The findings of new research suggests that while statins like Lipitor and Crestor carry benefits for older patients, they may also carry significant side effects, including a risk of severe muscle pain and cognitive problems.
In a study published in the Annals of Internal Medicine last wek, researchers indicate that the benefits provided by the popular cholesterol-lowering drugs, known as statins, may be offset by the side effects, raising questions about their cost effectiveness.
Researchers from Oregon State University looked at data on all adults aged 75 and older provided by the National Health and Nutrition Examination Survey. They found that, overall, the risk of high cholesterol and diabetes was about 7.5%. If all of these individuals were placed on statins, it would result in 8 million additional users, and would prevent 105,000 heart attacks and 68,000 deaths. However, those benefits come at the cost of increased muscle weakness and cognitive impairment.
“An increased relative risk for functional limitation or mild cognitive impairment of 1.1 to 1.29 could offset the cardiovascular benefits,” the researchers determined. “At effectiveness similar to that in trials, statins are projected to be cost-effective for primary prevention, however, even a small increase in geriatric-specific adverse effects could offset the cardiovascular benefit. Improved data on the potential benefits and harms of statins are needed to inform decision making.”
Statin Diabetes Risks
The study comes amid increasing concerns and a number of studies that link statins and an increased risk of diabetes, which is a serious health condition associated with an increased risk of cardiovascular disease and other complications.
In September 2014, research was published in The Lancet, which found that the enzyme statins are designed to inhibit to control cholesterol is also tied to a number of factors affecting blood sugar.
The enzyme is known as 3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR), and the researchers looked at gene variants and how they affected plasma lipid, glucose, and insulin concentrations. The study substituted the gene variants for the effects statins have on HMGCR production. Researchers had data on more than 200,000 individuals from 43 genetic studies.
Researchers found that some gene variants had the same effects on HMGCR enzyme production as statins, and in those cases, the genes also had similar effects on bodyweight, waist circumference and the risk of type 2 diabetes. The study suggested that the way statins effect HMGCR enzyme production is the same as the gene variant, meaning that since statins inhibit HMGCR production, they cannot help but increase the risk of diabetes as well.
The Lancet study came out just two months after Italian researchers published a study in the medical journal Diabetes Care, which determined that there was a dose-specific response that suggests that the longer a user takes Lipitor and similar drugs, the higher their risk of developing diabetes.
In June 2014, 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. 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.
Researchers in the U.K. reached similar conclusions in findings published in the European Journal of Preventative Cardiology in early 2014. 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 Lawsuits
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.