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FDA: Statins Don't Increase Risk of Lou Gehrig's Disease

Posted by Chrissie Cole
Tuesday, September 30, 2008 10:43 AM EST
Category: Major Medical
Tags: FDA & Prescription Drugs, Lou Gehrig's Disease, ALS, Statins, Cholesterol Drugs, Lipitor, Crestor, Zocor

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IMAGE SOURCE: Wikimedia Commons / Atorvastatin marketed as Lipitor / author: Benjah-bmm27

A review of several studies found that commonly used statin cholesterol drugs do not increase the risk of Lou Gehrig’s disease, according to the U.S. Food and Drug Administration.

U.S. health officials began analyzing 41 long-term controlled clinical trials after receiving a high number of reports of Lou Gehrig’s disease in patients treated with cholesterol-lowering medications.

Amyotrophic lateral sclerosis (ALS), sometimes called Lou Gehrig's disease, is a rapidly progressive, invariably fatal neurological disease that attacks the nerve cells (neurons) responsible for controlling voluntary muscles.

The disease belongs to a group of disorders known as motor neuron diseases, which are characterized by the gradual degeneration and death of motor neurons.

An estimated 5,600 people in the United States are diagnosed with ALS every year. ALS is responsible for nearly two deaths per hundred thousand annually.

Millions of people worldwide take statin cholesterol-lowering drugs, which include AstraZeneca’s Crestor and Pfizer’s Lipitor, Merck’s Zocor and Bristol-Myers Squibb Pravachol.

Health official researchers found that nine out of an estimated 64,000 patients treated with statins were diagnosed with ALS, during long-term clinical trials, compared to 10 of 56,000 patients given placebos.

“The trial results show no increased incidence of ALS in patients treated with statins compared with a placebo,” said an FDA statement.

The findings are “reassuring,” but “given the comprehensive use of this class of drugs and the serious nature of ALS, continued research of this issue is recommended, said Dr. Mark Avigan, M.D., director of pharmacovigilance, in the FDA’s drug center.

Results from an earlier study by Kaiser Permanente and researchers at Stanford University are expected to be released in six to nine months, according to the FDA. The agency is also considering launching studies of its own.

The study was published in the journal Pharmacoepidemiology and Drug Safety. #


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