scholarly journals Real-world experience with new migraine treatments in Brazil

2020 ◽  
Author(s):  
Abouch Valenty Krymchantowski ◽  
Ana Gabriela Ferreira Krymchantowski ◽  
Carla da Cunha Jevoux

Introduction Migraine is a highly prevalent disorder. Current treatments are far from desired regarding efficacy and tolerability. Recent knowledge has been indicating targets whose antagonism may improve outcomes. Blocking CGRP or its receptor with monoclonal antibodies (mAb) can interfere with migraine mechanisms and decrease the frequency of attacks.Erenumab, galcanezumab, fremanezumab and epitnezumab were recently approved for migraine treatment and the first three are available in Brazil. Although the figures of efficacy were not astonishing, tolerability and higher adherence were demonstrated. However, real-world experience is limited in Brazil, since these new therapies have been used for only a year. Objective We present a summary of pivotal studies with the four mAb and preliminary results of this short-term option for migraine in real-world Brazilian patients. Methods One hundred twelve episodic or chronic migraineurs received the prescription of a mAb during the last 12 months in a tertiary center. This initial study was performed with 83 patients who should have taken, at the time of this writing, at least three-monthly doses of a mAb, which was chosen by a neurologist with full time dedication to headache medicine.Results Sixty-four women (77.1%) and 19 men (22.9%), with episodic (n=49; 59%) or chronic migraine (n=34; 41%), mean age of 43.6 years and mean headache history of 26.2 years were retrospectively studied. Baseline frequency was 14.8 headache days/month in the three months prior to the mAb use. Erenumab was prescribed to 40 (48.2%) patients; galcanezumab was given to 37 (44.6%) patients and fremanezumab was prescribed to 6 (7.2%) migraineurs. The mean headache frequency among the 77 patients who returned was reduced to 5.6 headache days/month in the following three months. Considering the headache frequency reduction of ≥50%, 44 (57%) migraine sufferers achieved a meaningful decrease. Mild adverse events were presented by 24.6% of the patients. Conclusion The authors present the first Brazilian experience in real-world patients using different mAbs in migraineurs' preventive treatment.

2010 ◽  
Vol 5 (2) ◽  
pp. 162-166 ◽  
Author(s):  
Wajd N. Al-Holou ◽  
Cormac O. Maher ◽  
Karin M. Muraszko ◽  
Hugh J. L. Garton

Object The authors reviewed their experience with pediatric pineal cysts to define the natural history and clinical relevance of this common intracranial finding. Methods The authors identified all patients with pineal cysts who had been clinically evaluated at their institution over an 11.5-year interval and were < 25 years of age at the time of diagnosis. All inclusion criteria were met in 106 patients, and included repeated MR imaging as well as repeated clinical evaluation over at least a 6-month interval. Results The mean age at diagnosis was 11.7 ± 7.2 years. Forty-two patients were male and 64 were female. On follow-up MR imaging evaluation at a mean interval of 3.0 years from the initial study, 98 pineal cysts had no increase in size and no change in imaging appearance. Six pineal cysts increased in size and 2 others had a change in imaging characteristics without associated growth. Younger age was associated with cyst change or growth on follow-up imaging (p = 0.02). The mean age of patients with cysts that changed or grew was 5.5 years, and the mean age of patients with stable pineal cysts was 12.2 years. Initial cyst size and appearance on MR imaging were not significant predictors of growth or change in imaging appearance at follow-up. Similarly, the patient's sex was not a significant predictor of growth or change in imaging characteristics. Conclusions Follow-up imaging and neurosurgical evaluation may be considered optional in older children with pineal cysts.


