2 Minute Medicine Rewind September 9, 2019

Prehospital Stroke Management Optimized by Use of Clinical Scoring vs Mobile Stroke Unit for Triage of Patients with Stroke: A Randomized Clinical Trial

The effective management of intracranial hemorrhage (ICH) or large-vessel occlusion (LVO) requires effective triaging to hospitals with appropriate treatment capabilities, ranging from comprehensive stroke centers (CSC) to primary stroke centers (PSC), the latter of which would not offer interventional treatment. In this randomized, multicenter clinical trial, 116 patients were randomly assigned to either optimized prehospital management (OPM) through the use of the Los Angeles Motor Scale (LAMS) or a Mobile Stroke Unit (MSU) with capabilities such as vascular imaging, telecommunication, and a point-of-care laboratory. The investigators sought to determine how these two triage methods compare in accurately transferring patients to stroke centers (CSC vs. PSC). Accurate triage decisions were achieved for 69.8% in the OPM group and 100% of the MSU group (difference 30.2%, 95% CI 17.8% to 42.5%, p<0.001). Researchers also found that 41.2% of OPM patients with either ICH or LVO required secondary transfers to more comprehensive stroke centers while 0% of the MSU patients required secondary transfers (difference 41.2%, 95% CI 17.8% to 64.6%, p=0.02). The LAMS cutoff score allowed for accurate diagnoses of ICH or LVO for 76.5% of patients (6 transferred to CSC), with 77.8% being accurately diagnosed specifically with LVO (2 transferred to CSC). Overall, patient outcomes between groups were not statistically significant. However, patient management via MSU performed strongly in accurately triaging patients, and therefore, should be considered in the prehospital management of stroke.

Safety and Efficacy of Ozanimod Versus Interferon Beta-1a in Relapsing Multiple Sclerosis (SUNBEAM): A Multicentre, Randomised, Minimum 12-Month, Phase 3 Trial

Multiple sclerosis (MS) is a progressive, degenerative disease that damages myelin sheaths in the central nervous system. The RADIANCE phase 2 study previously established that ozanimod, a sphingosine 1-phosphate receptor modulator, demonstrates greater efficacy on MRI measures in patients with relapsing MS. SUNBEAM, a randomized, double-dummy, double-blind, active-controlled phase 3 trial, was conducted at 152 centres across 20 countries to determine the efficacy and safety of ozanimod compared to intramuscular interferon beta-1a in those with relapsing MS. Relapsing MS was defined using the expanded disability status scale (EDSS) as well as either 1) one relapse in the past year or 2) one relapse in the past two years plus one or more gadolinium-enhancing lesions within 12 months of screening. Participants were randomly assigned to one of three groups: 1) daily oral ozanimod 1.0 mg, 2) daily oral ozanimod 0.5 mg, or 3) interferon beta-1a 30 ug. Researchers found that the annualized relapse rates were 0.35 (95% CI 0.28 to 0.44) for interferon beta-1a, 0.18 (95% CI 0.14 to 0.24) for ozanimod 1.0 mg (RR 0.52, 95% CI 0.41 to 0.66, p<0.0001), and 0.24 (95% CI 0.19 to 0.31) for ozanimod 0.5 mg (RR 0.69, 95% CI 0.55 to 0.86, p=0.0013). Over the course of the 12-month study, the number of participants who discontinued was 91, with 39.6% of these being from the interferon beta-1a group. The incidence of significant adverse events was low and similar across treatment groups, with no serious infections reported in ozanimod-treated participants. This study therefore shows that in patients with relapsing MS, ozanimod treatment results in a significantly decreased relapse rate with greater tolerance than interferon beta-1a. As such, ozanimod may represent an effective oral therapy for individuals with relapsing MS.

Safety and Efficacy of Dabigatran Etexilate vs Dose-Adjusted Warfarin in Patients with Cerebral Venous Thrombosis

