Report demonstrates triptans safer than NSAIDs for some patients

Since triptans (Imitrex/sumatriptan, Maxalt/rizatriptan, etc.) were introduced in 1992, some doctors have been reluctant to prescribe them because of concerns about cardiovascular safety. Some refused to prescribe them for patients beyond a certain age even if they had no history of or risk factors for coronary artery disease.

The Triptan Cardiovascular Safety Expert Panel¹ of the American Headache Society (AHS), after reviewing dozens of studies and adverse event reports on triptans from the US Food and Drug Administration's Adverse Event Reporting System, has come to a conclusion vital to those who suffer from Migraines and cluster headaches.

"While serious cardiovascular events have been reported after the use of triptans, their occurrence appears to be extremely low -- on the order of less than one in 1 million."²

Such figures put triptans in a better safety position than over-the-counter non-steroidal anti-inflammatory medications (NSAID's) such as ibuprofen, acetaminophen, and aspirin. The risk of death from those medications is as little as one in 1,200, while prescription NSAID's contribute to approximately 16,500 deaths per year.³

The panel's findings add to a growing body of evidence of the safety of triptans. Two recent studies analyzed more than 194,000 Migraine patients in the United States and United Kingdom, and when comparing them to non-Migraine sufferers, found no evidence of increased risk of heart attacks, stroke or death in those who used triptans. In addition, the FDA presented information suggesting that the risk of a person experiencing a heart attack or sudden cardiac death was less than 1 for 10 million patients treated per year, and less than 10 per 10 million Migraine attacks treated per year. Essentially, the risk of these events for patients taking triptans is the same as the risk of these events occurring in the general population.³

Dr. Stephen Silberstein, director of the Jefferson Headache Center in Philadelphia, agreed with the findings, saying, "There's good evidence that triptans are far superior in fighting Migraine than whatever else is out there ... It usually takes doctors about 10 years to prescribe any new drugs because they weren't taught about them in medical school."²

The Conclusions of the Panel"

• Chest symptoms occurring during use of triptans are usually nonserious and usually not attributed to ischemia (deficiency of blood flow).
• While serious cardiovascular adverse events have occurred after use of triptans, their incidence in clinical trials and clinical practice appears to be extremely low.
• The cardiovascular risk-benefit profile of triptans favors their use in the absence of contraindications.
• Most clinical trials and clinical practice data on triptans are derived from patients without known coronary artery disease.
• These data support the conclusion that, in patients at low risk of coronary artery disease, triptans can be prescribed confidently without the need for prior cardiac status evaluation.¹

"We hope this study enables physicians to make informed decisions when prescribing medications for their patients with Migraines," said Robert B. Daroff, M.D., president of the American Headache Society. "There's no reason for those who get Migraine to suffer when there is an effective remedy available that is safe for the overwhelming majority of Migraine sufferers."³

Dr. Fred Sheftell -- founder and directory of the New England Center for Headache, Medical Advisor Chair for MAGNUM, President-Elect of the American Council for Headache Education (ACHE), and Past Chairman of the World Headache Alliance (WHA) -- commented:

"The data from the Triptan Cardiovascular Safety Expert Panel gives us a thoughtful and scientific review of safety issues related to a class of medication that in my experience represents the most significant advance in the treatment of the acute attack of migraine in the past one hundred years. It is important to recognize that no triptan should be regarded as 'safer' than another. Indeed all provide a margin of safety that should give clinicians and patients alike comfort in their use.

Nevertheless, one must still pay attention to the contraindications for the class."⁴

Take Note:

• One out of ten people have Migraine disease.
• 90% of Migraineurs report some disability cause by their attacks according to the American Migraine Study II.
• The World Health Organization ranks Migraine among the world's most disabling illnesses.
• Triptans are effective for approximately 80% of Migraineurs, BUT
• Triptans are prescribed for only approximately 30% of Migraineurs, SO
• Many Migraineurs haven't had the opportunity to try triptans.

Thus, just a bit beyond the ten-year mark Dr. Silberstein mentioned, the Panel gives us safety information about triptans that will hopefully benefit millions of sufferers. While those Migraineurs who have coronary and other contraindications still should not take triptans, those who don't have those contraindications and their doctors should now be far more comfortable in taking advantage of the benefits triptans can offer.

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References:

¹ Dodick, David, Lipton, Richard B., Martin, Vincent, Papademetriou, Vasilios, Rosamond, Wayne, MaassenVanDenBrink, Antoinette, Loutfi, Hassan, Welch, K. Michael, Goadsby, Peter J., Hahn, Steven, Hutchinson, Susan, Matchar, David, Silberstein, Stephen, Smith, Timothy R., Purdy, R. Allan & Saiers, Jane (2004). Consensus Statement: Cardiovascular Safety Profile of Triptans (5-HT1B/1D Agonists) in the Acute Treatment of Migraine. Headache: The Journal of Head and Face Pain 44 (5), 414-425. doi: 10.1111/j.1526-4610.2004.04078.x

² Mundell, E.J.; HealthDay Reporter. "Migraine Sufferers Not Getting Best Drugs." Forbes.com. May 5, 2004.

³ U.S. Newswire Press Release. "Triptans Safer Than Many Common Drugs; Underused Treatment Most Effective Migraine Medication." May 5, 2004.

⁴ Interview with Dr. Fred Sheftell by Teri Robert. May 8, 2004.

Originally published May 10, 2004.
© Teri Robert