Italian researchers indicate that the findings of a new study adds to the mounting evidence that side effects of Lipitor, Crestor and other statin-based cholesterol drugs increase the risk of new-onset diabetes.
In a study published late last month in the medical journal Diabetes Care, researchers from the University of Milano-Bicocca indicate that they have found a dose-specific response that suggests the longer a user adheres to statin therapy, the higher the risk of diabetes they may face.
Researchers examined data on 115,709 residents in the Italian Lombardy region, who were newly prescribed Lipitor, Crestor or another statin between 2003 and 2004. The study looked at their adherence to the popular cholesterol therapy by 2010, and compared patients with a low adherence, medium adherence, and high adherence to statin therapy over the intervening years.
The results suggest that low adherence patients were 12% more likely to be diagnosed with diabetes than those who did not take statins, while patients with a medium level of statin therapy adherence were 22% more likely to be diagnosed with diabetes, and those with the most adherence to statin therapy also had the highest risk of diabetes; 32% higher than people not taking the drugs.
Statins are a popular class of cholesterol drugs, which are among the most widely used medications in the world. The findings come amid mounting concerns about the link between diabetes and Lipitor or other statins.
While the findings do strengthen evidence about the relationship and highlight the importance of users monitoring for changes in blood glucose levels during treatment, the Italian researchers indicated that the benefits from statins are still significantly high enough that the risk of diabetes should not prevent their use.
“In a real-world setting, the risk of new-onset diabetes rises as adherence with statin therapy increases,” the researchers concluded. “Benefits of statins in reducing cardiovascular events clearly overwhelm the diabetes risk.”
The study came out less than a month after Canadian researchers reported in the British Medical Journal (BMJ) that they had found users of high potency statins, including Lipitor, Crestor, and Zocor, may face a 15% increased risk of being diagnosed with diabetes within two years of starting treatment. The researchers estimated that for every 350 patients given a high potency statin instead of a low potency statin, one of them would contract diabetes.
Crestor, Lipitor and Zocor are not only high potency statins, but they are also among the most popular drugs in the class. All other statin-based medications were considered to be lower potency cholesterol drugs.
Earlier this year, researchers in the U.K. reached similar conclusions in findings published in the European Journal of Preventative Cardiology. That study conducted by researchers from the National heart and Lung Institute in Imperial College London found that 3% of those taking statins were later diagnosed with diabetes, compared to only 2.4% who were given a placebo.
Crestor, Lipitor Diabetes Concerns
Statins generate combined sales of more than $14.5 billion per year, and are increasingly used to block the body’s creation of cholesterol, which is a key contributor to coronary artery disease. Although the medications are widely used, 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.
Late last year, the American Heart Association and the American College of Cardiology called for new heart guidelines which some say would put millions of additional Americans on Lipitor, Crestor and other cholesterol drugs indefinitely. The recommendations suggest that statins should be the only drugs doctors prescribe to lower cholesterol levels and call for doctors to toss out cholesterol goal numbers, potentially keeping patients on the drugs permanently. Critics have suggested that the recommendations will result in the “statinization” of America.