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Statins Do Not Increase ALS Risk

Armen Hareyan's picture

A new long-term study has shown that there is no link between cholesterol lowering drug statins and amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease.

The U.S. Food and Drug Administration had received notes to Adverse Event Reporting System linking cholesterol lowering statins to ALS. The numbers of those reports were higher than it was expected to be. This is why FDA started examining the possible link between Lou Gehrig's disease and and statins to ensure patient safety.

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Amyotrophic lateral sclerosis (ALS) is a serious neurodegenerative disease, which occurs in 1 or 2 out of 100000 people. ALS, which is also called Lou Gehrig's Disease, risk increases with age. Statins are the most commonly used cholesterol lowering drugs, which are also known to cut heart risk in some patients.

FDA conducted 41 long-term, placebo controlled trial to clarify the suspected link. Overall, the studies involved 64,000 patients receiving statins and 56,000 patients taking placebos. The trials showed that 9 patients from statin group and 10 patients from placebo group developed ALS. This means that patients who use statins to lower cholesterol may have 4.2 out of 100000 risk to develop the disease, while placebo patients may have 5 out of 100,000.

“While the FDA finds the lack of an increase in the incidence of amyotrophic lateral sclerosis in patients treated with statins in clinical trials reassuring, given the extensive use of this class of drugs and the serious nature of ALS, continued study of this issue is warranted,” Mark Avigan, who heads the division of pharmacovigilance at the FDA’s Center for Drug Evaluation and Research, in a statement.

The study clearly shows that cholesterol lowering drugs do not increase ALS risk, and both patients and physicians are advised to keep taking and prescribing the necessary drugs. However, the Agency will further watch the link, because statins are very commonly used drugs and ALS is a very serious neurodegenerative disease, and health officials must be sure that there is no link at all.