Zosano Developing Dermal Patch to Quickly Relieve Migraine Pain

MedicalResearch.com Interview with:
Zosano Pharma
Dr. Peter Schmidt, MD, MSc

Senior Director, medical Affairs and Clinical Development
Zosano Pharma

 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This was a post-hoc analysis of Zosano’s pivotal efficacy trial using its adhesive dermally-applied microarray (ADAM) zolmitriptan formulation, M207. The trial found that M207 was effective versus placebo for the co-primary endpoints of pain freedom and most bothersome symptom (MBS) freedom, both at two hours. The MBS endpoint was just ratified as a new endpoint in the FDA’s February 2018 guidance for acute migraine trials. The stated aim of this new endpoint is “…to better align the study outcome with the symptom(s) of primary importance to patients…” This is logical, as a given migraine patient may not experience all four previous symptom endpoints (pain, photophobia, phonophobia, nausea). Continue reading

Women and Uninsured More Likely to Suffer from Migraines

MedicalResearch.com Interview with:

Paul B. Rizzoli, M.D., FAAN, FAHS Department of Neurology Brigham and Women’s Hospital Clinical and Fellowship Director, John R Graham Headache Center Brigham and Women’s Faulkner Hospital Assistant Professor of Neurology Harvard Medical School

Dr. Rizzoli

Paul B. Rizzoli, M.D., FAAN, FAHS
Department of Neurology
Brigham and Women’s Hospital
Clinical and Fellowship Director, John R Graham Headache Center
Brigham and Women’s Faulkner Hospital
Assistant Professor of Neurology
Harvard Medical School

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Migraine and other recurrent headache disorders disproportionately affect otherwise healthy, middle-aged people, particularly women, and are a leading cause of suffering and disability.

Accurate epidemiologic information is vital for providers, researchers and policy makers. In this paper we surveyed the most recent data from population-based studies in the United States to assess the burden and impact of these conditions. Our search included such sources as the National Health Interview Study (NHIS), the National Hospital Ambulatory Medical Care Survey (NHAMCS) and the National Ambulatory Medical Care Survey (NAMCS).

We found that the prevalence and burden of self-reported migraine and other severe headache has remained stable but high in the past 19 years, affecting roughly 1 out of every 6 Americans (15.3%) and 1 in 5 women (20.7%) over a 3-month period.

Among other findings was that headache is proportionately more burdensome those in middle age (elderly also), those who are unemployed and those who are disabled or who have low family income. Headache represents roughly 3% of all annual emergency department visits.  Continue reading

Migraine Linked To Increased Risk of Heart Disease and Stroke

MedicalResearch.com Interview with:

Islam Elgendy MD Division of Cardiovascular Medicine University of Florida  

Dr. Elgendy

Islam Elgendy MD
Division of Cardiovascular Medicine
University of Florida  

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Migraine headache is a prevalent medical condition, often being chronic and debilitating to many. Previous studies have shown that migraine, particularly migraine with aura, is associated with an increased risk of cardiovascular events. Recently, a number of these studies have reported long-term follow up data. To better understand the long-term morbidity that is associated with migraines, we performed a systematic evaluation to study the link between migraine and risk of cardiovascular and cerebrovascular events.

This study demonstrated that migraine is associated with an increased risk of major adverse cardiovascular and cerebrovascular events, which was driven by an increased long-term risk of myocardial infarction and stroke. This effect was predominantly observed in migraineurs who have aura.  Continue reading

Migraine Linked To Increased Risk of Stroke, AFib, PE and Cardiovascular Disease

MedicalResearch.com Interview with:
“Headache.” by Avenue G is licensed under CC BY 2.0
Kasper Adelborg, MD, PhD
Postdoctoral Fellow
Department of Clinical Epidemiology
Aarhus University Hospital 

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: Around one billion people worldwide are affected by migraine. Migraine has considerable impact on quality of life and imposes a substantial burden on society. Migraine is primarily a headache disorder, but previous studies have suggested a link between migraine and stroke and myocardial infarction, particularly among women, while the link between migraine and other heart problems are less well known.

