Statin intolerance – an attempt at a unified definition. Position paper from an International Lipid Expert Panel

Abstract

Statins are one of the most commonly prescribed drugs in clinical practice. They are usually well tolerated and effectively prevent cardiovascular events. Most adverse effects associated with statin therapy are muscle-related. The recent statement of the European Atherosclerosis Society (EAS) has focused on statin-associated muscle symptoms (SAMS), and avoided the use of the term ‘statin intolerance’. Although muscle syndromes are the most common adverse effects observed after statin therapy, excluding other side effects might underestimate the number of patients with statin intolerance, which might be observed in 10 – 15% of patients.

In clinical practice, statin intolerance limits effective treatment of patients at risk of, or with, cardiovascular disease. Knowledge of the most common adverse effects of statin therapy that might cause statin intolerance and the clear definition of this phenomenon is crucial to effectively treat patients with lipid disorders. Therefore, the aim of this position paper was to suggest a unified definition of statin intolerance, and to complement the recent EAS statement on SAMS, where the pathophysiology, diagnosis and the management were comprehensively presented.

Keywords:

• definition
• muscle symptoms
• risk factors
• statin intolerance

Acknowledgments

This paper is also published in parallel in Archives of Medical Science [Banach et al. Statin intolerance – an attempt at a unified definition. Position paper from an International Lipid Expert Panel. Arch Med Sci 2015; 11, 1: 1–23]. Each publisher holds its own copyright.

Declaration of interest

M Banach has given lectures, received honoraria or research support, and participated in conferences, advisory boards and clinical trials sponsored by Abbott, Amgen, Daiichi-Sankyo, MSD, and Sanofi-Regeneron; M Rizzo – AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Bromatech, Chiesi Farmaceutici, Kowa, MSD Merck Sharp & Dohme, Novartis, Novo Nordisk, Rikrea and Servier; PP Toth – Amarin, Amgen, AstraZeneca, Genzyme, GSK, Kowa, Merck, Novartis, Regeneron; M Farnier – Abbott, Amgen, AstraZeneca, Eli Lilly, Genzyme, Kowa, Merck, Novartis, Pfizer, Recordati, Roche and Sanofi-Regeneron; RS Greenfield – Aegerion, Merck and Sanofi-Regeneron; GK Hovingh – Amgen, AstraZeneca, Pfizer, Roche and Sanofi; SJ Nicholls – Amgen, Anthera, AstraZeneca, Atheronova, Boehringer Ingelheim, Cerenis, CSL Behring, Kowa, Merck, Novartis, Omthera, Pfizer, Resverlogix, Roche, Sanofi-Regeneron, Takeda and The Medicines Company; L Bajnok – AstraZeneca, Amgen, Krka and MSD; KK Ray – Abbott, Aegerion, Amgen, AstraZeneca, Cerenis, Eli Lilly, Kowa, MSD, Pfizer, Resverlogix, Roche and Sanofi-Regeneron; DP Mikhailidis – AstraZeneca, Genzyme and MSD. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.