Why was this work needed?
When this research was carried out, there were major questions about whether or not treatment with a statin would, in the long term, be safe and reduce deaths or whether there might be ongoing additional benefits contributing to the cost effectiveness of prescribing statins to men without a history of heart attacks. This study looked at the long term impacts on the men involved.
The West of Scotland Coronary Prevention Study (WOSCOPS) was a five year clinical trial looking at the use of statins by middle aged men without a history of heart attacks. After five years, the trial showed a reduction in the number of deaths from coronary heart disease. With permission, the participants’ were also monitored for up to 15 years after the trial, so that the researchers could study the long term impact of their statin use for five years.
What were the benefits?
This research showed no evidence of harm and lasting health benefits for the men involved, and showed that five years of treating 1,000 men with the statin being trialled (pravastatin) saved the NHS £710,000 over 15 years. Further work showed lasting benefit in preventing deaths and repeated hospital admissions for heart disease over 20 years. This kind of work not only improves treatment for patients, it also supports the NHS to decide where to spend limited resources to get the most benefit. By using routinely collected data to follow the progress of the study participants, the researchers were able to monitor the long term health and economic impacts of the trial.
What type of data was involved?
The data collected as part of the original trial was used, as well as routinely collected data, including hospital records, cancer registry data and death records.
What was the legal basis for accessing the data?
The study was approved by the ethics committees of the University of Glasgow and the participating health boards. All participants on the trial gave written, informed consent and permission for access to their medical records, including primary care records, to allow follow up studies. Researchers apply for permission from the Scotland Public Benefit and Privacy Panel for Health and Social Care and renewed the ethical approval before undertaking new follow up studies involving linkage of data sets held by NHS Scotland. Linkage takes place within a secure environment and researchers do not see identifiable patient data.
Who funded and collaborated on this work?
The original trial, completing in 1995, was funded by Bristol-Myers Squibb. The first 5 years of the extended follow-up, completed in 2000, was supported by Bristol-Myers Squibb and the Sankyo Company. The final 10 years was supported by unrestricted grants from the Chief Scientist’s Office Scotland, Wellcome Trust (Scottish Health Informatics Programme), Celera Diagnostics and the Farr Institute.
Where can I go for more information?
- Page updated: 31 August 2017
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