In this large register-based Danish study published in the BMJ, we confirmed that migraine is associated with increased risks of stroke and myocardial infarction, but we also found that migraine was associated with increased risks of other cardiovascular diseases (specifically, venous thromboembolism and atrial fibrillation). Migraine was not associated with increased risks of heart failure or peripheral artery disease.

In contrast to most previous studies, our study had a very large sample size and an age- and sex- matched comparison cohort from the general population, which allowed us to put migraine in a population context and to perform several subgroup analyses. Here, we found several interesting findings.

  • In general, the associations were strongest in the first year after diagnosis but persisted in the long term (up to 19 years after diagnosis).
  • Most associations applied to both migraine patients with aura (warning signs before a migraine, such as seeing flashing lights) and in those without aura, and in both women and in men. 

Continue reading

Migraine Surgery Markedly Reduced Pain Intensity and Disability

MedicalResearch.com Interview with:
“Migraine” by makelessnoise is licensed under CC BY 2.0Lisa Gfrerer, MD PhD

Clinical Fellow in Surgery
Brigham and Women’s Hospital
William Gerald Austen MD
Chief, Plastic and Reconstructive Surgery
Chief, Division of Burn Surgery
Massachusetts General Hospital

 MedicalResearch.com: What are the main findings?

Response: Migraine surgery patients at our institution are chronic pain patients who have failed conservative therapy and are severely disabled by their disease.

We initiated this study to understand two important points. First, it was previously unclear how to categorize these patients in terms of pain intensity and disability on the spectrum of better known pain conditions such as chronic back pain/ nerve pain/ carpal tunnel.  This is very important to appreciate the extent of this disease. Second, instead of collecting migraine characteristic such as decrease in migraine days/ duration/ pain, we wanted to understand how functionally disabled these patients are in their daily lives and how much better they get after surgery. This is ultimately what matters to patients.

We therefore decided to evaluate our outcomes by using the Pain Self Efficacy Questionnaires (PSEQ). This validated pain questionnaire has been used to describe pain intensity/disability in patients with different acute and chronic pain conditions.

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Migraine Associated With Cervical Artery Dissection In Some Young Adults

MedicalResearch.com Interview with:
Alessandro Pezzini, MD, FESO

Professore Associato di Neurologia
Dipartimento di Scienze Cliniche e Sperimentali
Clinica Neurologica
Università degli Studi di Brescia
Italia

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Scarce reports have suggested that a relation might exist between migraine and cervical artery dissection (CEAD), the most frequent cause of ischemic stroke in young adults in Western countries. However, data available so far were obtained from few studies conducted on small cohorts of patients, which limits the generalizability of their findings.

In our study we analysed the data from the Italian Project on Stroke in Young Adults (IPSYS) project, one of the largest registries of young ischemic stroke patients, and observed that migraine, especially the subtype without aura was strongly and independently associated to CEAD. This seems particularly true for men and for people younger than 39 years.

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Migraine Increases Risk of Perioperative Stroke and Hospital Readmission

MedicalResearch.com Interview with:

Dr. Matthias Eikermann, MD, PhD Associate Professor of Anaesthesia, Harvard Medical School Clinical Director, Critical Care Division

Dr. Matthias Eikermann

Dr. Matthias Eikermann, MD, PhD
Associate Professor of Anaesthesia
Harvard Medical School
Clinical Director, Critical Care Division 

MedicalResearch.com: What is the background for this study?

Response: Up to one fifth of the general population have migraine, a primary, chronic-intermittent headache disorder affecting the neuronal and vascular systems and characterized by severe headache accompanied by nausea and/or sensory hypersensitivities such as photophobia and phonophobia. In approximately 20-30% of patients, the headache phase is preceded or accompanied by transient focal neurological disturbances presenting as visual symptoms but also sensory, aphasic, or motor symptoms known as migraine aura.

Stroke is responsible for approximately 6.2 million deaths a year and is a leading global cause of long term disability. Considering that more than 50 million patients in hospital and 53 million ambulatory patients undergo surgical procedures in the United States every year.

We found that patients with migraine, particularly migraine with aura, undergoing a surgical procedure are at increased risk of perioperative ischemic stroke and readmission to hospital within 30 days after discharge.

