Carolyn Shimek takes cholesterol-decreasing medications like millions of Americans. However she does not have high cholesterol like others. This is since she is taking part in a different clinical study found only at the Methodist Neurological Institute (NI) to view the benefits of Lipitor on the immune system in patients with Lou Gehrig's disease, or amyotrophic lateral sclerosis (ALS).
Physicians at the Methodist NI's MDA/ALS Clinical Center diagnosed the 48-year-old Victoria, Texas resident in 2005. When she learned of this investigator-initiated research, Shimek knew she had to give it a chance.
'I have a lot to live for - my family and friends,' said Shimek, a wife, mother of three, and one of 12 siblings. 'If participating in this study means it will help me or other ALS patients down the road then it's worth it.'
Dr. Ericka Simpson, co-director of Methodist's ALS Clinic, is the primary investigator who oversees this double-blind study in which patients will be randomly assigned to receive the drug or a placebo. Simpson believes the immune system plays an important role in how ALS affects patients.
'Lipitor has been shown to regulate immune responses that may provide protection in diseases of the central nervous system. Our goal is to determine whether Lipitor has the ability to improve the course of disease progression and quality of life for our ALS patients,' said Simpson.
Currently, the only FDA-approved drug therapy for ALS is Rilutek. The drug has been shown to modestly improve patient survival, but has no measurable affect on function or the rate of disease progression. ALS is a progressive neurodegenerative disease characterized by degeneration of the upper and lower motor neurons in the brain and spinal cord which stimulate skeletal muscle movement. As more motor neurons die, muscle weakness gets progressively worse. An estimated 30,000 people throughout the U.S. have ALS, and 8,000 new cases are diagnosed each year.