SAN FRANCISCO—Unmet treatment needs among migraineurs receiving oral prescription medications include therapies to reduce nausea and disturbed sleep, according to a study described at the 60th Annual Scientific Meeting of the American Headache Society. The population also has unmet needs for therapies that provide pain freedom and rapid onset of action.
Richard B. Lipton, MD
In 2017, investigators conducted the Migraine in America Symptoms and Treatment (MAST) study, which focused on migraine symptoms, current treatment patterns, and the assessment of unmet treatment needs. Richard B. Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine in the Bronx, New York, and colleagues examined MAST data to empirically characterize the patterns of poorly controlled migraine and assess corresponding rates of migraine-related disability.
A Survey of American Migraineurs
The MAST survey data were obtained from a general US population sample of migraineurs age 18 and older. Migraineurs were identified using a validated migraine symptom screen based on modified ICHD-3b criteria. Eligible participants had an average of at least one headache day per month during the previous three months.
Respondents provided information about sociodemographics and medication use and responded to a 13-item battery evaluating headache burden and response to medication. The items on the battery were derived from a review of relevant literature, clinician input, and interviews with migraine patients. Participants provided frequency data for each item on a five-point scale ranging from “1) Never” to “5) All or Nearly All of the Time.” To measure construct validity for the scale, the investigators assessed moderate to severe disability for each respondent using the Migraine Disability Assessment Scale (MIDAS).
To determine the underlying structure of unmet treatment needs, Dr. Lipton and colleagues conducted Exploratory Factor Analysis (EFA) among the subset of respondents currently using oral acute prescription medications. They assessed the internal consistency for the derived factors using Cronbach’s alpha. Mean factor scores (range, 1 to 5) were calculated by summing item responses for each factor and dividing by the number of items loading on that factor. The researchers used Mantel-Haenszel Chi Square Test for Trend to evaluate the relationship between mean factor score and rates of moderate to severe migraine-related disability.
Treatment May Act Too Slowly
Among 15,133 respondents meeting inclusion criteria, 3,930 reported current use of acute oral prescription headache medication (mean age, 45.0, 73.6% women, 81.6% Caucasian). Injection and nasal spray medication users were eliminated from the sample. The most commonly endorsed needs were “severe headache attacks come on very rapidly” (52.8%), “attacks reach peak intensity in less than 30 minutes” (50.4%), “severe headache presents upon awakening” (40.9%), and “the return of pain within 24 hours after initial pain relief” (38.6%). EFA identified the following four unmet needs: nausea interference, disturbed sleep, rapid onset, and lack of pain freedom. Internal consistency exceeded acceptable levels for all factors except disturbed sleep. MIDAS disability increased in a clear linear pattern with increasing mean factor scores.
Suggested Reading
Blumenfeld AM, Aurora SK, Laranjo K, Papapetropoulos S. Unmet clinical needs in chronic migraine: Rationale for study and design of COMPEL, an open-label, multicenter study of the long-term efficacy, safety, and tolerability of onabotulinumtoxinA for headache prophylaxis in adults with chronic migraine. BMC Neurol. 2015;15:100.
Lipton RB, Buse DC, Serrano D, et al. Examination of unmet treatment needs among persons with episodic migraine: results of the American Migraine Prevalence and Prevention (AMPP) Study. Headache. 2013;53(8):1300-1311.