A new study led by Johns Hopkins researchers has identified a significant gap between the number of U.S. patients for whom cholesterol-lowering drugs such as statins are recommended and the actual number of patients who take them.
Coronary artery disease remains a leading cause of death in the U.S. and globally, despite the development of statins and other cholesterol-lowering medications in recent decades. Many adults who should be taking these drugs to lower their low-density-lipoprotein (LDL) levels are not—even though these drugs are considered safe and there is a large body of evidence supporting their effectiveness. In their new study, the researchers sought to quantify this treatment gap.
In a nationally representative analysis of nearly 5,000 U.S. adults, the researchers found that among those who had never had a major cardiovascular event, just under half—47%—were eligible for cholesterol-lowering drugs under U.S. guidelines but only 23% were taking them. Among those who had a record of a major cardiovascular event, just over two-thirds—68%—were receiving cholesterol-lowering treatment when 100% were eligible for them under 2018 U.S. guidelines.
The researchers estimate that closing this treatment gap could help prevent nearly 100,000 non-fatal heart attacks in the U.S. each year and up to 65,000 strokes overall in the U.S. each year, and also prevent tens of thousands of heart bypass surgeries and stent-placement procedures annually in the U.S.
Bringing treatment in line with recommended U.S. guidelines could save up to $30.6 billion in annual medical costs in the U.S. for these prevented events, the researchers estimate.
The findings were published online June 30 in the Journal of General Internal Medicine.
“These results add to a growing body of evidence that there are important shortcomings in the quality of care for common and costly chronic diseases such as high cholesterol, and that addressing those shortcomings would yield major public health benefits,” says study lead author G. Caleb Alexander, MD, a practicing internist and professor in the Johns Hopkins Bloomberg School of Public Health’s Department of Epidemiology.
For their study, the researchers analyzed data on a nationally representative sample of 4,980 American adults, ages 40–75, from U.S. National Health and Nutrition Examination Surveys taken from 2013 to 2020. The researchers used data for each individual that included LDL-cholesterol levels and cardiovascular risk profiles to determine eligibility for lipid-lowering medications based on 2018 U.S. guidelines, as well as actual use of such medications by U.S. patients.
The researchers also analyzed U.S. patient data applying E.U. guidelines. The European guidelines had more aggressive LDL-C goals compared to U.S. guidelines, resulting in wider gaps between observed and recommend care.
The vast majority of the individuals in the sample—89%—didn’t have a record of a major cardiovascular event such as a stroke, heart attack, or coronary bypass surgery. In this “primary prevention” group, representing about 116 million U.S. adults, only 23% were using lipid-lowering drugs to prevent such events, although 47% were eligible for such drugs under U.S. guidelines.
Among the 11% of the sample who did have a record of a major cardiovascular event—a “secondary prevention” sample representing about 15 million U.S. adults—only 68% received any LDL-lowering treatment, despite 100% being eligible under both the U.S. and E.U guidelines examined.
The researchers estimated that if treatment for all eligible individuals were fully aligned with U.S. or E.U. guidelines, including the use of non-statin LDL-lowering drugs in many cases, median levels of LDL cholesterol would drop sharply, reducing the risk of major cardiovascular events in the U.S. by up to 27%.
“Several factors account for the gaps that we document,” says Alexander. “They include differences in clinician training, patient preferences, barriers to accessing care, financial incentives that don’t always support best practices, and the difficulty of putting clinical guidelines into practice in busy, real-world settings.”
Bringing actual treatment closer to what guidelines recommend could be achieved through various measures including better patient education on the benefits of treatment for those who know they have high LDL-cholesterol levels, and better screening for everyone else, the researchers say.
“High cholesterol is an important chronic health condition that silently claims far too many lives —there are millions of people walking around with this condition that don’t even know they have it, and then when it is recognized it too often goes undertreated. Evidence-based action is critical to close the gap and prevent devastating cardiovascular events,” says study senior author Seth S. Martin, MD, MHS, a practicing cardiologist and professor at the Johns Hopkins University School of Medicine.
“U.S. Public Health Gains from Improved Treatment of Hypercholesterolemia: A Simulation Study of NHANES Adults Treated to Guideline-Directed Therapy” was co-authored by G. Caleb Alexander, Jill Curran, Alejandro Victores, Hemalkumar Mehta, Shanshan Lin, Xuya Xiao, Erin Michos, Jeromie Ballreich, Lori Bash, Jason Exter, Kathryn Foti, and Seth Martin.
Funding was provided by Merck Sharp & Dohme LLC.
Disclosures: Caleb Alexander is past chair of FDA’s Peripheral and Central Nervous System Advisory Committee and is a co-founding principal and equity holder in Stage Analytics. Outside of this work, Seth Martin has received personal consulting fees from Amgen, AstraZeneca, BMS, Kaneka, Merck, NewAmsterdam, Novartis, Novo Nordisk, Premier, Sanofi, and 89bio. Outside of this work, Erin Michos has received personal consulting fees from Amgen, Arrowhead, AstraZeneca, Boehringer Ingelheim, Edwards Lifescience, Esperion, Ionis, Lilly, Medtronic, Merck, NewAmsterdam, Novartis, Novo Nordisk, and Pfizer. These arrangements have been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies. Alejandro Victores, Lori Bash and Jason Exter are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, New Jersey, USA. Jill Curran is now employed by Boehringer Ingelheim.
# # #
Media contacts: Jon Eichberger je@jhu.edu or Kris Henry khenry39@jhu.edu
