Risks Associated With Statin Therapy

Kashani, Amir; Phillips, Christopher; Foody, JoAnne M.; Wang, Yongfei; Mangalmurti, Sandeep; Ko, Dennis T.; Krumholz, Harlan M.

doi:10.1161/circulationaha.106.624890

Cited by 421 publications

(136 citation statements)

References 72 publications

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“…However, they are not supported by the randomized controlled trial evidence: in particular, statin therapy has been found to be no less well tolerated than placebo (see below and webtable). 52,62,[236][237][238][239] As is discussed above, the potential biases inherent in studies without both randomly assigned control groups and blinded ascertainment of outcomes limit their ability to demonstrate causal associations (except for large effects on rare outcomes). This is particularly the case for symptomatic adverse events that are attributed to statin use, especially if such reports have been prompted by guidance from clinicians to their patients or from patient information leaflets and other sources.…”

Section: Other Adverse Events That Have Been Attributed To Statin Thementioning

confidence: 99%

Interpretation of the evidence for the efficacy and safety of statin therapy

et al. 2016

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General rightsThis document is made available in accordance with publisher policies. Please cite only the published version using the reference above. Full terms of use are available: http://www.bristol.ac.uk/pure/about/ebr-terms SummaryThis review is intended to help clinicians, patients and the public make informed decisions about statin therapy for the prevention of heart attacks and strokes. It explains how the evidence that is available from randomized controlled trials yields reliable information about both the efficacy and safety of statin therapy. In addition, it discusses how claims that statins commonly cause adverse effects reflect a failure to recognise the limitations of other sources of evidence about the effects of treatment.Large-scale randomized trial evidence shows that statin therapy reduces the risk of heart attacks, ischaemic strokes and coronary revascularization procedures ("major vascular events") by about one quarter for each mmol/L reduction in low density lipoprotein (LDL) cholesterol during each year (after the first) that it continues to be taken. The absolute benefits of statin therapy depend on an individual's absolute risk of occlusive vascular events and the absolute reduction in LDL cholesterol that is achieved. For example, lowering LDL cholesterol by 2 mmol/L (77 mg/dL) with an effective low-cost statin regimen (e.g. atorvastatin 40 mg daily, costing about £2 per

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Section: Other Adverse Events That Have Been Attributed To Statin Thementioning

confidence: 99%

Interpretation of the evidence for the efficacy and safety of statin therapy

et al. 2016

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“…Therefore, statin therapy is currently the recommended standard‐of‐care treatment for lowering LDL‐C in patients at increased CVD risk 2, 3. In contrast to all major randomized controlled trials, which have found comparable rates of muscle adverse events (AEs) between statin and placebo arms,4, 5, 6 observational studies reported higher rates of statin‐associated muscle symptoms (SAMS) in 7% to 29% of patients 7. As a consequence, patients with SAMS often receive a suboptimal statin dose or no statin therapy 7.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Alirocumab 150 mg Every 4 Weeks in Patients With Hypercholesterolemia Not on Statin Therapy: The ODYSSEY CHOICE II Study

