New Statin Guides Would Affect Nearly All Older European Men: Study

European researchers indicate that if new new heart health guidelines issued in the U.S. are followed, then nearly every European male over the age of 55 will end up taking a statin-based cholesterol drug, such as Lipitor or Crestor.  

In a study published in the Journal of the American Medical Association (JAMA), researchers from the Netherlands became the first to look at how controversial guidelines issued last year by the American College of Cardiology and American Heart Association may affect populations outside of the U.S.

The guidelines have been the subject of much debate, due to recommendations that doctors should only prescribe statin medications to lower cholesterol and for indicating that doctors should toss out cholesterol goal numbers, potentially keeping patients on the drugs permanently.

Researchers applied the guidelines to 4,854 participants over the age of 55 in a Rotterdam study from 1997 to 2001 and used the new guidelines to calculate the risk of cardiovascular disease among the participants. The findings suggested that if European doctors used the new guidelines, statins would be recommended in 96.4% of men and 65.8% of women with a mean age of 65.5.

In addition, the new guidelines predicted that 21.5% of the subjects should have developed hard atherosclerotic cardiovascular disease during that time, but just over 12% actually did. However, previous risk models fared no better in predictions, but also did not require as many to be on statins.

“The ACC/AHA guideline would recommend statins for nearly all men and two-thirds of women,” the researchers concluded. “Improving risk predictions and setting appropriate population-wide thresholds are necessary to facilitate better clinical decision making.”

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.

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 use of the medication as a preventative measure to prevent heart failure has caused them to develop diabetes, which carries a number of health risks, including an increased risk of heart disease. Plaintiffs claim that the drug maker knew or should have known about Lipitor diabetes problems for years, but withheld information 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.