GLACIER: An open-label, randomized, multicenter study to assess the safety and tolerability of glatiramer acetate 40 mg three-times weekly versus 20 mg daily in patients with relapsing-remitting multiple sclerosis.

BACKGROUND: The efficacy and safety of glatiramer acetate (GA) 20 mg/mL once-daily subcutaneous injections (GA20) in relapsing-remitting multiple sclerosis (RRMS) is well-established. However, injection-related adverse events (IRAEs) may impede treatment adherence and tolerability. GA 40 mg/mL three-times weekly (GA40) also has a favorable efficacy and safety profile. OBJECTIVE: To evaluate the safety, tolerability, and patient experience when converting from GA20 to GA40. METHODS/TRIAL DESIGN: GLACIER was an open-label, randomized, parallel-group trial conducted at 31 sites in the US between June 2013 and December 2013. Stable RRMS patients on GA20 were randomized in a 1:1 ratio to continue with GA20 or convert to GA40. The adjusted mean annualized rate of IRAEs was the primary endpoint for this study. Additionally, the severity of IRAEs, rate of injection-site reactions (ISRs), and patient-reported MS impact and treatment satisfaction were compared for the two treatment groups over the 4-month core study. RESULTS: A total of 209 patients were randomized to convert to GA40 (n=108) or continue with GA20 (n=101). The adjusted mean annualized rate of IRAEs was reduced by 50% with GA40 (35.3 events per year; n=108) versus GA20 (70.4 events per year; n=101) (risk ratio (RR)=0.50; 95% confidence interval [CI]=0.34-0.74; p=0.0006). There was a 60% reduction in the rate of moderate/severe events (GA40 (n=108): 0.9 events per year versus GA20 (n=101): 2.2 events per year; RR=0.40; p=0.0021). Perception of treatment convenience improved for GA40-treated patients soon after converting and was sustained. CONCLUSIONS: The GLACIER study demonstrates a favorable IRAE and convenience profile of GA40 for RRMS patients. TRIAL REGISTRATION: NCT01874145 available at clinicaltrial.gov.

Statewide efforts to narrow the rural-urban gap in acute stroke care.

BACKGROUND: Rural-urban gaps in stroke care remain challenging in part because of the lack of resources, personnel, and necessary infrastructure. PURPOSE: The purpose of this study was to assess changes in the acute stroke diagnosis and treatment capacity among rural hospitals before and after implementation of a regionwide stroke initiative. METHODS: In 2004, the Montana Cardiovascular Health Program partnered with stroke stakeholders throughout the state and surveyed hospitals in Montana and northern Wyoming to assess the availability of technology, services, and personnel for acute stroke care. The Montana Stroke Initiative (MSI) developed protocols, educational material, and stroke awareness campaigns to address the geographic disparities identified in the survey. From 2004 to 2006, protocols and educational material were made available on a website and distributed to rural and critical-access hospitals throughout the region. Stroke awareness campaigns were completed, and MSI members conducted acute stroke care training of prehospital, nursing, and primary providers throughout the region. A follow-up survey in 2008 assessed changes in the stroke systems of care between 2004 and 2008. Data were analyzed in 2009. RESULTS: There were significant increases in availability of prehospital stroke screens, written emergency department protocols, computed tomographic scanning capability, acute stroke teams, and community stroke awareness programs. CONCLUSIONS: A systematic statewide effort to improve stroke care led to improved acute stroke care capabilities in necessary infrastructure in rural facilities and a narrowing of the gap between these facilities and the urban facilities.

Stroke knowledge among urban and frontier first responders and emergency medical technicians in Montana.

PURPOSE: To assess stroke knowledge and practice among frontier and urban emergency medical services (EMS) providers and to evaluate the need for additional prehospital stroke training opportunities in Montana. METHODS: In 2006, a telephone survey of a representative sample of EMS providers was conducted in Montana. Respondents were stratified into 2 groups: those working in urban and frontier counties. FINDINGS: Compared to EMS providers from urban counties, those from frontier counties were significantly more likely to be older (mean age 44.7 vs 40.1 years), have fewer personnel working in their service (mean 17.7 vs 28.6), to be located farther away from a computed tomography scan (CT scan) (mean 41.3 vs 17.6 miles), and to be volunteers (84% vs 49%). They were also less likely to have a stroke protocol (58% vs 66%) and use a stroke screening tool (36% vs 47%) than their urban counterparts. There were no significant differences between frontier and urban EMS respondents' ability to correctly identify 4 or more stroke warning signs (58% vs 61%), 4 or more stroke risk factors (46% vs 43%), or the 3-hour recombinant tissue plasminogen activator (rt-PA) treatment window (56% vs 57%). Approximately two thirds of respondents from urban and frontier counties believed they had adequate stroke knowledge, but 90% indicated they were interested in additional stroke-related training. CONCLUSIONS: Although stroke knowledge did not differ between urban and frontier groups, stroke screens and stroke protocols were less likely to be used in the frontier areas. Training opportunities and the implementation of stroke protocols and screening tools are needed for EMS providers, particularly in frontier counties.

