Studies

Cholesterol Drugs May Slow MS

FRIDAY, April 16 (HealthDay News) -- Cholesterol-lowering statin drugs may slow the progression of multiple sclerosis, according to a new study.

It included 81 patients with early-stage MS randomly selected to take either 80 milligrams a day of Lipitor (atorvastatin) or a placebo. After 12 months of treatment, 55.3 percent of patients taking the drug had developed no new brain lesions, compared with 27.6 percent of those who took the placebo.

The results of the phase II, multi-center trial were presented Wednesday at the annual scientific meeting of the American Academy of Neurology. Lipitor, placebo and additional support were provided by Pfizer, Inc., which makes Lipitor.

"Our data is preliminary, and we need a larger study to confirm the effects of the drug and their magnitude," study co-leader Dr. Emmanuelle Waubant, an associate professor of neurology at the MS Center at the University of California, San Francisco, said in a news release.

"It is important that we understand how statins impact the progression of multiple sclerosis in order to better inform physicians and patients of their effect since these drugs are so broadly used throughout the United States and the world, and to learn whether a relatively inexpensive oral therapy can slow the course of the disease," he added.

MS is an autoimmune disease in which immune cells attack the central nervous system and destroy the protective sheath (myelin) that surrounds nerves. This results in scars or lesions in demyelinated areas of the brain and spinal cord.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about multiple sclerosis.

SOURCE: University of California, San Francisco, news release, April 14, 2010

Childbirth May Slow Progression of Multiple Sclerosis

TUESDAY, Nov. 24 (HealthDay News) -- Having children may slow the progression of multiple sclerosis, new research suggests.

Belgian researchers followed 330 women who had experienced their first MS symptoms between the ages of 22 and 38.

Women who had given birth to at least one child were 34 percent less likely to have the disease progress to a stage in which they needed walking assistance, such as a cane or brace, than women without children.

While having a baby either before or after the onset of MS symptoms seemed to help, women who had a child after they began experiencing MS symptoms were even better off. During the study, women with MS symptoms who'd had a baby were 39 percent less likely to have their disease progress to the point of needing walking assistance. In the study, women had the disease for an average of 18 years.

"Women with MS who have children seem to have a more benign MS course than those who don't," said study author Marie D'hooghe, of the department of neurology at Nationaal MS Centrum in Melsbroek, Belgium.

The research appears in the Nov. 24 online issue of the Journal of Neurology, Neurosurgery & Psychiatry.

Multiple sclerosis is an autoimmune disease in which the body's own defense system attacks myelin, or the protective fatty substance that surrounds nerve fibers in the central nervous system, according to the National Multiple Sclerosis Society. The damage causes a disruption to nerve signals traveling to and from the brain, which causes the numbness, walking problems, blurry vision and fatigue.

About 85 percent of those with MS start with a relapsing-remitting course, in which attacks are followed by partial or total recovery, according to the study. More than half go on to develop a more progressive form of the disease, in which symptoms worsen over time and there are fewer, shorter periods without symptoms. Eventually, the disease can lead to loss of vision and paralysis.

Women are twice as likely to develop MS as men, though women tend to have less severe cases than men, according to the study.

About three-quarters of the women in the study had children. The researchers measured the time it took for women to reach level 6 on the Expanded Disability Status Scale (EDSS), a rating system used by doctors to describe symptoms, with level 1 being the least severe and 10 being death due to MS. Level 6 is defined as needing a cane, crutch or brace to walk.

Women who did not have children took an average of 13 to 15 years to progress to EDSS 6, while women who had children took an average of 22 to 23 years to reach that stage, the researchers found.

"Having one or more children does seem to be beneficial," said Patricia O'Looney, director of biomedical research for the National Multiple Sclerosis Society. "But we don't know enough about the patient demographics to really draw some major conclusions."

Among the unknowns are the treatments the women in the study were getting for MS or if perhaps the women who decided to have children were feeling better and having fewer symptoms.

Though much remains to be learned about the role of pregnancy in MS, a possible reason why it may help slow the progression of the disease is that during pregnancy, the immune system is "downregulated," in part to prevent the mother's body from rejecting the fetus, O'Looney explained. Suppressing the immune system may also help to control MS, O'Looney noted.

Treatments for MS, such as interferon beta-1a and -1b, work by suppressing the immune system.

