scholarly journals Fremanezumab for preventive treatment of migraine

Neurology ◽  
2018 ◽  
Vol 91 (12) ◽  
pp. e1152-e1165 ◽  
Author(s):  
Juliana VanderPluym ◽  
David W. Dodick ◽  
Richard B. Lipton ◽  
Yuju Ma ◽  
Pippa S. Loupe ◽  
...  

ObjectiveTo evaluate the effect of fremanezumab on the functional status on headache-free days in phase 2 episodic migraine (EM) and chronic migraine (CM) studies.MethodsFunctional status data were collected prospectively via the electronic headache diary on all headache-free days by patients answering questions regarding work/school/household chore performance, speed of work completion, concentration, and feeling of fatigue. Individuals with EM receiving monthly doses of fremanezumab 225 mg (n = 96) or 675 mg (n = 97) or placebo (n = 104) were compared. Individuals with CM receiving fremanezumab 675 mg followed by monthly 225 mg (n = 88) and 900 mg (n = 86) were also independently compared to those receiving placebo (n = 89).ResultsIn patients with EM, compared to patients receiving placebo, those receiving fremanezumab experienced an increased number of headache-free days with normal function in work/school/household chore performance and concentration/mental fatigue measures compared to their baseline over the entire treatment period (all p < 0.005). An increased number of headache-free days with normal functional performance for some measures was also found in the CM group in those treated with fremanezumab.ConclusionThere was an increased number of headache-free days with normal functional performance on all measures for the patients with EM and some measures for patients with CM in the fremanezumab-treated groups. Further research is required to confirm these findings in a prospective study and to clarify the underlying mechanism(s).ClinicalTrials.gov identifier:NCT02025556 and NCT02021773.Classification of evidenceThis study provides Class II evidence that for patients with migraine, fremanezumab increases normal functional performance on headache-free days.

2021 ◽  
Author(s):  
Chun-Hsiang Chuang ◽  
Kuan-Lin Lai ◽  
Jhe-Yu Li ◽  
Jung-Tai King ◽  
Wei-Ta Chen ◽  
...  

Abstract Background : Chronic migraine (CM) is a disabling headache disorder. Autonomic nervous system (ANS) disturbance, as evidenced from heart rate variability (HRV) studies, has been documented in patients with episodic migraine and other pain disorders but not specifically in patients with CM. This study aimed to explore whether the HRV in patients with CM was impaired and whether it could be used to predict treatment outcomes.Methods : Patients with CM were recruited, along with age- and gender-matched healthy controls (CTLs). The time-domain, frequency-domain, and nonlinear metrics of HRV were calculated to evaluate the sympathetic and parasympathetic aspects of ANS function in patients with CM before and after 3-month (12 weeks) treatment with flunarizine as well as in CTLs. The patients were asked to keep a headache diary throughout the study period to determine the treatment efficacy.Results : A total of 81 patients with CM and 58 CTLs completed the study. Most HRV values in patients with CM were significantly lower than those in CTLs, suggesting decreased overall autonomic modulation and parasympathetic hypofunction but not sympathetic dysfunction. By unsupervised clustering analysis, patients with CM were divided into two cluster groups with high and low HRV at baseline. Patients with high baseline HRV, which was comparable to that of CTLs, showed significantly higher absolute and relative reductions in averaged monthly headache days across a 3-month preventive treatment compared with patients with low baseline HRV (-9.1 days vs. -6.4 days or -43.2% vs. -30.1%, both p < 0.05). The HRV increased after preventive treatment in the low-HRV group but not in the high-HRV group.Conclusions : HRV could distinguish patients with CM from CTLs, indicating the involvement of ANS dysfunction. Moreover, patients with CM having a near-normal baseline HRV, indicating a preserved parasympathetic function and overall ANS modulation reservoir, predicted a better outcome to preventive treatment with flunarizine than those with low HRV.Trial registration: Neurologic Signatures of Chronic Pain Disorders, NCT02747940.Registered 22 April 2016, https://clinicaltrials.gov/ct2/show/NCT02747940


Author(s):  
Joel R Petashnick ◽  
Amit Shrira ◽  
Yaakov Hoffman ◽  
Yuval Palgi ◽  
Gitit Kavé ◽  
...  

