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Prior onabotulinumtoxin-A improves subsequent anti-CGRP mAb response in chronic migraine

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Key clinical point: Prior treatment with onabotulinumtoxin-A may improve subsequent clinical response to preventive treatment with anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) in patients with chronic migraine.

Major finding: At 3 months of treatment with anti-CGRP mAb, patients who received vs did not receive prior onabotulinumtoxin-A had fewer mean monthly migraine days (3.3 days vs 5.2 days; P = .017), lower pain intensity (Numerical Rating Scale scores: 5.9 vs 6.6; P = .013), and a lower mean Migraine Disability Assessment score (23.2 vs 37.4; P = .013).

Study details: The data come from a retrospective observational study including 128 patients with chronic migraine who received treatment with anti-CGRP mAb, of whom 39.9% received prior treatment with onabotulinumtoxin-A.

Disclosures: This study did not receive any external funding. Three authors declared receiving speaker honoraria from or serving as consultants or scientific advisory board members for various sources.

Source: Ceccardi G et al. Onabotulinumtoxin-A: Previous prophylactic treatment might improve subsequent anti-CGRP monoclonal antibodies response in patients with chronic migraine. Toxins. 2023;15(12):677 (Nov 30). doi: 10.3390/toxins15120677

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Key clinical point: Prior treatment with onabotulinumtoxin-A may improve subsequent clinical response to preventive treatment with anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) in patients with chronic migraine.

Major finding: At 3 months of treatment with anti-CGRP mAb, patients who received vs did not receive prior onabotulinumtoxin-A had fewer mean monthly migraine days (3.3 days vs 5.2 days; P = .017), lower pain intensity (Numerical Rating Scale scores: 5.9 vs 6.6; P = .013), and a lower mean Migraine Disability Assessment score (23.2 vs 37.4; P = .013).

Study details: The data come from a retrospective observational study including 128 patients with chronic migraine who received treatment with anti-CGRP mAb, of whom 39.9% received prior treatment with onabotulinumtoxin-A.

Disclosures: This study did not receive any external funding. Three authors declared receiving speaker honoraria from or serving as consultants or scientific advisory board members for various sources.

Source: Ceccardi G et al. Onabotulinumtoxin-A: Previous prophylactic treatment might improve subsequent anti-CGRP monoclonal antibodies response in patients with chronic migraine. Toxins. 2023;15(12):677 (Nov 30). doi: 10.3390/toxins15120677

Key clinical point: Prior treatment with onabotulinumtoxin-A may improve subsequent clinical response to preventive treatment with anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibodies (mAb) in patients with chronic migraine.

Major finding: At 3 months of treatment with anti-CGRP mAb, patients who received vs did not receive prior onabotulinumtoxin-A had fewer mean monthly migraine days (3.3 days vs 5.2 days; P = .017), lower pain intensity (Numerical Rating Scale scores: 5.9 vs 6.6; P = .013), and a lower mean Migraine Disability Assessment score (23.2 vs 37.4; P = .013).

Study details: The data come from a retrospective observational study including 128 patients with chronic migraine who received treatment with anti-CGRP mAb, of whom 39.9% received prior treatment with onabotulinumtoxin-A.

Disclosures: This study did not receive any external funding. Three authors declared receiving speaker honoraria from or serving as consultants or scientific advisory board members for various sources.

Source: Ceccardi G et al. Onabotulinumtoxin-A: Previous prophylactic treatment might improve subsequent anti-CGRP monoclonal antibodies response in patients with chronic migraine. Toxins. 2023;15(12):677 (Nov 30). doi: 10.3390/toxins15120677

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Galcanezumab effective for migraine prevention in women with menstrually related migraine

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Key clinical point: Galcanezumab effectively reduced the effect of menstrually related migraine (MRM) and led to improved functioning in women with episodic migraine.

Major finding: Across months 4 through 6, galcanezumab vs placebo led to greater mean reduction in the monthly migraine headache days (MHD; least squares mean change from baseline [Δ] −5.1 vs −3.2), monthly perimenstrual MHD (Δ −0.75 vs −0.49), non-perimenstrual MHD (Δ −4.6 vs −2.8), and greater improvement in Role Function-Restrictive domain scores of the Migraine-Specific Quality of Life Questionnaire (Δ 30.9 vs 22.3 points; all P < .001).

Study details: This post hoc analysis of the EVOLVE-1 and EVOLVE-2 trials included 1133 women with episodic migraine who received either 120 mg galcanezumab per month or placebo, of whom 40.8% met the criteria for MRM.

Disclosures: This study was sponsored by Eli Lilly and Company. Four authors declared being current or former employees and stockowners of Eli Lilly and Company. Two authors declared receiving consulting honoraria from various sources including Eli Lilly.

Source: MacGregor EA et al. Effect of galcanezumab in women with episodic migraine meeting criteria for menstrually related migraine: A post hoc analysis of EVOLVE-1 and EVOLVE-2. Headache. 2023 (Nov 28). doi: 10.1111/head.14652

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Key clinical point: Galcanezumab effectively reduced the effect of menstrually related migraine (MRM) and led to improved functioning in women with episodic migraine.

Major finding: Across months 4 through 6, galcanezumab vs placebo led to greater mean reduction in the monthly migraine headache days (MHD; least squares mean change from baseline [Δ] −5.1 vs −3.2), monthly perimenstrual MHD (Δ −0.75 vs −0.49), non-perimenstrual MHD (Δ −4.6 vs −2.8), and greater improvement in Role Function-Restrictive domain scores of the Migraine-Specific Quality of Life Questionnaire (Δ 30.9 vs 22.3 points; all P < .001).

Study details: This post hoc analysis of the EVOLVE-1 and EVOLVE-2 trials included 1133 women with episodic migraine who received either 120 mg galcanezumab per month or placebo, of whom 40.8% met the criteria for MRM.

Disclosures: This study was sponsored by Eli Lilly and Company. Four authors declared being current or former employees and stockowners of Eli Lilly and Company. Two authors declared receiving consulting honoraria from various sources including Eli Lilly.

Source: MacGregor EA et al. Effect of galcanezumab in women with episodic migraine meeting criteria for menstrually related migraine: A post hoc analysis of EVOLVE-1 and EVOLVE-2. Headache. 2023 (Nov 28). doi: 10.1111/head.14652

Key clinical point: Galcanezumab effectively reduced the effect of menstrually related migraine (MRM) and led to improved functioning in women with episodic migraine.

Major finding: Across months 4 through 6, galcanezumab vs placebo led to greater mean reduction in the monthly migraine headache days (MHD; least squares mean change from baseline [Δ] −5.1 vs −3.2), monthly perimenstrual MHD (Δ −0.75 vs −0.49), non-perimenstrual MHD (Δ −4.6 vs −2.8), and greater improvement in Role Function-Restrictive domain scores of the Migraine-Specific Quality of Life Questionnaire (Δ 30.9 vs 22.3 points; all P < .001).

Study details: This post hoc analysis of the EVOLVE-1 and EVOLVE-2 trials included 1133 women with episodic migraine who received either 120 mg galcanezumab per month or placebo, of whom 40.8% met the criteria for MRM.

Disclosures: This study was sponsored by Eli Lilly and Company. Four authors declared being current or former employees and stockowners of Eli Lilly and Company. Two authors declared receiving consulting honoraria from various sources including Eli Lilly.

Source: MacGregor EA et al. Effect of galcanezumab in women with episodic migraine meeting criteria for menstrually related migraine: A post hoc analysis of EVOLVE-1 and EVOLVE-2. Headache. 2023 (Nov 28). doi: 10.1111/head.14652

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Fremanezumab offers a safe and effective long-term treatment option for drug-resistant migraine

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Key clinical point: Monthly fremanezumab appeared to be effective and well-tolerated for ≤ 12 months in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) and multiple failures to previous preventive treatments.

Major finding: At 12 months of fremanezumab treatment, the monthly headache days (MHD) were reduced significantly (median reduction −9.0; P < .001), with 76.5% of patients achieving ≥ 50% response rate. Acute medication use, disability scores, and the percentage of patients with medication overuse reduced significantly from baseline (all P < .001). No severe treatment-related adverse events were reported.

Study details: Findings are from a prospective multicenter long-term study including 83 patients with HFEM (n = 16) or CM (n = 67) and multiple preventive treatment failures who received monthly fremanezumab.

Disclosures: This study was funded by Università degli Studi di Firenze, Italy, within the CRUI-CARE Agreement. Several authors declared receiving travel or research grants, personal fees as speakers or advisors, or honoraria for scientific presentations from various sources.

