Study Finds That Millions Who Take Statins May Not Need Them
- by Amber Baker
- Published
- Environment
A new study has determined that millions of people currently taking widely prescribed statin drugs to prevent heart disease may not need them. Statins, which are sold under brand names like Lipitor, Crestor, and Zocor, are the most commonly prescribed drugs in the United States. They are used to lower LDL cholesterol, a primary driver of heart disease, which is the leading cause of death among Americans.
Currently, doctors prescribe the drugs using Pooled Cohort Equations (PCE) based on 2013 guidelines by the American Heart Association and American College of Cardiology to estimate the risk for heart disease. PCEs are algorithms used to estimate a person’s 10-year risk of cardiovascular events based on age, sex, race, cholesterol levels, blood pressure, and diabetes status. 1 2 3
Tim Anderson, MD, assistant professor of medicine at the University of Pittsburgh and the study’s lead author, analyzed the potential impact of the American Heart Association’s new heart disease risk calculator, PREVENT. Dr. Anderson and his colleagues examined data from 3,785 adults aged 40 to 75 in the National Health and Nutrition Examination Survey (NHANES) and compared estimates from PREVENT to the 2013 guidelines.
The study found notable disparities between the PCE and PREVENT estimates, resulting in a significant reduction in the number of individuals eligible for statin therapy. The study also identified a new subset of the population eligible for treatment who were not previously considered. 1 3
About 40 Percent Fewer Americans Would Quality for Statins According to New Heart Disease Risk Calculator
The new PREVENT calculator incorporates additional risk factors, such as kidney disease, blood sugar control (hemoglobin A1C), and obesity, to more accurately assess heart disease risk. The study, published in JAMA Internal Medicine, found that the 10-year risk of developing heart disease with PREVENT was about half that estimated by previous tools. Consequently, about 40 percent fewer people would meet the criteria for a statin prescription, suggesting that up to four million Americans currently taking statins for primary prevention of heart disease might not need them.1
Among other updates, the PREVENT model removes race from the calculation, replacing it with zip code as an indicator of socioeconomic status. According to the U.S. Centers for Disease Control and Prevention (CDC), socioeconomic status (SES) is essential to health outcomes. Those with lower SES tend to have poorer health, higher rates of illness and death, and lower life expectancy than those with higher SES.1 4
Statins Can Cause Cognitive Impairment, Depression and Organ Damage
In light of these findings, Anderson encourages people taking statins for primary prevention to ask their doctors if they should continue taking the medication. While he says it’s vital to preventatively treat heart disease risks before a serious medical event, the drug does carry numerous mild-to-severe side effects; these include muscle pain, headaches, sleep problems, digestive problems, cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion), depression, muscle cell, kidney, and liver damage. The medication can also lead to type 2 diabetes, another risk factor for heart disease.1 5
“For patients who are right on the edge, they should know that there are other things not captured by these calculators, like family history, so it’s very important to discuss this with their physician,” Anderson said.1
Disagreement Over Updating of Statin Recommendations
Not all doctors agree with the findings that suggest a copious number of Americans are taking a drug they may not need. Robert Rosenson, MD, director of lipids and metabolism for the Mount Sinai Health System in New York City, expressed concerns that the small number of participants in the study is not representative of the U.S. population. “Their main point, that fewer patients should be eligible for statins, is based on the limited numbers of people in the NHANES database,” Dr. Rosenson said. “That is alarming.”1
If PREVENT were rolled out nationwide, the number of people meeting the statin criteria would decline from 45.4 million to 28.3 million. “In other words,” the authors of the study wrote, “17.3 million adults recommended statins based on the PCEs would no longer be recommended statins based on PREVENT equations, including 4.1 million adults currently taking statins.”3
Sadiya Khan, MD, who was chair of the PREVENT development committee and a professor of cardiovascular epidemiology at Northwestern University Feinberg School of Medicine, says new guidance is warranted after the study findings. “Risk models don’t determine who is recommended to take statins, guidelines do,” Dr. Khan said. “I think the most important thing is the determination of when it will be recommended to initiate statins. That has not been decided yet.”3
“We need to focus on treating high risk, not high cholesterol,” said Adam M. Cohen, MD, a noninvasive cardiologist and director of the preventive cardiology and dyslipidemia program at Abington Medical Specialists in Abington, Pennsylvania. “I think these guidelines are in a lot of ways trying to say the same thing a little more practically.”3
In Trials, Statins Not Proven to Prevent Heart Disease-Related Deaths
To date, the effectiveness of statins in preventing death from heart disease is not definitively proven. Statin trials show only small differences in outcomes between users and non-users. For instance, overall death rates differed by less than 1 percent to 3.3 percent, and heart attack rates (both fatal and nonfatal) by 1.1 percent to 4.7 percent. These modest differences can appear more significant when expressed in relative terms, a technique sometimes used by pharmaceutical companies to make their products seem more effective. For example, stating that statins reduce the risk of death by 22 percent sounds more impressive than saying they lower the death rate by 3.1 percent. This can mislead people into thinking the benefits are greater than they actually are. 6
“This success profits not only the pharmaceutical industry but also all those whose finances and careers are furthered by the research and the sales,” reads an article published in the National Center for Biotechnology Information (NCBI) about the advent of statins. “But to what extent is it also a success for the general public? The case for statin drugs, especially for primary prevention, has not been made,” the article concludes.6
The global statins market size reached a staggering $15 billion in 2021 and is projected to reach $22 billion by 2032. 7
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