Naturalistic assessment of patterns and predictors of acute headache medication use among women with comorbid migraine and overweight or obesity

Author(s):  
Kathryn E Smith ◽  
J Graham Thomas ◽  
Kristine J Steffen ◽  
Richard B Lipton ◽  
Samantha G Farris ◽  
...  

Lay Summary Obesity may contribute to more severe migraine symptoms and negatively impact migraine treatment outcomes. The present study aimed to understand patterns of acute medication use among 170 women with migraine and obesity who were seeking behavioral migraine treatment. Data were collected in participants’ natural environment using experience sampling methodology, during which participants reported daily migraine symptoms for 4 weeks. Approximately, 30% of attacks were not treated with any medications, and one in five attacks (i.e., 20%) was treated with migraine-specific medication. Participants were more likely to use medication during longer and more severe attacks that started earlier in the day. Participants were also more likely to use migraine-specific medication when attacks were precipitated by an aura and associated with work-related pain interference. Questionnaire-assessed factors were not related to medication use, although older age and higher educational attainment related to more frequent use. In general, these results also suggest that naturalistically assessed factors are more salient correlates of medication use compared to questionnaires. Additional investigation of barriers to medication use is needed among younger individuals and those of lower socioeconomic status.

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Stewart J Tepper ◽  
Messoud Ashina ◽  
Uwe Reuter ◽  
Yngve Hallström ◽  
Gregor Broessner ◽  
...  

Abstract Background In patients with migraine, overuse of acute medication, including migraine-specific medication (MSM) such as triptans and ergots, can lead to adverse health outcomes, including development of medication overuse headache. Here, we examined the effect of erenumab on reducing acute medication use, in particular MSM, in patients with episodic migraine (EM) and chronic migraine (CM). Methods The current post-hoc analyses were based on data from the double-blind treatment phase (DBTP) of two erenumab studies, a pivotal EM (N = 955) and a pivotal CM (N = 667) trial, and their respective extensions. Patients were administered subcutaneous placebo or erenumab (70 or 140 mg) once monthly. Daily acute headache medication use (including MSM and non-MSM) was recorded using an electronic diary during a 4-week pretreatment baseline period until the end of the treatment period. Outcome measures included change in monthly acute headache medication days (HMD) in acute headache medication users at baseline, and changes in monthly MSM days (MSMD) in MSM users at baseline and non-MSMD in non-MSM users at baseline. Results In total, 60 and 78 % of patients (all acute headache medication users) with EM and CM used MSM at baseline, respectively. For acute headache medication users, the change in mean monthly acute HMD over Months 4, 5 and 6 compared with the pre-DBTP was 1.5, 2.5, and 3.0 for placebo, erenumab 70 mg and 140 mg, respectively for the EM study. The respective change in monthly MSMD in MSM users was 0.5, 2.1 and 2.8, and in monthly non-MSMD in non-MSM users was 2.3, 2.6, and 2.7. In the acute headache medication users at baseline, the change in monthly acute HMD at Month 3 compared with pre-DBTP was 3.4, 5.5, and 6.5 for placebo, erenumab 70 mg and 140 mg, respectively for the CM study. The respective change in monthly MSMD in MSM users was 2.1, 4.5, and 5.4, and in monthly non-MSMD in non-MSM users was 5.9, 6.4, and 6.6. Reductions in MSMD versus placebo were sustained in the extension periods of both studies. Erenumab was also associated with a higher proportion of MSM users achieving ≥ 50 %, ≥ 75 and 100 % reduction from baseline in monthly MSMD versus placebo in both EM and CM. Conclusions In both EM and CM, treatment with erenumab is associated with a significant and sustained reduction in the use of acute headache medication, in particular MSM. Trial registrations NCT02456740; NCT02066415; NCT02174861.


