Millions of Americans who take cholesterol-lowering pills may not need them and may be at risk for side effects such as liver damage.
Using a new risk calculator, researchers estimate that 40 percent of people in the US who take statins to prevent heart disease will not actually develop the condition.
That figure equates to about 17 million Americans, including 4 million currently taking statins, who would no longer need the pills.
If the findings translate into new recommendations and policies, it could have enormous consequences. As one of America’s most popular drugs, statins represent a $15 billion industry, expected to grow to $22 billion by 2032.
And for patients, the pills have been linked to a host of unpleasant side effects, including headaches, muscle aches, liver damage and blood clotting problems.
Statins, used by millions of Americans, are an inexpensive class of medications intended to lower cholesterol, reducing the risk of heart disease and stroke
Researchers in a new study published in JAMA Internal Medicine found that fewer Americans need statins than previously thought, amounting to more than 17 million patients
However, experts warn patients not to suddenly stop taking statins, which can lead to ‘dangerous’ side effects such as heart attack and stroke.
Dr. Chiadi Ndumele, chair of one of the American Heart Association’s (AHA) scientific advisory groups, said while no new guidelines have been implemented, “analysis is ongoing.”
“Guidelines will need to consider whether and how to update recommendations to include PREVENT risk thresholds to guide clinical decision-making,” he said. STAT news.
Statins work by limiting the production of ‘bad cholesterol’ – LDL (low-density lipoprotein) cholesterol – which can harden and narrow the arteries and increase the risk of cardiovascular disease.
They are usually taken in the form of daily pills and cost patients as little as $40 per year.
Because they are so cheap to make, statins such as atorvastatin (Lipitor) have become some of the most popular medications in America.
Current guidelines from the AHA and the American College of Cardiology recommend that adults with a 10-year risk of at least 7.5 percent of developing heart disease take a statin.
At a risk of five percent, the guidelines suggest that the patient and their doctor should consider this.
Their risk is based on factors such as BMI, cholesterol, smoking status and diabetes.
But in November, the AHA unveiled a new risk calculator called PREVENT, which estimates a patient’s 10- and 30-year risk of developing heart disease based on heart, kidney and metabolic health.
PREVENT (predicting the risk of cardiovascular disease) is a calculator used to evaluate the risk of heart disease, stroke, kidney disease and heart failure.
It asks patients about their gender, age and risk factors such as cholesterol, blood pressure, BMI, diabetes and smoking.
The CDC estimates that statins reduce the risk of heart attack by 25 percent, although the drug has been linked to side effects such as headaches, diarrhea and liver damage.
In the new research, published Monday in JAMA Internal Medicinethe team analyzed data from 3,785 adults ages 40 to 75 who participated in the CDC’s National Health and Nutrition Examination Survey between January 2017 and March 2020.
The researchers calculated the participants’ 10-year risk of heart disease using a 2023 PREVENT model and then compared the risk estimates to the 2013 Pooled Cohort Equations (PCE), on which current statin guidelines are based.
They found that 28.3 million Americans are eligible for statins, compared to 45.4 million under current guidelines.
Meanwhile, the UK’s National Institute for Health and Care Excellence (NICE), which sets healthcare guidelines, recommends that patients can be given statins if they have a risk score of less than 10 percent and have not had a heart attack or stroke.
However, statins have long been shrouded in controversy over a series of studies claiming they cause side effects.
In Britain, health officials warned about seven statins, including atorvastatin (Lipitor) and rosuvastatin (Crestor), linked to myasthenia gravis, a serious muscle-weakening condition.
Although the disease does not affect life expectancy for most people, it can be life-threatening if the muscles needed for breathing become weakened.
According to Cleveland Clinic, the pills have also been linked to headaches, nausea, dizziness, gas, diarrhea, constipation, memory loss and liver and kidney damage.
However, a team of cardiologists from the Medical University of Lodz in Poland claimed in 2022 that 70 percent of statin side effects are “all in the mind.”
They called this the “nocebo” phenomenon, which occurs when someone experiences an uncomfortable side effect from a drug simply because they expected it.
Meanwhile, Dr. Leslie Cho, a cardiologist at the Cleveland Clinic, alerted at a hospital blog post that tapering off statins without a doctor’s warning can cause cholesterol to rise rapidly, resulting in an increased risk of heart attack, stroke and heart failure.
“High cholesterol is a silent killer because you don’t feel anything until something extreme happens,” she said. ‘Keep taking your statins. Stay strong.’