Developing a new technology to detect people who experience side effects from statins

Statin side effect or not? A patient-empowering within-subject randomized controlled trial and development of a practical technology to support 21st century primary prevention decisions

Professor Darrel Francis and his team are studying new ways to help doctors work out which patients are experiencing side effects from statins. Statins are drugs that lower cholesterol and markedly reduce the chance of heart attacks and strokes. Despite their effectiveness many people stop taking statins, believing they cause side effects. Large analyses of the many people who have received statins in clinical trials have shown no increase in side effects in those taking statins, suggesting that most side effects may be caused by the psychological effects of taking medication. But currently, doctors currently have no way of establishing if the side effects their patients report are directly due to the statin or not. In this project, Professor Francis will develop and test a method that assesses whether side effects experienced by people on statins are directly caused by the drug or if they may be psychological. He will recruit around 50 people who are taking statins but who have stopped taking their drugs because of perceived side effects. These people will then alternate randomly between taking statins and taking a dummy drug or placebo (without knowing which they are taking). They will document their side effects using an app on a smartphone. Analysis of these results will determine if the side effects they record are related to the statin or related to taking medicine (even a dummy drug). This new technology will be freely available for doctors, patients and researchers, and could, in principle, be used for any drug. This research will lead to a tool to help to establish whether people are getting side effects from statins, empowering them to make more accurate, more informed decisions about whether to continue taking these drugs.