London School of Hygiene & Tropical Medicine

The Statin: Web-based Investigation of Side Effects (Statin WISE) trial, funded by the National Institute of Health Research (NIHR), aims to determine whether muscle pain symptoms occurring during statin use are caused by the drug. It will use a bespoke mobile smartphone app to record whether muscle pains are more common in patients taking statins, compared to those taking a placebo.

Statins, drugs that lower cholesterol and reduce the risk of heart attacks and strokes, are the most commonly prescribed treatment in the UK. They can cause very rare but serious side effects such as rhabdomyolysis (breakdown of muscle tissue) and its milder form, myopathy.

Many patients stop taking statins due to less severe symptoms, such as muscle pain or fatigue. However, so far trials have not been able to show if these symptoms are more common in patients taking statins or placebo. It has been suggested that patients' awareness of rare muscle breakdown side effects may cause them to expect similar symptoms, and to attribute their muscle pains to statins in a 'nocebo' effect. 

The Statin WISE trial, starting in April 2016, will involve 200 participants who have recently either stopped taking statins due to less severe muscle pains, or discussed such symptoms with their doctor. After taking either a statin or placebo for two months, the patients will use a purpose-built smartphone app or paper diary to record their symptoms.

Patients will use the app to measure and record their muscle symptoms, including pain, weakness, tenderness, stiffness or cramps. The researchers will use this information to assess whether statins are in fact directly causing muscle pain or other adverse side-effects in patients.

Liam Smeeth, Chief Investigator in the trial and Professor of Clinical Epidemiology at the School, said: "Statins are known to be effective in reducing heart disease and strokes, and more than 2 million people in the UK are eligible to be prescribed these drugs by their doctor. Therefore, it is vital that we have accurate data on the symptoms people are experiencing while taking statins, so that patients and doctors can make informed treatment choices."

Trial participants will be recruited from GP surgeries and randomly allocated to two groups. They will be given either a statin (atorvastatin, 20mg) or placebo for two months, with data collected on the final seven days of each two-month period. This process will be repeated six times during the year-long study.

As this is a double-blind placebo controlled trial, neither the participants themselves nor the researchers analysing the data will know which medicine they have been given.

Patients will continue to receive standard care by their GP for the duration of the study and any serious adverse events will be reported to the study team.

The research is funded by a major grant of more than £950,000 from NIHR, and is coordinated by the London School of Hygiene & Tropical Medicine Clinical trials Unit with partners at the University of Oxford and University of Manchester.

This article presents independent research funded by the National Institute for Health Research(NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.