scholarly journals The Role of Galcanezumab in Migraine Prevention: Existing Data and Future Directions

2021 ◽  
Vol 14 (3) ◽  
pp. 245
Author(s):  
Panagiotis Gklinos ◽  
Dimos D. Mitsikostas

Galcanezumab is a humanized monoclonal antibody blocking the calcitonin gene-related peptide (CGRP) pathway by targeting the CGRP. Data from four phase-3 randomized placebo-controlled clinical trials showed that galcanezumab is superior to placebo in reducing migraine headaches, migraine-specific quality of life, and headache-related disability. Most of the adverse events (AEs) were mild to moderate and did not affect trial completion rates significantly. Along with erenumab, fremanezumab, and eptinezumab, galcanezumab forms a novel class of anti-migraine preventative treatments that is disease-specific and mechanism-based, unlike the standard ones. In addition, galcanezumab has also been shown to be effective in cluster headache, though more clinical trials are required. Overall, galcanezumab is a promising emerging treatment in migraine prophylaxis. However, it needs to be tested in larger clinical trials focused on treatment-resistant migraine. Furthermore, its safety profile, especially its potential association with an increased cardiovascular risk, needs to be established through long-term, real-world data. This review aims to give an overview of its pharmacological properties as well as to report and discuss data from clinical trials and its potential place in headache therapeutics.

2020 ◽  
Vol 13 ◽  
pp. 175628642092711 ◽  
Author(s):  
Anna P. Andreou ◽  
Matteo Fuccaro ◽  
Giorgio Lambru

Calcitonin gene related peptide (CGRP) monoclonal antibodies (mAbs) have been the first class of specifically developed preventive treatments for migraine. Clinical trials data suggest superiority of the CGRP mAbs to placebo in terms of prevention of migraine symptoms, migraine-specific quality of life and headache related disability. Treatment-related side effects overall did not differ significantly from placebo and discontinuation rate due to side effects has been low across the clinical trials, perhaps in view of their peripheral mode of action. Along with their route and frequency of administration, these novel class of drugs may constitute an improvement compared with the established arsenal of migraine treatments. Erenumab is a fully human antibody and the only mAb acting on the CGRP pathway by blocking its receptor. It is the first of the CGRP mAb class approved by the US Food and Drug Administration (May 2018) and the European Medicines Agency (July 2018). Erenumab exists in two different doses (70 mg and 140 mg) and it is administered with monthly subcutaneous injections. This review summarises erenumab pharmacological characteristics, clinical trials data, focusing on the potential role of this treatment in clinical practice.


1996 ◽  
Vol 30 (6) ◽  
pp. 656-661 ◽  
Author(s):  
Gena W Cramer ◽  
John A Bosso ◽  
Wanda T Maldonado ◽  
Chantal Guévremont

Objective To review the current utility and proper role of dornase alfa (recombinant human DNase or rhDNase), which has been approved for use in cystic fibrosis. Several aspects related to these issues are addressed including the drug's mechanism of action, administration and dosing, and clinical safety and efficacy. We also critically examine the agent's role in the treatment of cystic fibrosis and consider the controversies involved with its use. data source A MEDLINE search was conducted to identify pertinent literature, including review articles and clinical trials. Study Selection Studies examining the efficacy and safety of dornase alfa in patients with cystic fibrosis. Data Extraction Results from published, prospective, randomized trials are presented and critiqued. Data Synthesis Production of viscous respiratory secretions is a hallmark phenomenon of cystic fibrosis, leading to a variety of symptoms. Dornase alfa targets this symptom and decreases the viscosity of these secretions. Clinical trials have indicated a small but statistically significant improvement in forced expiratory volume in 1 second and forced vital capacity. Enhancement in a patient's dyspnea and quality of life has varied between the trials, with few of the studies noting no statistically significant improvement. Adverse reactions are minimal and did not result in any patient withdrawals from the trials. A positive impact on infection rates, length of hospitalization, and need for intravenous antibiotic therapy was noted in one trial. However, reports of similar results have not yet been published, and thus the clinical significance or impact of this phenomenon is not fully understood. Moreover, results of more long-term use and in patients whose conditions are less stable have yet to undergo the scrutiny of peer/editorial review. Administration of the drug, which must be maintained continuously, is relatively expensive. Conclusions Dornase alfa appears to produce small but sustained improvements in lung function in patients with cystic fibrosis. It may also slow the progression of pulmonary disease. Infection rates appear to be reduced, which may well have important long-term consequences. However, evidence to date has not clarified the most appropriate use of dornase alfa in the treatment of cystic fibrosis. Whether quality of life is affected in a meaningful and measurable way is yet to be clarified. A trial of the drug in patients with cystic fibrosis who have obvious lung disease is reasonable, but continued treatment should be based on clear clinical response. Therefore, questions about the drug's exact role in the overall management of cystic fibrosis remain to be answered. Although benefits received may not prove to be cost-effective, long-term effects on disease progression may well justify use of this agent.