Source: Caponnetto V et al for The Italian Headache Registry (RICe) Study Group. Long-term treatment over 52 weeks with monthly fremanezumab in drug-resistant migraine: A prospective multicenter cohort study. CNS Drugs. 2023;37:1069-1080 (Nov 24). doi: 10.1007/s40263-023-01050-3

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Key clinical point: Monthly fremanezumab appeared to be effective and well-tolerated for ≤ 12 months in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) and multiple failures to previous preventive treatments.

Major finding: At 12 months of fremanezumab treatment, the monthly headache days (MHD) were reduced significantly (median reduction −9.0; P < .001), with 76.5% of patients achieving ≥ 50% response rate. Acute medication use, disability scores, and the percentage of patients with medication overuse reduced significantly from baseline (all P < .001). No severe treatment-related adverse events were reported.

Study details: Findings are from a prospective multicenter long-term study including 83 patients with HFEM (n = 16) or CM (n = 67) and multiple preventive treatment failures who received monthly fremanezumab.

Disclosures: This study was funded by Università degli Studi di Firenze, Italy, within the CRUI-CARE Agreement. Several authors declared receiving travel or research grants, personal fees as speakers or advisors, or honoraria for scientific presentations from various sources.

Source: Caponnetto V et al for The Italian Headache Registry (RICe) Study Group. Long-term treatment over 52 weeks with monthly fremanezumab in drug-resistant migraine: A prospective multicenter cohort study. CNS Drugs. 2023;37:1069-1080 (Nov 24). doi: 10.1007/s40263-023-01050-3

Key clinical point: Monthly fremanezumab appeared to be effective and well-tolerated for ≤ 12 months in patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) and multiple failures to previous preventive treatments.

Major finding: At 12 months of fremanezumab treatment, the monthly headache days (MHD) were reduced significantly (median reduction −9.0; P < .001), with 76.5% of patients achieving ≥ 50% response rate. Acute medication use, disability scores, and the percentage of patients with medication overuse reduced significantly from baseline (all P < .001). No severe treatment-related adverse events were reported.

Study details: Findings are from a prospective multicenter long-term study including 83 patients with HFEM (n = 16) or CM (n = 67) and multiple preventive treatment failures who received monthly fremanezumab.

Disclosures: This study was funded by Università degli Studi di Firenze, Italy, within the CRUI-CARE Agreement. Several authors declared receiving travel or research grants, personal fees as speakers or advisors, or honoraria for scientific presentations from various sources.

Source: Caponnetto V et al for The Italian Headache Registry (RICe) Study Group. Long-term treatment over 52 weeks with monthly fremanezumab in drug-resistant migraine: A prospective multicenter cohort study. CNS Drugs. 2023;37:1069-1080 (Nov 24). doi: 10.1007/s40263-023-01050-3

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Fremanezumab is effective and safe for migraine prevention under real-world conditions

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Key clinical point: The interim analysis of this real-world study confirmed the effectiveness and safety of fremanezumab for the prevention of both chronic migraine (CM) and episodic migraine (EM) attacks.

Major finding: The majority of patients (55.9%) with migraine achieved ≥50% reduction in monthly migraine days (MMD) during 6 months after fremanezumab initiation, with 69.4% and 51.9% of participants with EM and CM, respectively, achieving ≥50% MMD reduction. Very few patients (2.2%) discontinued treatment due to adverse events.

Study details: This interim analysis of the pan-European Real Life study, an ongoing phase 4 study, included 574 patients with EM (25.8%) or CM (74.2%) who initiated fremanezumab on a monthly or quarterly basis.

Disclosures: This study was funded by Teva Pharmaceuticals. Four authors declared being current or former employees or shareholders of Teva Pharmaceuticals. Other authors declared receiving personal fees, research grants, travel grants, honoraria, or research support from or having other ties with various sources, including Teva.

Source: Ashina M et al. Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study. Cephalalgia. 2023;43(11):3331024231214987 (Nov 21). doi: 10.1177/03331024231214987

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Key clinical point: The interim analysis of this real-world study confirmed the effectiveness and safety of fremanezumab for the prevention of both chronic migraine (CM) and episodic migraine (EM) attacks.

Major finding: The majority of patients (55.9%) with migraine achieved ≥50% reduction in monthly migraine days (MMD) during 6 months after fremanezumab initiation, with 69.4% and 51.9% of participants with EM and CM, respectively, achieving ≥50% MMD reduction. Very few patients (2.2%) discontinued treatment due to adverse events.

Study details: This interim analysis of the pan-European Real Life study, an ongoing phase 4 study, included 574 patients with EM (25.8%) or CM (74.2%) who initiated fremanezumab on a monthly or quarterly basis.

Disclosures: This study was funded by Teva Pharmaceuticals. Four authors declared being current or former employees or shareholders of Teva Pharmaceuticals. Other authors declared receiving personal fees, research grants, travel grants, honoraria, or research support from or having other ties with various sources, including Teva.

Source: Ashina M et al. Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study. Cephalalgia. 2023;43(11):3331024231214987 (Nov 21). doi: 10.1177/03331024231214987

Key clinical point: The interim analysis of this real-world study confirmed the effectiveness and safety of fremanezumab for the prevention of both chronic migraine (CM) and episodic migraine (EM) attacks.

Major finding: The majority of patients (55.9%) with migraine achieved ≥50% reduction in monthly migraine days (MMD) during 6 months after fremanezumab initiation, with 69.4% and 51.9% of participants with EM and CM, respectively, achieving ≥50% MMD reduction. Very few patients (2.2%) discontinued treatment due to adverse events.

Study details: This interim analysis of the pan-European Real Life study, an ongoing phase 4 study, included 574 patients with EM (25.8%) or CM (74.2%) who initiated fremanezumab on a monthly or quarterly basis.

Disclosures: This study was funded by Teva Pharmaceuticals. Four authors declared being current or former employees or shareholders of Teva Pharmaceuticals. Other authors declared receiving personal fees, research grants, travel grants, honoraria, or research support from or having other ties with various sources, including Teva.

Source: Ashina M et al. Real-world effectiveness of fremanezumab for the preventive treatment of migraine: Interim analysis of the pan-European, prospective, observational, phase 4 PEARL study. Cephalalgia. 2023;43(11):3331024231214987 (Nov 21). doi: 10.1177/03331024231214987

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Sustained migraine prevention with eptinezumab in initial non-responders

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Key clinical point: Eptinezumab vs placebo reduced the monthly migraine days by ≥30% in a significantly higher proportion of patients with migraine during the first infusion (weeks 1-12), with further improvements in migraine response following the second infusion (weeks 13-24).

Major finding: A significantly higher proportion of patients receiving 100 mg and 300 mg eptinezumab vs placebo achieved ≥30% reduction in monthly migraine days during weeks 1-12 (65.9% and 71.0% vs 36.9%, respectively; P < .0001) and weeks 13-24 (70.4% and 74.5% vs 43.1%, respectively; P < .0001).

Study details: This post hoc analysis of the DELIVER trial included 890 patients with migraine who had experienced 2-4 prior preventive treatment failures and were randomly assigned to receive 100 mg or 300 mg eptinezumab or placebo every 12 weeks.

Disclosures: This study was funded by H. Lundbeck A/S. Three authors declared being full-time employees of H. Lundbeck A/S or one of its subsidiary companies. Other authors declared having ties with various sources including H. Lundbeck A/S.

Source: Ashina M et al. Responder rates with eptinezumab over 24 weeks in patients with prior preventive migraine treatment failures: Post hoc analysis of the DELIVER randomized clinical trial. Eur J Neurol. 2023 (Nov 13). doi: 10.1111/ene.16131

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Key clinical point: Eptinezumab vs placebo reduced the monthly migraine days by ≥30% in a significantly higher proportion of patients with migraine during the first infusion (weeks 1-12), with further improvements in migraine response following the second infusion (weeks 13-24).

Major finding: A significantly higher proportion of patients receiving 100 mg and 300 mg eptinezumab vs placebo achieved ≥30% reduction in monthly migraine days during weeks 1-12 (65.9% and 71.0% vs 36.9%, respectively; P < .0001) and weeks 13-24 (70.4% and 74.5% vs 43.1%, respectively; P < .0001).

Study details: This post hoc analysis of the DELIVER trial included 890 patients with migraine who had experienced 2-4 prior preventive treatment failures and were randomly assigned to receive 100 mg or 300 mg eptinezumab or placebo every 12 weeks.

Disclosures: This study was funded by H. Lundbeck A/S. Three authors declared being full-time employees of H. Lundbeck A/S or one of its subsidiary companies. Other authors declared having ties with various sources including H. Lundbeck A/S.