2019 ◽  
Vol 184 (7-8) ◽  
pp. e207-e211 ◽  
Author(s):  
Karen A Williams ◽  
Robin M Lawson ◽  
Osvaldo H Perurena ◽  
John D Coppin

Abstract Introduction The rate of chronic migraine (CM) has been shown to be 20% or greater in the post 9/11 combat veteran population with a history of traumatic brain injury, while the rate is much lower at 3–5% in the general population. Studies have shown that medications such as oral topiramate or intramuscular injections of onabotulinum toxin A (Botox) have been used for CM prevention, and occipital blocks have been shown to be helpful in treating occipital neuralgia and short-term relief of CM. However, there are no known studies that have specifically evaluated the use of Botox and occipital blocks for reducing headache frequency in the US veteran population. The purpose of this study was to evaluate the effectiveness of using occipital blocks and Botox as dual therapy for reducing headache frequency in post 9/11 combat veterans with CM, occipital neuralgia, and a history of TBI or neck trauma. Materials and Methods Following Institutional Review Board approval, a retrospective chart review was completed on post 9/11 combat veterans treated in a headache clinic located at the Central Texas Veteran Health Care System. The electronic medical record was used to retrieve the charts of post 9/11 combat veterans who (1) had a confirmed deployment-related history of TBI or neck trauma; (2) were diagnosed with CM and occipital neuralgia; and (3) were treated in the headache clinic between January 1, 2014 and December 31, 2015 with the administration of occipital blocks and Botox within the first six months. Of 282 charts that were reviewed, a total of 30 (N = 30) veterans fit the criteria. The mean number of self-reported headache days per month (28 days) for the month prior to starting treatment was compared to the number of headache days per month (28 days) 6 months after initiation of therapy. Results Results revealed that the mean number of headache days in the month prior to treatment was 24.1 (22.0, 25.7). The mean number of headache days in the month post-treatment (6 months after the initiation of dual therapy with occipital blocks and Botox) was 12.9 (9.7, 16.4). The mean difference in the number of headache days from pre- to post-treatment (pre-treatment minus post-treatment) was 11.2 (8.2, 14.2). Conclusion This study evaluated the effectiveness of using occipital blocks and Botox as dual therapy for reducing headache frequency for post 9/11 combat veterans with CM, occipital neuralgia, and a history of TBI or neck trauma. Results revealed a statistically significant reduction in the number of headache days per month after the dual therapy. There were multiple limitations to the study to include a small sample size, lack of a control group, self-reported headaches for only 1 month pre-and post-treatment, and no control for other interventions or events which may have influenced the outcome. There is a strong need for randomized, double blinded, placebo- controlled studies involving dual therapy in this population. This study, though small, may be helpful in stimulating additional studies and treatments in this veteran population.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5157-5157
Author(s):  
Naz Rashid ◽  
Han A. Koh ◽  
Kathy Lin ◽  
Christian Dimaano ◽  
Eugene Felber