Abstract Objectives The present study examined the longitudinal relationships between subjective age (SA) and future functional status in later life, via depressive symptoms. Additionally, we assessed the role of subjective nearness to death (SNtD) as a potential moderator within these pathways. Methods Older adults (average age 81.14 at T1) were interviewed once a year for three consecutive years (N=224 at T1, N=178 at T2, and N=164 at T3), Participants reported their SA, SNtD, depressive symptoms, and functional status. Additionally, grip strength was employed as an objective measure of functional status. Results Data analysis revealed distinct pathways leading from T1 SA to T3 functional status through T2 depressive symptoms. Moreover, T1 SNtD was found to significantly moderate most of these indirect pathways, so that the mediation model of T1 SA-T2 depressive symptoms-T3 functional status was mostly significant among those who felt closer to death. Discussion The findings contribute to our understanding of the underlying mechanism through which SA predicts long-term functioning sequelae by underscoring the indirect effect of depressive symptoms. They further indicate the importance of gauging the effects of SNtD on these longitudinal relationships. Present results may further contribute to establishing an integrative model for predicting long-term functional outcomes based on older adults' earlier subjective views of aging.


Cephalalgia ◽  
2013 ◽  
Vol 34 (4) ◽  
pp. 298-306 ◽  
Author(s):  
Geoffrey L Heyer ◽  
Sara Q Perkins ◽  
Sean C Rose ◽  
Shawn C Aylward ◽  
JoEllen M Lee

Aim The aim of this article is to compare 90-day and 30-day recall of Pediatric Migraine Disability Assessment (PedMIDAS) elements and headache frequency against daily entries from an Internet headache diary among pediatric patients and their parents. Methods In a prospective cohort study, patients aged 10–18 years with episodic migraine or probable migraine completed a 90-day Internet-based headache diary that incorporated PedMIDAS questions. Following the 90-day diary period, patients and parents completed modified PedMIDAS instruments to assess 90-day and 30-day recall. Intraclass correlation coefficients (ICC) were calculated to measure recall reliability. The Kruskal-Wallis and Jonckheere-Terpstra tests were used to explore recall accuracy as it relates to each participant’s self-reported confidence in recall and to patient age. Results Fifty-two subjects completed 90 consecutive diary entries. Comparing 30-day to 90-day recall of PedMIDAS elements, ICC scores improved by 26.2% (patients) and 17.5% (parents). Patients had better recall than their parents for all study measures. Self-reported confidence in recall and patient age had limited and inconsistent effects on recall accuracy. Conclusion The optimal recall interval to assess migraine disability must balance recall accuracy with generalizability across a range of headache frequencies. When compared to daily diary entries, recall accuracy of PedMIDAS elements and headache frequency improves at 30 days compared to 90 days. Parent report of migraine disability should not be used as a replacement for patient report.


2020 ◽  
Author(s):  
Yanbo Yang ◽  
Mingjia Chen ◽  
Zilan Wang ◽  
Yue Sun ◽  
Fan Jiang ◽  
...  