Source: Ashina M et al. Responder rates with eptinezumab over 24 weeks in patients with prior preventive migraine treatment failures: Post hoc analysis of the DELIVER randomized clinical trial. Eur J Neurol. 2023 (Nov 13). doi: 10.1111/ene.16131

Key clinical point: Eptinezumab vs placebo reduced the monthly migraine days by ≥30% in a significantly higher proportion of patients with migraine during the first infusion (weeks 1-12), with further improvements in migraine response following the second infusion (weeks 13-24).

Major finding: A significantly higher proportion of patients receiving 100 mg and 300 mg eptinezumab vs placebo achieved ≥30% reduction in monthly migraine days during weeks 1-12 (65.9% and 71.0% vs 36.9%, respectively; P < .0001) and weeks 13-24 (70.4% and 74.5% vs 43.1%, respectively; P < .0001).

Study details: This post hoc analysis of the DELIVER trial included 890 patients with migraine who had experienced 2-4 prior preventive treatment failures and were randomly assigned to receive 100 mg or 300 mg eptinezumab or placebo every 12 weeks.

Disclosures: This study was funded by H. Lundbeck A/S. Three authors declared being full-time employees of H. Lundbeck A/S or one of its subsidiary companies. Other authors declared having ties with various sources including H. Lundbeck A/S.

Source: Ashina M et al. Responder rates with eptinezumab over 24 weeks in patients with prior preventive migraine treatment failures: Post hoc analysis of the DELIVER randomized clinical trial. Eur J Neurol. 2023 (Nov 13). doi: 10.1111/ene.16131

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Ubrogepant effective and safe for migraine treatment during prodrome

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Key clinical point: When taken during the prodrome, ubrogepant was more effective than placebo in reducing headaches in patients with a ≥1-year history of migraine and had a tolerable safety profile.

Major finding: A significantly higher proportion of patients reported the absence of moderate or severe headaches within 24 hours of receiving ubrogepant vs placebo (46% vs 29%; odds ratio 2.09; P < .0001). Nausea, fatigue, dizziness, and somnolence were reported by ≤5% of patients receiving ubrogepant.

Study details: The PRODROME trial included 518 patients with migraine who were randomly assigned to receive placebo followed by 100 mg ubrogepant to treat the first and second qualifying prodrome events, respectively, or 100 mg ubrogepant followed by placebo to treat the first and second qualifying prodrome events, respectively.

Disclosures: This study was funded by AbbVie. Six authors declared being current or former employees of or holding stocks in AbbVie. Other authors declared having ties with various sources including AbbVie.

Source: Dodick DW et al. Ubrogepant for the treatment of migraine attacks during the prodrome: A phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023 (Nov 15). doi: 10.1016/S0140-6736(23)01683-5

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Key clinical point: When taken during the prodrome, ubrogepant was more effective than placebo in reducing headaches in patients with a ≥1-year history of migraine and had a tolerable safety profile.

Major finding: A significantly higher proportion of patients reported the absence of moderate or severe headaches within 24 hours of receiving ubrogepant vs placebo (46% vs 29%; odds ratio 2.09; P < .0001). Nausea, fatigue, dizziness, and somnolence were reported by ≤5% of patients receiving ubrogepant.

Study details: The PRODROME trial included 518 patients with migraine who were randomly assigned to receive placebo followed by 100 mg ubrogepant to treat the first and second qualifying prodrome events, respectively, or 100 mg ubrogepant followed by placebo to treat the first and second qualifying prodrome events, respectively.

Disclosures: This study was funded by AbbVie. Six authors declared being current or former employees of or holding stocks in AbbVie. Other authors declared having ties with various sources including AbbVie.

Source: Dodick DW et al. Ubrogepant for the treatment of migraine attacks during the prodrome: A phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023 (Nov 15). doi: 10.1016/S0140-6736(23)01683-5

Key clinical point: When taken during the prodrome, ubrogepant was more effective than placebo in reducing headaches in patients with a ≥1-year history of migraine and had a tolerable safety profile.

Major finding: A significantly higher proportion of patients reported the absence of moderate or severe headaches within 24 hours of receiving ubrogepant vs placebo (46% vs 29%; odds ratio 2.09; P < .0001). Nausea, fatigue, dizziness, and somnolence were reported by ≤5% of patients receiving ubrogepant.

Study details: The PRODROME trial included 518 patients with migraine who were randomly assigned to receive placebo followed by 100 mg ubrogepant to treat the first and second qualifying prodrome events, respectively, or 100 mg ubrogepant followed by placebo to treat the first and second qualifying prodrome events, respectively.

Disclosures: This study was funded by AbbVie. Six authors declared being current or former employees of or holding stocks in AbbVie. Other authors declared having ties with various sources including AbbVie.

Source: Dodick DW et al. Ubrogepant for the treatment of migraine attacks during the prodrome: A phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023 (Nov 15). doi: 10.1016/S0140-6736(23)01683-5

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CGRP in migraine prodrome can stop headache, reduce severity

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BARCELONA, SPAIN — For the first time, new research shows that taking a specific class of migraine medication during the prodromal phase reduces the development and severity of the subsequent headache. In the randomized, placebo-controlled crossover PRODROME trial, treatment with ubrogepant (Ubrelvy) 100 mg, one of the new CGRP receptor antagonists, during the prodrome prevented the development of moderate/severe headache at both 24 hours and 48 hours post-dose. The medication also reduced headache of any intensity within 24 hours and functional disability compared with placebo.

“This represents a totally different way of treating a migraine attack – to treat it before the headache starts. This is a paradigm shift in the way we approach the acute treatment of migraine,” study investigator Peter Goadsby, MBBS, MD, PhD, professor of neurology at Kings College London, UK, said in an interview.

The findings were presented at 17th European Headache Congress (EHC) and were also recently published online in The Lancet
 

A New Way to Manage Migraine?

The prodrome is usually the earliest phase of a migraine attack and is believed to be experienced by the vast majority of patients with migraine. It consists of various symptoms, including sensitivity to light, fatigue, mood changes, cognitive dysfunction, craving certain foods, and neck pain, which can occur several hours or days before onset.

Dr. Goadsby notes that, at present, there isn’t very much a patient can do about the prodrome. 

“We advise patients if they feel an attack is coming not to do anything that might make it worse and make sure they have their acute treatment available for when the headache phase starts. So, we just advise people to prepare for the attack rather than doing anything specific to stop it. But with new data from this study, we now have something that can be done. Patients have an option,” he said.

Dr. Goadsby explained that currently patients are not encouraged to use acute migraine medications such as triptans in the prodrome phase. 

“There is actually no evidence that taking a triptan during the prodromal phase works. The advice is to take a triptan as soon as the headache starts, but not before the headache starts.”

He noted that there is also the problem of medication overuse that is seen with triptans, and most other medications used to treat acute migraine, which leads to medication overuse headache, “so we don’t like to encourage patients to increase the frequency of taking triptans for this reason.” 

But ubrogepant and other members of the “gepant” class do not seem to have the propensity for medication overuse problems. “Rather, the more a patient takes the less likely they are to get a headache as these drugs also have a preventative effect,” Dr. Goadsby said. 

Major Reduction in Severity

The PRODROME trial was conducted at 75 sites in the United States in 518 patients who had at least a 1-year history of migraine with or without aura and a history of two to eight migraine attacks per month with moderate to severe headache in each of the 3 months before study entry. 

Participants underwent a rigorous screening period during which they were required to show that they could identify prodromal symptoms that were reliably followed by migraine headache within 1-6 hours.

They were randomly assigned to receive either placebo to treat the first qualifying prodrome event and ubrogepant 100 mg to treat the second qualifying prodrome event or vice versa, with instructions to take the study drug at the onset of the prodrome event.

Efficacy assessments during the double-blind treatment period were recorded by the participant in an electronic diary. On identifying a qualifying prodrome, the patient recorded prodromal symptoms, and was then required to report the absence or presence of a headache at regular intervals up to 48 hours after the study drug dose. If a headache was reported, participants rated the intensity as mild, moderate, or severe and reported whether rescue medication was taken to treat it.

The primary endpoint was absence of moderate or severe intensity headache within 24 hours after study-drug dose. This occurred after 46% of 418 qualifying prodrome events that had been treated with ubrogepant and after 29% of 423 qualifying prodrome events that had been treated with placebo (odds ratio, 2.09; 95% CI, 1.63 - 2.69; P < .0001). 

“The incidence of moderate to severe headache was almost halved when ubrogepant was taken in the prodrome,” Dr. Goadsby reported. 

Ubrogepant also showed similar impressive results for the secondary endpoints in the absence of moderate to severe headache within 48 hours post-dose and the absence of any headache of any intensity at 24 hours. 

Little to No Disability

The researchers also evaluated functional ability, and more participants reported “no disability or able to function normally” during the 24 hours after treatment with ubrogepant than after placebo (OR, 1.66; P < .0001).

