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Hypercholesterolaemia - familial - Management
Basis for recommendation
These recommendations are in line with a guideline published by the National Institute for Health and Clinical Excellence (NICE), Identification and management of familial hypercholesterolaemia [NICE, 2008].
- Although evidence is inconclusive, there may be a small increase in the rate of fetal malformations if statins have been taken in the first trimester. However, most pregnancies have a normal outcome [National Collaborating Centre for Primary Care, 2008b].
- The risk of a maternal cardiovascular event during pregnancy, either on or off medication, is not known, but it is possible that pregnancy increases the risk of an event in women and girls with familial hypercholesterolaemia (FH) [National Collaborating Centre for Primary Care, 2008b].
- FH appears to increase the risk of aortic stenosis or atheroma involving the aortic valve, although these findings are mainly in people with homozygous FH, or people with heterozygous FH who have prolonged, severe hypercholesterolaemia [Rallidis et al, 1998].
- Although NICE recommend that prescribers should refer to summaries of product characteristics for individual drugs regarding potential interactions, they identified one small study of concomitant use of rosuvastatin and a third generation COC which showed no decrease in contraceptive efficacy or cholesterol-lowering efficacy [National Collaborating Centre for Primary Care, 2008b].
- NICE identified observational studies that did not demonstrate a significant increase in the risk of myocardial infarction in women taking a third generation COC [National Collaborating Centre for Primary Care, 2008b]. NICE also reported (then unpublished) results from a cohort study, that found no 'significant increase' in the risk of coronary heart disease in women of reproductive age taking statins. The study has now been published: there was one death in 4107 person-years of observation in women likely to have been on statins who were 20–39 years of age [Neil et al, 2008]. It is unsurprising that no statistical significance was found given such low frequencies, but this mortality rate represents a standardized mortality ratio (SMR) of 3333.
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