WASHINGTON – Almost half of patients with episodic migraine report having at least one unmet medical need, according to the findings of more than 20,000 people participating in a population-based survey.

The findings suggest that despite the expanding armamentarium of acute migraine-specific therapies, patient satisfaction with treatment is at best low to moderate for many, Dawn Buse, Ph.D., said at the annual meeting of the American Headache Society.

"You all know this is nothing new. You keep working to meet your patients’ needs while considering side effects, cost, effectiveness, and speed of onset." But despite all these efforts, some patients report unsatisfactory results.

Dr. Buse, director of behavioral medicine at the Montefiore Headache Center, New York, and her colleagues examined data from the AMPP (American Migraine Prevalence and Prevention) study (Headache 2008 Sept. 2 [doi:10.1111/j.1526-4610.2008.01217.x]). This population-based survey began in 2004, when a general-population headache screening netted 162,756 respondents, 36,000 of whom reported having severe headache.

The study that was presented at the meeting examined data from the 2009 sample of 11,792 who had been followed since 2005, including 5,600 who met the International Classification of Headache Disorders definition of episodic migraine. A control group comprised 8,315 who were free of severe headache or migraine in the original 2004 survey.

Dr. Buse and her coinvestigators identified five domains of possible unmet treatment needs, and resurveyed the migraine population for their response. The domains included the following:

• Dissatisfaction with current acute treatment (assessed by the 3-item summary from the Patient Perception of Migraine Questionnaire).

• Moderate or severe headache-related disability (defined by a score of at least 11 on the Migraine Disability Assessment Test).

• Excessive use of opioids or barbiturates (that is, using the drugs at least 4 days per month or meeting the DSM-IV criteria for dependence).

• Excessive use of the emergency department or urgent care clinic for headache (that is, at least two visits in the preceding year).

• History of cardiovascular events that might preclude triptan therapy (including heart attack, stroke, angina, claudication, stent placement, or coronary artery bypass graft).

The samples were not significantly different in demographics; most (81%) were women. The mean age in the control group was 51 years vs. 52 years in the two groups with unmet needs. The mean body mass index also differed slightly. Among the control group, the mean BMI was 29 kg/m², compared with 30 in the group with one unmet need and 32 in the group with two or more unmet needs.

Headache days per month also varied between the groups. Those with no unmet needs reported a mean of 2 days per month with headache, compared with 3 days per month for the group with one unmet need, and 5 days per month for those with two or more needs.

Overall, 41% of those with episodic migraine reported having at least one unmet need; 26% reported one and 14% reported two or more.

The unmet need that was most commonly reported was headache-related disability of moderate to severe intensity (19%). Some 15% claimed dissatisfaction with their current therapy. Opioid or barbiturate use or dependence was seen in 13% of respondents. In all, 10% reported cardiovascular disease that could preclude triptan use, although 26% of these used the drugs despite these risks. Finally, 2% reported frequent headache-related visits to the ED or urgent care center.

"When we looked at the three most frequently reported areas, we saw an interesting overlap," Dr. Buse said. "Of the 19% who met the criteria for moderate to severe headache-related disability, 10% met that area only. But 4% of them also reported opioid overuse, 3% also reported dissatisfaction with their medications, and 2% endorsed all three of these areas."

The investigators then contrasted psychological comorbidities between the group with unmet needs and the 60% who reported no unmet needs. Anxiety and depression correlated significantly with the number of unmet needs.

Among the control group, 5% met criteria for anxiety and 10% for depression. Among the group with one unmet need, the rates were 11% for anxiety and 22% for depression. Among the group with at least two unmet needs, the rates were 21% for anxiety and 41% for depression.

In an interview, Dr. Buse said the relationship between headache and psychiatric disorders is not well-understood, but appears to be bidirectional. Anxiety increases the likelihood and the severity of headache, whereas headaches increase the risk of anxiety. The brain neurotransmitters that are involved in depression may also predispose a person to headache, but years of headache pain also increase the risk of becoming depressed, she said.

The AMPP study is funded by the American Headache Society through grants from Ortho-McNeil Neurologics and Merck Sharp & Dohme Corp., a subsidiary of Merck.

Dr. Buse has received research support from Allergan Pharmaceuticals, Iroko Pharmaceuticals, MAP Pharmaceuticals, and Merck.

Nearly Half of Migraine Sufferers Report Unmet Medical Needs