2011 ◽  
pp. 85-89 ◽  
Author(s):  
Giorgio Pezzi

No real improvement in the technological quality of beet has been recorded over the last 15 years in Northern Italy. Among the possible explanations for the quality stagnation is that the traditional formulae cannot correctly differentiate between sugarbeet varieties which produce thick juice of very high purity. This seems to be connected with the role of potassium. The use of a standard purification procedure gives reliable and accurate data which is immediately comparable with the factory data. Research projects on medium/long term storage are currently being performed by Co.Pro.B., Italy, in cooperation with Syngenta and Beta. Up to now the results have shown that storage of sugarbeet in autumn time in northern Italy is possible provided that suitable varieties and proper handling of the roots are employed. Results obtained in the storage trials are reported. Correlations have been found between quality parameters (purity, color and lime salts) of the purified juice with the glucose content of the raw juice. An interesting correlation is reported between purified juice purity and raw juice purity.


Author(s):  
Giuseppe Lassandro ◽  
Valentina Palladino ◽  
Giovanni Carlo Del Vecchioa ◽  
Viviana Valeria Palmieri ◽  
Paola Carmela Corallo ◽  
...  

Background and Objective: Immune thrombocytopenia (ITP) is a common bleeding disorder in childhood. The management of ITP in children is controversial, requiring personalized assessment of patients and therapeutic choices. Thrombopoietin receptor agonists (TPO-RAs), eltrombopag and romiplostim, have been shown to be safety and effective for the treatment of pediatric ITP. The aim of our research is defining the role of thrombopoietin receptor agonists in the management of pediatric ITP. Method: This review focuses on the use of TPO-RAs in pediatric ITP, in randomized trials and in clinical routine, highlighting their key role in management of the disease. Results: Eltrombopag and romiplostim appear effective treatment options for children with ITP. Several clinical studies have assessed that the use of TPO-RAs increases platelet count, decreases bleeding symptoms and improves health-related quality of life. Moreover, TPO-RAs are well tolerated with minor side effects. Conclusion: Although TPO-RAs long term efficacy and safety still require further investigations, their use is gradually expanding in clinical practice of children with ITP.


Author(s):  
Maureen L. Whittal ◽  
Melisa Robichaud

The cornerstone of cognitive treatment (CT) for OCD is based upon the knowledge that unwanted intrusions are essentially a universal experience. As such, it is not the presence of the intrusion that is problematic but rather the associated meaning or interpretation. Treatment is flexible, depending upon the nature of the appraisals and beliefs, but can include strategies focused on inflated responsibility and overestimation of threat, importance and control of thoughts, and the need for perfectionism and certainty. The role of concealment and the relationship to personal values are important maintaining and etiological factors. The short-term and long-term treatment outcome is reviewed, along with predictors of treatment response and mechanisms of action, and the chapter concludes with future directions regarding CT for OCD.


2020 ◽  
Vol 32 (S1) ◽  
pp. 15-16
Author(s):  
William E. Reichman ◽  
L. Bradford Perkins ◽  
Hilde Verbeek