Availability of diagnostic and treatment services for acute stroke in frontier counties in Montana and Northern Wyoming.

CONTEXT: Rapid diagnosis and treatment of ischemic stroke can lead to improved patient outcomes. Hospitals in rural and frontier counties, however, face unique challenges in providing diagnostic and treatment services for acute stroke. PURPOSE: The aim of this study was to assess the availability of key diagnostic technology and programs for acute stroke evaluation and treatment in Montana and northern Wyoming. METHODS: In 2004, hospital medical directors or their designees were mailed a survey about the availability of diagnostic technology, programs, and personnel for acute stroke care. FINDINGS: Fifty-eight of 67 (87%) hospitals responded to the survey. Seventy-nine percent (46/58) of responding hospitals were located in frontier counties, with an average bed size of 18 (11 SD). Of the hospitals in frontier counties, 44% reported emergency medical services prehospital stroke identification programs, 39% had 24-hour computed tomography capability, 44% had an emergency department stroke protocol, and 61% had a recombinant tissue plasminogen activator protocol. Thirty percent of hospitals in frontier counties reported that they met 6-10 of the criteria established by the Brain Attack Coalition to improve acute stroke care compared to 67% of hospitals in the nonfrontier counties. CONCLUSION: A stroke network model could enhance care and improve outcomes for stroke victims in frontier counties.

Randomized, controlled trial of dextromethorphan/quinidine for pseudobulbar affect in multiple sclerosis.

OBJECTIVE: To evaluate the efficacy and safety of DM/Q (capsules containing dextromethorphan [DM] and quinidine [Q]) compared with placebo, taken twice daily, for the treatment of pseudobulbar affect over a 12-week period in multiple sclerosis patients. METHODS: A total of 150 patients were randomized in a double-blind, placebo-controlled study to assess pseudobulbar affect with the validated Center for Neurologic Study-Lability Scale. Each patient also recorded the number of episodes experienced between visits, estimated quality of life and quality of relationships on visual analog scales, and completed a pain rating scale. RESULTS: Patients receiving DM/Q had greater reductions in Center for Neurologic Study-Lability Scale scores than those receiving placebo (p < 0.0001) at all clinic visits (days 15, 29, 57, and 85). All secondary end points also favored DM/Q, including the number of crying or laughing episodes (p

Perceived risk for developing stroke among older adults.

BACKGROUND: Persons who perceive their risk for stroke accurately may be more likely to engage in prevention practices to reduce their risk. METHODS: In 2004, 800 adults aged 45 years and older in two counties participated in a telephone survey to assess their perceived risk for stroke and their history of stroke risk factors. RESULTS: Overall, 39% of respondents perceived themselves to be at risk for having a stroke. In the multivariate analyses, younger age, current smoking, and a history of diabetes, high blood pressure, high cholesterol, heart disease, and stroke/TIA were independently associated with perceived risk for stroke. Respondents with atrial fibrillation were no more likely to report being at risk for stroke compared to respondents without atrial fibrillation. Perceived risk for stroke increased as the number of risk factors increased. However, 46% of respondents with three or more risk factors did not perceive themselves to be at risk. CONCLUSIONS: Many adults with multiple risk factors do not perceive themselves to be at risk for stroke. Clinical and public health efforts are needed to increase awareness of the risk for stroke.

Rural community knowledge of stroke warning signs and risk factors.

INTRODUCTION: Rapid identification and treatment of ischemic stroke can lead to improved patient outcomes. Public education campaigns in selected communities have helped to increase knowledge about stroke, but most data represent large metropolitan centers working with academic institutions. Much less is known about knowledge of stroke among residents in rural communities. METHODS: In 2004, 800 adults aged 45 years and older from two Montana counties participated in a telephone survey using unaided questions to assess awareness of stroke warning signs and risk factors. The survey also asked respondents if they had a history of atrial fibrillation, diabetes, high blood pressure, high cholesterol, smoking, heart disease, or stroke. RESULTS: More than 70% of survey participants were able to correctly report two or more warning signs for stroke: numbness on any side of the face/body (45%) and speech difficulties (38%) were reported most frequently. More than 45% were able to correctly report two or more stroke risk factors: smoking (50%) and high blood pressure (44%) were reported most frequently. Respondents aged 45 to 64 years (odds ratio [OR] 2.44; 95% confidence interval [CI], 1.78-3.46), women (OR 2.02; 95% CI, 1.46-2.80), those with 12 or more years of education (OR 1.96; 95% CI, 1.08-3.56), and those with high cholesterol (OR 1.68; 95% CI, 1.17-2.42) were more likely to correctly identify two or more warning signs compared with respondents without these characteristics. Women (OR 1.48; 95% CI, 1.07-2.05) and respondents aged 45 to 64 years (OR 1.35; 95% CI, 1.01-1.81) were also more likely to correctly identify two or more stroke risk factors compared with men and older respondents. CONCLUSION: Residents of two rural counties were generally aware of stroke warning signs, but their knowledge of stroke risk factors was limited.