Abstract INTRODUCTION: BCR-ABL Tyrosine Kinase Inhibitors (TKI) have demonstrated efficacy in patients with chronic myeloid leukemia (CML) in the clinical trial setting. However, additional real world data evaluating first line TKI treatment patterns are still needed. Moreover, real world data captured within integrated, managed care organizations are scarce. This study evaluates treatment patterns among newly diagnosed CML patients initiated on frontline TKI therapy within the Kaiser Permanente Southern California (KPSC) integrated managed care organization. METHODS: A retrospective analysis was conducted using KPSC data between 1/1/2007 to 12/31/2014. Patients were identified with CML diagnosis from the KPSC cancer registry database during 1/1/2007 to 12/31/2013. Patients > 18 years on date of CML diagnosis, with no history of other prior cancers or stem cell transplant during the 12 months prior to diagnosis date were eligible for inclusion. Index date was defined as the date of the first TKI prescription identified during the period 1/1/2007 to 12/31/2013, and no history of TKI use in the prior 12 months. All patients had continuous membership and drug benefit eligibility 12 months prior to index date. Patients were followed from their index date until one of the following outcomes: 1) death, 2) disenrollment from health plan, 3) switch to another TKI, 4) discontinuation of index TKI therapy, or 5) end of study period of 12/31/2014. Discontinuation, switch and persistence of index TKI therapy were defined using a 60 day gap calculation: estimated date of depleting the second to last prescription supply, plus days' supply of the last prescription, plus 60 days. If a patient did not fill any TKI prescription before or during the 60 day gap, this was labeled as a discontinuation. If a patient filled a different TKI prescription before or during the 60 day gap, this was labeled as switch, and if a patient refilled their index TKI prescription, then this was labeled as continuation of index therapy. RESULTS: 216 patients were identified with incident CML and with first line TKI therapy: 19 (8.8%) on dasatinib, 189 (87.5%) on imatinib, and 8 (3.7%) on nilotinib. The mean age on diagnosis date was 53 years and 63% were male. The mean age for patients who initiated nilotinib was 45.5 years, 48.3 years for dasatinib, and 54.1 years for imatinib. The Charlson comorbidity index was highest for patients on dasatinib (3.0) but similar for the patients initiated on imatinib and nilotinib (2.51 and 2.50). The mean days until an outcome was identified was 347 (SD ± 311). 93 patients (43%) continued their index therapy; 95 patients (44%) discontinued their index therapy, 3 patients (1.4%) switched their index therapy, 7 patients (3.2%) died during follow up, and 18 patients (8.3%) disenrolled from the health plan. The majority of the patients were initiated on imatinib and 45% of these patients discontinued their index therapy per our study definition. CONCLUSIONS: 44% of incident CML patients initiated on TKIs discontinued therapy by an average of 347 days (less than 1 year) from the start of treatment. Imatinib was the initial TKI therapy for 87.5% of the patients. Additional data will be presented which may assist in healthcare decision making for those newly diagnosed CML patients initiating first line TKI therapy in a managed care setting. Figure 1: Summary Table of Outcomes from First Line Index TKI Therapy Disclosures Dimaano: Bristol Myers Squibb: Employment, Equity Ownership. Felber:Bristol Myers Squibb: Employment, Equity Ownership.


2020 ◽  
Author(s):  
Marianna Diletta Delussi ◽  
Eleonora Vecchio ◽  
Silvia Giovanna Quitadamo ◽  
Giuseppe Libro ◽  
Marina De Tommaso

Abstract BACKGROUND Despite the criteria of acute migraine treatment and prevention have been well described , there are still unmet needs, for a general underuse and low benefit of preventive treatments. The aim of the present study was to observe retrospectively the short term effect of preventive treatment in a cohort of migraine patients come at a tertiary headache center, using data from an electronic medical record. METHODS This was an observational retrospective cohort study on data collected in a tertiary headache center. Data were extracted from an electronic dataset collected between January 2009 to December 2019. Main selection criteria were age 18-75, diagnosis of migraine without aura(MO), with aura (MA) and chronic migraine (CM), a control visit after three months from the first access, prescription of preventive treatment with level of evidence 1 as reported by Italian guidelines. As primary outcome measure we considered the change of frequency of headache at follow up , as second outcomes disability scores , intensity of headache, allodynia; as predictive factors age, migraine duration, sex and headache frequency, allodynia, anxiety and depression at baseline; comorbidity with fibromyalgia. RESULTS Among 6430 patients screened,2800 met the selection, 1800 returned to follow up, 550 withdrawn for adverse events, 1100 were introduced into analysis. One hundred thirty four had a frequency reduction of 50% or more. Flunarizine was used in less severe migraine, with a better effect as compared to other drugs (odds ratio 1.48; p 0.022). Low headache frequency and absent or mild allodynia predicted a better outcome. CONCLUSIONSThe mild effect of preventive drugs on migraine features and the number of patients lost to follow up or dropped out for adverse events confirm that in severely and chronic sufferers the first line preventive approach could delay a more focused therapeutic approach.


