Amid increasing concerns about the risk of diabetes and other side effects associated with statin-based cholesterol drugs, such as Lipitor, Crestor and Zocor, researchers from Johns Hopkins indicate that the benefits provided by the medication still justify the known risks.
In a study published by the British Medical Journal on July 31, researchers reviewed 20 years of published data involving statins, determining that the cardiovascular health benefits provided by the popular medications outweigh any currently known side effects of Lipitor, Crestor and other related cholesterol drugs.
Statins are among the most widely used medications in the world, with an estimated 200 million people worldwide using the medication to lower cholesterol levels and reduce the risk of heart disease. The drugs are prescribed to prevent heart attacks, strokes, and other cardiovascular problems by lowering “bad” cholesterol levels. However, statins have been linked to a number of debilitating side effects, including diabetes and muscle damage that can eventually lead to kidney failure.
Researchers looked through studies on statins published since 1994, focusing on randomized clinical trials, that involved a total of about 150,000 people overall. They confirmed that statins can increase the risk of type 2 diabetes and a serious muscle condition known as rhabdomyolysis. However, the researchers concluded that their findings suggest the diabetes side effects appeared in patients who were at-risk of diabetes already, raising questions as to whether they would have eventually developed diabetes anyway.
The findings may be contradicted by some other studies, which suggest that Lipitor may increase the risk of health benefits for women with a healthy weight and active life-style, without providing much benefit. Pfizer currently faces a growing number of Lipitor lawsuits filed by women who allege they developed diabetes after taking the drug as a preventative measure.
In a study published by the medical journal Diabetes Care in June 2014, researchers found that there is a dose-specific response between the levels of statins prescribed and the risk of diabetes. They found that the longer a user adheres to statin therapy, the higher the risk of diabetes. However, they also determined that the benefits of statins still outweigh the risks.
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.
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.
Lawsuits pending against Pfizer allege that the drug maker has known, or should have known about the diabetes risk from Lipitor side effects, yet allegedly withheld warnings to avoid a negative impact on sales and growth of the blockbuster medication. Otherwise health women diagnosed with diabetes after use of Lipitor allege that they never would have agreed to use the medication if they had been informed of the potential risks.
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.
Muscle Injury No Longer An Issue
The latest study’s authors also noted that rhabdomyolysis appeared to no longer be an issue since the FDA warned about the link between the condition and high statin doses.
Rhabdomyolysis causes muscle fibers to begin to break down, releasing a protein called myoglobin, which can damage the kidneys as they attempt to filter it out of the bloodstream. Symptoms of rhabdomyolysis include muscle cramps, tenderness, stiffness, pain or spasms. The illness is usually reported in patients over 65 years of age or those who have renal impairment or uncontrolled hypothyroidism.
In June 2011, the FDA placed restrictions on the use of 80 mg Zocor, which could include twice-a-day 40mg doses, due to the risk of myopathy and rhabdomyolysis, warning doctors that no new patients should be placed on the high dose regimen due to the risk of muscle problems.