Why is StatinWISE important?
Our Chief Investigator, Professor Liam Smeeth, talks about the need for a trial like StatinWISE.
What are statins?
Statins are the most commonly prescribed drug treatment in the UK and are given to patients to reduce the risk of heart attacks and strokes, by lowering cholesterol.
Do statins have side effects?
Statins are known to cause very rare but serious side effects such as rhabdomyolysis (breakdown of muscle tissue) but many patients stop taking statins due to less severe muscle symptoms, such as cramps, pain or fatigue.
Trials have not found any differences in these less severe muscle symptoms between patients taking statins and patients taking placebo, but some have questioned whether the information collected in the trials was adequate. Many people stop taking statins because they are having muscle symptoms, but it is often not clear whether the symptoms are caused by statins, or something else.
What is StatinWISE?
StatinWISE is a trial designed to find out whether the muscle symptoms experienced during statin use are caused by statins. The trial is coordinated by the London School of Hygiene and Tropical Medicine (LSHTM) Clinical Trials Unit (CTU) and is funded by the National Institute for Health Research Health Technology Assessment Programme.
What is an N-of-1 trial?
An N-of-1 trial is a trial that takes place within an individual participant. Each participant that joins the trial will be followed-up through a number of different treatment periods. In StatinWISE there are six treatment periods, each of which is two months long.
In some treatment periods, the participant will be given statins, and in other treatment periods, the participant will be given a placebo. The participant will not know whether he/she is taking statins or placebo. During each of the treatment periods, the participant will report back to us on their symptoms. Patients will report their muscle symptoms using a specially designed StatinWISE mobile app, through a website, by post, or over the phone to a member of the StatinWISE team.
At the end of the trial, patients will be shown graphs of their symptom scores and how that related to statin and placebo use. This will help them to understand whether statins are the cause of their muscle symptoms and whether to continue taking statins. The trial team will combine the results from all 200 patients to see how frequently statins are causing side effects in people who think their muscle symptoms are due to statins.
The following video explains the StatinWISE design:
When will the results be available?
The trial has just started recruitment and results are expected in late 2018, though each patient will receive their own results at the end of their 12 month treatment. For the latest news on the StatinWISE trial, please click here.
I have an experience with statins that I would like to share. How can I join the discussion?
We welcome your past experiences with statins, or about participating in the StatinWISE trial, or any other comments or questions that you might like to share with other participants. The comments will be published on our noticeboard after review. Please contact us by emailing statinwise@lshtm.ac.uk.