Two new studies suggest that recent treatment guidelines, which many expect will result in millions more Americans being prescribed cholesterol drugs like Lipitor and Crestor, are accurate and cost-effective.
Both studies were conducted by researchers from Harvard and other Boston-based universities and hospitals, and were published on July 14 in the Journal of the American Medical Association (JAMA).
One study looked at the accuracy of guidelines on the use of statins released in 2013 by the American College of Cardiology (ACC) and the American Heart Association (AHA). The other study looked at the cost-effectiveness of those guidelines.
The study on accuracy and effectiveness used data from the Framingham Heart Study, looking at statin eligibility of 2,435 participants who had not yet been placed on statins. The researchers found that those who were statin eligible under the new guidelines had increased risks of cardiovascular disease when compared to those who were eligible for older statin use guidelines.
The other study looked at hypothetical models for patients ages 40 to 75, and studied health outcomes, discount rates and other factors for those who would likely experience cardiovascular disease. The findings indicate that the guidelines had an acceptable cost-effectiveness profile, but the outcomes were sensitive to whether patients took a daily pill, changes to drug prices and the risk of diabetes caused by statin side effects.
Statin Health Concerns
The studies come amid increasing concerns about the potential “statinization” of America that may result from the ACC/AHA guidelines. The groups indicate that statins are the only drugs doctors should prescribe to lower cholesterol and call for doctors to toss out traditional cholesterol goal numbers, potentially keeping patients on the drugs permanently.
Statins generate combined sales of more than $14.5 billion per year, and are used to block the body’s creation of cholesterol, which is a key contributor to coronary artery disease.
There have been a number of studies that have also shown that the cardiovascular disease risk calculators doctors use to determine which patients to put on cholesterol drug therapy may be in error and could result in millions of Americans taking the drugs unnecessarily for the rest of their lives.
Although the medications are widely used and generally regarded as safe, a number of studies have linked statins to an increased risk of potentially serious injuries, including muscle damage, kidney problems, and diabetes.
In February 2012, the FDA required the makers of Lipitor, Crestor and other statins to add new warnings about the potential impact of the medication on blood glucose levels. However, many critics have suggested that the warnings are not strong enough for certain medications, indicating that users and the medical community should be provided with more accurate information about the diabetes risks with Lipitor, Crestor and other statins.
Pfizer currently faces hundreds of Lipitor diabetes lawsuits filed by women throughout the United States, who allege that the drug maker knew or should have known about risks associated with their medication for years, but withheld diabetes warnings to avoid a negative impact on sales and growth of the blockbuster medication.
AstraZeneca also faces a number of Crestor lawsuits filed on behalf of former users of the cholesterol drug who were diagnosed with diabetes. Most of those cases are currently pending in California state court.