Statin intolerance – a question of definition

Algharably, Engi Abd El-Hady; Filler, Iris; Rosenfeld, Stephanie; Grabowski, K; Kreutz, Reinhold

doi:10.1080/14740338.2017.1238898

Cited by 16 publications

(12 citation statements)

References 64 publications

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“…Thus, just as there are different definitions for the diagnosis of statin intolerance and SAM, the studies also differ in their methodological approaches to reporting the incidence rate. Our estimate, for example, is lower compared to the information from practitioners on the frequency of statin‐associated symptoms in their patients, whom Hovingh et al.…”

Section: Discussionmentioning

confidence: 99%

“…Thus, just as there are different definitions for the diagnosis of statin intolerance and SAM, 21,[34][35][36] the studies also differ in their methodological approaches to reporting the incidence rate. Our estimate, for example, is lower compared to the information from practitioners on the frequency of statin-associated symptoms in their patients, whom Hovingh et al 33 There are some international studies that address estimating the frequency of SAM using administrative data, 26,37-41 but they consider either only severe SAM based on hospital data (hospitalization due to SAM) or SAM restricted to rhabdomyolysis 42 and/or include laboratory values, and thus from a methodological standpoint are not comparable with the study conducted here, which observes SAM exclusively by means of diagnoses (including in the outpatient sector).…”

Section: Frequency Of Statin-associated Myopathy (Sam)mentioning

confidence: 99%

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Statin‐associated myopathy. Assessment of frequency based on data of all statutory health insurance funds in Germany

Ihle

Dippel

Schubert

2018

Pharmacology Res & Perspec

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Aim of the study was to assess the incidence of statin‐associated myopathy (SAM) under real‐life conditions in Germany. Database: Administrative data (master data, diagnoses, prescriptions) for all individuals in Germany insured with the Statutory Health Insurance. Basic population: individuals 18 years and older who have been insured continually from 2009 to 2011 (52.9 million; 29.9 million men, 23.9 million women). Data access is provided by the German Institute of Medical Documentation and Information, DIMDI) according to the Data Transparency Regulation of 2012. Statins: identification with the ATC–Codes: C10AA, C10BA and C10BX. Study population: incident statin users in 2010 with a diagnosis of lipid disorders (ICD‐10‐GM E78, excluding patients with: E78.1, E78.3, E78.6 in eight quarters before index prescription. Definition of SAM: documentation of myopathy (ICD‐10‐GM G72.0, G72.8; G72.9, M60.8, M60.9, M79.1) in the first statin prescription quarter or in one of the three following quarters. The first event is considered for the incidence estimate. The daily doses included in a package were classified as “days under therapy” (by assuming one DDD) and taken as exposition time. SAM was found in 1.9% of 531 672 incident statin users. The percentage differs according to the patterns of statin use: the lowest incidence is observed in those with only one prescription (1.3%), the highest incidence with 5.0% is observed in those who not only stopped the treatment within 365 days, but who also had their statin changed. Administrative data including diagnoses from ambulatory care provide a realistic estimate of SAM frequency in every day practice.

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Section: Discussionmentioning

confidence: 99%

Section: Frequency Of Statin-associated Myopathy (Sam)mentioning

confidence: 99%

Statin‐associated myopathy. Assessment of frequency based on data of all statutory health insurance funds in Germany

Ihle

Dippel

Schubert

2018

Pharmacology Res & Perspec

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“…The definition of statin intolerance (Table 1 ) is a question of great interest and debate [ 20 ]. Intolerance (partial or complete) should be defined as an inability to tolerate a suitable dose of a statin required for a given patient’s CV risk (e.g., intolerance of atorvastatin 40–80 mg or rosuvastatin 20–40 mg by a patient with ACS).…”

Section: Methodsmentioning

confidence: 99%

“…Intolerance can become clinically apparent with a variety of clinical adverse effects that significantly impair organ function and/or quality of life after intake of any statin at any dose (complete intolerance) with or without associated laboratory abnormality (increase in creatine kinase [CK]), or can manifest with temporal associations between symptoms and the onset of therapy or increased dose (partial intolerance) (usually within 3–6 months). Discontinuation or dose reduction of the drug (statin dechallenge) or replacement with another statin can result in remission of symptoms and confirms a diagnosis of statin intolerance [ 20 ]. According to Mancini et al [ 21 ], about 70–80% of statin-treated patients are tolerant to treatment, and 20–30% are suspected to be statin intolerant.…”

