October NUI Galway Research Highlights Uncertainties Around the Benefits and Harms of Statins

New article in The BMJ focuses on the use of statins amongst people at low risk of cardiovascular disease and the need for better data to help shared decision making

Findings from a five-year study on statin use led by Dr Paula Byrne and Dr John Cullinan, J.E. Cairnes School of Business & Economics at NUI Galway along with Professor Susan M Smith, RCSI, has been published today (17 October 2019) in the leading medical journal The BMJ.

Statins are among the most commonly used drugs in Ireland and the western world. While originally intended for those who have suffered prior cardiovascular disease, they are now commonly used by people with no prior disease to prevent cardiovascular disease in the future. This is called primary prevention. This new research highlights that eligibility for statins has expanded considerably over the past two decades and that clinical guidelines have gone from potentially recommending statin treatment in a small minority of older patients, to recommending treatment in a majority.

At present nearly two-thirds of Irish adults aged over 50 with no history of cardiovascular disease could now be eligible for statins, even though there are significant uncertainties regarding the benefits of these cholesterol-lowering drugs.

To date, most studies have not differentiated between the impact of statins in those with and without cardiovascular disease, which makes it difficult for doctors to support patients when making decisions about taking statins. This new research explores the deficiencies in the available evidence. It shows that considerable uncertainty remains about the benefits of their use for primary prevention of cardiovascular disease and that the effects of statins in certain groups, such as women and the elderly, may differ from effects in middle aged men. In addition, the absolute benefits from statins for low-risk patients can be very small and patients may consider that they do not justify taking a daily medication or the risk of adverse effects.

Overall the research shows that for lower risk categories, many people may need to be treated to prevent one serious cardiovascular event. In addition, the authors highlight that much of the data on the side effects of statins remain unavailable for independent analysis. The authors call for better data on both the benefits and harms of statins, in particular for low-risk populations, in order to better facilitate shared decision making.

Lead author Dr Paula Byrne, SPHeRE Researcher, J.E. Cairnes School of Business & Economics, NUI Galway, said: “Some patients may achieve very small reductions in risk of cardiovascular disease by taking statins. As a result, the individual patient and their doctor need to consider if these reductions justify taking a medication daily and the risk of side effects. From a societal perspective, we need to ask whether or not statin use in such low-risk people represents value for money in the health sector.”

Co-author Dr John Cullinan, Senior Lecturer in Economics, J.E. Cairnes School of Business & Economics, NUI Galway, said: “In the context of overstretched healthcare budgets, the concept of overuse of medicines and low-value care should become integral to policymaking and reimbursement. We have highlighted one area of drug spending that warrants more careful consideration and would urge those responsible for the implementation of health policy and Sláintecare to seriously consider and deal with areas of potentially wasteful spending.”

Co-author Professor Susan M Smith, RCSI, said: Given the on-going debate on the appropriateness of statin use in primary prevention, it is significant that the evidence to support this use is so limited, particularly for women. Doctors need more evidence on the benefits and harms of statins in low-risk individuals to support shared decision making with patients.”

To read the full study in The BMJ, visit: http://press.psprings.co.uk/bmj/october/statins.pdf and https://www.bmj.com/content/367/bmj.l5674

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