The effectiveness of simvastatin compared to atorvastatin - a feasibility study
- Conditions
- Cardiovascular illnessCirculatory SystemComplications and ill-defined descriptions of heart disease
- Registration Number
- ISRCTN33113202
- Lead Sponsor
- niversity of Liverpool (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
1. Aged 40 years or over, either sex
2. Able and willing to provide informed consent to study participation
3. Fully registered with the general practice for at least 6 months (i.e. subjects who are newly registered with the practice will not be eligible)
4. Subjects who had not been prescribed a statin previously
5. Subjects who in the opinion of the GP Investigator should be prescribed a statin
6. Subjects who in the opinion of the GP Investigator have primary hypercholesterolaemia (cholesterol of 5.0 mmol/l or above) and have not responded adequately to diet or other appropriate measures (i.e. one of licensed indications of statins)
7. Subjects who in the opinion of the GP Investigator would require a statin for primary prevention according to the 2008 NICE guideline on lipid modification: adults over 40 who have a 20% or greater 10-year risk of developing cardiovascular disease, based on Framingham 1991 10-year risk equations and clinical judgement
Further details can be found in the British National Formulary (section 2.12) and in the 2008 NICE guideline on lipid modification [5], which will be available on the study website.
Statins are contra-indicated in active liver disease (or persistently abnormal liver function tests), in pregnancy (adequate contraception required during treatment and for 1 months afterwards) and breast-feeding. Further details can be found in the British National Formulary (section 2.12).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method