Triptans Contraindicated in Almost 5 Million Americans

Pauline Anderson

July 03, 2013

BOSTON — Almost 5 million Americans with episodic migraine (EM) should not be prescribed a triptan, a widely used US Food and Drug Administration (FDA)–approved drug, because of the presence of cardiovascular contraindications, according to results from the American Migraine Prevalence and Prevention (AMPP) study.

"These data highlight an area of unmet need for acute migraine treatment without cardiovascular risk and contraindications," said study coinvestigator Dawn Buse, PhD, associate professor of neurology, Albert Einstein College of Medicine, Montefiore Headache Center, New York City. "As our population ages, the number of migraineurs with cardiovascular events, conditions, and procedures will likely increase, and the resulting unmet need will increase."

Five million Americans with a contraindication limiting prescriptions for triptans seems "a sizeable concern," Dr. Buse told delegates. "At least, it's something people have to keep in mind as they're treating patients, which limits their options, especially when this is the only migraine treatment specifically approved by the FDA. Certainly, we hope, and I think patients hope, that more options will be coming down the pike."

Dr. Buse reported the study results here during the 2013 International Headache Congress (IHC).

Longitudinal Survey

Episodic migraines occur on fewer than 15 days of the month. The triptan drug class, approved for the treatment of migraine, includes such commonly used agents as sumatriptan and rizatriptan.

The cardiovascular risks linked to triptans are well known. The FDA recommends that patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, and diabetes be evaluated for silent myocardial ischemia before receiving a triptan.

The AMPP is a longitudinal survey that started in 2004 with a population-based mailing to 120,000 households in the United States. This was followed by a mailing to 24,000 individuals in 2005, 2006, 2007, 2008, and 2009. The current study includes results from the 2009 survey.

Of the 11,799 respondents, 6723 met criteria for migraine (5227 females and 1496 males).

Respondents were asked whether they had ever had a cardiovascular condition such as a myocardial infarction (MI), transient ischemic attack (TIA), stroke, claudication or angina, or a cardiovascular procedure such as coronary bypass surgery, coronary angioplasty/stenting, carotid artery surgery/stenting, or peripheral artery bypass surgery.

Researchers generated frequency counts for each cardiovascular event and procedure, and applied observed rates of cardiovascular contraindications to estimates of episodic migraine by sex within the total sample and by 3 age groups (younger than 40 years; 40-59 years; and 60 years and older) derived from US census data.

Increases With Age

As expected, rates of at least 1 cardiovascular condition or procedure in the EM sample increased with age, from 11% in those younger than 40 years to 18.7% in those aged 40 to 59 years and 33.6% for those 60 years and older.

Rates were also generally slightly higher in men. For example, the rate of MI in men aged 60 years and older was about 8% but significantly less than the 1% for women younger than 40. The rate of angina in the oldest male category was close to 14%, but it was only about 4% in the youngest female category.

It was generally a similar picture with procedures. Rates of coronary angioplasty were about 6.5% in the oldest men and about 1% in the youngest women, whereas the rates of coronary bypass surgery were just over 3% for the oldest men and less than 1% for the youngest women.

"While rates may seem relatively low, as some of these are in the 2% to 3% range, when we add these up in aggregate and look at the sample of who has had at least 1 of these, we come to a fairly sizeable portion of people," said Dr. Buse. "In fact, when we look at the current US census data, based on our analyses, we find that triptans are contraindicated in an estimated 4.7 million Americans with migraine, based on the existence of cardiovascular events, conditions, and procedures."

Limited Options

David W. Dodick, MD, professor, Department of Neurology, Mayo Clinic, Phoenix, Arizona, selected this study as one of the highlights in clinical science research during 2012 and 2013.

According to Dr. Dodick, although the triptan class is generally very safe, physicians in the United States are "loath" to prescribe such a drug for patients who have established cardiovascular disease. He also noted that a recent meta-analysis showed that only about 20% of migraine patients get a sustained pain-free response from a triptan.

"So while triptans have been a remarkable advance, there are many patients who don't achieve optimal results with them, and there are many patients for whom they are contraindicated. That means that we need new therapies."

Dr. Buse has received grant support and honoraria from Allergan/MAP Pharmaceuticals, Novartis, and NuPathe.

2013 International Headache Congress (IHC). Abstract OR28. Presented June 30, 2013.

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