Why was this work needed?
The Heart Protection Study was a large scale clinical trial designed to assess the potential benefits of using drugs to lower cholesterol (statins) and anti-oxidant vitamins for those with a higher than average risk of cardiovascular disease.
The researchers recruited over 20,000 participants with existing heart problems and randomly allocated some to receive a statin or anti-oxidant vitamins, while another group took a placebo. The participants were followed up for the five years that they received treatment and a further five years after, by questionnaire.
What were the benefits?
This trial demonstrated that statins significantly lowered the risk of death, while no effect of taking anti-oxidant vitamins was seen. Combined with other research studies, the Heart Protection Study has provided evidence to support the widespread prescription of statins to people with a high risk of cardiovascular disease.
What type of data was involved?
Potentially identifiable candidates were identified using records of patient discharges and of special wards or clinics. Subsequently, they were followed up during clinic visits and through questionnaires.
What was the legal basis for accessing the data?
Senior nurses ran clinics to support this study at 69 hospitals and local ethical approval was gained at each of these centres. Potentially eligible participants were contacted with the permission of their GPs. If they responded to the invitation, they were then asked for their consent to participate.
Who funded and collaborated on this work?
This trial was funded by the UK Medical Research Council, the British Heart Foundation and by Merck, who provided simvastatin and matching placebo, and Roche who provided the anti-oxidant vitamin capsules and matching placebo. The analysis of the data was carried out by the Clinical Trial Support Unit independently of Merck and Roche. The long-term follow-up was funded by a grant from the British Heart Foundation and epidemiological studies have been funded by core grants to the Clinical Trial Service Unit (Nuffield Department of Population Health) from the Medical Research Council, British Heart Foundation and Cancer Research UK.
Where can I go for more information?
- Page updated: 26 January 2018
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