Abstract Background Erenumab is a novel monoclonal calcitonin gene–related peptide receptor antibody that is used for the preventive treatment of migraine.Objectives To evaluate overall safety and efficacy and dose-response relationship of erenumab in patients with episodic migraine and patients with prior migraine treatment failures.Methods We searched randomized clinical trials on PUBMED, EMBASE database, and Cochrane Library database. A pair-wise meta-analysis and Bayesian network analysis were performed.Results For efficacy outcomes, the network meta-analysis suggests that compared with erenumab 70 mg, participants received erenumab 140 mg reported significantly decreased MSMD and increased 50% response rate, and erenumab was most likely to be ranked first for MMD, MSMD and 50% response rate. For safety outcomes, the network meta-analysis has found no significant difference between the 70 mg group and the 140 mg group measured by AE and SAE. For patients with ≥2 treatment failures, 140mg erenumab group, patients with ≥2 treatment failures reported significantly reduced MMD and MSMD, increased 50%, and 75% response rate, compared with placebo. For safety outcomes, no significant difference was found between 140 mg erenumab group and the placebo group.Conclusion Erenumab was effective in patients with episodic migraine. 140 mg erenumab was associated with better efficacy outcomes without increased risk for developing adverse events compared with 70 mg erenumab, and 140 mg erenumab was effective in patients with prior migraine treatment failures.Registration number: CRD42020198985


2019 ◽  
Vol 90 (e7) ◽  
pp. A31.1-A31
Author(s):  
Lauren Giles ◽  
Uwe Reuter ◽  
Peter Goadsby ◽  
Michel Lanteri-Minet ◽  
Peggy Hours-Zesiger ◽  
...  

IntroductionTo assess efficacy of erenumab in the first three months of the open-label extension phase (OLEP; 13–24 weeks) of the LIBERTY study.MethodsIn the double-blind treatment phase (DBTP), 246 patients were randomized to placebo and erenumab 140 mg for 12 weeks, following which, patients completing that phase (N=240) were enrolled in OLEP, to receive monthly erenumab 140 mg. Outcomes measured monthly throughout to week 24 were achievement of at least 50%/75%/100% reduction in monthly migraine days (MMD), change from DBTP baseline in MMD, monthly acute migraine-specific medication days (MSMD), Headache Impact Test (HIT-6TM) total score, everyday activities (EA) and physical impairment (PI) as measured by the Migraine Physical Function Impact Diary (MPFID).ResultsOverall, 228/240(95.0%) patients completed the 24 week visit of the OLEP. In the overall population at Week 24, 39.2%, 15.9% and 7.0% patients achieved ≥50%/≥75%/100% reduction in MMD. The mean (standard deviation) change from DBTP baseline in MMD was −2.7(4.4) and −1.4(3.0) in MSMD; and −7.6(8.0), −2.5(9.2) and −4.0(9.0) in HIT-6TM, MPFID-PI and MPFID-EA scores respectively. Patients with continuous use of erenumab showed sustained efficacy in all outcomes assessed. Patients who switched from placebo to erenumab in the OLEP showed improvement from the first measurement at Week 16 on all outcomes assessed.ConclusionsEfficacy of erenumab was sustained throughout 24 weeks in a hard to treat patient population with multiple prior preventive treatment failures. Overall, efficacy data over 24 weeks (assessed over weeks 13–16,17–20 and 21–24) was generally in line with prior erenumab trials.


2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S445-S445
Author(s):  
Daniel Liebzeit ◽  
Lisa Bratzke ◽  
Barbara King

Abstract Transitions older adults experience post hospital discharge have primarily focused on the process of moving care from one setting to another (e.g. hospital to home). Older adults often experience a significant transition in terms of losing functional status after a hospital stay. Little is known about how older adults regain their functional ability, the type of work they engage in to recover, and conditions that influence their ability to work after a hospital stay. The objective of this Grounded Theory study was to understand strategies older adults use post discharge as they work to regain their functional status and what conditions facilitate or limit their ability to work toward returning to normal. A qualitative study was conducted. Adults aged 65 and older discharged from a large Midwestern teaching hospital (N = 14) were interviewed using in-depth one-on-one interviews. Data were analyzed using open, axial, and selective coding. Participants described key strategies they employed to regain their normal function following hospitalization and illness: doing exercises, expanding physical space, resuming prior activities and daily cares, and tracking improvement with benchmarks. Several conditions such as, presence of informal (family, friends) and formal (healthcare providers) support, perceived threats (relocation), and having poor physical or physiologic function, acted as barriers and facilitators to participants ability to work back to normal function. This study provides empirical data on work older adults engage in to transition back to normal function during the post discharge period. It presents opportunities for better supporting their work of regaining function.