Author(s):  
J. Terrence Jose Jerome

Abstract Background The natural history of scaphoid nonunion is the development of degenerative arthritis. A lot of information is still unclear about this progression. The purpose of this study is to analyze patients with scaphoid nonunions who had not received any kind of treatment and to assess the functional outcome. Materials and Methods This is a retrospective study that analyzed the patients with chronic scaphoid nonunions between 2009 and 2019. None of the patients received any treatment. The age at the time of injury, examination, pattern of fracture, types of scaphoid nonunion, symptoms, and duration of nonunion were noted. Diagnosis was confirmed by radiographs, computed tomography (CT) scan, and magnetic resonance imaging (MRI). Scapholunate and radiolunate angles were recorded. Pain score, modified mayo wrist score, grip strength, range of movement, and the functional outcome of these scaphoid nonunions were analyzed. A statistical correlation between the scaphoid nonunion presentations and the functional outcome was assessed. Results The mean age of the patients was 62 years (range: 35–82 years.). There were 17 male and 3 female patients. There were 9 waist and 11 proximal pole scaphoid nonunions. The mean duration of scaphoid nonunion was 34 years (range: 10–62 years). None of the patients had avascular necrosis (AVN) of the proximal scaphoid. The age at examination, gender, side of injury, fracture pattern (waist/proximal pole), fracture displacement ≤ 1 mm or > 1 mm, nonunion duration, and radiographic arthritic parameters had no significant impact on the functional outcome. Conclusions Untreated chronic scaphoid nonunion leads to the development of degenerative arthritis over a period of years, which is still unpredictable. Most of the patients become aware of the nonunion following a precedent injury or other reasons. Most of the patients have fair/good functional outcome despite reduced range of movements and grip strength. Many do not favor surgical intervention in the course of nonunion. Chronic nonunions open a lot of unanswered questions. Clinical relevance There have been numerous studies on the treatment aspects of scaphoid nonunion, with little knowledge about certain people with nonunion who did not have any kind of treatment. The demographics, clinical findings, and radiological parameters do confirm the progression of these nonunion to arthritis, but most of them had fair-to-good outcome throughout their life. It opens our thinking about the real need of treatment in such nonunions and raises numerous questions about the disease. Level of evidence This is a Level IV study.


Author(s):  
Stephen Verderber

The interdisciplinary field of person-environment relations has, from its origins, addressed the transactional relationship between human behavior and the built environment. This body of knowledge has been based upon qualitative and quantitative assessment of phenomena in the “real world.” This knowledge base has been instrumental in advancing the quality of real, physical environments globally at various scales of inquiry and with myriad user/client constituencies. By contrast, scant attention has been devoted to using simulation as a means to examine and represent person-environment transactions and how what is learned can be applied. The present discussion posits that press-competency theory, with related aspects drawn from functionalist-evolutionary theory, can together function to help us learn of how the medium of film can yield further insights to person-environment (P-E) transactions in the real world. Sampling, combined with extemporary behavior setting analysis, provide the basis for this analysis of healthcare settings as expressed throughout the history of cinema. This method can be of significant aid in examining P-E transactions across diverse historical periods, building types and places, healthcare and otherwise, otherwise logistically, geographically, or temporally unattainable in real time and space.


2006 ◽  
Vol 33 (2) ◽  
pp. 1-37 ◽  
Author(s):  
Cheryl S. McWatters ◽  
Yannick Lemarchand

The Guide du commerce occupies a distinctive place in the French-language literature on accounting. Passed over by most specialists in the history of maritime trade and the slave trade, the manual has never been the subject of a documented historical study. The apparent realism of the examples, the luxury of details and their precision, all bear witness to a deep concern to go beyond a simple apprenticeship in bookkeeping. Promoting itself essentially as “un guide du commerce,” the volume offers strategic examples for small local businesses, as well as for those engaged in international trade. Yet, the realism also demonstrated the expertise of the author in the eyes of potential purchasers. Inspired by the work of Bottin [2001], we investigate the extent to which the manual reflects real-world practices and provides a faithful glimpse into the socio-economic context of the period. Two additional questions are discussed briefly in our conclusion. First, can the work of Gaignat constitute a source document for the history of la traite négrière? The second entails our early deliberations about the place of this volume in the history of the slave trade itself.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1961.1-1961
Author(s):  
J. Knitza ◽  
J. Mohn ◽  
C. Bergmann ◽  
E. Kampylafka ◽  
M. Hagen ◽  
...  