Continue reading

Rosacea May Be a Cutaneous Manifestation of Migraine

MedicalResearch.com Interview with:

Alexander Egeberg, MD PhD National Allergy Research Centre, Departments of Dermato-Allergology and Cardiology Herlev and Gentofte University Hospital, University of Copenhagen Hellerup, Denmark

Dr. Alexander Egeberg

Alexander Egeberg, MD PhD
Gentofte Hospital
Department of Dermatology and Allergy
Hellerup Denmark

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Patients with rosacea frequently report symptoms of migraine, and this link has been discussed for many years. However, very little research has actually been performed in this area, and the prevalence varies greatly between studies. We examined the prevalence of migraine in patients with rosacea, nationwide, as well as the risk of new-onset migraine in patients with manifest rosacea. We found a markedly increased prevalence of migraine among patients with rosacea. The risk of new-onset migraine was also higher among patients with rosacea, but only among women. Perhaps most notably was the observation that risk of new-onset migraine was highest among patients older than 50 years. This was surprising, since new-onset migraine in older individuals is often considered a “red flag”.

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Inflammatory Biomarker CRP Elevated in Migraine

MedicalResearch.com Interview with:

Dr. Gretchen Tietjen MD Professor and Chair of Neurology Director of UTMC Headache Treatment and Research Program Director of the UTMC Stroke Program

Dr. Gretchen Tietjen

Dr. Gretchen Tietjen MD
Professor and Chair of Neurology
Director of UTMC Headache Treatment and Research Program
Director of the UTMC Stroke Program

MedicalResearch.com: What is the background for this study?

Dr. Tietjen : C-reactive protein (CRP) is a well-established biomarker of inflammation. Elevated levels of CRP predict future cardiovascular events, such as myocardial infarction (heart attack) and stroke. Evidence linking higher CRP levels with migraine is limited and results from large population-based studies are conflicting. The National Health and Nutrition Examination Survey (NHANES) data for children and adolescents linked elevated CRP to headache, particularly in girls, and the Women’s Health Study showed an association of CRP with migraine in women over 45 years of age. In the Reykjavik study, CRP levels in persons with migraine were similar to levels in those without migraine. The aim of our study was to examine the relationship of CRP and migraine in a large population-based sample of over 9,000 young adults (24 to 32 years old) from The National Longitudinal Study of Adolescent to Adult Health (Add Health).

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Women With Migraine At Increased Risk of Cardiovascular Disease

MedicalResearch.com Interview with:

Prof. Dr. Dr. Tobias Kurth Professor of Public Health and Epidemiology and Director of the Institut of Public Health, Charité – Universitätsmedizin Berlin, Germany. Co-director, Centre Virchow-Villermé, for Public Health Paris – Berlin, Campus Berlin. Adjunct Associate Epidemiologist, Division of Preventive Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA.

Dr. Tobias Kurth

Prof. Dr. Dr. Tobias Kurth
Professor of Public Health and Epidemiology and Director of the Institut of Public Health, Charité – Universitätsmedizin Berlin, Germany.
Co-director, Centre Virchow-Villermé, for Public Health Paris – Berlin, Campus Berlin.
Adjunct Associate Epidemiologist, Division of Preventive Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA.

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Kurth: Migraine has been consistently associated with increased risk of stroke. Associations with other (non-stroke) Cardiovascular Disease (CVD) was less clear.

MedicalResearch.com: What should readers take away from your report?

Dr. Kurth: Women with migraine are at increased risk of any CVD event, including Myocardial infarction, stroke and cardivoascular death.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Dr. Kurth:  We do not yet understand the mechanism of this association and strong efforts are needed to find solution to reduce the increased risk.

MedicalResearch.com: Is there anything else you would like to add?

Dr. Kurth: I am aware of the importance of the finding but we hope to not scare patients with migraine. Nevertheless, women with migraine should be evaluated for their vascular risk.

