1. 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. 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 disability for 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. 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. 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. Adding Acute Treatments for Patients on Triptans and Headache-Related Disability: Results of the American Migraine Prevalence and Prevention (AMPP) Study Richard B. Lipton MD 1 ; Daniel Serrano PhD 2 ; Shashi H. Kori MD 3 ; Cedric M. Cunanan MPH 4 ; Aubrey N. Manack PhD 4 ; Michael L. Reed PhD 2 ; Dawn C. Buse PhD 1 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 RESULTS 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 on starting 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). METHODS OBJECTIVE Table 1. Summary of Headache-Related Disability for Treatment Groups by Headache Frequency Figure 2. Difference in MIDAS Associated with Adding a NSAID: LFEM vs. HFEM/CM 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. 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. Headache Frequency Adding a Triptan Adding an NSAID Adding a Barbiturate or Opioid Analgesic LFEMNo change MFEMNo changeSignificant decreaseNo change HFEM/CMSignificant increase No change Figure 3. Difference in MIDAS Associated with Adding an Opioid/Barbiturate: LFEM vs. HFEM/CM Figure 1. Difference in MIDAS Associated with Adding a Triptan: LFEM vs. HFEM/CM BACKGROUND