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Lipid modification - primary and secondary CVD prevention - Management
Which bile acid sequestrants are recommended?
- Colestyramine is the preferred bile acid sequestrant.
- Other licensed bile acid sequestrants (colesevelam and colestipol) (see Table 1) may be considered if the person is poorly compliant on colestyramine.
Clarification / Additional information
- The formulation and licensed indications and for bile acid sequestrants available in the UK are shown in Table 1.
Table 1. Bile acid sequestrants available in the UK: licensed indications and dosages.
Products | Colesevelam hydrochloride | Colestipol hydrochloride | Colestyramine |
|---|
Formulation | Tablets containing colesevelam hydrochloride 625 mg (Cholestagel®) | Granules for oral suspension Sachets containing 5 g colestipol hydrochloride (Colestid®) A sugar-free version is available (Colestid Orange®) | Powder for oral administration Sachets containing colestyramine 4 g (available generically or as Questran®) A sugar-free version is available (Questran Light®) |
Licensed indications | Adjunct therapy with a statin and diet: people with primary hypercholesterolaemia who are not adequately controlled with a statin alone. Monotherapy: people with isolated primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated. | Management of people with elevated cholesterol levels who have not responded adequately to diet. It may be used alone or in combination with additional lipid-modifying agents. It is licensed for all types of hypercholesterolaemia including Fredrickson's type II hyperlipoproteinaemia. | Primary prevention of coronary heart disease in men 35–59 years of age and with primary hypercholesterolaemia who have not responded to diet and other appropriate measures. Reduction of plasma cholesterol in hypercholesterolaemia, particularly in people who have been diagnosed as Fredrickson's Type II (high plasma cholesterol with normal or slightly elevated triglycerides). |
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Basis for recommendation
- The National Institute for Health and Clinical Excellence does not recommend any particular bile acid sequestrant for use in the primary or secondary prevention of cardiovascular disease (CVD) for people who can not tolerate a statin [National Collaborating Centre for Primary Care, 2008a; NICE, 2008a].
- CKS could find no randomized controlled trials comparing the different bile acid sequestrants for primary and secondary prevention of CVD.
- Colestyramine is preferred over colesevelam and colestipol because:
- There is limited trial evidence supporting the use of colestyramine for primary (but not secondary) prevention of CVD (as reflected in its product licence — see Table 1).
- For colesevelam and colestipol, CKS could find no trials that reported health-related quality of life or clinical endpoints such as cardiovascular morbidity and mortality. Neither colesevelam nor colestipol are licensed for primary or secondary prevention of CVD.
- Colestyramine is available generically and is less expensive than the other two bile acid sequestrants.
- Colesevelam is currently under intensive post-marketing surveillance by the Commission on Human Medicines (black triangle drug).
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