Cardiovascular disease, dementia, cancer Other
Conditions
Interventions
Record-level electronic health data will be requested from NHS England and equivalent registries in Scotland & Wales. These records will be used to follow up the original HPS cohort for an extended pe
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Participants are all part of the original HPS cohort (randomised between 1994 and 1997). They were between 40 and 80 years old when invited to participate. Eligibility criteria were broad and included: 1. Patients at high risk of CHD (e.g., because of a history of vascular disease or diabetes) 2. Without clear indication for or contra-indication to statin 3. Male and female adults 4. Non-fasting blood total cholesterol concentrations of at least 3.5 mmol/L (135 mg/dL) For inclusion into the legacy cohort, participants had to be residents of the UK.
Exclusion criteria
Exclusion criteria: 1. The patient's doctor considered statin therapy to be clearly indicated or contra-indicated 2. A past history of: stroke, myocardial infarction or angina hospitalisation within the previous six months 3. Chronic liver disease or evidence of abnormal liver function 4. Severe renal disease or evidence of substantially impaired renal function 5. Inflammatory muscle disease or evidence of muscle problems 6. Concurrent treatment with cyclosporin, fibrates or high-dose niacin 7. Child-bearing potential 8. Severe heart failure 9. Life-threatening conditions other than vascular disease or diabetes (including any cancer except non-melanoma skin cancer) 10. Any other condition that might limit long-term compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Risk ratios for the first occurrence post-randomisation of each outcome of interest (dementia, stroke, all major cardiovascular disorders, other vascular disease complications, myopathies, heart failure, renal impairment, other health and care outcomes and death) between both allocated treatment groups measured using appropriate analysis methods. This will be based on at least 25 years of follow-up from trial initiation with further analyses planned at approximately 5 yearly intervals based on ongoing linkage to NHS records | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactMichelle Nunn
Outcome results
None listed