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MILLIONS of Americans taking popular daily drugs don't need them and may be putting themselves at risk of nasty side effects, says major study
Millions of Americans on cholesterol-lowering pills may not need them and could be putting themselves at risk of side effects like liver damage.
Using a new risk calculator, researchers estimated that 40 percent of people in the US taking statins to prevent heart disease won't actually develop the condition.
That figure adds up about 17million Americans, including 4million currently taking statins, who would no longer need to take the pills.
If the findings translate into new recommendations and policy, it could be hugely consequential. As one of America's most popular drugs, statins, represent a $15billion industry, which is expected to grow to $22billion by 2032.
And for patients, the pills have been linked to a host of nasty side effects such as headaches, muscle pain, liver damage, issues with blood clotting.
Statins, taken by millions of Americans, are a cheap class of drugs that are meant to lower cholesterol, reducing the risk of heart disease and stroke
Researchers in a new study published in JAMA Internal Medicine found fewer Americans need to be taking statins than previously thought, adding up to over 17million patients
However, experts are warning patients not to suddenly stop taking statins, which can lead to 'dangerous' side effects like heart attack and stroke.
Dr Chiadi Ndumele, chair of one of the American Heart Association's (AHA) scientific advisory groups, said that while no new guidelines have been implemented, 'analyses are underway.'
'Guidelines will have to consider whether and how to update recommendations to include PREVENT risk thresholds to guide clinical decision making,' he told STAT News.
Statins work by limiting the production of 'bad cholesterol' — low-density lipoprotein (LDL) 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 as little as $40 a year for patients.
Because they are so cheap to make, statins like atorvastatin (Lipitor) have become some of the most popular drugs in America.
Current AHA and American College of Cardiology guidelines state that adults with a 10-year risk of at least 7.5 percent for developing heart disease are advised to take a statin.
At a five percent risk, the guidelines suggest the patient and their doctor should consider it.
Their risk is based on factors like 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 risk of cardiovascular disease events) is a calculator used to evaluate the risk of heart disease, stroke, kidney disease, and heart failure.
It asks patients for their sex, age, and risk factors such as cholesterol, blood pressure, BMI, diabetes, and smoking.
The CDC estimates that statins reduce heart attack risk by 25 percent, though the drug has been linked to side effects like headaches, diarrhea, and liver damage
In the new research, published Monday in JAMA Internal Medicine, the team analyzed data from 3,785 adults ages 40 to 75 who took part 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 PREVENT model from 2023 and then compared risk estimates to the 2013 Pooled Cohort Equations (PCE), on which current statin guidelines are based.
They found that 28.3million Americans be eligible for statins, compared to 45.4million under current guidelines.
Meanwhile, the UK's National Institute for Health and Care Excellence (NICE) agency, which sets healthcare guidance, recommends that patients could be put on statins if they have a risk score of less than 10 percent and have not had a heart attack or stroke.
Statins, however, have long been shrouded in controversy over a series of studies claiming that they cause side effects.
In the UK, health officials warned against seven statins, including atorvastatin (Lipitor) and rosuvastatin (Crestor), which were linked to myasthenia gravis, a severe muscle-weakening condition.
While the disease doesn't affect life expectancy for most people, it can be life-threatening if weakens the muscles needed for breathing.
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 at Medical University of Lodz in Poland in 2022 claimed that 70 percent of statin side effects are 'all in the mind.'
They called this the 'nocebo' phenomenon, which occurs when someone faces an uncomfortable side effect from a drug simply because they expected to.
Meanwhile, Dr Leslie Cho, a cardiologist at the Cleveland Clinic, warned in a hospital blog post that going off statins without warning a doctor could cause cholesterol to quickly rise, resulting in an increased risk of heart attack, stroke, and heart failure.
'High cholesterol is a silent killer because you won’t feel anything until something extreme happens,' she said. 'Keep taking your statins. Stay well.'