Other findings showed that the prodromal symptoms themselves, such as light sensitivity and cognitive dysfunction, were also reduced with ubrogepant. 

Dr. Goadsby said he was pleased but not surprised by the results, as the “gepant” class of drugs are used in both the acute treatment of migraine and as preventive agents, although different agents have been approved for different indications in this regard.

“The ‘gepants’ are a class of medication that can be used in almost any way in migraine — to treat an acute migraine headache, to prevent migraine if taken chronically, and now we see that they can also stop a migraine from developing if taken during the initial prodromal phase. That’s unique for a migraine medication,” he said. 

While the current study was conducted with ubrogepant, Dr. Goadsby suspects that any of the “gepants” would probably have a similar effect. 

He noted that the prodromal phase of migraine has only just started to be explored, with functional imaging studies showing that structural brain changes occur during this phase. 

Dr. Goadsby said the current study opens up a whole new area of interest, emphasizing the clinical value of identifying the prodrome in individuals with migraine, better characterizing the symptomology of the prodrome and understanding more about how to treat it.

“It’s the ultimate way of treating migraine early, and by taking this type of medication in the prodromal phase, patients may be able to stop having pain. That’s quite an implication,” he concluded. 

The PRODROME study was funded by AbbVie. Dr. Goadsby reports personal fees from AbbVie.

A version of this article appeared on Medscape.com.

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BARCELONA, SPAIN — For the first time, new research shows that taking a specific class of migraine medication during the prodromal phase reduces the development and severity of the subsequent headache. In the randomized, placebo-controlled crossover PRODROME trial, treatment with ubrogepant (Ubrelvy) 100 mg, one of the new CGRP receptor antagonists, during the prodrome prevented the development of moderate/severe headache at both 24 hours and 48 hours post-dose. The medication also reduced headache of any intensity within 24 hours and functional disability compared with placebo.

“This represents a totally different way of treating a migraine attack – to treat it before the headache starts. This is a paradigm shift in the way we approach the acute treatment of migraine,” study investigator Peter Goadsby, MBBS, MD, PhD, professor of neurology at Kings College London, UK, said in an interview.

The findings were presented at 17th European Headache Congress (EHC) and were also recently published online in The Lancet
 

A New Way to Manage Migraine?

The prodrome is usually the earliest phase of a migraine attack and is believed to be experienced by the vast majority of patients with migraine. It consists of various symptoms, including sensitivity to light, fatigue, mood changes, cognitive dysfunction, craving certain foods, and neck pain, which can occur several hours or days before onset.

Dr. Goadsby notes that, at present, there isn’t very much a patient can do about the prodrome. 

“We advise patients if they feel an attack is coming not to do anything that might make it worse and make sure they have their acute treatment available for when the headache phase starts. So, we just advise people to prepare for the attack rather than doing anything specific to stop it. But with new data from this study, we now have something that can be done. Patients have an option,” he said.

Dr. Goadsby explained that currently patients are not encouraged to use acute migraine medications such as triptans in the prodrome phase. 

“There is actually no evidence that taking a triptan during the prodromal phase works. The advice is to take a triptan as soon as the headache starts, but not before the headache starts.”

He noted that there is also the problem of medication overuse that is seen with triptans, and most other medications used to treat acute migraine, which leads to medication overuse headache, “so we don’t like to encourage patients to increase the frequency of taking triptans for this reason.” 

But ubrogepant and other members of the “gepant” class do not seem to have the propensity for medication overuse problems. “Rather, the more a patient takes the less likely they are to get a headache as these drugs also have a preventative effect,” Dr. Goadsby said. 

Major Reduction in Severity

The PRODROME trial was conducted at 75 sites in the United States in 518 patients who had at least a 1-year history of migraine with or without aura and a history of two to eight migraine attacks per month with moderate to severe headache in each of the 3 months before study entry. 

Participants underwent a rigorous screening period during which they were required to show that they could identify prodromal symptoms that were reliably followed by migraine headache within 1-6 hours.

They were randomly assigned to receive either placebo to treat the first qualifying prodrome event and ubrogepant 100 mg to treat the second qualifying prodrome event or vice versa, with instructions to take the study drug at the onset of the prodrome event.

Efficacy assessments during the double-blind treatment period were recorded by the participant in an electronic diary. On identifying a qualifying prodrome, the patient recorded prodromal symptoms, and was then required to report the absence or presence of a headache at regular intervals up to 48 hours after the study drug dose. If a headache was reported, participants rated the intensity as mild, moderate, or severe and reported whether rescue medication was taken to treat it.

The primary endpoint was absence of moderate or severe intensity headache within 24 hours after study-drug dose. This occurred after 46% of 418 qualifying prodrome events that had been treated with ubrogepant and after 29% of 423 qualifying prodrome events that had been treated with placebo (odds ratio, 2.09; 95% CI, 1.63 - 2.69; P < .0001). 

“The incidence of moderate to severe headache was almost halved when ubrogepant was taken in the prodrome,” Dr. Goadsby reported. 

Ubrogepant also showed similar impressive results for the secondary endpoints in the absence of moderate to severe headache within 48 hours post-dose and the absence of any headache of any intensity at 24 hours. 

Little to No Disability

The researchers also evaluated functional ability, and more participants reported “no disability or able to function normally” during the 24 hours after treatment with ubrogepant than after placebo (OR, 1.66; P < .0001).

Other findings showed that the prodromal symptoms themselves, such as light sensitivity and cognitive dysfunction, were also reduced with ubrogepant. 

Dr. Goadsby said he was pleased but not surprised by the results, as the “gepant” class of drugs are used in both the acute treatment of migraine and as preventive agents, although different agents have been approved for different indications in this regard.

“The ‘gepants’ are a class of medication that can be used in almost any way in migraine — to treat an acute migraine headache, to prevent migraine if taken chronically, and now we see that they can also stop a migraine from developing if taken during the initial prodromal phase. That’s unique for a migraine medication,” he said. 

While the current study was conducted with ubrogepant, Dr. Goadsby suspects that any of the “gepants” would probably have a similar effect. 

He noted that the prodromal phase of migraine has only just started to be explored, with functional imaging studies showing that structural brain changes occur during this phase. 

Dr. Goadsby said the current study opens up a whole new area of interest, emphasizing the clinical value of identifying the prodrome in individuals with migraine, better characterizing the symptomology of the prodrome and understanding more about how to treat it.

“It’s the ultimate way of treating migraine early, and by taking this type of medication in the prodromal phase, patients may be able to stop having pain. That’s quite an implication,” he concluded. 

The PRODROME study was funded by AbbVie. Dr. Goadsby reports personal fees from AbbVie.

A version of this article appeared on Medscape.com.

BARCELONA, SPAIN — For the first time, new research shows that taking a specific class of migraine medication during the prodromal phase reduces the development and severity of the subsequent headache. In the randomized, placebo-controlled crossover PRODROME trial, treatment with ubrogepant (Ubrelvy) 100 mg, one of the new CGRP receptor antagonists, during the prodrome prevented the development of moderate/severe headache at both 24 hours and 48 hours post-dose. The medication also reduced headache of any intensity within 24 hours and functional disability compared with placebo.

“This represents a totally different way of treating a migraine attack – to treat it before the headache starts. This is a paradigm shift in the way we approach the acute treatment of migraine,” study investigator Peter Goadsby, MBBS, MD, PhD, professor of neurology at Kings College London, UK, said in an interview.

The findings were presented at 17th European Headache Congress (EHC) and were also recently published online in The Lancet
 

A New Way to Manage Migraine?

The prodrome is usually the earliest phase of a migraine attack and is believed to be experienced by the vast majority of patients with migraine. It consists of various symptoms, including sensitivity to light, fatigue, mood changes, cognitive dysfunction, craving certain foods, and neck pain, which can occur several hours or days before onset.

Dr. Goadsby notes that, at present, there isn’t very much a patient can do about the prodrome. 

“We advise patients if they feel an attack is coming not to do anything that might make it worse and make sure they have their acute treatment available for when the headache phase starts. So, we just advise people to prepare for the attack rather than doing anything specific to stop it. But with new data from this study, we now have something that can be done. Patients have an option,” he said.

Dr. Goadsby explained that currently patients are not encouraged to use acute migraine medications such as triptans in the prodrome phase. 

“There is actually no evidence that taking a triptan during the prodromal phase works. The advice is to take a triptan as soon as the headache starts, but not before the headache starts.”

He noted that there is also the problem of medication overuse that is seen with triptans, and most other medications used to treat acute migraine, which leads to medication overuse headache, “so we don’t like to encourage patients to increase the frequency of taking triptans for this reason.” 

But ubrogepant and other members of the “gepant” class do not seem to have the propensity for medication overuse problems. “Rather, the more a patient takes the less likely they are to get a headache as these drugs also have a preventative effect,” Dr. Goadsby said. 