2019 ◽  
Vol 76 (Suppl 1) ◽  
pp. A28.1-A28
Author(s):  
Lode Godderis ◽  
Lieve Vandersmissen ◽  
Martijn Schouteden

IntroductionIn order to investigate the impact of work on health, we hypothesize that medication consumption registered in medical files of workers could serve as a proxy for work-related health problems. In this study, we describe variations in prevalence of specific medication groups between sectors, adjusting for age and gender. In addition, we investigated whether a change in job/sector can have an impact on medication use.MethodLogistic regression analysis is being performed to investigate the effect of occupational sector on the prevalence of specific medication groups, adjusted for year, age and gender. For this, an occupational surveillance dataset of 6 86 434 workers collected between 2011 and 2017 was used. Additionally, regarding the impact on job changes on medication use, analyses are currently being performed by comparing prevalence of specific medication groups in 2011 with 2017 for those employees who changed job during this time period.Results and discussionIn 2011 30,6% male and 49,8% female workers used medication. These figures roze to 43,1% and 67,3% respectively in 2017. The use of medication increased with age: in 2017 38,2% for workers<25 year, 43,6% for 25–34 year old employees, 48,7% between 35–44 year, 61,6% between 45–54 year and 74,1% for older workers>=55 year. Big differences were observed between sectors. Medication use was highest in health care (67,1% in 2017), government and education. These differences remained after adjustment for age and gender. 9,8% and 9,1% of the workers were treated for respectively pain and neuropsychological disorders in 2017.ConclusionSignificant differences in workers’ medical consumption were observed between sectors. This information is now being used for the implementation of a sector-oriented health surveillance program.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Messoud Ashina ◽  
Joshua M. Cohen ◽  
Maja Galic ◽  
Verena Ramirez Campos ◽  
Steve Barash ◽  
...  

Abstract Background Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) selectively targets the calcitonin gene-related peptide and has proven efficacy for the preventive treatment of migraine. In this study, we evaluated the long-term efficacy, safety, and tolerability of monthly and quarterly fremanezumab. Methods Episodic migraine and chronic migraine patients completing the 12-week double-blind period of the FOCUS trial entered the 12-week open-label extension and received 3 monthly doses of fremanezumab (225 mg). Changes from baseline in monthly migraine days, monthly headache days of at least moderate severity, days of acute headache medication use, days with photophobia/phonophobia, days with nausea or vomiting, disability scores, and proportion of patients achieving a ≥50% or  ≥75% reduction in monthly migraine days were evaluated. Results Of the 807 patients who completed the 12-week double-blind treatment period and entered the open-label extension, 772 patients completed the study. In the placebo, quarterly fremanezumab, and monthly fremanezumab dosing regimens, respectively, patients had fewer average monthly migraine days (mean [standard deviation] change from baseline: − 4.7 [5.4]; − 5.1 [4.7]; − 5.5 [5.0]), monthly headache days of at least moderate severity (− 4.5 [5.0]; − 4.8 [4.5]; − 5.2 [4.9]), days per month of acute headache medication use (− 4.3 [5.2]; − 4.9 [4.6]; − 4.8 [4.9]), days with photophobia/phonophobia (− 3.1 [5.3]; − 3.4 [5.3]; − 4.0 [5.2]), and days with nausea or vomiting (− 2.3 [4.6]; − 3.1 [4.5]; − 3.0 [4.4]). During the 12-week open-label extension, 38%, 45%, and 46% of patients, respectively, achieved a ≥50% reduction and 16%, 15%, and 20%, respectively, achieved a ≥75% reduction in monthly migraine days. Disability scores were substantially improved in all 3 treatment groups. There were low rates of adverse events leading to discontinuation (<1%). Conclusion Fremanezumab demonstrated sustained efficacy up to 6 months and was well tolerated in patients with episodic migraine or chronic migraine and documented inadequate response to multiple migraine preventive medication classes. Trial registration ClinicalTrials.gov NCT03308968 (FOCUS).


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Stephen D. Silberstein ◽  
Joshua M. Cohen ◽  
Ronghua Yang ◽  
Sanjay K. Gandhi ◽  
Evelyn Du ◽  
...  