This symposium will review the latest data on the influence of environmental design and its attributes on the cognitive and psychological wellbeing of older adults living with dementia. The presenters will cover the myriad ways in which the physical environment of care can adapt to the changing demands of older adults with sensory, motor and cognitive deficits and foster optimal functioning and quality of life. The role of emerging technologies will also be reviewed as they complement the contribution of the design of the physical environment to the wellbeing of older adults with cognitive impairment. Information will be offered through a review of the existing research literature as well as case studies that illustrate the impact of environmental modification on fostering wellbeing and minimizing the emergence of the behavioral and psychological symptoms of dementia. The presenters will represent and integrate sensibilities that have emerged from the fields of architecture, cognitive neuroscience and psychology.How the Principles of the Culture Change Movement Inform Environmental Design and the Application of Technology in the Care of Older Adults Living with DementiaWilliam E. ReichmanThe culture change movement informs a number of principles that have been applied to more contemporary design concepts for the congregate care of older adults living with dementia. This talk will review the core tenets of the Culture Change Movement as exemplified by the Greenhouse, Dementia Village and other innovative models of congregate long-term care. Specific reference will be made to how these tenets have been operationalized around the world into the design of programming and the creation of residential care environments that foster a better quality of life for older adults and an enhanced work environment for care providers. This talk will also include the emerging role of technologies that complement innovative design of the environment and which foster optimized social and recreational functioning of older adults living with dementia.A Better Life Through a Better Nursing Home DesignL. Bradford PerkinsOver the last 20 years there has been extensive experimentation related to the role of the environment in the housing, care and treatment of persons with Alzheimer’s and other age related dementias. Prior to that time the typical housing and care environment was a locked unit in a skilled nursing or other restrictive senior living facility. In 1991 the Presbyterian Association on Aging in Western Pennsylvania opened Woodside Place on its Oakmont campus. This small 36 bed facility was designed to incorporate the latest research and care experience with persons suffering from these issues. This one small project, as well as the long post occupancy research led by Carnegie Mellon University, clearly demonstrated that individuals with Alzheimer’s and related forms of dementia could lead a healthier, happier, higher quality of life in a more residential, less restrictive environment. Not everything in this pioneering project worked, and five generations of living and care models have followed that have refined the ideas first demonstrated by Woodside Place. Bradford Perkins, whose firm designed Woodside Place and over 100 other related projects, will discuss what was learned from Woodside Place as well as the five generations of projects (and post occupancy research) that followed.Innovative dementia care environments as alternatives for traditional nursing homes: evidence and experiences from the NetherlandsHilde VerbeekKey goals of the dementia care environment focus on increasing autonomy, supporting independence and trying to enable one’s own lifestyle for as long as possible. To meet these goals, innovative, small-scale and homelike care environments have been developed that have radically changed the physical, social and organizational aspects of long-term care in the Netherlands. This presentation discusses various Dutch models that have implemented small-scale and homelike care environments, including green care farms, dementia village and citizen initiatives. The models reflect a common care concept, focusing on residents’ remaining strengths, providing opportunity for choice and aiming to sustain a sense of self and control. A small number of residents (usually 6 to 8) live together in a homelike environment and nursing staff are part of the household. Residents are encouraged to participate in daily household activities, emphasizing normalization of daily life with person-centred care. The physical environment resembles an archetypal home. This talk presents the scientific evidence on the impact and effects of these small-scale, homelike models on residents, their family caregivers and staff. Furthermore, the presentation will highlight working approaches and how these initiatives have positively influenced routine care across the long-term care spectrum.


2021 ◽  
Vol 10 (11) ◽  
pp. 2501
Author(s):  
Angelo Cignarelli ◽  
Valentina Annamaria Genchi ◽  
Rossella D’Oria ◽  
Fiorella Giordano ◽  
Irene Caruso ◽  
...  

Erectile dysfunction (ED) is a long-term complication of type 2 diabetes (T2D) widely known to affect the quality of life. Several aspects of altered metabolism in individuals with T2D may help to compromise the penile vasculature structure and functions, thus exacerbating the imbalance between smooth muscle contractility and relaxation. Among these, advanced glycation end-products and reactive oxygen species derived from a hyperglycaemic state are known to accelerate endothelial dysfunction by lowering nitric oxide bioavailability, the essential stimulus of relaxation. Although several studies have explained the pathogenetic mechanisms involved in the generation of erectile failure, few studies to date have described the efficacy of glucose-lowering medications in the restoration of normal sexual activity. Herein, we will present current knowledge about the main starters of the pathophysiology of diabetic ED and explore the role of different anti-diabetes therapies in the potential remission of ED, highlighting specific pathways whose activation or inhibition could be fundamental for sexual care in a diabetes setting.


