This document is a summary of the European Public Assessment Report (EPAR) for Cholestagel. 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 Cholestagel.
What is Cholestagel?
Cholestagel is a medicine that contains the active substance colesevelam. It is available as white tablets (625 mg).
What is Cholestagel used for?
Cholestagel is used to lower cholesterol levels in adults with primary hypercholesterolaemia (high blood cholesterol levels). ‘Primary’ means that there is no disease causing the high cholesterol levels. Cholestagel is used in the following ways:
•together with ezetimibe (another
The medicine can only be obtained with a prescription.
© European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged.
How is Cholestagel used?
The recommended dose of Cholestagel is six tablets a day when it is taken on its own, and four to six tablets a day when it is taken in combination with other medicines. The tablets need to be taken with food and drink. They can either be taken all at once, or split into two doses during the day. The maximum dose is seven tablets a day when it is taken on its own, and six tablets a day when it is taken with other medicines.
Patients should start a
How does Cholestagel work?
The active substance in Cholestagel, colesevelam, is not absorbed by the body, but stays in the gut, where it attaches to substances called bile acids and carries them out of the body in the faeces. Because the bile acids are prevented from being absorbed into the bloodstream, the liver is forced to make more bile acids. As the liver uses cholesterol to make bile acids, this reduces cholesterol levels in the blood. Lowering cholesterol, especially LDL cholesterol, can reduce the risk of heart disease.
How has Cholestagel been studied?
Cholestagel has been compared with placebo (a dummy treatment) in seven main studies involving adults with primary hypercholesterolaemia. Three of these studies looked at Cholestagel taken in combination with a statin (lovastatin, simvastatin or atorvastatin) in 491 patients, two looked at Cholestagel taken on its own in 592 patients, and one looked at Cholestagel in combination with ezetimibe in 86 patients. The final study looked at Cholestagel as an
What benefit has Cholestagel shown during the studies?
Looking at the results of the three studies in which Cholestagel was used with a statin, there was an 8% reduction in
In the studies looking at Cholestagel taken on its own, more than half of the patients receiving 3.8 or 4.5 g Cholestagel (about six to seven tablets) had a decrease in
The combination of Cholestagel and ezetimibe was more effective than ezetimibe taken with placebo: there was a fall of 32% in
What is the risk associated with Cholestagel?
In studies, the most common side effects with Cholestagel (seen in more than 1 patient in 10) were flatulence (gas) and constipation. For the full list of all 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 used in patients whose gut or bile duct is blocked.
Why has Cholestagel been approved?
The CHMP concluded that Cholestagel’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Other information about Cholestagel:
The European Commission granted a marketing authorisation valid throughout the European Union for Cholestagel to Genzyme Europe B.V. on 10 March 2004. The marketing authorisation is valid for an unlimited period.
The full EPAR for Cholestagel can be found here. For more information about treatment with Cholestagel, read the Package Leaflet (also part of the EPAR).
This summary was last updated in