2014

New Study Results regarding Cardiovascular Contraindications to Triptans in the Migraine Population to be presented at the 16th Congress of the International Headache Society, June 30, in Boston, MA

DURHAM, N.C., June 26, 2013 /PRNewswire/ -- The abstract of a recent study, "Cardiovascular Contraindications to Triptans in the Migraine Population:  Results from the American Migraine Prevalence and Prevention (AMPP) Study", has been selected for a platform presentation at the 16th Congress of the International Headache Society taking place June 27-30, 2013 in Boston, MA.

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The triptan drug class, which includes agents such as sumatriptan and rizatriptan, is the most widely prescribed drug class for the treatment of acute migraine.  However, because triptans constrict blood vessels, they are contraindicated in patients with cardiovascular, cerebrovascular or peripheral vascular disease.

In addition, the FDA recommends that migraine patients with CVD risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, women with surgical or physiological menopause, men over 40 years of age) should be evaluated for silent myocardial ischemia before receiving a triptan, and in some cases, have their first dose administered in a medically supervised setting.

In order to determine the scope of individuals with episodic migraine (EM) for whom triptans are contraindicated, investigators examined the prevalence of these conditions by evaluating 6,723 people with EM obtained by screening a representative sample of over 160,000 Americans in the American Migraine Prevention and Prevalence (AMPP) Study database.

Results indicate that a substantial proportion of persons with EM also have cardiovascular events, cardiovascular disease (CVD), or CVD risk factors.  The study showed that:

  • 18.4% of episodic migraineurs had a contraindication to triptan use based on a history of at least one cardiovascular event including: heart attack, stroke, claudication, or angina, or procedure such as stenting or bypass surgery.
  • Rates of a history of at least one cardiovascular event or procedure increased with age from 11% of those younger than 40, to 18.7% of those age 40-59 to 33.6% for those 60 and older.
  • Rates were slightly higher in males compared to females across the lifespan.

Table 1.


Rates of Cardiovascular Events and Procedures among the AMPP Study sample by Age Group


CV Events and Procedures

Aged <40

Aged 40-59

Aged ≥60

Myocardial Infarction

6 (0.4%)

112 (3.4%)

104 (8.0%)

TIA

17 (1.2%)

135 (3.9%)

101 (7.2%)

Stroke

11 (0.8%)

72 (2.1%)

76 (5.4%)

Claudication

85 (6.2%)

294 (8.6%)

182 (13.1%)

Angina

58 (4.2%)

271 (7.9%)

192 (13.7%)

Coronary Bypass Surgery

11 (0.8%)

41 (1.1%)

49 (3.2%)

Coronary Angioplasty/Stenting

15 (1.0%)

114 (3.1%)

100 (6.5%)

Carotid Artery Surgery/Stenting

10 (0.7%)

28 (0.8%)

22 (1.4%)

Peripheral Artery Bypass Surgery

10 (0.7%)

32 (0.9%)

16 (1.0%)

Respondents with ≥1 Event/Procedure

151 (11.1%)

623 (18.7%)

460 (33.6%)

"Despite their efficacy, only a small percentage of migraine attacks are treated with triptans.  Low rates of treatment are due in part to cardiovascular events and disease and in part to worry about CVD on the part of prescribing clinicians and people with migraine.  Highly effective and safe treatments free of cardiovascular risk would be a welcome addition to the therapeutic armamentarium," remarked Richard B. Lipton, MD, Professor and Vice Chair of Neurology, Albert Einstein College of Medicine and Director, Montefiore Headache Center and AMPP Study primary investigator.

"Based on these findings, we estimate that there are 4.7 million Americans over age 18 with episodic migraine for whom triptan medications are contraindicated based on a history of cardiovascular events or procedures," said Dawn C. Buse, PhD, Associate Professor of Neurology at Albert Einstein College of Medicine, Montefiore Headache Center, and study co-investigator.  "Additionally, there is also a group who has risk factors for CVD that mandate caution in using triptans."

"These data highlight an area of unmet need for acute migraine treatment that does not have cardiovascular risks and contraindications.  As our population ages, the number of migraineurs with CV conditions, events and procedures and the resulting unmet need will increase," noted Dr. Lipton.

Thomas P. Mathers, CEO of CoLucid Pharmaceuticals, Inc., noted that "It is an honor for this study to be selected as a platform presentation and we appreciate IHC's recognition of the importance of this work in highlighting the significant unmet needs of migraineurs who cannot, or are unwilling to, take triptans due to cardiovascular safety concerns."  He added that "CoLucid is working diligently to bring lasmiditan, a new drug that lacks the vasoconstrictor activity of current therapies, through Phase 3 clinical development to address this unmet need."  

Additional key findings of the study will be presented Sunday, June 30 beginning at 9:26 am in the Scientific Paper Presentations-Session 5: Clinical and Treatment by study co- investigator Dawn Buse, PhD.

STUDY SPONSORSHIP

The AMPP Study was funded through a research grant to the National Headache Foundation (NHF) from McNeil-Janssen Scientific Affairs LLC, Raritan, NJ (MJSA).  The AMPP database was donated by MJSA to the NHF for use in various projects.  Additional analyses and abstract preparation were supported by a grant from CoLucid Pharmaceuticals, Inc., Durham, NC to the National Headache Foundation.

ABOUT MIGRAINE

Some 36 million Americans have migraine, more than have asthma or diabetes combined.  More than six million Americans have chronic migraine, a highly disabling neurological disorder.  Migraine can be extremely disabling and costly, accounting for more than $20 billion in direct (e.g. doctor visits, medications) and indirect (e.g. missed work, lost productivity) expenses each year in the United States.

ABOUT THE INTERNATIONAL HEADACHE SOCIETY

IHS, founded in the United Kingdom in 1982, is the world's leading membership organization for those with a professional commitment to helping people affected by headache. The purpose is to advance headache science, education, and management, and promote headache awareness worldwide. IHS publishes the international journal Cephalalgia.

ABOUT THE AMERICAN HEADACHE SOCIETY

The American Headache Society (AHS) is a professional society of health care providers dedicated to the study and treatment of headache and face pain. The Society's objectives are to promote the exchange of information and ideas concerning the causes and treatments of headache and related painful disorders. Educating physicians, health professionals and the public and encouraging scientific research are the primary functions of this organization. AHS activities include an annual scientific meeting, a comprehensive headache symposium, regional symposia for neurologists and family practice physicians, publication of the journal Headache and sponsorship of the AHS Committee for Headache Education (ACHE).  www.americanheadachesociety.org

ABOUT COLUCID PHARMACEUTICALS, INC.

CoLucid was founded in 2005 by Pappas Ventures to advance innovative drug candidates with the potential to provide safe and effective treatments for CNS disorders. The company's investors include Pappas Ventures, Domain Associates, Care Capital, Pearl Street Venture Funds and Triathlon Medical Ventures. The company's pipeline includes lasmiditan, a novel treatment for migraine headache. Lasmiditan is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies such as triptans.  Lasmiditan is a member of a novel drug class called "ditans" and, unlike triptans, penetrates the central nervous system (CNS) and selectively targets receptors expressed in the trigeminal pathway.  Lasmiditan does not interact with vasoconstrictor receptors on peripheral blood vessels which are activated by triptans. For more information, please visit CoLucid at www.colucid.com.

SOURCE CoLucid Pharmaceuticals, Inc



RELATED LINKS
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