Abstract Background Monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway, including the fully humanized monoclonal antibody (IgG2Δa) fremanezumab, have demonstrated safety and efficacy for migraine prevention. Clinical trials include responders and nonresponders; efficacy outcomes describe mean values across both groups and thus provide little insight into the clinical benefit in responders. Clinicians and their patients want to understand the extent of clinical improvement in patients who respond. This post hoc analysis of fremanezumab treatment attempts to answer this question: what is the benefit in subjects who responded to treatment during the two, phase 3 HALO clinical trials? Methods We included subjects with episodic migraine (EM) or chronic migraine (CM) who received fremanezumab quarterly (675 mg/placebo/placebo) or monthly (EM: 225 mg/225 mg/225 mg; CM: 675 mg/225 mg/225 mg) during the 12-week randomized, double-blind, placebo-controlled HALO EM and HALO CM clinical trials. EM and CM responders were defined as participants with a reduction of ≥ 2 or ≥ 4 monthly migraine days, respectively. Treatment benefits evaluated included reductions in monthly migraine days, acute headache medication use, and headache-related disability, and changes in health-related quality of life (HRQoL). Results Overall, 857 participants from the HALO trials were identified as responders (EM: 429 [73.8%]; CM: 428 [56.7%]). Reductions in the monthly average number of migraine days were greater among EM (quarterly: 5.4 days; monthly: 5.5 days) and CM (quarterly: 8.7 days; monthly: 9.1 days) responders compared with the overall population. The proportion of participants achieving ≥ 50% reduction in the average monthly number of migraine days was also greater in responders (EM: quarterly, 59.8%; monthly, 63.7%; CM: quarterly, 52.8%; monthly, 59.0%) than in the overall population. Greater reductions in the average number of days of acute headache medication use, greater reductions in headache-related disability scores, and larger improvements in HRQoL were observed among EM and CM responders compared with the overall populations. Conclusions Fremanezumab responders achieved clinically meaningful improvements in all outcomes. The magnitude of improvements with fremanezumab across efficacy outcomes was far greater in responders than in the overall trial population, providing insight into expected treatment benefits in participants who respond to fremanezumab in clinical practice. Trial registration ClinicalTrials.gov identifiers: NCT02629861 (HALO EM) and NCT02621931 (HALO CM).


Author(s):  
Anne Spinewine ◽  
Perrine Evrard ◽  
Carmel Hughes

Abstract Purpose Polypharmacy, medication errors and adverse drug events are frequent among nursing home residents. Errors can occur at any step of the medication use process. We aimed to review interventions aiming at optimization of any step of medication use in nursing homes. Methods We narratively reviewed quantitative as well as qualitative studies, observational and experimental studies that described interventions, their effects as well as barriers and enablers to implementation. We prioritized recent studies with relevant findings for the European setting. Results Many interventions led to improvements in medication use. However, because of outcome heterogeneity, comparison between interventions was difficult. Prescribing was the most studied aspect of medication use. At the micro-level, medication review, multidisciplinary work, and more recently, patient-centered care components dominated. At the macro-level, guidelines and legislation, mainly for specific medication classes (e.g., antipsychotics) were employed. Utilization of technology also helped improve medication administration. Several barriers and enablers were reported, at individual, organizational, and system levels. Conclusion Overall, existing interventions are effective in optimizing medication use. However there is a need for further European well-designed and large-scale evaluations of under-researched intervention components (e.g., health information technology, patient-centered approaches), specific medication classes (e.g., antithrombotic agents), and interventions targeting medication use aspects other than prescribing (e.g., monitoring). Further development and uptake of core outcome sets is required. Finally, qualitative studies on barriers and enablers for intervention implementation would enable theory-driven intervention design.


2021 ◽  
Vol 12 ◽  
Author(s):  
Alan P. Pan ◽  
Jennifer Meeks ◽  
Thomas Potter ◽  
Joseph C. Masdeu ◽  
Sudha Seshadri ◽  
...  

