New Recommendations Seek to Improve Adherence to Statin Therapy

The International Lipid Expert Panel (ILEP) has issued a new set of recommendations for how to differentiate between true adverse effects (AEs) caused by statins prescribed to lower cholesterol levels and AEs associated with patient expectations regarding what will occur.

The position paper, published in Journal of Cachexia, Sarcopenia and Muscle, details the “nocebo/drucebo” effect and gives a step-by-step approach to diagnosing and managing symptoms, such as muscle aches, so patients can continue to take statins and lower their risk of heart problems, stroke, and death.

According to the paper, “nocebo” refers to the AEs that a patient may experience when given a pill containing no active ingredient, or an inert tablet, whereas “drucebo” refers to the difference in AEs experienced when a tablet containing an active ingredient is taken, whether it is known or blinded that it is a statin.

“The ‘nocebo/drucebo’ effect is when patients’ expectations that they will experience side effects from the statins result in them actually experiencing these symptoms,” said professor Maciej Banach, president of the ILEP and originator of the recommendations, in a press release. “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.”

A recent meta-analysis of statins showed that prevalence of statin intolerance is less than 10%, according to the panel. However, approximately 1 in 2 patients stop taking statins, reduce the dose, or take them irregularly because of fears they will cause AEs.

The study authors added that the Personalized Lipid Intervention Plan (PLIP) proposed in the paper helps patients understand the reasoning and benefits of statin treatment, including, that the medications may prolong their lives. This way, patients can make fully informed decisions about commencing and continuing therapy. Further, the PLIP summarizes important lifestyle advice to help decrease the risk of heart attacks and strokes.

Some of the new recommendations include:

• Health care 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.
• The PLIP is recommended in this process, because it estimates the patient’s 10-year risk of cardiovascular disease with and without statin therapy and provides clear information on AEs.
• Routine follow-ups to check the safety and efficacy of the therapy.
• How to effectively diagnose statin intolerance and exclude nocebo/drucebo effect.
• How to manage patients with no biomarkers that indicate abnormalities and with tolerable statin-associated muscle symptoms (SAMS).
• How to manage patients with biomarker abnormalities and/or intolerable SAMS.
• Strategies for managing patients with complete statin intolerance.

“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,” said Peter Penson, first study author and reader in Cardiovascular Pharmacology at Liverpool John Moores University, in a press release. “However, if prescribers find the advice helpful, we encourage them to share it with colleagues.”

REFERENCE

Are statin side effects all in the mind? International experts recommend ways to improve adherence to statin therapy. EurekAlert! March 10, 2022. Accessed April 5, 2022. https://www.eurekalert.org/news-releases/945907