New and Noteworthy Information—February 2014
Alcohol consumption may reduce the risk of developing multiple sclerosis (MS) and attenuate the effect of smoking, according to research published online ahead of print January 6 in JAMA Neurology. Scientists examined data from the Epidemiological Investigation of MS (EIMS), which included 745 cases and 1,761 controls, and from the Genes and Environment in MS (GEMS) study, which recruited 5,874 cases and 5,246 controls. In EIMS, women who reported high alcohol consumption (>112 g/week) had an odds ratio (OR) of 0.6 of developing MS, compared with nondrinking women. Men with high alcohol consumption (>168 g/week) in EIMS had an OR of 0.5, compared with nondrinking men. The OR for the comparison in GEMS was 0.7 for women and 0.7 for men. In both studies, the detrimental effect of smoking was more pronounced among nondrinkers.
A lentiviral vector-based gene therapy may be safe and improve motor behavior in patients with Parkinson’s disease, according to a study published online ahead of print January 10 in Lancet. In a phase I–II open-label trial, 15 patients received bilateral injections of gene therapy into the putamen and were followed up for 12 months. Participants received a low dose (1.9 × 107 transducing units [TU]), medium dose (4.0 × 107 TU), or a high dose (1 × 108 TU) of gene therapy. Patients reported 51 mild adverse events, three moderate adverse events, and no serious adverse events. The investigators noted a significant improvement in mean Unified Parkinson’s Disease Rating Scale part III motor scores off medication in all patients at six months, compared with baseline.
The FDA has approved a three-times-per-week formulation of Copaxone 40 mg/mL. The new formulation will enable a less-frequent dosing regimen to be administered subcutaneously to patients with relapsing forms of multiple sclerosis (MS). The approval is based on data from the Phase III Glatiramer Acetate Low-Frequency Administration study of more than 1,400 patients. In the trial, investigators found that a 40-mg/mL dose of Copaxone administered subcutaneously three times per week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with relapsing-remitting MS. In addition to the newly approved dose, daily Copaxone 20 mg/mL will continue to be available. The daily subcutaneous injection was approved in 1996. Both formulations are manufactured by Teva Pharmaceutical Industries, which is headquartered in Jerusalem.
When administered with amitriptyline, cognitive behavioral therapy (CBT) may result in greater reductions in days with headache and in migraine-related disability among young persons with chronic migraine, compared with headache education, according to research published December 25, 2013, in JAMA. In a randomized clinical trial, 135 children (ages 10 to 17) with chronic migraine and a Pediatric Migraine Disability Assessment Score (PedMIDAS) greater than 20 points were assigned to CBT plus amitriptyline or headache education plus amitriptyline. At the 20-week end point, days with headache were reduced by 11.5 for the CBT plus amitriptyline group, compared with 6.8 for the headache education plus amitriptyline group. The PedMIDAS decreased by 52.7 points for the CBT group and by 38.6 points for the headache education group.
Low levels of vitamin D early in the course of multiple sclerosis (MS) are a strong risk factor for long-term disease activity and progression in patients who were primarily treated with interferon beta-1b, according to a study published online January 20 in JAMA Neurology. Researchers compared early and delayed interferon beta-1b treatment in 468 patients with clinically isolated syndrome, measuring serum levels of 25-hydroxyvitamin D (25[OH]D) at baseline and at six, 12, and 24 months. “A 50-nmol/L (20-ng/mL) increment in average serum 25(OH)D levels within the first 12 months predicted a 57% lower rate of new active lesions, 57% lower relapse rate, 25% lower yearly increase in T2 lesion volume, and 0.41% lower yearly loss in brain volume from months 12 to 60,” stated the study authors.
Excessive alcohol consumption in men was associated with faster cognitive decline, compared with light to moderate alcohol consumption, researchers reported online ahead of print January 15 in Neurology. The findings are based on data from 5,054 men and 2,099 women (mean age, 56) who had their alcohol consumption analyzed three times in the 10 years preceding the first cognitive assessment. In men, the investigators observed no differences in cognitive decline among alcohol abstainers, those who quit using alcohol, and light or moderate alcohol drinkers (<20 g/day). Alcohol consumption ≥36 g/day was associated with faster decline in all cognitive domains, compared with consumption between 0.1 and 19.9 g/day. In women, 10-year abstainers had a faster decline in the global cognitive score and executive function, compared with those drinking between 0.1 and 9.9 g/day of alcohol.