Major Reduction in Severity

The PRODROME trial was conducted at 75 sites in the United States in 518 patients who had at least a 1-year history of migraine with or without aura and a history of two to eight migraine attacks per month with moderate to severe headache in each of the 3 months before study entry. 

Participants underwent a rigorous screening period during which they were required to show that they could identify prodromal symptoms that were reliably followed by migraine headache within 1-6 hours.

They were randomly assigned to receive either placebo to treat the first qualifying prodrome event and ubrogepant 100 mg to treat the second qualifying prodrome event or vice versa, with instructions to take the study drug at the onset of the prodrome event.

Efficacy assessments during the double-blind treatment period were recorded by the participant in an electronic diary. On identifying a qualifying prodrome, the patient recorded prodromal symptoms, and was then required to report the absence or presence of a headache at regular intervals up to 48 hours after the study drug dose. If a headache was reported, participants rated the intensity as mild, moderate, or severe and reported whether rescue medication was taken to treat it.

The primary endpoint was absence of moderate or severe intensity headache within 24 hours after study-drug dose. This occurred after 46% of 418 qualifying prodrome events that had been treated with ubrogepant and after 29% of 423 qualifying prodrome events that had been treated with placebo (odds ratio, 2.09; 95% CI, 1.63 - 2.69; P < .0001). 

“The incidence of moderate to severe headache was almost halved when ubrogepant was taken in the prodrome,” Dr. Goadsby reported. 

Ubrogepant also showed similar impressive results for the secondary endpoints in the absence of moderate to severe headache within 48 hours post-dose and the absence of any headache of any intensity at 24 hours. 

Little to No Disability

The researchers also evaluated functional ability, and more participants reported “no disability or able to function normally” during the 24 hours after treatment with ubrogepant than after placebo (OR, 1.66; P < .0001).

Other findings showed that the prodromal symptoms themselves, such as light sensitivity and cognitive dysfunction, were also reduced with ubrogepant. 

Dr. Goadsby said he was pleased but not surprised by the results, as the “gepant” class of drugs are used in both the acute treatment of migraine and as preventive agents, although different agents have been approved for different indications in this regard.

“The ‘gepants’ are a class of medication that can be used in almost any way in migraine — to treat an acute migraine headache, to prevent migraine if taken chronically, and now we see that they can also stop a migraine from developing if taken during the initial prodromal phase. That’s unique for a migraine medication,” he said. 

While the current study was conducted with ubrogepant, Dr. Goadsby suspects that any of the “gepants” would probably have a similar effect. 

He noted that the prodromal phase of migraine has only just started to be explored, with functional imaging studies showing that structural brain changes occur during this phase. 

Dr. Goadsby said the current study opens up a whole new area of interest, emphasizing the clinical value of identifying the prodrome in individuals with migraine, better characterizing the symptomology of the prodrome and understanding more about how to treat it.

“It’s the ultimate way of treating migraine early, and by taking this type of medication in the prodromal phase, patients may be able to stop having pain. That’s quite an implication,” he concluded. 

The PRODROME study was funded by AbbVie. Dr. Goadsby reports personal fees from AbbVie.

A version of this article appeared on Medscape.com.

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Is migraine really a female disorder?

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Tue, 12/19/2023 - 06:47

BARCELONA, SPAIN — Migraine is widely considered a predominantly female disorder. Its frequency, duration, and severity tend to be higher in women, and women are also more likely than men to receive a migraine diagnosis. However, gender expectations, differences in the likelihood of self-reporting, and problems with how migraine is classified make it difficult to estimate its true prevalence in men and women. 

Epidemiologists and migraine specialists discussed these apparent sex differences and the difficulties in obtaining accurate estimates of migraine prevalence in a debate session at the 17th European Headache Congress in Barcelona. 

Different Symptoms

Headache disorders are estimated to affect 50% of the general population ; tension-type headache and migraine are the two most common. According to epidemiologic studies, migraine is more prevalent in women, with a female-to-male ratio of 3:1. There are numerous studies of why this might be, most of which focus largely on female-related factors, such as hormones and the menstrual cycle

“Despite many years of research, there isn’t one clear factor explaining this substantial difference between women and men,” said Tobias Kurth of Charité – Universitätsmedizin Berlin, Germany. “So the question is: Are we missing something else?”

One factor in these perceived sex differences in migraine is that women seem to report their migraines differently from men, and they also have different symptoms. For example, women are more likely than men to report severe pain, and their migraine attacks are more often accompanied by photophobia, phonophobia, and nausea, whereas men’s migraines are more often accompanied by aura. 

“By favoring female symptoms, the classification system may not be picking up male symptoms because they’re not being classified in the right way,” Dr. Kurth said, with one consequence being that migraine is underdiagnosed in men. “Before trying to understand the biological and behavioral reasons for these sex differences, we first need to consider these methodological challenges that we all apply knowingly or unknowingly.” 

Christian Lampl, professor of neurology at Konventhospital der Barmherzigen Brüder Linz, Austria, and president of the European Headache Federation, said in an interview, “I’m convinced that this 3:1 ratio which has been stated for decades is wrong, but we still don’t have the data. The criteria we have [for classifying migraine] are useful for clinical trials, but they are useless for determining the male-to-female ratio. 

“We need a new definition of migraine,” he added. “Migraine is an episode, not an attack. Attacks have a sudden onset, and migraine onset is not sudden — it is an episode with a headache attack.” 

Inadequate Menopause Services

Professor Anne MacGregor of St. Bartholomew’s Hospital in London, United Kingdom, specializes in migraine and women’s health. She presented data showing that migraine is underdiagnosed in women; one reason being that the disorder receives inadequate attention from healthcare professionals at specialist menopause services. 

Menopause is associated with an increased prevalence of migraine, but women do not discuss headache symptoms at specialist menopause services, Dr. MacGregor said. 

She then described unpublished results from a survey of 117 women attending the specialist menopause service at St. Bartholomew’s Hospital. Among the respondents, 34% reported experiencing episodic migraine and an additional 8% reported having chronic migraine. 

“Within this population of women who were not reporting headache as a symptom [to the menopause service until asked in the survey], 42% of them were positive for a diagnosis of migraine,” said Dr. MacGregor. “They were mostly relying on prescribed paracetamol and codeine, or buying it over the counter, and only 22% of them were receiving triptans. 

“They are clearly being undertreated,” she added. “Part of this issue is that they didn’t spontaneously report headache as a menopause symptom, so they weren’t consulting for headache to their primary care physicians.” 

Correct diagnosis by a consultant is a prerequisite for receiving appropriate migraine treatment. Yet, according to a US study published in 2012, only 45.5% of women with episodic migraine consulted a prescribing healthcare professional. Of those who consulted, 89% were diagnosed correctly, and only 68% of those received the appropriate treatment.

A larger, more recent study confirmed that there is a massive unmet need for improving care in this patient population. The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, which analyzed data from nearly 90,000 participants, showed that just 4.8% of people with chronic migraine received consultation, correct diagnosis, and treatment, with 89% of women with chronic migraine left undiagnosed. 

The OVERCOME Study further revealed that although many people with migraine were repeat consulters, they were consulting their physicians for other health problems. 

“This makes it very clear that people in other specialties need to be more aware about picking up and diagnosing headache,” said MacGregor. “That’s where the real need is in managing headache. We have the treatments, but if the patients can’t access them, they’re not much good to them.”

A version of this article appeared on Medscape.com.

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BARCELONA, SPAIN — Migraine is widely considered a predominantly female disorder. Its frequency, duration, and severity tend to be higher in women, and women are also more likely than men to receive a migraine diagnosis. However, gender expectations, differences in the likelihood of self-reporting, and problems with how migraine is classified make it difficult to estimate its true prevalence in men and women. 

Epidemiologists and migraine specialists discussed these apparent sex differences and the difficulties in obtaining accurate estimates of migraine prevalence in a debate session at the 17th European Headache Congress in Barcelona. 

Different Symptoms

Headache disorders are estimated to affect 50% of the general population ; tension-type headache and migraine are the two most common. According to epidemiologic studies, migraine is more prevalent in women, with a female-to-male ratio of 3:1. There are numerous studies of why this might be, most of which focus largely on female-related factors, such as hormones and the menstrual cycle

“Despite many years of research, there isn’t one clear factor explaining this substantial difference between women and men,” said Tobias Kurth of Charité – Universitätsmedizin Berlin, Germany. “So the question is: Are we missing something else?”

One factor in these perceived sex differences in migraine is that women seem to report their migraines differently from men, and they also have different symptoms. For example, women are more likely than men to report severe pain, and their migraine attacks are more often accompanied by photophobia, phonophobia, and nausea, whereas men’s migraines are more often accompanied by aura. 

