A previous analysis of the AMPP study found that 91.7% of respondents with migraine used acute...

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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 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. Headache Frequency Adding a Triptan Adding an NSAID Adding a Barbiturate or Opioid Analgesic LFEM No change No change No change MFEM No change Significant decrease No change HFEM/CM Significant increase Significant 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

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Page 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.

• 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.

CONCLUSIONSCONCLUSIONS

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 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

RESULTSRESULTS

• 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).

METHODSMETHODS

OBJECTIVEOBJECTIVE

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 triptan3. 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

LFEM No change No change No change

MFEM No change Significant decrease No change

HFEM/CM Significant increase Significant 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

BACKGROUNDBACKGROUND