A second possibility for why childbirth might help delay the progression of MS is that during pregnancy, estrogen levels rise. Previous research has suggested estrogen may help protect from MS by stimulating the cells that make myelin. The MS Society is currently funding a clinical trial in which women with MS are given estriol, a form of estrogen, along with standard MS treatments.

"The sex hormones do seem to have some neuroprotective role, though we are not quite sure how," O'Looney said.

Still, O'Looney stressed that women should not interpret the results as reason to have a baby to delay the progression of the disease, or blame themselves if they decided not to have children.

"We still don't know a lot about the great variability of MS -- why does one person become more progressive while another follows a more benign course," O'Looney said. "What's certain is that one should not conclude it's based on whether or not you have a child. There are so many other factors, including possibly genetic factors, that determine that."

More information

The National Multiple Sclerosis Society has more on pregnancy and MS.

SOURCES: Marie D'hooghe, department of neurology, Nationaal MS Centrum in Melsbroek, Belgium; Patricia O'Looney, Ph.D., director, biomedical research, National Multiple Sclerosis Society; Nov. 24, 2009, Journal of Neurology, Neurosurgery & Psychiatry, online

Ampyra Approved for Adults With MS

FRIDAY, Jan. 22 (HealthDay News) -- Dalfampridine (Ampyra) extended-release tablets have been approved by the U.S. Food and Drug Administration to help adults with multiple sclerosis (MS) who have trouble walking.

In clinical testing, people who took Ampyra had faster walking speeds that those who took a placebo, the agency said in a news release.

MS is a chronic, often disabling disease affecting the brain, spinal cord and optic nerves. Some 400,000 people in the United States and 2.5 million globally have been diagnosed with the disease, the FDA said.

The drug, if given at doses higher than the recommended 10 milligrams twice daily, can cause seizures, the agency warned. The most common reported side effects include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, nasal or throat swelling, irregularity, indigestion and burning or itchy skin.

People with moderate-to-severe kidney disease shouldn't take Ampyra, the FDA said.

The drug is marketed in the United States by Hawthorne, N.Y.-based Acorda Therapeutics.

More information

The FDA has more about this approval.

Added Drug Aids MS Treatment

TUESDAY, Feb. 16 (HealthDay News) -- Adding the drug daclizumab to standard treatment with interferon beta may reduce multiple sclerosis disease activity more than interferon beta alone, a new study reports.

Previous non-randomized studies found that daclizumab -- a humanized monoclonal antibody -- reduced MS disease activity.

This new phase 2 study at 51 centers in the United States, Canada, Germany, Italy and Spain included 230 patients with active relapsing MS who were taking interferon beta. They were randomly selected to also receive either high-dose daclizumab (2 milligrams/kilogram every two weeks), low-dose daclizumab (1 milligram/kilogram every four weeks) or an inactive placebo. The combined treatments continued for 24 weeks.

MRI scans of the patients' brains were taken every four weeks between weeks 8 and 24 of the study in order to determine the number of new or enlarged gadolinium contrast-enhancing lesions, which indicate MS disease activity.

By the end of the study, the adjusted mean number of new or enlarged gadolinium contrast-enhancing lesions was 1.32 in the high-dose group (75 patients), 3.58 in the low-dose group (78 patients) and 4.75 in the placebo group (77 patients).

Levels of CD56bright natural killer cells were seven to eight times higher in patients taking daclizumab than in those taking the placebo.

"This study provides confirmatory data that daclizumab treatment causes an expansion of CD56bright natural killer cells and adds support to the theory that expansion of CD56bright natural killer cells might mediate some of the effects of daclizumab on reducing multiple sclerosis lesion activity. In addition to the results of previous trials of daclizumab in multiple sclerosis, several lines of evidence have suggested a potential immunoregulatory function for CD56bright natural killer cells: they are expanded during conditions of natural immune tolerance, for example, pregnancy," the researchers from the Neurovirology Research Laboratory at the VA Medical Center in Salt Lake City, and the University of Utah, reported in a news release.

"This randomized controlled trial indicates that daclizumab can reduce new lesion formation in relapsing multiple sclerosis compared with interferon-beta alone," the researchers concluded. "Multiple sclerosis treatments that have the potential to improve in risk-benefit ratios when compared with available treatments are needed; thus, additional studies to define the long-term clinical risks and benefits of daclizumab are warranted."

