Researchers at the University of Oxford have created a new calculator to estimate an individual’s risk of developing serious muscle damage while taking statins. This tool is designed to help patients and doctors make more informed decisions about these commonly prescribed cholesterol-lowering drugs, which are widely used to prevent heart attacks and strokes.
This study lancet digital healthfound that over 98% of people identified by their general practitioner as a candidate for statin therapy had a low predicted risk of developing serious muscle disorders over the next 10 years. The findings suggest that fears of severe muscle-related side effects may be overstated for most people who could benefit from treatment.
New tool aims to personalize statin decisions
Researchers also identified significant treatment gaps. More than 60% of people eligible to take statins were not taking them, even though some faced a higher risk of heart attack or stroke. The research team believes the new calculator could improve conversations between patients and clinicians by providing personalized estimates of risk, rather than relying on general statistics or broad concerns about side effects.
The calculator, available from the Oxford University Innovation Software Store, is based on a clinical prediction model developed and tested using the anonymised health records of more than 5.6 million people registered with GPs across the UK. The researchers used data from more than 1.7 million people to build their model and tested its accuracy using records from an additional 3.9 million people.
How the statin risk calculator works
The model analyzes 22 regularly collected health factors to estimate the likelihood of developing a serious muscle disease over 1, 5, and 10 years. These factors include age, gender, ethnicity, BMI, smoking status, pre-existing medical conditions, past muscle problems, vitamin D deficiency, drug use, and whether you are prescribed a statin.
The researchers hope the calculator will be used in conjunction with cardiovascular risk assessment tools such as QRISK. Together, these tools could help doctors and patients weigh both the benefits of lowering the risk of heart attack and stroke against the potential risks of serious muscle complications when deciding whether statin treatment is appropriate.
Keeping in mind the side effects of statins
Statins are one of the most commonly prescribed drugs to prevent cardiovascular disease. However, even with great potential benefits, concerns about muscle-related side effects often deter people from starting treatment or causing them to stop taking the drug.
The researchers emphasized that their study focused only on severe muscle disorders that can lead to hospitalization and death, rather than the mild muscle aches and pains that some people experience. Previous studies have shown that many of the mild muscle symptoms reported during statin treatment are not actually caused by the statin and should not prevent patients from starting treatment. Although severe muscle disorders are less common, it is still important to understand the possibility of these rare events when balancing the risks and benefits of treatment.
Dr Ting Kai, a research fellow at the Nuffield School of Primary Care and Health Sciences at the University of Oxford and lead author of the study, said:
“Severe myopathy is one of the most widely discussed concerns regarding statins, but the results of this study suggest that the risk is very low for the majority of people who could benefit from treatment. Understanding individual risks can help address those concerns. For a small number of people who are at high risk, clinicians have a clearer basis for monitoring, checking or discussing alternative treatment options.”
Personalized risk could improve treatment decisions
Professor James Shepherd, Professor of Primary Care Research at the University of Oxford and lead author of the study, said:
“Treatment decisions are often made based on estimates of a person’s future cardiovascular risk, but much less information is available about an individual’s risk of adverse outcomes. This study helps address that gap by providing a way to estimate a person’s risk of severe myopathy and cardiovascular risk. Integrating these two pieces of information could support more individualized and better-informed decisions about statin treatment.”
Professor Konstantinos Kosiaris, assistant professor of medical statistics at the Faculty of Medicine of the University of Nicosia and lead author of the study, said:
“Clinical decisions are often made based on estimates of potential benefit, but it is equally important to understand the potential harm. This model provides a way to quantify that risk at an individual level, supporting a more balanced discussion of treatment options.”
The researchers hope that by providing personalized estimates of both potential benefits and risks, the calculator will help patients and healthcare professionals make more confident, evidence-based decisions about statin treatment and long-term cardiovascular disease prevention.
An online calculator based on this model will be available from the Oxford University Innovation Software Store as STRATIFY-StatinMD Risk Calculator — Academic use.
This research was funded by a British Heart Foundation Doctoral Scholarship (Reference: FS/19/13/34235). James Shepherd and Konstantinos Kosiaris were supported by the Wellcome Trust and the Royal Society (Sir Henry Dale Fellowship, ref: 211182/Z/18/Z) and the National Institute for Health Research (NIHR) School of Primary Care Research. Richard McManus was supported by an NIHR Senior Researcher Award. Richard Hobbs was partially supported by the NIHR Applied Research Collaboration Oxford and Thames Valley.
