@article{f159f6893be9491ba8662406d7f93ca4,
title = "With Current Safety and Efficacy Data, Should Statins Be Made Available as Nonprescription Over-the-Counter Drugs?",
abstract = "Purpose of Review: Statins inhibit the enzyme 3-hydroxy-3-methylglutaryl-coenzyme A reductase in the liver and reduce atherosclerotic cardiovascular disease (ASCVD) risk by enhancing low-density lipoprotein (LDL) clearance from the circulation. In this review, we discuss their efficacy, safety, and real-world utilization to make a case for reclassifying statins as nonprescription over-the-counter drugs to improve access and availability with the overarching goal of increasing statin utilization in patients most likely to benefit from this class of therapy. Recent Findings: Statin efficacy for reducing risk in primary and secondary ASCVD prevention populations as well as their safety and tolerability has been thoroughly investigated in large-scale clinical trials over the past 3 decades. Despite the overwhelming scientific evidence, statins are underutilized even among those at the highest ASCVD risk. Summary: We propose a nuanced approach to use statins as nonprescription drugs that leverages a multi-disciplinary clinical model. It integrates lessons learned from experiences outside the USA with a proposed Food and Drug Administration rule change that allows nonprescription drug products with an additional condition for nonprescription use.",
keywords = "Dyslipidemia, Hydroxymethylglutaryl-CoA reductase inhibitors, Nonprescription drugs, Primary prevention, Secondary prevention",
author = "Anurag Mehta and Dixon, {Dave L.} and Anum Saeed and Kelly, {Michael S.} and Martha Gulati and Shapiro, {Michael D.} and Sperling, {Laurence S.} and Virani, {Salim S.}",
note = "Funding Information: Anurag Mehta reports a VCU Health Pauley Heart Center research grant. Dave L. Dixon reports a research grant from Boehringer Ingelheim; Co-Chair, Scientific Statements Committee, National Lipid Association (unpaid). Martha Gulati reports payments or honoraria from Siemens and Medtronics; participation on a Data Safety Monitoring Board of Advisory Board for Novartis; and President, American Society for Preventive Cardiology (unpaid). Michael D. Shapiro reports contracted research from NHLBI, Amgen, Novartis, Esperion, and Ionis (all payments made to Atrium Health Wake Forest Baptist); consulting fees from Ionis, Novartis Regeneron, and EmendoBio (paid to him); participation on a Data Safety Monitoring Board of Advisory Board for Novartis, Amgen, Ionis, and Precision BioScience (paid to him); and President-Elect, American Society of Preventive Cardiology; Scientific Advisory Board, Family Heart Foundation (no payments). Salim S. Virani reports research grants from the Department of Veterans Affairs, NIH, Tahir, and Jooma Family; and payment or honoraria from the American College of Cardiology as the Associate Editor for Innovations (acc.org) and from Current Cardiology Reports and Current Atherosclerosis Reports as a Section Editor. The other authors declare that they have no conflict of interest. Publisher Copyright: {\textcopyright} 2023, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.",
year = "2023",
month = may,
doi = "10.1007/s11886-023-01861-2",
language = "English",
volume = "25",
pages = "423--430",
journal = "Current Cardiology Reports",
issn = "1523-3782",
publisher = "Current Medicine Group",
number = "5",
}