New Statin Guidelines Having Unintended Consequences, Conference Attendees Told

A growing number of health experts are warning that revised heart guidelines issued almost a year ago, which tossed out cholesterol goal numbers and recommended that statin-based medications like Lipitor and Crestor are the only drugs that doctors should prescribe to lower cholesterol levels, are leading to unintended consequences.  

Doctors and researchers met last week at the Cardiometabolic Health Conference in Boston, Massachusetts, and much of the conference focused on cardiovascular risk assessment and treatment guidelines issued late last year by the American College of Cardiology (ACC) and the American Heart Association (AHA), which some say would place millions of Americans on cholesterol fighting drugs like Lipitor and Crestor unnecessarily, exposing them to diabetes and other potential side effects.

Experts at the conference, including some involved with the creation of the guidelines, warned that doctors are misinterpreting the guidelines, no longer ordering cholesterol tests, and failing to talk to patients about the risk of side effects. Additionally, some insurance companies have stopped covering any cholesterol drug that does not belong to the statin drug category.

The guidelines were released in November 2014, indicating doctors should only prescribe statins to lower cholesterol and calling for doctors to toss out cholesterol goal numbers, which critics indicate may result in patients being kept on the drugs indefinitely.

Unintended Consequences

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.

However, commentators at the conference said that the guidance, if misinterpreted, can lead to even more problems. The researchers warned that a growing number of doctors are prescribing statins to patients without having a discussion about the risks of Crestor and Lipitor side effects.

In addition, because the guidelines get rid of LDL cholesterol level goals, some doctors have stopped testing their patients cholesterol levels. In both cases, that is a misinterpretation of the guidelines, commentators said, noting that cholesterol levels still need to be monitored and patients need to be made aware of cholesterol drug risks.

The working group that developed the guidelines have reportedly written letters to a number of health care professional groups to address the misconceptions.

Cholesterol Drug Health Risks

Statins are among the best-selling drugs in the United States, with $14.5 billion in combined sales in 2008. They use the liver to block the body’s creation of cholesterol, which is a key contributor to coronary artery disease. However, a number of studies have linked the drugs to an increased risk of potentially serious injuries, including muscle damage, kidney problems and diabetes.

All statins carry warnings about the potential risk of serious muscle injury, known as myopathy. The most severe form of the muscle damage is rhabdomyolysis, which may lead to severe kidney damage, kidney failure and death.

More recently, Lipitor, Crestor and other statins have been linked to an increased risk of diabetes, leading the FDA to require new warnings in February 2012 about potential impact the medications may have on blood sugar levels. Studies have suggested that otherwise healthy individuals who begin taking statins to reduce their risk of heart disease, may actually face an increased risk of diabetes, which itself increases the risk of cardiovascular disease.

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.