Introduction: Persistent knowledge gaps exist as to the extent that preexisting cognitive impairment is a risk factor for susceptibility to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and mortality from the coronavirus disease 2019 (COVID-19).Methods: We conducted a cross-sectional analysis of adults tested for SARS-CoV-2 at a tertiary healthcare system. Cognitive impairment was identified utilizing diagnosis codes (mild cognitive impairment, Alzheimer's disease, vascular, and other dementias) or cognitive impairment-specific medication use. Propensity score (PS) matched analyses were utilized to report odds ratios (OR) and 95% confidence intervals (CI) for association of cognitive impairment with SARS-CoV-2 susceptibility and COVID-19 mortality.Results: Between March-3rd and December-11th, 2020, 179,979 adults were tested, of whom 21,607 (12.0%) tested positive. We identified 6,364 individuals with preexisting cognitive impairment (mean age: 78.5 years, 56.8% females), among whom 843 (13.2%) tested positive and 139 (19.5%) of those hospitalized died. In the pre-PS matched cohort, cognitive impairment was significantly associated with increased SARS-CoV-2 susceptibility (OR, CI: 1.12, 1.04–1.21) and COVID-19 mortality (OR, CI: 2.54, 2.07–3.12). One-to-one matches were identified for 6,192 of 6,364 (97.3%) individuals with prior cognitive impairment and 687 of 712 (96.5%) hospitalized patients with prior cognitive impairment. In the fully balanced post-matched cohort, preexisting cognitive impairment was significantly associated with higher likelihood of SARS-CoV-2 infection (OR, CI: 1.51, 1.35–1.70); however, cognitive impairment did not confer higher risk of COVID-19 mortality (OR, CI: 0.96, 0.73–1.25).Discussion: To mitigate the effects of healthcare catastrophes such as the COVID-19 pandemic, strategies for targeted prevention and risk-stratified comorbidity management are warranted among the vulnerable sub-population living with cognitive impairment.


2010 ◽  
Vol 2010 ◽  
pp. 1-6 ◽  
Author(s):  
Helena Eri Shimizu ◽  
Djalma Ticiani Couto ◽  
Edgar Merchán-Hamann ◽  
Anadergh Barbosa Branco

This study analyzed occupational health hazards for Intensive Care Unit (ICU) nurses and nursing technicians, comparing differences in the number and types of hazards which occur at the beginning and end of their careers. A descriptive cross-sectional study was carried out with 26 nurses and 96 nursing technicians from a public hospital in the Federal District, Brazil. A Likert-type work-related symptom scale (WRSS) was used to evaluate the presence of physical, psychological, and social risks. Data were analyzed with the use of the SPSS, version 12.0, and the Kruskal-Wallis test for statistical significance and differences in occupational health hazards at the beginning and at the end of the workers' careers. As a workplace, ICUs can cause work health hazards, mostly physical, to nurses and nursing technicians due to the frequent use of physical energy and strength to provide care, while psychological and social hazards occur to a lesser degree.


Cephalalgia ◽  
2019 ◽  
Vol 39 (8) ◽  
pp. 931-944 ◽  
Author(s):  
Dustin D Ruff ◽  
Janet H Ford ◽  
Antje Tockhorn-Heidenreich ◽  
Matthew Sexson ◽  
Sriram Govindan ◽  
...  

Background Efficacy of galcanezumab in chronic migraine has been demonstrated in a pivotal Phase 3 study. Here, we assess efficacy in patients who have failed ≥2 and ≥1 prior migraine preventives for efficacy and/or safety reasons, and in those who never failed. Study design/methods REGAIN (NCT02614261) was a Phase 3, randomized, double-blind, placebo-controlled study in patients with chronic migraine. Patients were randomized 2:1:1 to receive placebo, galcanezumab 120 mg/240 mg once monthly during a double-blind treatment period lasting three months. Subgroup analyses were conducted among patients who failed ≥2 and ≥1 prior preventives and who never failed previously. Outcomes assessed were change from baseline in number of monthly migraine headache days, proportion of patients with ≥50% and ≥75% response (reduction in monthly migraine headache days), change in number of monthly migraine headache days with acute medication use and change in patient functioning per Migraine-Specific Quality of Life Questionnaire Role Function Restrictive (MSQ RF-R) domain score. Results Treatment with galcanezumab versus placebo resulted in significant improvements ( p < 0.01) in overall reduction (Months 1–3) from baseline in the number of monthly migraine headache days in patients with prior failures (LS mean change [SE]: ≥2 prior failures: galcanezumab 120 mg: −5.35 (0.71); galcanezumab 240 mg: −2.77 (0.66); placebo: −1.01 (0.54); ≥1 prior failures: galcanezumab 120 mg: −5.53 (0.60), galcanezumab 240 mg: −3.53 (0.59); placebo: −2.02 (0.49). Similarly, significant results were seen with galcanezumab versus placebo for ≥50% and ≥75% response rates, reductions in acute medication use and improvements in MSQ RF-R domain score. In the subgroup with no prior preventive failures, results were statistically significant for the 240 mg galcanezumab group versus placebo on all outcome measures, and for the 120 mg group on the reduction in migraine headache days with acute medication use. There was also a higher placebo response observed in the patients with no prior preventive failures. Conclusion Galcanezumab is consistently efficacious versus placebo in reducing monthly migraine headache days and several other key outcomes in patients with chronic migraine who have failed ≥2 or ≥1 preventives previously. In the subgroup with no prior failures, greater numerical differences were seen with galcanezumab, but statistical separation from placebo varied by dose and outcome. Clinicaltrials.gov identifier number NCT02614261.