The study was released online Feb. 15 in advance of publication in the April issue of The Lancet Neurology.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about multiple sclerosis.

SOURCE: The Lancet Neurology, news release, Feb. 15, 2010

Childbirth May Slow Progression of Multiple Sclerosis

TUESDAY, Nov. 24 (HealthDay News) -- Having children may slow the progression of multiple sclerosis, new research suggests.

Belgian researchers followed 330 women who had experienced their first MS symptoms between the ages of 22 and 38.

Women who had given birth to at least one child were 34 percent less likely to have the disease progress to a stage in which they needed walking assistance, such as a cane or brace, than women without children.

While having a baby either before or after the onset of MS symptoms seemed to help, women who had a child after they began experiencing MS symptoms were even better off. During the study, women with MS symptoms who'd had a baby were 39 percent less likely to have their disease progress to the point of needing walking assistance. In the study, women had the disease for an average of 18 years.

"Women with MS who have children seem to have a more benign MS course than those who don't," said study author Marie D'hooghe, of the department of neurology at Nationaal MS Centrum in Melsbroek, Belgium.

The research appears in the Nov. 24 online issue of the Journal of Neurology, Neurosurgery & Psychiatry.

Multiple sclerosis is an autoimmune disease in which the body's own defense system attacks myelin, or the protective fatty substance that surrounds nerve fibers in the central nervous system, according to the National Multiple Sclerosis Society. The damage causes a disruption to nerve signals traveling to and from the brain, which causes the numbness, walking problems, blurry vision and fatigue.

About 85 percent of those with MS start with a relapsing-remitting course, in which attacks are followed by partial or total recovery, according to the study. More than half go on to develop a more progressive form of the disease, in which symptoms worsen over time and there are fewer, shorter periods without symptoms. Eventually, the disease can lead to loss of vision and paralysis.

Women are twice as likely to develop MS as men, though women tend to have less severe cases than men, according to the study.

About three-quarters of the women in the study had children. The researchers measured the time it took for women to reach level 6 on the Expanded Disability Status Scale (EDSS), a rating system used by doctors to describe symptoms, with level 1 being the least severe and 10 being death due to MS. Level 6 is defined as needing a cane, crutch or brace to walk.

Women who did not have children took an average of 13 to 15 years to progress to EDSS 6, while women who had children took an average of 22 to 23 years to reach that stage, the researchers found.

"Having one or more children does seem to be beneficial," said Patricia O'Looney, director of biomedical research for the National Multiple Sclerosis Society. "But we don't know enough about the patient demographics to really draw some major conclusions."

Among the unknowns are the treatments the women in the study were getting for MS or if perhaps the women who decided to have children were feeling better and having fewer symptoms.

Though much remains to be learned about the role of pregnancy in MS, a possible reason why it may help slow the progression of the disease is that during pregnancy, the immune system is "downregulated," in part to prevent the mother's body from rejecting the fetus, O'Looney explained. Suppressing the immune system may also help to control MS, O'Looney noted.

Treatments for MS, such as interferon beta-1a and -1b, work by suppressing the immune system.

A second possibility for why childbirth might help delay the progression of MS is that during pregnancy, estrogen levels rise. Previous research has suggested estrogen may help protect from MS by stimulating the cells that make myelin. The MS Society is currently funding a clinical trial in which women with MS are given estriol, a form of estrogen, along with standard MS treatments.

"The sex hormones do seem to have some neuroprotective role, though we are not quite sure how," O'Looney said.

Still, O'Looney stressed that women should not interpret the results as reason to have a baby to delay the progression of the disease, or blame themselves if they decided not to have children.

"We still don't know a lot about the great variability of MS -- why does one person become more progressive while another follows a more benign course," O'Looney said. "What's certain is that one should not conclude it's based on whether or not you have a child. There are so many other factors, including possibly genetic factors, that determine that."

More information

The National Multiple Sclerosis Society has more on pregnancy and MS.

SOURCES: Marie D'hooghe, department of neurology, Nationaal MS Centrum in Melsbroek, Belgium; Patricia O'Looney, Ph.D., director, biomedical research, National Multiple Sclerosis Society; Nov. 24, 2009, Journal of Neurology, Neurosurgery & Psychiatry, online