With fresh research adding a further dimension to the debate on statins, North-East GP Dr Zak Uddin looks at a medication that seems to always spark controversy

NEW research suggests that thousands of people could be unnecessarily placing themselves at an increased risk of heart attack or stroke, due to exaggerated concern over side effects attributed to the cholesterol lowering drugs known as statins.

The study, led by Professor Peter Sever, from the National Heart and Lung institute at Imperial College London, observed almost 10,000 patients. In the first part of the trial, half of the patients were prescribed a low dose statin, and the other half a placebo. Both doctors and patients were unaware of which patients were assigned to the statin or placebo group.

For the second phase of research, those patients taking statins were made aware of this fact. It was demonstrated that reported side effects rose massively once patients became aware that they were taking a statin, the so-called “nocebo effect”.

The authors suggest therefore that reported side effects, including muscle ache, insomnia and erectile dysfunction, are not actually due to the medication itself, and are calling on the Medicines and Healthcare Regulatory Authority (MHRA), to remove these side effects from the product literature.

Cardiovascular death, including heart attacks and strokes, is the cause of over a quarter of all mortalities in the UK, with 160,000 deaths a year, or one every three minutes. It is estimated that statins prevent around 80,000 deaths per year, yet despite this tens if not hundreds of thousands of patients have discontinued these medications, often without consulting a medical professional beforehand.

When levels of circulating cholesterol are high, some of this is deposited in the walls of arteries. These deposits, or plaques, hinder smooth blood flow. If the plaques rupture, this can lead to immediate and complete blockage of the vessel. When this happens in the arteries supplying the heart, a heart attack may ensue, or if in the brain, a stroke. Permanent disability and even death may be immediate. Statins work by reducing the total amount of cholesterol manufactured in the liver. As a result, the liver takes up more cholesterol from the circulation. A secondary benefit is that statins stabilise plaques, reducing their chance of rupture.

Despite their obvious benefits, statins are not completely risk free. The list of potential side effects encompasses the entire body and ranges from general unwell and stomach upset through to intolerable muscle ache, the main reason cited for discontinuing the statins. The one life-threatening complication associated with statins is rhabdomyolysis, where muscle tissue is broken down by the drug. This leads to excess muscle protein in the circulation, which can block the kidneys this preventing them from removing waste products, resulting in life threatening renal failure.

The decision for a person to commence a statin is not based entirely on the level of cholesterol in the blood stream. Using an algorithm which takes into account sex, age, blood pressure, smoking status and family history, the risk of heart attack or stroke in the next ten years is calculated. If the risk is greater than ten per cent, current advice is that the clinician considers commencing a statin, after an informed discussion with the patient.

As suggested above, reducing your cardiovascular risk relies on addressing multiple lifestyle aspects. Regular mild to moderate exercise and a healthy diet low in saturated fats, as well as a reduction in alcohol consumption to sensible levels has long been recognised as a starting point. Smoking has been proven to promote the formation of plaques as well as their chance of rupture, so any attempts at smoking cessation will undoubtedly help.

Despite their best efforts, there will still be a group of people whose cardiovascular risk remains above ten per cent and in these individuals, statins may be appropriate.

The current belief, which I wholeheartedly ascribe to, is that statins do more good than harm, and that the benefits outweigh the risks. Even if you are on a statin, it remains important to address lifestyle issues, as this will still help to lower your risk of a heart attack or stroke. I do not believe that the side effects of statins are entirely due to the nocebo effect. One of the limitations of the study is that the dose of statin used was lower than that traditionally prescribed, and side effects can be dose related.

If you are struggling with symptoms you feel may be down to your statin, it is worth discussing these with your routine GP. Much can be done including lowering the dose, changing to an alternate preparation, or even having a temporary statin holiday, providing you are followed up in a timely manner.