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Statin Safety: What Every Health Care Provider Needs to Know

  • NOVEL and EMERGING RISK FACTORS (K. Nasir, Section Editor)
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Abstract

Purpose of Review

A key target for quality improvement in preventive cardiology is statin therapy, which is underutilized in appropriate high-risk patients for LDL-lowering to prevent atherosclerotic cardiovascular disease events. Translation of statin evidence to practice may be impeded by exaggerated concerns about adverse effects. We aim to cut through an immense amount of controversy in the scientific and mainstream discourse of statin safety by clearly demarcating the reported adverse events based on the reliability of the supporting evidence.

Recent Findings

In large-scale randomized controlled trials, statin therapy achieving 80 mg/dl (2 mmol/L) reduction in serum LDL-C for 5 years in 10,000 patients would prevent major vascular events in ~ 1000 secondary prevention and ~ 500 primary prevention patients with cardiovascular risk factors. Compared to these benefits, the incidence of adverse events is remarkably low. Based on the same high-quality trial evidence, treatment of 10,000 patients with a standard statin therapy for 5 years would be expected to lead to 5 new cases of myopathy, 50–100 cases of diabetes, and possibly 5–10 cases of hemorrhagic stroke. These adverse effects have already been accounted for in estimates of benefits. Various other adverse events have been misattributed to statins mainly as a result of the large biases inherent in observational studies, which are not designed to assess drug treatment effects.

Summary

Large-scale randomized evidence indicates that a small increase in myopathy, diabetes, and hemorrhagic stroke may occur with statin therapy, but these adverse effects are greatly outweighed by the cardiovascular benefit of statin therapy. When evaluating statin safety, the reliability of underlying evidence warrants close consideration.

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Authors and Affiliations

  1. Division of Cardiology, Department of Medicine, Johns Hopkins Ciccarone Center for the Prevention of Heart Disease, Johns Hopkins University School of Medicine, Baltimore, MD, USA

    Shamsudini Hashi, Vasanth Sathiyakumar, Kathleen Byrne, Steven R. Jones & Seth S. Martin

  2. Pediatric Cardiology, Johns Hopkins Hospital, Baltimore, MD, USA

    Kathleen Byrne

  3. Division of Cardiology, Department of Medicine, Weill Cornell Medical College-Qatar, Education City, Doha, Qatar

    Mohamed B. Elshazly

  4. Department of Epidemiology, Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA

    Seth S. Martin

  5. 600 N. Wolfe St, Carnegie 591, Baltimore, MD, 21287, USA

    Seth S. Martin

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  1. Shamsudini Hashi
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Correspondence to Seth S. Martin.

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Conflict of Interest

Dr. Byrne, Dr. Elshazly, Dr. Sathiyakumar, and Hashi have nothing to declare.

Dr. Jones and Dr. Martin have a patent novel method for estimation of LDL Cholesterol licensed to Johns Hopkins University.

Dr. Martin reports grants from the PJ Schafer Cardiovascular Research Fund, David and June Trone Family Foundation, Maryland Innovation Initiative, American Heart Association, Aetna Foundation, CASCADE FH, Google, and Apple. He reports participation on scientific advisory boards for Quest, Amgen, and Sanofi/Regeneron.

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This article is part of the Topical Collection on Novel and Emerging Risk Factors

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Hashi, S., Sathiyakumar, V., Byrne, K. et al. Statin Safety: What Every Health Care Provider Needs to Know. Curr Cardiovasc Risk Rep 12, 1 (2018). https://doi.org/10.1007/s12170-018-0565-x

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