“By favoring female symptoms, the classification system may not be picking up male symptoms because they’re not being classified in the right way,” Dr. Kurth said, with one consequence being that migraine is underdiagnosed in men. “Before trying to understand the biological and behavioral reasons for these sex differences, we first need to consider these methodological challenges that we all apply knowingly or unknowingly.” 

Christian Lampl, professor of neurology at Konventhospital der Barmherzigen Brüder Linz, Austria, and president of the European Headache Federation, said in an interview, “I’m convinced that this 3:1 ratio which has been stated for decades is wrong, but we still don’t have the data. The criteria we have [for classifying migraine] are useful for clinical trials, but they are useless for determining the male-to-female ratio. 

“We need a new definition of migraine,” he added. “Migraine is an episode, not an attack. Attacks have a sudden onset, and migraine onset is not sudden — it is an episode with a headache attack.” 

Inadequate Menopause Services

Professor Anne MacGregor of St. Bartholomew’s Hospital in London, United Kingdom, specializes in migraine and women’s health. She presented data showing that migraine is underdiagnosed in women; one reason being that the disorder receives inadequate attention from healthcare professionals at specialist menopause services. 

Menopause is associated with an increased prevalence of migraine, but women do not discuss headache symptoms at specialist menopause services, Dr. MacGregor said. 

She then described unpublished results from a survey of 117 women attending the specialist menopause service at St. Bartholomew’s Hospital. Among the respondents, 34% reported experiencing episodic migraine and an additional 8% reported having chronic migraine. 

“Within this population of women who were not reporting headache as a symptom [to the menopause service until asked in the survey], 42% of them were positive for a diagnosis of migraine,” said Dr. MacGregor. “They were mostly relying on prescribed paracetamol and codeine, or buying it over the counter, and only 22% of them were receiving triptans. 

“They are clearly being undertreated,” she added. “Part of this issue is that they didn’t spontaneously report headache as a menopause symptom, so they weren’t consulting for headache to their primary care physicians.” 

Correct diagnosis by a consultant is a prerequisite for receiving appropriate migraine treatment. Yet, according to a US study published in 2012, only 45.5% of women with episodic migraine consulted a prescribing healthcare professional. Of those who consulted, 89% were diagnosed correctly, and only 68% of those received the appropriate treatment.

A larger, more recent study confirmed that there is a massive unmet need for improving care in this patient population. The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, which analyzed data from nearly 90,000 participants, showed that just 4.8% of people with chronic migraine received consultation, correct diagnosis, and treatment, with 89% of women with chronic migraine left undiagnosed. 

The OVERCOME Study further revealed that although many people with migraine were repeat consulters, they were consulting their physicians for other health problems. 

“This makes it very clear that people in other specialties need to be more aware about picking up and diagnosing headache,” said MacGregor. “That’s where the real need is in managing headache. We have the treatments, but if the patients can’t access them, they’re not much good to them.”

A version of this article appeared on Medscape.com.

BARCELONA, SPAIN — Migraine is widely considered a predominantly female disorder. Its frequency, duration, and severity tend to be higher in women, and women are also more likely than men to receive a migraine diagnosis. However, gender expectations, differences in the likelihood of self-reporting, and problems with how migraine is classified make it difficult to estimate its true prevalence in men and women. 

Epidemiologists and migraine specialists discussed these apparent sex differences and the difficulties in obtaining accurate estimates of migraine prevalence in a debate session at the 17th European Headache Congress in Barcelona. 

Different Symptoms

Headache disorders are estimated to affect 50% of the general population ; tension-type headache and migraine are the two most common. According to epidemiologic studies, migraine is more prevalent in women, with a female-to-male ratio of 3:1. There are numerous studies of why this might be, most of which focus largely on female-related factors, such as hormones and the menstrual cycle

“Despite many years of research, there isn’t one clear factor explaining this substantial difference between women and men,” said Tobias Kurth of Charité – Universitätsmedizin Berlin, Germany. “So the question is: Are we missing something else?”

One factor in these perceived sex differences in migraine is that women seem to report their migraines differently from men, and they also have different symptoms. For example, women are more likely than men to report severe pain, and their migraine attacks are more often accompanied by photophobia, phonophobia, and nausea, whereas men’s migraines are more often accompanied by aura. 

“By favoring female symptoms, the classification system may not be picking up male symptoms because they’re not being classified in the right way,” Dr. Kurth said, with one consequence being that migraine is underdiagnosed in men. “Before trying to understand the biological and behavioral reasons for these sex differences, we first need to consider these methodological challenges that we all apply knowingly or unknowingly.” 

Christian Lampl, professor of neurology at Konventhospital der Barmherzigen Brüder Linz, Austria, and president of the European Headache Federation, said in an interview, “I’m convinced that this 3:1 ratio which has been stated for decades is wrong, but we still don’t have the data. The criteria we have [for classifying migraine] are useful for clinical trials, but they are useless for determining the male-to-female ratio. 

“We need a new definition of migraine,” he added. “Migraine is an episode, not an attack. Attacks have a sudden onset, and migraine onset is not sudden — it is an episode with a headache attack.” 

Inadequate Menopause Services

Professor Anne MacGregor of St. Bartholomew’s Hospital in London, United Kingdom, specializes in migraine and women’s health. She presented data showing that migraine is underdiagnosed in women; one reason being that the disorder receives inadequate attention from healthcare professionals at specialist menopause services. 

Menopause is associated with an increased prevalence of migraine, but women do not discuss headache symptoms at specialist menopause services, Dr. MacGregor said. 

She then described unpublished results from a survey of 117 women attending the specialist menopause service at St. Bartholomew’s Hospital. Among the respondents, 34% reported experiencing episodic migraine and an additional 8% reported having chronic migraine. 

“Within this population of women who were not reporting headache as a symptom [to the menopause service until asked in the survey], 42% of them were positive for a diagnosis of migraine,” said Dr. MacGregor. “They were mostly relying on prescribed paracetamol and codeine, or buying it over the counter, and only 22% of them were receiving triptans. 

“They are clearly being undertreated,” she added. “Part of this issue is that they didn’t spontaneously report headache as a menopause symptom, so they weren’t consulting for headache to their primary care physicians.” 

Correct diagnosis by a consultant is a prerequisite for receiving appropriate migraine treatment. Yet, according to a US study published in 2012, only 45.5% of women with episodic migraine consulted a prescribing healthcare professional. Of those who consulted, 89% were diagnosed correctly, and only 68% of those received the appropriate treatment.

A larger, more recent study confirmed that there is a massive unmet need for improving care in this patient population. The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, which analyzed data from nearly 90,000 participants, showed that just 4.8% of people with chronic migraine received consultation, correct diagnosis, and treatment, with 89% of women with chronic migraine left undiagnosed. 

The OVERCOME Study further revealed that although many people with migraine were repeat consulters, they were consulting their physicians for other health problems. 

“This makes it very clear that people in other specialties need to be more aware about picking up and diagnosing headache,” said MacGregor. “That’s where the real need is in managing headache. We have the treatments, but if the patients can’t access them, they’re not much good to them.”

A version of this article appeared on Medscape.com.

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Commentary: CGRP Monoclonal Antibodies for Migraine, December 2023

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Wed, 12/20/2023 - 17:59
Dr Berk scans the journal, so you don't have to!

Depression is one of the most common comorbidities associated with migraine. Major depressive disorder is both a risk factor for chronic migraine and a condition that one is more likely to develop after being diagnosed with chronic migraine. The study by de Vries Lentsch and colleagues investigated the use of two of the calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) treatments — erenumab and fremanezumab — compared with a control group of patients with chronic migraine, with an eye on outcomes to measure depression. Of note, reduction in headache frequency (defined as reduction in monthly migraine days) was also investigated as an independent variable.

This was a single-center study performed at the University of Leiden Headache Center. It was not a randomized trial, but all patients were followed with an e-diary and Day 0 vs Day 90 questionnaires that tracked their headache frequency and severity as well as a number of metrics related to depression. Depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS) and the Center for Epidemiological Studies Depression Scale (CES-D). The Headache Impact Test (HIT-6) was used to follow headache-related impact and disability, and the Perceived Stress Scale (PSS) was used to measure the degree of stressful situations the patient was experiencing.

The baseline depression scales between the three groups were 70%, 60%, and 66%, respectively; there were similar baseline levels of migraine frequency and disability as well. Both intervention groups showed a significant decrease in the symptoms of depression, and having a greater level of depression was negatively associated with reduction in monthly migraine days after 3 months. Of note, logistic-regression analysis determined that the reduction in depressive symptoms was independent of the reduction in migraine frequency.

