Statin myopathy: the fly in the ointment for the prevention of cardiovascular disease in the 21st century?

Keen, Helen; Krishnarajah, Janakan; Bates, Timothy R.; Watts, Gerald F.

doi:10.1517/14740338.2014.937422

Cited by 37 publications

(33 citation statements)

References 71 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Despite treatment of these, a residual risk remains. Other barriers include nonadherence with statin therapy, often due to adverse effects [8,9], particularly myopathy; genetic disorders such as familial hypercholesterolemia (FH) causing extremely high plasma levels of LDL-C that cannot be sufficiently lowered by statin therapy alone [10]; and elevation in the plasma concentration of lipoprotein(a) [Lp(a)], an atherogenic LDL-like particle for which no proven therapeutic agent exists [11]. Late detection and treatment of atherogenic dyslipidemia also presents a challenge to cardiovascular risk reduction.…”

Section: Introductionmentioning

confidence: 99%

Evolocumab in the treatment of dyslipidemia: pre-clinical and clinical pharmacology

Page

Watts

2015

Expert Opinion on Drug Metabolism & Toxicology

Self Cite

View full text Add to dashboard Cite

The dramatic reduction in plasma levels of LDL-C attributable to evolocumab is anticipated to translate into lower rates of atherosclerotic cardiovascular disease, but this hypothesis remains to be proven. Also to be established are the long-term safety and economic benefits of evolocumab. PCSK9 inhibitors will also probably provide a valuable option for patients with statin intolerance, those with FH and patients with elevated plasma levels of Lp(a).

show abstract

Section: Introductionmentioning

confidence: 99%

Evolocumab in the treatment of dyslipidemia: pre-clinical and clinical pharmacology

Page

Watts

2015

Expert Opinion on Drug Metabolism & Toxicology

Self Cite

View full text Add to dashboard Cite

show abstract

“…Despite best efforts, including modified dosing strategies and specialist input, ~30% of these patients will not be able to take a statin . Myopathy, gastrointestinal symptoms and elevated liver enzymes account for most cases of statin intolerance …”

Section: Need For New Therapies Targeting Apob100‐containing Lipoprotmentioning

confidence: 99%

“…48 Myopathy, gastrointestinal symptoms and elevated liver enzymes account for most cases of statin intolerance. [49][50][51] Statin-associated muscle symptoms (SAMS) include any muscle pain or weakness, with or without elevated plasma levels of creatine kinase, and incorporate myalgia, myositis, rhabdomyolysis and asymptomatic elevations in creatine kinase. 52 It is noteworthy that myopathy was reported in many statin trials as being no more frequent in statin-treated groups than placebo groups.…”

Section: Statin Intolerancementioning

confidence: 99%

PCSK9 in context: A contemporary review of an important biological target for the prevention and treatment of atherosclerotic cardiovascular disease

Page

Watts

2017

Diabetes Obesity Metabolism

View full text Add to dashboard Cite

The identification of the critical role of proprotein convertase subtilisin/kexin type 9 (PCSK9) has rapidly led to the development of PCSK9 inhibition with monoclonal antibodies (mAbs). PCSK9 mAbs are already in limited clinical use and are the subject of major cardiovascular outcomes trials, which, if universally positive, could see much wider clinical application of these agents. Patients with familial hypercholesterolaemia are the most obvious candidates for these drugs, but other patients with elevated cardiovascular risk, statin intolerance or hyperlipoproteinaemia(a) may also benefit. PCSK9 mAbs, administered once or twice monthly, reduce LDL cholesterol levels by 50% to 70%, and appear to be safe and acceptable to patients over at least 2 years of treatment; however, treatment-emergent adverse effects are not always identified in clinical trials, as well-evidenced by statin myopathy. Inclisiran is a promising RNA-based therapy that promotes the degradation of PCSK9 mRNA transcripts and has similar efficacy to mAbs, but with a much longer duration of action. The cost-effectiveness and long-term safety of therapies targeted at inhibiting PCSK9 remain to be demonstrated if they are to be used widely in coronary prevention.

show abstract

“…Nonetheless, in Germany, there is a lack of reliable data, such as how frequently muscle disorders and muscle ailments occur. The frequency estimates of statin intolerance are scattered in the literature depending on the definition and investigation method, from 0.01% to 10% . Registries and observational studies identified values from 7% to 29% .…”

Section: Introductionmentioning

confidence: 99%

“…The frequency estimates of statin intolerance are scattered in the literature depending on the definition and investigation method, from 0.01% to 10%. 13 Registries and observational studies identified values from 7% to 29%. 14,15 In clinical trials (RCTs), in contrast, there are only minor differences in the side effects compared to placebo.…”

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

View full text Add to dashboard Cite

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.

show abstract

Statin myopathy: the fly in the ointment for the prevention of cardiovascular disease in the 21st century?

Cited by 37 publications

References 71 publications

Evolocumab in the treatment of dyslipidemia: pre-clinical and clinical pharmacology

Evolocumab in the treatment of dyslipidemia: pre-clinical and clinical pharmacology

PCSK9 in context: A contemporary review of an important biological target for the prevention and treatment of atherosclerotic cardiovascular disease

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

Contact Info

Product

Resources

About