Author(s):  
Irene Worthington ◽  
Tamara Pringsheim ◽  
Marek J. Gawel ◽  
Jonathan Gladstone ◽  
Paul Cooper ◽  
...  

ABSTRACT:Background:In our targeted review (Section 2), 12 acute medications received a strong recommendation for use in acute migraine therapy while four received a weak recommendation for use. Strong recommendations were made to avoid use of two other medications, except for exceptional circumstances. Two anti-emetics received strong recommendations for use as needed.Objective:To organize the available acute migraine medications into acute migraine treatment strategies in order to assist the practitioner in choosing a specific medication(s) for an individual patient.Methods:Acute migraine treatment strategies were developed based on the targeted literature review used for the development of this guideline (Section 2), and a general literature review. Expert consensus groups were used to refine and validate these strategies.Results:Based on evidence for drug efficacy, drug side effects, migraine severity, and coexistent medical disorders, our analysis resulted in the formulation of eight general acute migraine treatment strategies. These could be grouped into four categories: 1) two mild-moderate attack strategies, 2) two moderate-severe attack or NSAID failure strategies, 3) three refractory migraine strategies, and 4) a vasoconstrictor unresponsive-contraindicated strategy. In addition, strategies were developed for menstrual migraine, migraine during pregnancy, and migraine during lactation. The eight general treatment strategies were coordinated with a “combined acute medication approach” to therapy which used features of both the “stratified” and the “step care across attacks” approaches to acute migraine management.Conclusions:The available medications for acute migraine treatment can be organized into a series of strategies based on patient clinical features. These strategies may help practitioners make appropriate acute medication choices for patients with migraine.


2017 ◽  
Vol 36 (3) ◽  
pp. 239-251 ◽  
Author(s):  
Brian S. Nielsen ◽  
Erik H. Larsen ◽  
Ole Ladefoged ◽  
Henrik R. Lam

Manganese (Mn) is neurotoxic and can induce manganism, a Parkinson-like disease categorized as being a serious central nervous system irreversible neurodegenerative disease. An increased risk of developing symptoms of Parkinson disease has been linked to work-related exposure, for example, for workers in agriculture, horticulture, and people living near areas with frequent use of Mn-containing pesticides. In this study, the focus was placed on neurochemical effects of Mn. Rats were dosed intraperitoneally with 0.9% NaCl (control), 1.22 mg Mn (as MnO2)/kg bodyweight (bw)/day, or 2.5 mg Mn (as MnCl2)/kg bw/day for 7 d/wk for 8 or 12 weeks. This dosing regimen adds relevant new knowledge about Mn neurotoxicity as a consequence of low-dose subchronic Mn dosing. Manganese concentrations increased in the striatum, the rest of the brain, and in plasma, and regional brain neurotransmitter concentrations, including noradrenaline, dopamine (DA), 5-hydroxytrytamine, glutamate, taurine, and γ-amino butyric acid, and the activity of acetylcholinesterase changed. Importantly, a target parameter for Parkinson disease and manganism, the striatal DA concentration, was reduced after 12 weeks of dosing with MnCl2. Plasma prolactin concentration was not significantly affected due to a potentially reduced dopaminergic inhibition of the prolactin release from the anterior hypophysis. No effects on the striatal α-synuclein and synaptophysin protein levels were detected.


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