Cardiovascular Events, Conditions, and Procedures Among People With Episodic Migraine in the US Population: Results from the American Migraine Prevalence and Prevention (AMPP) Study

2016 ◽  
Vol 57 (1) ◽  
pp. 31-44 ◽  
Author(s):  
Dawn C. Buse ◽  
Michael L. Reed ◽  
Kristina M. Fanning ◽  
Tobias Kurth ◽  
Richard B. Lipton
2021 ◽  
Vol 10 (8) ◽  
pp. 1660
Author(s):  
Annika Vestergaard Kvist ◽  
Junaid Faruque ◽  
Enriqueta Vallejo-Yagüe ◽  
Stefan Weiler ◽  
Elizabeth M. Winter ◽  
...  

Background: Cardiovascular safety concerns for major cardiovascular events (MACE) were raised during the clinical trials of romosozumab. We aimed to evaluate the cardiovascular safety profile of romosozumab in a large pharmacovigilance database. Methods: All cases reported between January 2019 and December 2020 where romosozumab was reported were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS). The outcome of interest was MACE (myocardial infarction (MI), stroke, or cardiovascular death). A disproportionality analysis was conducted by estimating the reporting odds ratios (RORs) and 95% confidence intervals. Disproportionality analyses were stratified by sex and reporting region (US, Japan, other). Results: Of the 1995 eligible cases with romosozumab, the majority (N = 1188; 59.5%) originated from Japan. Overall, 206 suspected MACE reports were identified, of which the majority (n = 164; 13.8%) were from Japan, and 41 (5.2%) were from the United States (US). Among Japanese reports, patients were older and more frequently male than reports from the US. Similarly, cases with a reported MACE were older and had higher reports of cardioprotective drugs than those without cardiovascular events. Elevated reports for MACE (ROR 4.07, 95% CI: 2.39–6.93) was identified overall, which was primarily driven by the significant disproportionality measures in the Japanese reports. Conclusions: The current pharmacovigilance study identified a potential signal for elevated MACE, particularly in Japan. The results support the current safety warnings from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to avoid use in high-risk patients.


2013 ◽  
Vol 53 (8) ◽  
pp. 1300-1311 ◽  
Author(s):  
Richard B. Lipton ◽  
Dawn C. Buse ◽  
Daniel Serrano ◽  
Starr Holland ◽  
Michael L. Reed

2011 ◽  
Vol 52 (2) ◽  
pp. 213-223 ◽  
Author(s):  
Min Kyung Chu ◽  
Dawn C. Buse ◽  
Marcelo E. Bigal ◽  
Daniel Serrano ◽  
Richard B. Lipton

US Neurology ◽  
2009 ◽  
Vol 05 (01) ◽  
pp. 72
Author(s):  
Susan L Hutchinson ◽  
Stewart J Tepper ◽  
◽  

The road ahead for migraine treatment depends on targeting pharmacological therapies to known pathophysiological mechananisms. Acute medications of the future may include calcitonin gene-related peptide antagonists, various glutamate antagonists, and serotonin 1F receptor agonists. New formulations of older medications include effervescent diclofenac, an orally inhaled dihydroergotamine, and sumatriptan iontophoretic patch and needless injection, all either approved in the US or in phase III trials. Preventive future treatments may include the use of botulinum neurotoxin type A for chronic daily headache and gabapentin enacarbil for episodic migraine, in addition to hormonal treatments and a potential for neuromodulators, but the preventive pipeline is far less developed. In the US, the United Council for Neurologic Subspecialty Board certification for headache medicine should raise quality of care and research in the future.


2020 ◽  
Vol 96 (1141) ◽  
pp. 655-659 ◽  
Author(s):  
Priya Chelliah ◽  
Xilong Li ◽  
Beverley Adams-Huet ◽  
Ildiko Lingvay

ObjectivesAn increasing percentage of the US population is obese. Cardiometabolic risk in the population increases with body mass index (BMI), but whether this correlation changes over time is unknown. We analysed the National Health and Nutrition Examination Survey (NHANES) database from 1999 to 2016 to determine if the prevalence of cardiometabolic disease and cardiovascular events within each BMI category is changing over time as the BMI of the population is increasing.Study designFor each of the nine survey cycles covering this period, we divided the population by BMI category (normal, overweight, class 1 obesity, class ≥2 obesity) and subsequently by the presence of cardiovascular events or cardiometabolic disease. NHANES participants are a group of 5000 individuals/cycle selected to be representative of the US population. We used the weighted data sets to perform trend analyses for each risk/BMI group adjusted for relevant confounders.ResultsThe distribution of the highest risk category (cardiovascular event) has not changed over time within any BMI category. The distribution of the lowest risk category (cardiometabolically healthy) increased significantly over time in all BMI categories. This was noted in the 18- to 45-year subgroup but not in the group aged >45 years.ConclusionsThe increase in the prevalence of overweight and obese individuals might be associated with a ‘healthy obesity’ phenotype in those <45 years; however, individuals >45 years showed a proportional increase in associated cardiometabolic risk.


2013 ◽  
Vol 326 (1-2) ◽  
pp. 10-17 ◽  
Author(s):  
Starr Holland ◽  
Kristina M. Fanning ◽  
Daniel Serrano ◽  
Dawn C. Buse ◽  
Michael L. Reed ◽  
...  

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