For decades, clinical trials have been ensuring and demonstrating the effectiveness of life-saving treatments. In 1992, a randomized clinical trial called the West of Scotland Coronary Prevention Study (WOSCOPS) looked at what happens when you give a treatment (statins) or a placebo to men with high cholesterol but without a history of heart attacks. The study demonstrated that statins led to a reduction in deaths, a substantial reduction in heart attacks and other reasons for being admitted to hospital for heart disease, and long-term follow up over fifteen years showed that this intervention was ultimately cost-effective for the NHS.

Why was this work needed?

Lowering cholesterol is a key part of preventing cardiovascular disease, which can cause risks like heart attacks. When this research was carried out, there were major questions about whether or not treating high cholesterol with statins would, in the long term, be safe and reduce deaths. There were also questions around whether potential long-term benefits of the treatment would provide cost effectiveness by reducing resource use in return for increasing quality of life.

What happened?

 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 clinical data in the original trial, such as cholesterol levels and blood pressure, was collected at trial centres, with follow-up elements utilising routinely collected data, such as hospital records, cancer registry data and death records.

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 applied 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 took place within a secure environment and researchers could not see identifiable patient data.

Who funded and collaborated on this work?

The original trial 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?

Long-Term Follow-up of the West of Scotland Coronary Prevention Study

Long-term impact on healthcare resource utilization of statin treatment, and its cost effectiveness in the primary prevention of cardiovascular disease: a record linkage study

Long Term Safety and Efficacy of Lowering LDL Cholesterol With Statin Therapy: 20-Year Follow-Up of West of Scotland Coronary Prevention Study