1998 ◽  
Vol 16 (1) ◽  
pp. 253-286 ◽  
Author(s):  
JANET L. LARSON ◽  
NANCY K. LEIDY

People with chronic obstructive pulmonary disease (COPD) experience deterioration in functional status, therefore improving functional status is a major goal of treatment. We reviewed interventions to improve functional status in people with COPD published from 1980 through September 1996. Randomized controlled clinical trials were reviewed to document outcomes in terms of functional capacity and functional performance for the following interventions: pharmacologic therapy including theophylline, inhaled bronchodilators, steroids, antianxiolytics and antidepressants; general exercise strategies including exercise training, exercise and comprehensive pulmonary rehabilitation, and upper extremity training; inspiratory muscle therapy including inspiratory muscle training and inspiratory muscle rest; nutritional therapy; oxygen therapy; and specialized nursing care. Improvements for functional capacity were documented in terms of strength of the inspiratory muscles and upper extremities, walking tests, and peak oxygen uptake. Most interventions were targeted to enhance functional capacity, and few were aimed at enhancing functional performance. Further research is needed to examine the relationship between functional capacity and functional performance and to design and test interventions to improve functional performance.


Cephalalgia ◽  
2016 ◽  
Vol 37 (3) ◽  
pp. 236-250 ◽  
Author(s):  
Marjolijn J Sorbi ◽  
Yannick Balk ◽  
Annet M Kleiboer ◽  
Emile GM Couturier

Aim This study examined the change over 20 months in 178 participants with frequent episodic migraine under adequate treatment as usual, who had completed online behavioural training (oBT) in migraine self-management either directly (group 1, n = 120) or after 10 months of watchful waiting (group 2, n = 58). Methods Participants completed questionnaires and an online headache diary and migraine monitor following the International Classification of Headache Disorders at T0 (baseline), T1 (post-training), T2 (6-month follow-up; extended baseline in group 2), T3 (post-training, group 2 only) and T4 (group 1: 16-month follow-up; group 2: 6-month follow-up). Statistical analyses were conducted on the observed data without imputation of missing observations. Results Both groups were highly comparable. The data over time revealed benefits in response to oBT, with significant between-group differences in the change achieved in the training episodes T2–T0 (group 1) and T4–T2 (group 2). Improved attack frequency ( M = –23%) was higher in participants with more (i.e. 4–6) attacks per month at baseline, and the effects of oBT were durable over 16 months of follow-up. Conclusions oBT is beneficial in frequent episodic migraine, which deserves special efforts in care. Self-management variants such as oBT reach patients easily and supplement these efforts with durable results.


2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Thais Bento Lima-Silva ◽  
Valéria Santoro Bahia ◽  
Ricardo Nitrini ◽  
Mônica Sanches Yassuda

The aim was to conduct a systematic review of studies that described the functional profile of patients with behavioral variant frontotemporal dementia (bvFTD), published between 2000 and 2013. The bibliographic search was conducted using the terms “frontotemporal dementia” and “frontotemporal lobar degeneration” in combination with “independence,” “functionality,” “basic activities of daily living,” “disability,” and scales that measure functional performance: “Disability Assessment for Dementia-DAD,” “Functional Activities Questionnaire (FAQ),” “Direct Assessment of Functional Status (DAFS).” To be included in the review, the study had to mention the characterization of the functional status of patients with bvFTD in the objectives of the study, using a previously validated instrument of functional assessment. Fourteen studies met this criterion. The reviewed studies suggested that individuals with bvFTD have greater functional impairment when compared to those with other subtypes of frontotemporal lobar degeneration or Alzheimer’s disease. The studies documented a significant association between cognitive impairment and measures of functionality in these patients. The cognitive profile of patients may predict faster functional decline.


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