Studies

Childhood Brain Cancer Causes Other Long-Term Problems

MONDAY, Nov. 2 (HealthDay News) -- Childhood brain cancer survivors have ongoing cognitive problems and achieve lower levels of education, employment and income than their siblings and survivors of other types of cancer, a U.S. study has found.

The findings, published by the American Psychological Association in the November issue of Neuropsychology, highlight the importance of programs to support childhood brain cancer survivors' transition to adulthood, said Leah Ellenberg, a clinical faculty member of the David Geffen School of Medicine at the University of California, Los Angeles.

Ellenberg and colleagues analyzed responses to a questionnaire filled out by 785 childhood brain cancer survivors 16 years after their diagnosis. The same questionnaire was completed by 5,870 survivors of cancers such as leukemia, Hodgkin's disease and bone tumors, and 379 siblings of childhood brain cancer survivors.

The study found that childhood brain cancer survivors reported significantly greater neurocognitive dysfunction than their siblings or other cancer survivors. All areas of cognitive function were affected in childhood brain cancer survivors, including organization and emotional regulation.

The most commonly reported problems were in memory and efficiency, such as forgetting what they're doing in the middle of a task and being slower than others at completing work. More than half of childhood brain cancer survivors reported significant difficulty with at least one task efficiency item, a rate three times higher than among their siblings.

The most serious neurocognitive problems were reported by childhood brain cancer survivors with significant motor or sensory problems after treatment, those who were treated with radiation to their brains, and those who had tumors in the brain cortex rather than in lower brain regions, the researchers found.

The neurocognitive issues reported by childhood brain cancer survivors were associated with significantly poorer adaptation to adult life, including lower achievement in education, full-time employment and income. They were also less likely to be married, the study authors noted.

The study "underscores the need for continued attention to mitigating the long-term negative effects of [childhood brain cancers] and their treatment," the study authors wrote. They added that it's "important to investigate the benefits of early and consistent use of compensatory strategies, including assistive technology, transitional facilities to promote independent living, and job placement and coaching, to enhance functional outcomes."

More information

The Nemours Foundation has more about childhood brain tumors.

SOURCE: American Psychological Association, news release, Nov. 2, 2009

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

Epilepsy Drugs Don't Raise Suicide Risk, Study Shows

WEDNESDAY, Aug. 4 (HealthDay News) -- In 2008, the U.S. Food and Drug Administration required epilepsy medications to bear a warning label about an increased risk of suicidal behaviors. The move came after an agency review of 199 studies that found patients taking the drugs showed about twice the risk of suicidal behavior.

But now a study of more than 5 million patients contradicts the FDA's findings. It suggests that the increased risk of suicide has more to do with the conditions for which these drugs are prescribed than the medications themselves.

For the study, researchers in Spain and the United States evaluated the health records of primary care patients in England. They found that people with epilepsy who currently use an antiepileptic drug are at no greater risk of suicide-related events than those who aren't taking the medications.

"In our opinion, in the long term, it is not the drugs themselves that raise the risk of suicide, but the underlying disease for which these drugs are prescribed," said study author Dr. Alejandro Arana, an epidemiologist and managing partner at Risk MR Pharmacovigilance Services, in Zaragoza, Spain. "Treatment with antiepileptic drugs [AEDs] helps to control the psychiatric syndromes that are at the root of suicidal behavior in these patients."

At least one epilepsy expert said the new findings, published in the Aug. 5 issue of the New England Journal of Medicine, are powerful enough to prompt the FDA to consider reversing its decision.

"The warning on AEDs and suicide was never justified, and this data strongly argues for its removal," said Dr. Orrin Devinsky, director of the New York University Comprehensive Epilepsy Center.

"This study examined a much larger and more meaningful 'real-life' group of patients on antiepileptic drugs than the FDA study did," added Devinsky, who noted that a major flaw of the FDA analysis was that many of the people studied had more severe cases of the condition, and these patients are known to have a higher risk of suicide to begin with. Another benefit of Arana's study is that patients were followed for an average of six years, rather than the 24 weeks' follow-up in the FDA analysis.

These new findings come on the heels of two other epidemiological studies that are also at odds with the FDA's findings. Those studies, one by Harvard researchers and the other by scientists in Germany, suggested that some antiepileptic medications raise the risk of suicide, while others do not.

Arana and his colleagues studied a total of 5,130,795 patients who were seen in a general practitioner's office for at least six months between July 1988 and March 2008. First, they identified how many patients were diagnosed with epilepsy, depression or bipolar disorder (since antiepileptic medications are often given to patients with one or more of these conditions). Then they looked at how many people had received an antiepileptic medication that was included in the FDA's agency review and was also available in the U.K.

The medications studied were carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote, Depakote ER, Depakene) and zonisamide (Zonegran). Participants were followed for an average of six years. During the study period, 8,212 people attempted suicide, and 464 of these patients died as a result of their injuries.

Two subgroups of patients taking these medications were found to have an increased risk of suicide: people diagnosed with depression, and those who were prescribed an antiepileptic drug for a condition other than epilepsy, depression or bipolar disorder. Patients in the latter group were roughly two and a half times more likely to attempt or commit suicide than those who didn't take an antiepileptic medication.

The researchers weren't able to determine why patients were taking an antiepileptic medication even though they didn't have epilepsy, depression or bipolar disorder. However, they noted that it may have been for chronic pain, which has been associated with an increased risk of suicide.

One possible reason for the increased risk seen among these two groups, the authors concluded, may be that "the use of antiepileptic drugs in these patients is a marker of severe depression or the presence of another condition that may be associated with an increased risk of suicide-related events."

"Research is dialogue, and our study is just another brick in the wall of knowledge," said Arana, who noted that the study was funded by an unrestricted grant from drug maker Sepracor. "There is still the need to fine-tune the role of antiepileptic drugs in indications other than epilepsy, to study the risk in the initial period of treatment compared to the use afterwards, and to compare individual antiepileptic drugs when used to treat patients with identical types of epilepsy."

More information

For more on epilepsy, go to U.S. National Library of Medicine.

SOURCES: Alejandro Arana, M.D., managing partner, Risk MR Pharmacovigilance Services, Zaragoza, Spain; Orrin Devinsky M.D., director, Epilepsy Center, New York University Langone Medical Center, and professor, neurology, neurosurgery and psychiatry, New York University School of Medicine; Aug. 5, 2010, New England Journal of Medicine

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

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