title: Statin intolerance - a question of definition.
abstract: Statin therapy is the backbone of pharmacologic therapy for low-density lipoproteins cholesterol lowering and plays a pivotal role in cardiovascular disease prevention. Statin intolerance is understood as the inability to continue using a statin to reduce individual cardiovascular risk sufficiently, due to the development of symptoms or laboratory abnormalities attributable to the initiation or dose escalation of a statin. Muscle symptoms are the most common side effects observed. Areas covered: The main aim of this article is to present a review on published definitions of statin intolerance. In addition, a brief review on clinical aspects and risk factors of statin intolerance is provided and features for a common definition for statin intolerance are suggested. Expert opinion: A definition of statin intolerance by major drug regulatory agencies is not available. In clinical studies, different definitions are chosen and results are not comparable; different medical associations do not agree on one common definition. There is an unmet need to establish a common definition of statin intolerance to ensure an appropriate clinical use of this important drug class. Further work is required to develop a consensus definition on statin intolerance that could have significant positive impact on both research and clinical management.
authors.affiliation: a Institut für Klinische Pharmakologie und Toxikologie , Charité - Universitätsmedizin Berlin , Berlin , Germany.|b Department of Clinical Pharmacy, Faculty of Pharmacy , Ain Shams University , Cairo , Egypt.
authors.forename: Engi Abdel-Hady
authors.initials: EA
authors.lastname: Algharably
authors.affiliation: a Institut für Klinische Pharmakologie und Toxikologie , Charité - Universitätsmedizin Berlin , Berlin , Germany.
authors.forename: Iris
authors.initials: I
authors.lastname: Filler
authors.affiliation: c Sanofi-Aventis Deutschland GmbH , Evidence Based Medicine , Berlin , Germany.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Rosenfeld
authors.affiliation: a Institut für Klinische Pharmakologie und Toxikologie , Charité - Universitätsmedizin Berlin , Berlin , Germany.
authors.forename: Katja
authors.initials: K
authors.lastname: Grabowski
authors.affiliation: a Institut für Klinische Pharmakologie und Toxikologie , Charité - Universitätsmedizin Berlin , Berlin , Germany.
authors.forename: Reinhold
authors.initials: R
authors.lastname: Kreutz
mesh_terms: D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control*; D008078:Cholesterol, LDL / Q000097:blood; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D006937:Hypercholesterolemia / Q000188:drug therapy*; D009135:Muscular Diseases / Q000139:chemically induced / Q000453:epidemiology; D012307:Risk Factors
chemical_list: D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
keywords: HMG-CoA reductase inhibitors; PCSK9 inhibitors; hypercholesterolemia; myopathy; statin adverse effects; statin discontinuation