Widespread Overprescribing of Lipitor, Similar Cholesterol Drugs Likely, Study Finds

Critics say the 2013 prescribing guidelines for drugs like Lipitor and Zocor led to the “statinization” of America.

Roughly 17.3 million people in the U.S. are taking statin-based drugs like Lipitor, Crestor and Zocor, which they may not actually need under a new cardiovascular disease risk assessment tool, according to the findings of a new study that highlights the rampant overprescribing of cholesterol drugs over the past decade.

Statins are a popular class of medications, which are commonly prescribed to reduce high cholesterol, or to help prevent heart attacks and stroke in patients who face a high risk of cardiovascular disease and other heart problems. The class includes blockbuster drugs like Lipitor, Crestor, and Zocor, which are used by more than a quarter of all older adults.

Currently, most doctors prescribe the medications based on 2013 guidelines by the American College of Cardiology, using information such as age, blood pressure, and diabetes status. However, new guidelines were issued by the American Heart Association in 2023, known as Predicting Risk of Cardiovascular Disease Events guidelines, or PREVENT, which also incorporates other factors when determining whether doctors should prescribe statins, including as obesity, kidney disease and blood sugar levels.

In a new study published this month in the medical journal JAMA Internal Medicine, University of Pittsburgh researchers warn that nearly half of patients taking statins for cholesterol control, or to prevent heart attacks and strokes, do not meet the criteria for being prescribed the drugs and are exposing themselves to unnecessary side effect risks.

Statin Prescribing and Side Effects Concerns

Immediately following the release of the 2013 guidelines, an editorial published in the Journal of the American Medical Association warned about the “statinization of America,” cautioning that the guidelines would result in widespread overuse of cholesterol drugs, especially among patients who don’t really need the medications.

In 2020, a study published by researchers from the University of Pennsylvania confirmed that the 2013 guidelines resulted in a spike in prescriptions for statins like Lipitor.  Additionally, research published in the BMJ Evidence-Based Medicine in 2020 highlighted how many patients were receiving cholesterol drug prescriptions they don’t need.

The overprescribing of statins has become a serious health concern, since a number of studies have identified potential side effects of statins, potentially exposing users to an increased risk of other health conditions.

Research published in the Journal of Nuclear Medicine in 2021 warned statins increase a patient’s risk of developing dementia. While another study published in JAMA Internal Medicine in 2021 warned drugs like Zocor could worsen the progression of diabetes and hyperglycemia.

New Guidelines Uncover Statin Overprescribing

In the new study published this month, Dr. Timothy S. Anderson from the University of Pittsburgh led a team of researchers who studied the differences in doctor prescribing when using the 2013 guidelines compared to 2023 American Heart Association PREVENT guidelines. Researchers evaluated data on 3,785 adults aged 40 to 75 years without atherosclerotic cardiovascular disease risk, using data from the National Health and Nutrition Examination Survey from 2017 to March 2020.

Using the different guidelines to calculate the risk of heart disease over 10 years, the 2013 guidelines estimated 8% of patients would develop heart disease and should be given statins. The PREVENT guidelines estimated only 4.3% of patients would develop heart disease and should take cholesterol drugs.

The largest difference was seen for Black patients. The risk was estimated at 11% using the 2013 guidelines, but at 5% using the PREVENT guidelines. For people 70 to 75 years old, the risk was estimated at 23% for the old guidelines and 10% for the new guidelines.

Anderson and his team determined that using the newer PREVENT guidelines, instead of 2013 guidelines, would reduce the number of patients prescribed statins by more than 44%. Total prescriptions would drop from 45.5 million to 28.3 million, saving 17.3 million adults from taking unnecessary cholesterol drugs.

The researchers found that roughly 4.1 million people who are currently taking drugs like Lipitor or Crestor should not be taking them. However, they also noted that the majority of adults who are eligible under PREVENT guidelines are not currently taking statins.

“Findings of this study suggest that use of the PREVENT equations could greatly reduce the number of patients eligible for primary prevention statin therapy,” the researchers noted. “This cross-sectional study found that use of the PREVENT equations was associated with fewer US adults being eligible for primary prevention statin therapy; however, the majority of adults eligible for receiving such therapy based on PREVENT equations did not report statin use.”