One-year sustained efficacy of erenumab in episodic migraine

ObjectiveTo assess efficacy and tolerability of 1-year erenumab treatment in patients with episodic migraine.MethodsPatients were randomized (n = 955; 1:1:1) during the 24-week double-blind treatment phase (DBTP) to monthly subcutaneous placebo or erenumab 70 or 140 mg. At week 24, 845 patients were rerandomized (1:1) to erenumab 70 or 140 mg during the 28-week dose-blinded active-treatment phase (ATP). Monthly migraine days (MMD), achieving ≥50%, ≥75%, and 100% reduction in MMD, and safety/tolerability were assessed.ResultsMean MMD at DBTP baseline was 8.3. At week 52, mean changes (SE) from pre-DBTP baseline/week 24 (pre-ATP baseline) in MMD were −4.2 (0.2)/−1.1 (0.2) (70 mg) and −4.6 (0.2)/−1.8 (0.2) (140 mg) irrespective of treatment during the DBTP. For patients reducing dose from 140 (DBTP) to 70 mg (ATP), change in MMD from week 24 to 52 was −0.1 (0.3), and for those increasing from 70 (DBTP) to 140 mg (ATP), −1.8 (0.3). At week 52, 61.0%, 38.5%, and 19.8% of patients on erenumab 70 mg, and 64.9%, 40.8%, and 21.2% on erenumab 140 mg, achieved ≥50%, ≥75%, and 100% reduction in MMD from DBTP baseline, respectively. Among erenumab-treated patients in DBTP who showed ≥50% reduction in MMD during the last 3 months of DBTP and completed ATP, 86% showed sustained responses at ≥50% during the last 3 months of ATP. Safety of erenumab in ATP was similar to DBTP; exposure-adjusted incidence rates of adverse events were similar for either dose.ConclusionOver 52 weeks, erenumab provided sustained efficacy in episodic migraine; the safety profiles were similar between erenumab dose groups in the presence of dose blinding.Clinicaltrials.gov identifierNCT02456740.Classification of evidenceClass II evidence that 52 weeks of treatment with erenumab 70 and 140 mg subcutaneously monthly results in sustained reductions in monthly migraine days and similar dose tolerability for patients with episodic migraine.

Preliminary Efficacy of Adapted Responsive Teaching for Infants at Risk of Autism Spectrum Disorder in a Community Sample

This study examined the (a) feasibility of enrolling 12-month-olds at risk of ASD from a community sample into a randomized controlled trial, (b) subsequent utilization of community services, and (c) potential of a novel parent-mediated intervention to improve outcomes. The First Year Inventory was used to screen and recruit 12-month-old infants at risk of ASD to compare the effects of 6–9 months of Adapted Responsive Teaching (ART) versus referral to early intervention and monitoring (REIM). Eighteen families were followed for ~20 months. Assessments were conducted before randomization, after treatment, and at 6-month follow-up. Utilization of community services was highest for the REIM group. ART significantly outperformed REIM on parent-reported and observed measures of child receptive language with good linear model fit. Multiphase growth models had better fit for more variables, showing the greatest effects in the active treatment phase, where ART outperformed REIM on parental interactive style (less directive), child sensory responsiveness (less hyporesponsive), and adaptive behavior (increased communication and socialization). This study demonstrates the promise of a parent-mediated intervention for improving developmental outcomes for infants at risk of ASD in a community sample and highlights the utility of earlier identification for access to community services earlier than standard practice.

EMDR and CBT for Cancer Patients: Comparative Study of Effects on PTSD, Anxiety, and Depression

This pilot study examined the efficacy of eye movement desensitization and reprocessing (EMDR) treatment compared with cognitive behavioral therapy (CBT) in treating posttraumatic stress disorder (PTSD) in oncology patients in the follow-up phase of the disease. The secondary aim of this study was to assess whether EMDR treatment has a different impact on PTSD in the active treatment or during the follow-up stages of disease. Twenty-one patients in follow-up care were randomly assigned to EMDR or CBT groups, and 10 patients in the active treatment phase were assigned to EMDR group. The Impact of Event Scale—Revised (IES-R) and Clinician-Administered PTSD Scale (CAPS) were used to assess PTSD at pretreatment and 1 month posttreatment. Anxiety, depression, and psychophysiological symptoms were also evaluated. For cancer patients in the follow-up stage, the absence of PTSD after the treatment was associated with a significantly higher likelihood of receiving EMDR rather than CBT. EMDR was significantly more effective than CBT in reducing scores on the IES-R and the CAPS intrusive symptom subscale, whereas anxiety and depression improved equally in both treatment groups. Furthermore, EMDR showed the same efficacy both in the active cancer treatment and during the follow-up of the disease.

Korean Red Ginseng Improves Blood Pressure Stability in Patients with Intradialytic Hypotension

Introduction. Intradialytic hypotension (IDH) is a common complication during hemodialysis which may increase mortality risks. Low dose of Korean red ginseng (KRG) has been reported to increase blood pressure. Whether KRG can improve hemodynamic stability during hemodialysis has not been examined.Methods. The 8-week study consisted of two phases: observation phase and active treatment phase. According to prehemodialysis blood pressure (BP), 38 patients with IDH were divided into group A (BP ≥ 140/90 mmHg,n= 18) and group B (BP < 140/90 mmHg,n= 20). Patients were instructed to chew 3.5 gm KRG slices at each hemodialysis session during the 4-week treatment phase. Blood pressure changes, number of sessions disturbed by symptomatic IDH, plasma levels of vasoconstrictors, blood biochemistry, and adverse effects were recorded.Results. KRG significantly reduced the degree of blood pressure drop during hemodialysis (P<0.05) and the frequency of symptomatic IDH (P<0.05). More activation of vasoconstrictors (endothelin-1 and angiotensin II) during hemodialysis was found. The postdialytic levels of endothelin-1 and angiotensin II increased significantly (P<0.01).Conclusion. Chewing KRG renders IDH patients better resistance to acute BP reduction during hemodialysis via activation of vasoconstrictors. Our results suggest that KRG could be an adjuvant treatment for IDH.