MRC/BHF Heart Protection Study (HPS) Long-term Follow-up
Research type
Research Study
Full title
Heart Protection Study Long-term Follow-up: A randomised study of the effects on mortality and morbidity of HMG CoA reductase inhibitors and of antioxidant vitamins in a wide range of people at high risk of coronary heart disease.
IRAS ID
262231
Contact name
Louise Bowman
Contact email
Sponsor organisation
University of Oxford
ISRCTN Number
ISRCTN48489393
Clinicaltrials.gov Identifier
ISRCTN44787209, ISRCTN
Duration of Study in the UK
66 years, 11 months, 31 days
Research summary
HPS was a large randomised controlled trial. Between 1994 and 1997, 20,536 individuals at increased risk of coronary heart disease were randomised to 40mg simvastatin daily versus matching placebo, and (in a 2X2 factorial design) to anti-oxidant vitamin supplementation with vitamins E, C and beta-carotene versus placebo. Participants took trial medications for an average 5years (scheduled treatment period), and the main trial closed in 2001. The aim was to study the overall effects on survival by preventing heart attacks, strokes and other major vascular events.
The main results of HPS showed clearly that allocation to cholesterol-lowering therapy with simvastatin was associated with a 20% reduction in the risk of heart attacks and stroke, and a reduction in all-cause mortality, chiefly driven by a very significant reduction in vascular deaths. These results changed clinical practice worldwide, and statins are now prescribed widely to many millions of patients.
Follow-up of all surviving participants continued after the end of the scheduled treatment period. Initially, annual questionnaires were sent to the surviving participants between 2001 and 2007. This follow-up was supplemented with cause-specific mortality data provided by ONS and incident cancers via national cancer registries. Additionally, and with the necessary approvals, Hospital Episodes Statistics (HES) data was provided by the NHS Information Centre (now called NHS Digital), giving details on non-fatal events occurring in the study population.
Post-trial follow-up showed that the reductions seen in heart attacks, strokes and vascular death associated with allocation to simvastatin were maintained during this 5-year period. This suggests that longer statin use would result in greater absolute benefits and supports the early initiation and long-term continuation of lipid-lowering therapy in those at increased vascular risk.
We plan to continue the assessment of the long-term effects of these treatments via central registries and further analysis of existing blood samples.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0262
Date of REC Opinion
24 Apr 2019
REC opinion
Favourable Opinion