Background:Symptom checkers (SC) promise to reduce diagnostic delay, misdiagnosis and effectively guide patients through healthcare systems. They are increasingly used, however little evidence exists about their real-life effectiveness.Objectives:The aim of this study was to evaluate the diagnostic accuracy, usage time, usability and perceived usefulness of two promising SC, ADA (www.ada.com) and Rheport (www.rheport.de). Furthermore, symptom duration and previous symptom checking was recorded.Methods:Cross-sectional interim clinical data from the first of three recruiting centers from the prospective, real-world, multicenter bETTeR-study (DKRS DRKS00017642) was used. Patients newly presenting to a secondary rheumatology outpatient clinic between September and December 2019 completed the ADA and Rheport SC. The time and answers were recorded and compared to the patient’s actual diagnosis. ADA provides up to 5 disease suggestions, Rheport calculates a risk score for rheumatic musculoskeletal diseases (RMDs) (≥1=RMD). For both SC the sensitivity, specificity was calculated regarding RMDs. Furthermore, patients completed a survey evaluating the SC usability using the system usability scale (SUS), perceived usefulness, previous symptom checking and symptom duration.Results:Of the 129 consecutive patients approached, 97 agreed to participate. 38% (37/97) of the presenting patients presented with an RMD (Figure 1). Mean symptom duration was 146 weeks and a mean number of 10 physician contacts occurred previously, to evaluate current symptoms. 56% (54/96) had previously checked their symptoms on the internet using search engines, spending a mean of 6 hours. Rheport showed a sensitivity of 49% (18/37) and specificity of 58% (35/60) concerning RMDs. ADA’s top 1 and top 5 disease suggestions concerning RMD showed a sensitivity of 43% (16/37) and 54% (20/37) and a specificity of 58% (35/60) and 52% (31/60), respectively. ADA listed the correct diagnosis of the patients with RMDs first or within the first 5 disease suggestions in 19% (7/37) and 30% (11/37), respectively. The average perceived usefulness for checking symptoms using ADA, internet search engines and Rheport was 3.0, 3.5 and 3.1 on a visual analog scale from 1-5 (5=very useful). 61% (59/96) and 64% (61/96) would recommend using ADA and Rheport, respectively. The mean SUS score of ADA and Rheport was 72/100 and 73/100. The mean usage time for ADA and Rheport was 8 and 9 minutes, respectively.Conclusion:This is the first prospective, real-world, multicenter study evaluating the diagnostic accuracy and other features of two currently used SC in rheumatology. These interim results suggest that diagnostic accuracy is limited, however SC are well accepted among patients and in some cases, correct diagnosis can be provided out of the pocket within few minutes, saving valuable time.Figure:Acknowledgments:This study was supported by an unrestricted research grant from Novartis.Disclosure of Interests:Johannes Knitza Grant/research support from: Research Grant: Novartis, Jacob Mohn: None declared, Christina Bergmann: None declared, Eleni Kampylafka Speakers bureau: Novartis, BMS, Janssen, Melanie Hagen: None declared, Daniela Bohr: None declared, Elizabeth Araujo Speakers bureau: Novartis, Lilly, Abbott, Matthias Englbrecht Grant/research support from: Roche Pharma, Chugai Pharma Europe, Consultant of: AbbVie, Roche Pharma, RheumaDatenRhePort GbR, Speakers bureau: AbbVie, Celgene, Chugai Pharma Europe, Lilly, Mundipharma, Novartis, Pfizer, Roche Pharma, UCB, David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, Timo Meinderink: None declared, Wolfgang Vorbrüggen: None declared, Cay-Benedict von der Decken: None declared, Stefan Kleinert Shareholder of: Morphosys, Grant/research support from: Novartis, Consultant of: Novartis, Speakers bureau: Abbvie, Novartis, Celgene, Roche, Chugai, Janssen, Andreas Ramming Grant/research support from: Pfizer, Novartis, Consultant of: Boehringer Ingelheim, Novartis, Gilead, Pfizer, Speakers bureau: Boehringer Ingelheim, Roche, Janssen, Jörg Distler Grant/research support from: Boehringer Ingelheim, Consultant of: Boehringer Ingelheim, Paid instructor for: Boehringer Ingelheim, Speakers bureau: Boehringer Ingelheim, Peter Bartz-Bazzanella: None declared, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Martin Welcker Grant/research support from: Abbvie, Novartis, UCB, Hexal, BMS, Lilly, Roche, Celgene, Sanofi, Consultant of: Abbvie, Actelion, Aescu, Amgen, Celgene, Hexal, Janssen, Medac, Novartis, Pfizer, Sanofi, UCB, Speakers bureau: Abbvie, Aescu, Amgen, Biogen, Berlin Chemie, Celgene, GSK, Hexal, Mylan, Novartis, Pfizer, UCB