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Kurth Tobias, Winter Anke C, Eliassen A Heather,Dushkes Rimma, Mukamal Kenneth J, Rimm Eric Bet al. Migraine and risk of cardiovascular disease in women: prospective cohort study

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Migraine with Aura Linked To Increased Risk of Stroke

MedicalResearch.com Interview with:

Souvik Sen, MD, MS, MPH, FAHA Professor and Chair, Neurology Department, South Carolina Smart State Endowed Stroke Chair University of South Carolina School of Medicine

Dr. Souvik Sen

Souvik Sen, MD, MS, MPH, FAHA
Professor and Chair,  Neurology Department,
South Carolina Smart State Endowed Stroke Chair
University of South Carolina School of Medicine 

Medical Research: What was the catalyst for conducting this study examining the association between migraine with aura and ischemic stroke subtypes?

Dr. Souvik Sen: South Carolina, North Carolina, and Georgia are located in the “buckle” of the stroke belt, with one of the highest stroke related death rates in the country. An unfortunate trend is that younger patients are having strokes leading to death and disability. As a part of the workup for young stroke we are interested in migraine with aura and the type of stroke associated with this condition.

Medical Research: What did you conclude as a result of the findings and how did they compare with your expectations at the beginning of the study?

Continue reading

Psoriasis Elevates Risk of Migraines

psoriasis foundationMedicalResearch.com Interview with:
Alexander Egeberg, MD
Department of Cardiology
Herlev and Gentofte Hospital
Hellerup, Denmark

Medical Research: What is the background for this study? What are the main findings?

Dr. Egeberg: Psoriasis is a common chronic skin disease, with a strong inflammatory component. Within the last decade, our understanding of psoriasis have advanced significantly, and psoriasis is now widely regarded as a systemic disease, where the skin is a direct marker of disease activity. The inflammatory pathways in psoriasis have also been implicated in several central nervous system diseases such as depression, uveitis, and multiple sclerosis. Moreover, pain generation and sensitization can occur as a result of the pro-inflammatory mediators which are upregulated in psoriasis.

In the present study, we investigated the association between psoriasis and psoriatic arthritis, and the risk of new-onset migraine. The main finding was a psoriasis-severity dependent increased risk of new-onset migraine, and patients with severe skin psoriasis, and psoriatic arthritis appeared to have the highest risk.

Continue reading

Study Compares Two Surgical Techniques To Relieve Migraine Headaches

MedicalResearch.com Interview with:
Dr. Bahman Guyuron MD

Cleveland and Lyndhurst, Ohio From the Department of Plastic Surgery, University Hospital Case Medical Center; and the American Migraine Center

Medical Research: What is the background for this study?

Dr. Guyuron: Through several studies including retrospective, prospective pilot, prospective randomized, prospective randomized study with sham surgery, prospective randomized study with 5 year follow up, basic science analysis comparing the nerves of the patients who do not have migraine to those who do not have migraine headaches we have demonstrated efficacy of migraine surgery and the rational for effectiveness of this operation. The later study demonstrated that the patients who experience migraine headaches may have deficiency in myelin membrane protecting the peripheral nerves. Four other centers have reported similar experience independently.

Medical Research: What are the main findings?

Dr. Guyuron: Most of the surgical procedures that the I have developed for migraine surgery in the forehead, occipital area and the nose focus on decompression of the nerves. However, in dealing with some of the temporal migraine headaches involving the zygomticotemporal branch of the trigeminal nerve we perform neurectomy for years. The nature of the this procedure which involves removing a small segment this 1 mm nerve, is unsettling to us, the patients and the neurologist. The purpose of this study was to compare the outcome of the neurectomy to decompression for the patients with temporal headaches.

Medical Research: What should clinicians and patients take away from your report?

Dr. Guyuron: The study demonstrated the there is no statistical difference between the outcome migraine surgery in temple area using neurectomy or nerve decompression. Based this study the clinician can use either technique having the some level of confidence. Should the decompression fail it would offer an opportunity for a plan B which would be removing a segment of the nerve.

Citation:

A Prospective Randomized Outcomes Comparison of Two Temple Migraine Trigger Site Deactivation Techniques

Guyuron B1, Harvey D, Reed D.

Plast Reconstr Surg. 2015 Jul;136(1):159-65. doi: 10.1097/PRS.0000000000001322.

Dr. Bahman Guyuron MD, & Cleveland and Lyndhurst (2015). Study Compares Two Surgical Techniques To Relieve Migraine Headaches