2021 ◽  
Vol 12 (4) ◽  
pp. 24-29
Author(s):  
Shruti . ◽  
C V Rajashekhar ◽  
Manjunatha Adiga

Apasmara (epilepsy) is defined as the apagama (deterioration) of smriti (memory) associated with bibhasta cheshta (seizures) due to derangement of dhi and satwa, mainly related to vata and rajo dosha vitiation, which effects both Sharira (body) and Mana (mind). The present antiepileptic drugs control the seizure attack, but long-term use generates adverse effect at cognitive level and leads to behavioral disorders, hence there is need of safe and effective treatment which not only controls seizure attack but helps to cure the disease. A 44-year-old man approached Kayachikitsa OPD with the complaints of frequent seizure attacks, since from at the age of one and half year with regular oral antiepileptic drugs medications (allopathic), the dose of medications increasing yearly and he was not satisfied with treatment, so he was advised with Panchakarma treatment starting from Deepana, Pachana, Vamana (medicated emesis), Virechana (medicated purgation), Basti (medicated enema), Shirodhara along with palliative treatment. After each treatment it was observed that the patient was satisfied with treatment and the complaints of seizure attack reduced in frequency and duration with improved quality of life. Palliative treatment was advised to continue along with modern medications.


2021 ◽  
Vol 10 (15) ◽  
pp. 3441
Author(s):  
Hashir Ali Awan ◽  
Mufaddal Najmuddin Diwan ◽  
Alifiya Aamir ◽  
Muneeza Ali ◽  
Massimo Di Giannantonio ◽  
...  

The second year of the COVID-19 (coronavirus disease) pandemic has seen the need to identify and assess the long-term consequences of a SARS-CoV-2 infection on an individual’s overall wellbeing, including adequate cognitive functioning. ‘Cognitive COVID’ is an informal term coined to interchangeably refer to acute changes in cognition during COVID-19 and/or cognitive sequelae with various deficits following the infection. These may manifest as altered levels of consciousness, encephalopathy-like symptoms, delirium, and loss of various memory domains. Dysexecutive syndrome is a peculiar manifestation of ‘Cognitive COVID’ as well. In the previous major outbreaks of viruses like SARS-CoV, MERS-CoV and Influenza. There have been attempts to understand the underlying mechanisms describing the causality of similar symptoms following SARS-CoV-2 infection. This review, therefore, is attempting to highlight the current understanding of the various direct and indirect mechanisms, focusing on the role of neurotropism of SARS-CoV-2, the general pro-inflammatory state, and the pandemic-associated psychosocial stressors in the causality of ‘Cognitive COVID.’ Neurotropism is associated with various mechanisms including retrograde neuronal transmission via olfactory pathway, a general hematogenous spread, and the virus using immune cells as vectors. The high amounts of inflammation caused by COVID-19, compounded with potential intubation, are associated with a deleterious effect on the cognition as well. Finally, the pandemic’s unique psychosocial impact has raised alarm due to its possible effect on cognition. Furthermore, with surfacing reports of post-COVID-vaccination cognitive impairments after vaccines containing mRNA encoding for spike glycoprotein of SARS-CoV-2, we hypothesize their causality and ways to mitigate the risk. The potential impact on the quality of life of an individual and the fact that even a minor proportion of COVID-19 cases developing cognitive impairment could be a significant burden on already overwhelmed healthcare systems across the world make it vital to gather further evidence regarding the prevalence, presentation, correlations, and causality of these events and reevaluate our approach to accommodate early identification, management, and rehabilitation of patients exhibiting cognitive symptoms.


2020 ◽  
Vol 25 (3) ◽  
pp. 192-197 ◽  
Author(s):  
Kaden Ridley ◽  
Michelle Condren

Elexacaftor-tezacaftor-ivacaftor is a newly approved triple-combination cystic fibrosis transmembrane conductance regulator (CFTR) modulating therapy that contains 2 correctors and a potentiator of the CFTR channel. Its labeled indication for use is for persons 12 years of age and older with at least 1 F508del mutation for the CFTR gene. This drug combination provides potential therapy to many patients who had previously been excluded from CFTR modulation therapy due to the nature of their genetic mutations. The efficacy demonstrated in clinical trials surpasses the currently available therapies related to lung function, quality of life, sweat chloride reduction, and reducing exacerbations. The most common adverse events seen in clinical trials included rash and headache, and laboratory monitoring is recommended to evaluate liver function. Continued evaluation of patient data is needed to confirm its long-term safety and efficacy. Elexacaftor-tezacaftor-ivacaftor is a monumental and encouraging therapy for cystic fibrosis; however, approximately 10% of the CF population are not candidates for this or any other CFTR modulation therapy.


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