2021 ◽  
Vol 4 ◽  
pp. 251581632110156
Author(s):  
Brian Plato ◽  
J Scott Andrews ◽  
Mallikarjuna Rettiganti ◽  
Antje Tockhorn-Heidenreich ◽  
Jennifer Bardos ◽  
...  

Objective: The efficacy of galcanezumab was evaluated in patients with episodic cluster headache and history of preventive treatment failure. Methods: In the randomized, 8-week, double-blind study (CGAL), patients with episodic cluster headache received once-monthly subcutaneous injections of galcanezumab 300 mg or placebo. Patients who completed CGAL and enrolled in an open-label study were queried for preventive treatment history. In a subset of patients with a known history of failure of verapamil or any other prior preventive treatment, a post hoc analysis of least square mean change from baseline in weekly cluster headache attack frequency across Weeks 1 to 3 was assessed. Results: Fifteen patients provided data for known history of prior preventive treatment failure (6 placebo, 9 galcanezumab), of whom 11 failed verapamil. The mean reduction in the weekly frequency of cluster headache attacks was greater with galcanezumab compared to placebo among patients with prior preventive treatment failure (8.2 versus 2.4); mean difference 5.8 (95% confidence interval [CI] 2.0, 13.6) and among patients with verapamil failure (10.1 versus 1.6); mean difference 8.5 (95% CI 0.4, 16.7). Conclusion: In this exploratory analysis of patients with a known history of prior preventive treatment failures, treatment with galcanezumab resulted in greater mean reductions in weekly cluster headache attacks compared with placebo. ClinicalTrials.gov: NCT02397473 (I5Q-MC-CGAL) NCT02797951 (I5Q-MC-CGAR)


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
D Kim ◽  
H Jung ◽  
P.S Yang ◽  
H.T Yu ◽  
T.H Kim ◽  
...  

Abstract Aims Pulse pressure (PP) is a well-known risk factor for cardiovascular disease. However, the association between the PP and dementia is not well identified. This study aimed to determine the effect of PP on the risk of dementia development in different age subgroups using a longitudinal, population-based, and stroke-free cohort from the general population. Methods The association of PP with the development of incident dementia was assessed from January 1, 2005, to December 31, 2013, in 433,154 participants without a history of dementia or stroke from the Korea National Health Insurance Service-Health Screening cohort. The diagnosis of dementia was defined using the 10th revision of the International Classification of Disease codes. Results The mean age of the cohort was 55.7±9.2 years, 45.7% were women. Hypertension was 23.6%. The mean systolic and diastolic blood pressure of the entire cohort were 125.9±16.6 and 78.4±10.7 mmHg, respectively. Mean PP was 47.5±10.9 mmHg. In the middle-age group (40 to 50 year-old), increasing of 10 mmHg of PP was associated with incident dementia after adjusting mean blood pressure and clinical variables with a hazard ratio (HR) of 1.21 (95% confidence interval [CI]: 1.19–1.23, p&lt;0.001). The association was still significant even after censoring for stroke (HR: 1.16, 95% CI: 1.08–1.22, p&lt;0.001). In the older population, elevation of PP was not associated with dementia development (HR: 0.98, 95% CI: 0.95–1.01, p=0.247) Conclusion PP was associated with increased risk of dementia only in middle-aged population beyond that of mean arterial pressure. Funding Acknowledgement Type of funding source: None


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