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New guidance on statin intolerance diagnosis

Friday March 11th 2022

International experts today set out guidance for doctors on how to diagnose statin intolerance correctly.

The International Lipid Expert Panel (ILEP) publishes a position paper in the Journal of Cachexia, Sarcopenia and Muscle, providing a step-by-step approach to diagnosing and managing side effects, such as muscle aches, so patients continue to take statins.

Professor Maciej Banach, of the Medical University of Lodz and the University of Zielona Góra, Poland, and president of the ILEP, said as many of 70% of reported statin side effects as due to the “nocebo” or “drucebo” effect.

Nocebo describes adverse side effects that a patient might experience when given an inert tablet, while drucebo refers to either beneficial or adverse side effects that a patient expects when a tablet containing an active ingredient.

“There is an enormous worldwide problem with diagnosing statin intolerance correctly,” he said.

“The ‘nocebo/drucebo’ effect is when patients’ expectations that they will experience side effects from the statins result in them actually experiencing these symptoms.

“Their knowledge is gained from the internet, leaflets, friends and family and other sources, and the most common side effects are muscle pain and liver complaints. It can result in them discontinuing their therapy and, therefore, increasing their risk of heart problems, stroke and death.”

More than 70 experts worldwide agreed the recommendations, which say that healthcare professionals should consider the nocebo/drucebo effect when they first prescribe statins and provide information to patients about the rationale and benefits of the therapy

They add that Personalised Lipid Intervention Plan (PLIP), which estimates the patient’s 10-year risk of cardiovascular disease with and without statin therapy, should be used to help this process.

The ILEP guidance also recommends ways for doctors to effectively diagnose statin intolerance and exclude nocebo/drucebo.

It suggests doctors offer routine follow-up to check the safety and efficacy of the therapy; manage patients with no biomarkers that indicate abnormalities and with tolerable statin-associated muscle symptoms (SAMS); manage patients with biomarker abnormalities and/or intolerable SAMS; and provide strategies for managing patients with statin intolerance.

It also discusses the evidence for non-statin drugs that can be used to lower cholesterol.

A recent meta-analysis showed statin intolerance affects fewer than 10% of people, but as many as one in two patients stop taking the drugs, reduce the dose or take them irregularly because they believe they are responsible for side effects.

First author Dr Peter Penson, a reader in cardiovascular pharmacology at Liverpool John Moores University, Liverpool, UK, said: “This is the first paper to deal explicitly with nocebo/drucebo effect. It offers practical and evidence-based suggestions which we hope will be of use to physicians in improving patient-centred care in individuals who are at risk of cardiovascular disease, but who experience adverse effects attributable to their medicines.

“The benefits of statins are not seen immediately by patients, whilst the associated adverse effects are more tangible, and so many patients stop taking statins, thereby putting themselves at risk of serious illness or death.

“The Personalised Lipid Intervention Plan (PLIP) proposed in our paper helps the patient to understand the reason for their treatment, the large benefits, including that statins may prolong their lives, and the potential harms.

“This allows the patient to make a fully informed decision about commencing and continuing therapy. The PLIP also summarises important lifestyle advice to help them reduce their risk of heart attacks and strokes.

“It’s important that physicians apply their own judgement in the context of the healthcare system in which they work and their knowledge of their individual patients when deciding whether to implement particular recommendations. However, if prescribers find the advice helpful, we encourage them to share it with colleagues.”

Penson PE et al. Step-by-step diagnosis and management of the nocebo/drucebo effect in statin associated muscle symptoms patients: a position paper from the International Lipid Expert Panel (ILEP). Journal of Cachexia, Sarcopenia and Muscle 11 March 2022


Tags: Europe | Heart Health | Pharmaceuticals

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