CompletedPhase IVInterventional

Web-based investigation of statin side-effects

Statins are common medicines that lower cholesterol and help protect against heart attacks and strokes. However, many people stop taking them because of muscle aches or tiredness. Aches are very common anyway, so it is often hard to know whether the statin or something else is causing them. Stopping statins can raise your risk of heart problems, so knowing the true cause of your pain is important. This study helps you and your GP find out if statins are truly causing your symptoms. Over one year, you take capsules sent to your home in the post. You will switch between a statin (atorvastatin) and a dummy pill (placebo) every two months in a random order. You report your muscle symptoms using an app, website, phone call, or paper form. At the end, you and your GP review your personal results together to decide the best step for your health.

At a glance

Status

Completed

Phase

Phase IV

Sponsor

London School of Hygiene and Tropical Medicine

Enrolment target

200

Start

01 Dec 2016

Estimated completion

04 Jun 2018

Cardiovascular disease

What is this study about?

Statins are widely used medicines across the UK that lower 'bad' cholesterol in the blood. By keeping cholesterol down, they help stop fatty deposits from clogging your arteries. This lowers the chance of having a serious heart attack or stroke. However, muscle aches, pains, and stiffness are frequently reported by people taking these medicines. Because everyday aches are already very common as we go about our lives, doctors and patients often struggle to tell if a statin is the true culprit or if something else is causing the discomfort.

When people stop taking their statin because of muscle pain, their long-term risk of cardiovascular disease rises by around a third. This creates a difficult choice: put up with uncomfortable aches, or stop the tablet and face a higher risk of heart problems. This clinical trial was designed to give patients clear, personal answers so they can make the best choice for their own health.

In this trial, you act as your own comparison. Over a 12-month period, you take treatment blocks of a real statin (atorvastatin) and a dummy pill that looks identical but contains no medicine. By tracking how you feel during both periods without knowing which pill you are taking, you can clearly see whether your muscle pain happens more often on the real medicine. Your GP will then use your results to help you decide whether staying on statins is right for you.

Key takeaways

Helps you find out if your muscle aches are truly caused by statins.
Compares a real statin (atorvastatin) against a dummy pill over 12 months.
Medicine is delivered directly to your home in convenient two-month supplies.
You track symptoms easily using an app, website, phone call, or paper form.
You and your GP receive your personal results at the end to guide your care.

Who may be eligible?

This study is open to adults aged 16 and over who have been prescribed a statin in the last three years. You may be able to join if you have recently stopped taking your statin, or are thinking about stopping, because of unwanted muscle symptoms like aches, pain, or weakness.

You cannot take part if you have certain health conditions that make taking statins unsafe. This includes having significantly raised liver enzyme levels or very high levels of a muscle enzyme called creatine kinase, especially alongside persistent muscle pain. Your GP will also check whether taking a standard 20mg dose of atorvastatin is suitable for you before you start.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 16 or over.
I was prescribed a statin within the last 3 years.
I have stopped or want to stop my statin due to muscle aches or pain.
I do not have known severe liver or muscle disease.
My GP agrees that taking 20mg of atorvastatin is safe for me.

Answer every question to see your result.

What does participation involve?

Taking part lasts for just over a year. It begins with a single visit to your GP surgery to meet a research nurse. They will answer your questions, check your blood pressure, height, and weight, and arrange a routine safety blood test. You can also choose to give an extra blood sample for genetic research, but this is completely optional.

Once enrolled, your study pills will be delivered directly to your home in the post. You will take one capsule daily for a total of 12 months. Every two months, the treatment changes between atorvastatin and a dummy pill in a random order. Neither you nor your doctor will know which capsule you have each month. Every two months, you will answer seven short questions about your muscle aches using a smartphone app, website, quick telephone call, or paper form.

After 12 months, you will have a consultation with your GP or nurse to look at your personal symptom report and decide what to do next. Three months later, the study team will contact you once more to see how you are getting on.

Potential risks and benefits

The main benefit of taking part is discovering whether your muscle aches are genuinely linked to statin use, which helps you and your GP make a well-informed choice about protecting your heart. The main risk is experiencing muscle aches during the months you receive the statin. Very rarely, statins can cause a serious muscle condition called rhabdomyolysis, but this affects fewer than 2 in 10,000 people. You are closely monitored throughout the trial, and you are free to leave the study at any time without it affecting your normal medical care.

Locations (58)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Albion Street Practice
Unverified
London, England
Bay Medical
Unverified
Heysham NO COUNTRY SPECIFIED, assuming England, England
Bentley Surgery
Unverified
Doncaster, England
Brigstock & South Norwood Partnership
Unverified
Surrey, England
Bromley Common Practice
Unverified
Bromley, England
Brownlow Health
Unverified
Liverpool, England
Clarence Medical Centre
Unverified
Rhyl, Wales
Cleverleys Group Practice
Unverified
Thornton-Cleveleys, England
Conisbrough Group Practice
Unverified
Conisbrough, England
Creffield Medical Centre
Unverified
Colchester, England
Everglades Medical Practice
Unverified
London, England
The Exchange Surgery
Unverified
London, England

Common questions

Will I know if I am taking the statin or the dummy pill?

No. The capsules look and taste identical. Keeping this hidden helps ensure that everyday aches are reported fairly. However, your doctor can find out immediately in an emergency.

What is a placebo?

A placebo is a harmless dummy pill that looks just like the real medicine but contains no active ingredients. It helps scientists see if symptoms are caused by the medicine itself.

Do I have to visit a hospital to take part?

No. The initial appointment takes place at your local GP surgery, the pills arrive by post, and you can report your symptoms from home using your phone, computer, or by post.

Do I have to agree to the optional genetic blood test?

No. The genetic test is entirely optional. You can still take part in the main statin study even if you prefer not to give a sample for genetic research.

What happens after the 12 months of tablets finish?

You will review your personal symptom chart with your GP. Seeing how your body responded to both the statin and the dummy pill will help you both agree on the best plan for your heart health.

How to find out more

Kieran Brack

statinwise@lshtm.ac.uk +44 207 958 8195 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.