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Adding Acute Treatments for Patients on Triptans and Headache-Related Disability: Results of the American Migraine Prevalence and Prevention (AMPP) Study
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Adding Acute Treatments for Patients on Triptans and Headache-Related Disability: Results of the American Migraine Prevalence and Prevention (AMPP) Study Richard B. Lipton MD1; Daniel Serrano PhD2; Shashi H. Kori MD3; Cedric M. Cunanan MPH4;Aubrey N. Manack PhD4; Michael L. Reed PhD2; Dawn C. Buse PhD1 1. Albert Einstein College of Medicine, Bronx, NY; 2. Vedanta Research, Chapel Hill, NC; 3. MAP Pharmaceuticals, Mountain View, CA; 4. Allergan Inc., Irvine, CA BACKGROUND RESULTS • A previous analysis of the AMPP study found that 91.7% of respondents with migraine used acute treatments for headache. Of these respondents18.3% used triptans to manage headache and 21.7% of triptan users report triptan monotherapy. Over half (53.0%) used multiple classes of medication for acute headache management. • Adding to an existing acute treatment regimen is common in clinical practice for a variety of reasons. However, adding to a triptan regimen has rarely been studied, and when it has, research has focused on two-hour response endpoints for a single attack. There is little data on the long-term real-world outcomes of adding to a triptan regimen with either another triptan or a different class of medication. • We classified treatment changes in 960 AMPP survey respondents with ICHD-2 defined migraine who were treated with a triptan in the first year of a couplet into the following four treatment groups: 1. Consistent triptan use (n=649) 2. Adding a different triptan (n=113) 3. Adding a NSAID (n=71) 4. Adding combination analgesics containing opioids or barbiturates (n=127) • Effects of adding to an existing triptan regimen on headache-related disability from baseline to the follow up year in a couplet varied based onstarting average headache day/month frequency and medication class (Table 1). • Among those with HFEM/CM, consistent users saw an improvement (reduction) in headache-related disability, while those who added a triptan saw an increase (Figure 1). There was a significant difference (interaction) between the LFEM and HFEM/CM groups when comparing the consistent and adding groups (Interaction= 18.54; 95% CI 4.8 - 32.3). • A similar pattern was seen when adding a NSAID. For those with HFEM/CM, adding a NSAID was associated with increased disability compared to consistent users, who saw a decrease in disability (Consistent users, cell mean= -18.28; Adding a NSAID group, cell mean = 7.0) (Figure 2). There was a significant interaction between MIDAS change scores for LFEM and HFEM when adding a NSAID (Interaction= 26.3; 95% CI 0.2 - 52.5). There was also a significant interaction when comparing MIDAS change scores between the MFEM and HFEM/CM groups who either remained consistent or added a NSAID (Interaction= 44.1; 95% CI 15.8 - 72.4). • Adding a barbiturate or opioid was not associated with significant changes in headache-related disability for any of the headache frequency groups (Figure 3). Table 1. Summary of Headache-Related Disability for Treatment Groups by Headache Frequency Figure 1. Difference in MIDAS Associated with Adding a Triptan: LFEM vs. HFEM/CM OBJECTIVE • To evaluate the influence of adding a triptan, NSAID or an opioid or barbiturate on headache-related disability in a population sample of individuals with migraine currently treated with a triptan. METHODS • The AMPP study is a longitudinal, US population-based study. • Surveys were mailed to a sample of 24,000 persons with severe headache identified in 2004 and followed annually through 2009. • Eligible subjects met ICHD-2 criteria for migraine and reported acute treatment with a triptan one year and data on treatment and outcomes the next year. • Pairs of adjacent years are herein referred to as “couplets”. • Patterns of acute pharmacologic treatment for migraine were monitored from one year to the next for the following couplets: 2005-2006, 2006-2007, 2007-2008, 2008-2009 • We classified four medication-change groups: 1. Maintaining current triptan use (consistent group) 2. Adding a different triptan 3. Adding a non-steroidal anti-inflammatory (NSAID) agent 4. Adding a combination analgesic containing opioids or barbiturates • Respondents with migraine were divided into the following groups based on attack frequency: • Low Frequency Episodic Migraine (LFEM) Average 0 to 4 headache-days/month • Moderate Frequency Episodic Migraine (MFEM) Average 5 to 9 headache-days/month • High Frequency Episodic Migraine (HFEM) Average 10 to 14 headache-days/month • Chronic Migraine (CM) Average 15 or more headache-days/month • The HFEM and CM groups were combined to maximize sample size. • We assessed change in raw scores of the Migraine Disability Assessment (MIDAS) from one year to the next based on change in treatment. • Each individual contributed only one couplet to the analysis. • Individuals who switched from a triptan are studied in a separate poster. Figure 2. Difference in MIDAS Associated with Adding a NSAID: LFEM vs. HFEM/CM CONCLUSIONS • Adding a triptan was associated with: • No change in headache-related disability for LFEM and MFEM. • A substantial increase in headache-related disability for HFEM/CM. • The LFEM and MFEM groups significantly differed in direction and magnitude of headache-related change when compared to HFEM/CM. • Adding a NSAID was associated with: • No change in headache-related disabilityfor LFEM. • A significant decrease in headache-related disability for MFEM. • A significant increase in headache-related disability for HFEM/CM. • All headache strata groups significantly differed from one another in the direction and magnitude of change in headache-related disability. • Adding a barbiturate or opioid was not associated with significant changes in headache-related disability. • Limitations include confounding by indication, heterogeneity in patterns of medication use, timing relative to MIDAS assessments, and statistical power. • Strengths include the real-world observation of clinically meaningful outcomes. • These data suggest that healthcare professionals may want to consider headache day/month frequency in relation to medication class when adding to an existing triptan regimen. Figure 3. Difference in MIDAS Associated with Adding an Opioid/Barbiturate: LFEM vs. HFEM/CM The American Migraine Prevalence and Prevention Study is funded through a research grant to the National Headache Foundation from Ortho-McNeil Neurologics, Inc., Titusville, NJ. Additional analyses and poster preparation were supported by a grant from MAP Pharmaceuticals, Mountain View, CA and Allergan Inc., Irvine, CA to the National Headache Foundation.