Section: Methodsmentioning

confidence: 99%

Management of Statin Intolerance in 2018: Still More Questions Than Answers

Tóth

Patti

Giglio

et al. 2018

Am J Cardiovasc Drugs

143

108

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Statin therapy is generally well tolerated and very effective in the prevention and treatment of cardiovascular disease, regardless of cholesterol levels; however, it can be associated with various adverse events (myalgia, myopathy, rhabdomyolysis, and diabetes mellitus, among others). Patients frequently discontinue statin therapy without medical advice because of perceived side effects and consequently increase their risk for cardiovascular events. In patients with statin intolerance, it may be advisable to change the dose, switch to a different statin, or try an alternate-day regimen. If intolerance is associated with all statins—even at the lowest dose—non-statin drugs and certain nutraceuticals can be considered. This review focuses on the definition of statin intolerance and on the development of clinical and therapeutic strategies for its management, including emerging alternative therapies.

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“…However, we often encounter patients with statin intolerance. Statin intolerance is understood as the inability to continue the statin therapy, due to the development of symptoms or laboratory abnormalities attributable to the initiation or dose escalation of statin [1]. Muscle symptoms are the most commonly observed adverse effect of statin.Familial hypercholesterolemia (FH) is characterized by severely elevated low-density lipoprotein-cholesterol (LDL-C) levels.…”

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confidence: 99%

Statin Intolerance in Familial Hypercholesterolemia

Yanai

Katsuyama

2020

J Endocrinol Metab

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Statin therapy is the gold standard for suppressing cardiovascular events in hypercholesterolemic patients. However, we often encounter patients with statin intolerance. Statin intolerance is understood as the inability to continue the statin therapy, due to the development of symptoms or laboratory abnormalities attributable to the initiation or dose escalation of statin [1]. Muscle symptoms are the most commonly observed adverse effect of statin.Familial hypercholesterolemia (FH) is characterized by severely elevated low-density lipoprotein-cholesterol (LDL-C) levels. Several mutations in genes have been noted in patients with FH: LDL receptor (most common), apolipoprotein B, proprotein convertase subtilin/kexin 9 (PCSK9) and LDL receptor adaptor protein [2]. The prevalence of the heterozygous state has been estimated at 1 in 200 to 1 in 500 and of the homozygous state from 1 in 160,000 to 1 in 1,000,000. FH is common in individuals who had coronary artery disease (CAD) such as myocardial infarction at young age [3]. Therefore, more aggressive cholesterol lowering therapy is required to prevent CAD in FH patients.In a previous study that analyzed the clinical influence of statins on age at the first clinical onset of CAD in 329 FH patients, the age at onset of CAD in patients on statins at onset was significantly higher than that in patients not on statins by more than 10 years old, suggesting that statins have improved the clinical course of patients with heterozygous FH [4]. In the study which examined possible statin intolerance by using the Japan Medical Data Center database, 10% had possible statin intolerance [5].Since heterozygous FH is a common inherited metabolic disorder and statin intolerance is also a common medical condition, we are likely to encounter heterozygous FH patients with statin intolerance. What should we do if we encounter such patients? We think that the advent of PCSK9 inhibitors is a gospel for such patients. PCSK9 plays a critical role controlling serum LDL-C levels. Several gain-of-function and loss-of-function mutations in the PCSK9 gene, which occur naturally, have been identified and linked to hypercholesterolemia and hypocholesterolemia, respectively [6]. PCSK9 acts mainly by enhancing degradation of LDL receptor protein in the liver [6]. Inactivation of PCSK9 in mice reduces plasma cholesterol levels primarily by increasing hepatic expression of LDL receptor protein and thereby accelerating clearance of circulating LDL-C.We experienced a heterozygous FH patient with statin intolerance. This patient showed myalgia and elevation of creatine phosphokinase (CPK) by using atorvastatin and rosuvastatin, and gave up the statin therapy and started to use PCSK9 inhibitor. The monotherapy of PCSK9 inhibitor reduced serum LDL-C from 235 to 80 mg/dL and did not induce myalgia and elevation of CPK.In conclusion, PCSK9 inhibitor is a promising therapeutic option for heterozygous FH patients with statin intolerance.

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Statin intolerance – a question of definition

Cited by 16 publications

References 64 publications

Statin‐associated myopathy. Assessment of frequency based on data of all statutory health insurance funds in Germany

Statin‐associated myopathy. Assessment of frequency based on data of all statutory health insurance funds in Germany

Management of Statin Intolerance in 2018: Still More Questions Than Answers

Statin Intolerance in Familial Hypercholesterolemia

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