Stroes

Guyton

Lepor

et al. 2016

JAHA

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BackgroundThe PCSK9 antibody alirocumab (75 mg every 2 weeks; Q2W) as monotherapy reduced low‐density lipoprotein‐cholesterol (LDL‐C) levels by 47%. Because the option of a monthly dosing regimen is convenient, ODYSSEY CHOICE II evaluated alirocumab 150 mg Q4W in patients with inadequately controlled hypercholesterolemia and not on statin (majority with statin‐associated muscle symptoms), receiving treatment with fenofibrate, ezetimibe, or diet alone.Methods and ResultsPatients were randomly assigned to placebo, alirocumab 150 mg Q4W or 75 mg Q2W (calibrator arm), with dose adjustment to 150 mg Q2W at week (W) 12 if W8 predefined LDL‐C target levels were not met. The primary efficacy endpoint was LDL‐C percentage change from baseline to W24. Mean baseline LDL‐C levels were 163.9 mg/dL (alirocumab 150 mg Q4W, n=59), 154.5 mg/dL (alirocumab 75 mg Q2W, n=116), and 158.5 mg/dL (placebo, n=58). In the alirocumab 150 mg Q4W and 75 mg Q2W groups (49.1% and 36.0% of patients received dose adjustment, respectively), least‐squares mean LDL‐C changes from baseline to W24 were −51.7% and −53.5%, respectively (placebo [+4.7%]; both groups P<0.0001 versus placebo). In total, 63.9% and 70.3% of alirocumab‐treated patients achieved their LDL‐C targets at W24. Treatment‐emergent adverse events occurred in 77.6% (alirocumab 150 mg Q4W), 73.0% (alirocumab 75 mg Q2W), and 63.8% (placebo) of patients, with injection‐site reactions among the most common treatment‐emergent adverse events.ConclusionsAlirocumab 150 mg Q4W can be considered in patients not on statin with inadequately controlled hypercholesterolemia as a convenient option for lowering LDL‐C.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02023879.

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“…2). Furthermore, a review of randomized statin trials demonstrated that statin therapy is associated with a slightly increased risk of transaminase elevations, but not of myalgias, creatine kinase elevations, rhabdomyolysis, or withdrawal of therapy compared with placebo 29. Last, ASCVD is one of the most important global causes of morbidity and mortality, and the most important and clinically treatable risk factor is LDL‐C 30.…”

Section: Discussionmentioning

confidence: 99%

“…Last, ASCVD is one of the most important global causes of morbidity and mortality, and the most important and clinically treatable risk factor is LDL‐C 30. Therefore, given the favorable safety profile of statins and disastrous outcomes of CHD, the benefits of statin therapy clearly outweigh the risks of overtreatment in an era when CHD remains a world‐wide public health issue 29, 30, 31…”

Section: Discussionmentioning

confidence: 99%

2013 ACC/AHA Cholesterol Guideline Versus 2004 NCEP ATP III Guideline in the Prediction of Coronary Artery Calcification Progression in a Korean Population

Cho

Jung

Kang

et al. 2016

JAHA

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BackgroundSince the release of the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines, significant controversy has surrounded the applicability of the new cholesterol guidelines and the Pooled Cohort Equations. In this present study, we investigated whether eligibility for statin therapy determined by the 2013 ACC/AHA guidelines on the management of blood cholesterol is better aligned with the progression of coronary artery calcification (CAC) detected by coronary computed tomography angiography (CCTA) than the previously recommended 2004 National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guidelines.Methods and ResultsWe enrolled 1246 asymptomatic participants who underwent repeated CAC score measurement during routine health examinations. The CAC score progression was defined as either incident CAC in a population free of CAC at baseline or increase ≥2.5 units between the baseline and final square root of CAC scores participants who had detectable CAC at baseline examination. Application of the ACC/AHA guidelines to the study population increased the proportion of statin‐eligible subjects from 20.5% (according to ATP III) to 54.7%. Statin‐eligible subjects, as defined by ACC/AHA guidelines, showed a higher odds ratio for CAC score progression than those considered statin eligible according to ATP III guidelines (2.73 [95% CI, 2.07–3.61] vs 2.00 [95% CI, 1.49–2.68]).ConclusionsCompared with the ATP III guidelines, the new ACC/AHA guidelines result in better discrimination of subjects with cardiovascular risk detected by CAC score progression in an Asian population.

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Risks Associated With Statin Therapy

Cited by 421 publications

References 72 publications

Interpretation of the evidence for the efficacy and safety of statin therapy

Interpretation of the evidence for the efficacy and safety of statin therapy

Efficacy and Safety of Alirocumab 150 mg Every 4 Weeks in Patients With Hypercholesterolemia Not on Statin Therapy: The ODYSSEY CHOICE II Study

2013 ACC/AHA Cholesterol Guideline Versus 2004 NCEP ATP III Guideline in the Prediction of Coronary Artery Calcification Progression in a Korean Population

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