Nearly all headache care providers are faced with challenging situations on a daily basis; often this is due to the comorbidity of mood disorders and high-frequency migraine. A traditional approach has been to provide the patient with a migraine preventive medication in the antidepressant family, such as a tricyclic antidepressant or serotonin and norepinephrine reuptake inhibitor (SNRI). Although these can be helpful, they are less specific for migraine prevention. Many patients are also already taking antidepressant medications, and the addition of a migraine-preventive antidepressant would be contraindicated. This study broadens the possibilities for prevention in these complicated patients and shows that there is benefit in both migraine-related outcomes and markers for depression when using CGRP-based therapy.

The way headache medicine is practiced changed dramatically in 2018 with the advent of CGRP monoclonal antibody (mAb) treatments for migraine. These medications have allowed us to target migraine specifically, whereas all of the preventive medications for migraine prior to 2018 were developed for other conditions and only secondarily helped migraine. These include the antidepressant, antihypertensive, and antiepileptic classes of medications, as well as onabotulinum toxin A, which, although approved for migraine, is not targeting a migraine-specific factor. Moskatel and colleagues sought to better understand the changing patterns of prescribing the nonspecific, or "traditional," migraine preventive medications in light of the advent of CGRP treatment.

This was a retrospective cohort study using aggregated data from the Stanford headache center. The percentage of patients with chronic migraine who had been prescribed one of the 10 most prescribed oral preventive medications or onabotulinum toxin A, or any of the four CGRP mAb, were calculated relative to the total number of patients with chronic migraine who received a prescription for any medication from the clinic during the pre-CGRP mAb years of 2015-2017 and post-approval years of 2019-2021.

The Stanford (STARR) database was filtered, searching for patients living in a California ZIP code with a diagnosis of chronic migraine who were followed from 2015 to 2021. The 10 most common non-CGRP preventive medications were amitriptyline/nortriptyline, valproate, duloxetine, gabapentin, memantine, propranolol, venlafaxine, verapamil, and onabotulinumtoxinA.

Erenumab was noted to initially be the most prescribed CGRP monoclonal antibody medication, but this was overtaken by galcanezumab after the second quarter of 2020 and throughout 2021. There is a statistically significant decrease in the percentage of patients receiving any of the non-CGRP preventive medications since 2018. The most significant decreases were in the tricyclic antidepressant class, as well as valproate, duloxetine, memantine, and onabotulinum toxin A. There was no statistically significant change in venlafaxine or gabapentin prescriptions.

This study highlights the changing face of headache medicine, and having a new class of migraine-specific treatment has significantly affected prescribing patterns. Although there is a statistically significant decrease in the prescribing of these non–migraine-specific preventive medications, they are still often recommended due to step-therapy regulations from insurance formularies, or as part of a polypharmacy regimen that may be more beneficial for a patient. These medications do improve patient outcomes and will remain a mainstay in migraine treatment.

Nearly all patients with migraine are recommended an acute medication to treat migraine attacks abortively; some patients are also recommended preventive therapies if migraine frequency significantly affects their quality of life. The American Headache Society/American Academy of Neurology guidelines for prevention recommend the initiation of a preventive medication at a frequency of 4-5 headache days per month or approximately 1 per week. Lipton and colleagues sought to determine whether there were any efficacy concerns in combining a CGRP mAb for prevention with ubrogepant, an oral CGRP antagonist, for acute treatment.

This was a prospective, open-level observational study assessing pain relief, return to normal function, and treatment satisfaction with patients given 50 or 100 mg of ubrogepant while concomitantly being given a seizure or mAb medication. Patients were allowed to be taking onabotulinumtoxinA as well as a CGRP mAb. The patients in this study were asked to track their headache symptoms using the Migraine Buddy e-diary. Meaningful pain relief was defined as a rating of migraine-related pain with one of the following choices 4 hours after taking the medication: no pain, mild pain, moderate pain, or severe pain. Return to normal function was defined as whether the patient determined they were able to function normally relative to their baseline at specific times post intervention. This was based on a functional disability scale. Treatment satisfaction was determined on the basis of a seven-point rating scale for how satisfied the patient felt with the medication at the end of the trial period.

A total of 245 participants provided at least 30 days of data, with 44.5% of the patients taking erenumab, 35.1% taking galcanezumab, 18.0% taking fremanezumab, and 2.9% taking eptinezumab. Meaningful pain relief was achieved by 61.6% of patients at 2 hours and 80.4% of patients at 4 hours post dose for both the 50-mg and 100-mg dose of ubrogepant. Return to normal function was achieved by 34.7% of patients at 2 hours and 50.5% at 4 hours post dose as well. Patients reported a 72.7% satisfaction level with the medication.

When CGRP acute medications were first approved, there was concern about the use of a mAb together with an oral antagonist. It was thought that CGRP medications would be associated with fewer benefits than when these medications were used alone, due to the belief that only a specific amount of CGRP could be blocked at any specific time. This trial shows that the efficacy of CGRP acute medications is not affected by concomitant use of mAb. Many patients who respond well to CGRP mAb will benefit significantly from the additional abortive use of oral antagonists.

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Neura Health and Thomas Jefferson University, Woodbury, NJ 

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Depression is one of the most common comorbidities associated with migraine. Major depressive disorder is both a risk factor for chronic migraine and a condition that one is more likely to develop after being diagnosed with chronic migraine. The study by de Vries Lentsch and colleagues investigated the use of two of the calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) treatments — erenumab and fremanezumab — compared with a control group of patients with chronic migraine, with an eye on outcomes to measure depression. Of note, reduction in headache frequency (defined as reduction in monthly migraine days) was also investigated as an independent variable.

This was a single-center study performed at the University of Leiden Headache Center. It was not a randomized trial, but all patients were followed with an e-diary and Day 0 vs Day 90 questionnaires that tracked their headache frequency and severity as well as a number of metrics related to depression. Depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS) and the Center for Epidemiological Studies Depression Scale (CES-D). The Headache Impact Test (HIT-6) was used to follow headache-related impact and disability, and the Perceived Stress Scale (PSS) was used to measure the degree of stressful situations the patient was experiencing.

The baseline depression scales between the three groups were 70%, 60%, and 66%, respectively; there were similar baseline levels of migraine frequency and disability as well. Both intervention groups showed a significant decrease in the symptoms of depression, and having a greater level of depression was negatively associated with reduction in monthly migraine days after 3 months. Of note, logistic-regression analysis determined that the reduction in depressive symptoms was independent of the reduction in migraine frequency.

Nearly all headache care providers are faced with challenging situations on a daily basis; often this is due to the comorbidity of mood disorders and high-frequency migraine. A traditional approach has been to provide the patient with a migraine preventive medication in the antidepressant family, such as a tricyclic antidepressant or serotonin and norepinephrine reuptake inhibitor (SNRI). Although these can be helpful, they are less specific for migraine prevention. Many patients are also already taking antidepressant medications, and the addition of a migraine-preventive antidepressant would be contraindicated. This study broadens the possibilities for prevention in these complicated patients and shows that there is benefit in both migraine-related outcomes and markers for depression when using CGRP-based therapy.

The way headache medicine is practiced changed dramatically in 2018 with the advent of CGRP monoclonal antibody (mAb) treatments for migraine. These medications have allowed us to target migraine specifically, whereas all of the preventive medications for migraine prior to 2018 were developed for other conditions and only secondarily helped migraine. These include the antidepressant, antihypertensive, and antiepileptic classes of medications, as well as onabotulinum toxin A, which, although approved for migraine, is not targeting a migraine-specific factor. Moskatel and colleagues sought to better understand the changing patterns of prescribing the nonspecific, or "traditional," migraine preventive medications in light of the advent of CGRP treatment.

This was a retrospective cohort study using aggregated data from the Stanford headache center. The percentage of patients with chronic migraine who had been prescribed one of the 10 most prescribed oral preventive medications or onabotulinum toxin A, or any of the four CGRP mAb, were calculated relative to the total number of patients with chronic migraine who received a prescription for any medication from the clinic during the pre-CGRP mAb years of 2015-2017 and post-approval years of 2019-2021.

The Stanford (STARR) database was filtered, searching for patients living in a California ZIP code with a diagnosis of chronic migraine who were followed from 2015 to 2021. The 10 most common non-CGRP preventive medications were amitriptyline/nortriptyline, valproate, duloxetine, gabapentin, memantine, propranolol, venlafaxine, verapamil, and onabotulinumtoxinA.

Erenumab was noted to initially be the most prescribed CGRP monoclonal antibody medication, but this was overtaken by galcanezumab after the second quarter of 2020 and throughout 2021. There is a statistically significant decrease in the percentage of patients receiving any of the non-CGRP preventive medications since 2018. The most significant decreases were in the tricyclic antidepressant class, as well as valproate, duloxetine, memantine, and onabotulinum toxin A. There was no statistically significant change in venlafaxine or gabapentin prescriptions.