Central venous thrombosis (CVT) is a form of stroke characterized by thrombosis of cerebral veins or dural sinuses. While less than 5% of the 1.3 to 1.6 per 100,000 who experience CVT die by this cause, those who survive are at an increased risk of venous thrombotic events, and therefore, require anticoagulation, traditionally warfarin. The use of non-vitamin K oral anticoagulants in this setting has not been evaluated in randomized trials. In this multicentre randomized clinical trial (RE-SPECT CVT), 120 patients with CVT were randomized to receive dabigatran 150 mg twice daily or dose-adjusted warfarin for a treatment period of 24 weeks to assess the efficacy and safety of dabigatran in preventing recurrent VTEs in this patient population. Researchers found that while no recurrent VTEs were noted during the study, one major intestinal bleeding event occurred in the dabigatran group (1.7%, 95% CI 0.0% to 8.9%) and two major intracranial bleeding events occurred in the warfarin group (3.3% 95% CI 0.4% to 11.5%). An additional participant in the warfarin group experienced a non-major, clinically relevant bleeding event. Recanalization occurred in 60% of patients from the dabigatran group (95% CI 45.9% to 73.0%) and 67.3% of the warfarin group (95% CI 52.9% to 79.7%). The findings of this study demonstrate that patients who had CVT anticoagulated with either dabigatran or warfarin had a low risk of recurrent VTEs. Risks of bleeding events were also low and similar between medication groups, suggesting comparable safety with either approach in CVT patients at risk for recurrent VTEs.

National Trends in the Provision of Human Milk at Hospital Discharge Among Very Low-Birth-Weight Infants

For very low-birth-weight (VLBW) infants, defined as 1500 g or less, human milk provides substantial health benefits. The degree to which the use of human milk has changed over time and the variables impacting its use, however, are less understood. This cohort study of 346,248 VLBW infants across 802 U.S. hospitals (2008 to 2017) aimed to characterize the extent of enteral human milk use and its provision across various racial and/or ethnic groups. Researchers found that the provision of human milk to infants at discharge increased from 44% to 52% between 2008 and 2017. Compared to the South states, human milk provision was higher in the Western states among single births (prevalence ratio (PR) 1.32, 95% CI 1.25 to 1.39) and multiple births (PR 1.28, 95% CI 1.21 to 1.35), as well as the Northeast states among single births (PR 1.11, 95% CI 1.04 to 1.19) and multiple births (PR 1.11, 95% CI 1.04 to 1.19). Compared to non-Hispanic white mothers, human milk provision was higher among Asian mothers for single births (PR 1.21, 95% CI 1.18 to 1.25) and multiple births (PR 1.12, 95% CI 1.09 to 1.15). Conversely, compared to non-Hispanic white mothers, human milk provision was lower among Native Americans for single births (PR 0.64, 95% CI 0.59 to 0.70) and multiple births (PR 0.59, 95% CI 0.50 to 0.69), Hispanic single births (PR 0.98, 95% CI 0.96 to 1.01) and multiple births (PR 0.88, 95% CI 0.86 to 0.91), and non-Hispanic black mothers for single births (PR 0.67, 95% CI 0.65 to 0.70) and multiple births (PR 0.57, 95% CI 0.54 to 0.60). These significant findings suggest that, in spite of an increase in human milk provision over the past decade, notable disparities by ethnicity and U.S. region exist.

Association Between Soft Drink Consumption and Mortality in 10 European Countries

High-sugar soft drinks are commonly consumed across the globe and are considered an understudied topic as they relate to mortality risk. In this population-based cohort study, investigators studied total, sugar-sweetened, and artificially sweetened soft drinks and associations with total and cause-specific mortality rates. Participants (n=451,743) were from the multinational, European Prospective Investigation into Cancer and Nutrition (EPIC) study, recruited across 10 European countries between January 1, 1992 and December 31, 2000. . During a mean follow-up time of 16.4 years, 41,693 deaths occurred. Greater all-cause mortality was discovered among those who reported consuming two or more glasses daily of total soft drinks, compared to those reporting less than one glass per month (HR 1.17; 95% CI 1.11 to 1.22, p<0.001). This was also found with sugar-sweetened soft drinks (HR 1.08. 95% CI 1.01 to 1.16, p=0.004) and artificially sweetened soft drinks (HR 1.26, 95% CI 1.16 to 1.35, p<0.001). Positive associations were also noted between artificially sweetened soft drinks and circulatory disease-related deaths when comparing two or more glasses per day and less than one glass per month (HR 1.52, 95% CI 1.30 to 1.78, p<0.001). A positive association between sugar-sweetened soft drinks and digestive disease-related deaths was also noted between these consumption groups (HR 1.59, 95% CI 1.24 to 2.05, p<0.001). This study therefore shows that total, sugar-sweetened and artificially sweetened soft drinks are positively associated with all-cause deaths in this large European cohort. This has important public health implications in curbing the consumption of soft drinks.

Image: PD

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