This study highlights the changing face of headache medicine, and having a new class of migraine-specific treatment has significantly affected prescribing patterns. Although there is a statistically significant decrease in the prescribing of these non–migraine-specific preventive medications, they are still often recommended due to step-therapy regulations from insurance formularies, or as part of a polypharmacy regimen that may be more beneficial for a patient. These medications do improve patient outcomes and will remain a mainstay in migraine treatment.

Nearly all patients with migraine are recommended an acute medication to treat migraine attacks abortively; some patients are also recommended preventive therapies if migraine frequency significantly affects their quality of life. The American Headache Society/American Academy of Neurology guidelines for prevention recommend the initiation of a preventive medication at a frequency of 4-5 headache days per month or approximately 1 per week. Lipton and colleagues sought to determine whether there were any efficacy concerns in combining a CGRP mAb for prevention with ubrogepant, an oral CGRP antagonist, for acute treatment.

This was a prospective, open-level observational study assessing pain relief, return to normal function, and treatment satisfaction with patients given 50 or 100 mg of ubrogepant while concomitantly being given a seizure or mAb medication. Patients were allowed to be taking onabotulinumtoxinA as well as a CGRP mAb. The patients in this study were asked to track their headache symptoms using the Migraine Buddy e-diary. Meaningful pain relief was defined as a rating of migraine-related pain with one of the following choices 4 hours after taking the medication: no pain, mild pain, moderate pain, or severe pain. Return to normal function was defined as whether the patient determined they were able to function normally relative to their baseline at specific times post intervention. This was based on a functional disability scale. Treatment satisfaction was determined on the basis of a seven-point rating scale for how satisfied the patient felt with the medication at the end of the trial period.

A total of 245 participants provided at least 30 days of data, with 44.5% of the patients taking erenumab, 35.1% taking galcanezumab, 18.0% taking fremanezumab, and 2.9% taking eptinezumab. Meaningful pain relief was achieved by 61.6% of patients at 2 hours and 80.4% of patients at 4 hours post dose for both the 50-mg and 100-mg dose of ubrogepant. Return to normal function was achieved by 34.7% of patients at 2 hours and 50.5% at 4 hours post dose as well. Patients reported a 72.7% satisfaction level with the medication.

When CGRP acute medications were first approved, there was concern about the use of a mAb together with an oral antagonist. It was thought that CGRP medications would be associated with fewer benefits than when these medications were used alone, due to the belief that only a specific amount of CGRP could be blocked at any specific time. This trial shows that the efficacy of CGRP acute medications is not affected by concomitant use of mAb. Many patients who respond well to CGRP mAb will benefit significantly from the additional abortive use of oral antagonists.

Depression is one of the most common comorbidities associated with migraine. Major depressive disorder is both a risk factor for chronic migraine and a condition that one is more likely to develop after being diagnosed with chronic migraine. The study by de Vries Lentsch and colleagues investigated the use of two of the calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) treatments — erenumab and fremanezumab — compared with a control group of patients with chronic migraine, with an eye on outcomes to measure depression. Of note, reduction in headache frequency (defined as reduction in monthly migraine days) was also investigated as an independent variable.

This was a single-center study performed at the University of Leiden Headache Center. It was not a randomized trial, but all patients were followed with an e-diary and Day 0 vs Day 90 questionnaires that tracked their headache frequency and severity as well as a number of metrics related to depression. Depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS) and the Center for Epidemiological Studies Depression Scale (CES-D). The Headache Impact Test (HIT-6) was used to follow headache-related impact and disability, and the Perceived Stress Scale (PSS) was used to measure the degree of stressful situations the patient was experiencing.

The baseline depression scales between the three groups were 70%, 60%, and 66%, respectively; there were similar baseline levels of migraine frequency and disability as well. Both intervention groups showed a significant decrease in the symptoms of depression, and having a greater level of depression was negatively associated with reduction in monthly migraine days after 3 months. Of note, logistic-regression analysis determined that the reduction in depressive symptoms was independent of the reduction in migraine frequency.

Nearly all headache care providers are faced with challenging situations on a daily basis; often this is due to the comorbidity of mood disorders and high-frequency migraine. A traditional approach has been to provide the patient with a migraine preventive medication in the antidepressant family, such as a tricyclic antidepressant or serotonin and norepinephrine reuptake inhibitor (SNRI). Although these can be helpful, they are less specific for migraine prevention. Many patients are also already taking antidepressant medications, and the addition of a migraine-preventive antidepressant would be contraindicated. This study broadens the possibilities for prevention in these complicated patients and shows that there is benefit in both migraine-related outcomes and markers for depression when using CGRP-based therapy.

The way headache medicine is practiced changed dramatically in 2018 with the advent of CGRP monoclonal antibody (mAb) treatments for migraine. These medications have allowed us to target migraine specifically, whereas all of the preventive medications for migraine prior to 2018 were developed for other conditions and only secondarily helped migraine. These include the antidepressant, antihypertensive, and antiepileptic classes of medications, as well as onabotulinum toxin A, which, although approved for migraine, is not targeting a migraine-specific factor. Moskatel and colleagues sought to better understand the changing patterns of prescribing the nonspecific, or "traditional," migraine preventive medications in light of the advent of CGRP treatment.

This was a retrospective cohort study using aggregated data from the Stanford headache center. The percentage of patients with chronic migraine who had been prescribed one of the 10 most prescribed oral preventive medications or onabotulinum toxin A, or any of the four CGRP mAb, were calculated relative to the total number of patients with chronic migraine who received a prescription for any medication from the clinic during the pre-CGRP mAb years of 2015-2017 and post-approval years of 2019-2021.

The Stanford (STARR) database was filtered, searching for patients living in a California ZIP code with a diagnosis of chronic migraine who were followed from 2015 to 2021. The 10 most common non-CGRP preventive medications were amitriptyline/nortriptyline, valproate, duloxetine, gabapentin, memantine, propranolol, venlafaxine, verapamil, and onabotulinumtoxinA.

Erenumab was noted to initially be the most prescribed CGRP monoclonal antibody medication, but this was overtaken by galcanezumab after the second quarter of 2020 and throughout 2021. There is a statistically significant decrease in the percentage of patients receiving any of the non-CGRP preventive medications since 2018. The most significant decreases were in the tricyclic antidepressant class, as well as valproate, duloxetine, memantine, and onabotulinum toxin A. There was no statistically significant change in venlafaxine or gabapentin prescriptions.

This study highlights the changing face of headache medicine, and having a new class of migraine-specific treatment has significantly affected prescribing patterns. Although there is a statistically significant decrease in the prescribing of these non–migraine-specific preventive medications, they are still often recommended due to step-therapy regulations from insurance formularies, or as part of a polypharmacy regimen that may be more beneficial for a patient. These medications do improve patient outcomes and will remain a mainstay in migraine treatment.

Nearly all patients with migraine are recommended an acute medication to treat migraine attacks abortively; some patients are also recommended preventive therapies if migraine frequency significantly affects their quality of life. The American Headache Society/American Academy of Neurology guidelines for prevention recommend the initiation of a preventive medication at a frequency of 4-5 headache days per month or approximately 1 per week. Lipton and colleagues sought to determine whether there were any efficacy concerns in combining a CGRP mAb for prevention with ubrogepant, an oral CGRP antagonist, for acute treatment.

This was a prospective, open-level observational study assessing pain relief, return to normal function, and treatment satisfaction with patients given 50 or 100 mg of ubrogepant while concomitantly being given a seizure or mAb medication. Patients were allowed to be taking onabotulinumtoxinA as well as a CGRP mAb. The patients in this study were asked to track their headache symptoms using the Migraine Buddy e-diary. Meaningful pain relief was defined as a rating of migraine-related pain with one of the following choices 4 hours after taking the medication: no pain, mild pain, moderate pain, or severe pain. Return to normal function was defined as whether the patient determined they were able to function normally relative to their baseline at specific times post intervention. This was based on a functional disability scale. Treatment satisfaction was determined on the basis of a seven-point rating scale for how satisfied the patient felt with the medication at the end of the trial period.

A total of 245 participants provided at least 30 days of data, with 44.5% of the patients taking erenumab, 35.1% taking galcanezumab, 18.0% taking fremanezumab, and 2.9% taking eptinezumab. Meaningful pain relief was achieved by 61.6% of patients at 2 hours and 80.4% of patients at 4 hours post dose for both the 50-mg and 100-mg dose of ubrogepant. Return to normal function was achieved by 34.7% of patients at 2 hours and 50.5% at 4 hours post dose as well. Patients reported a 72.7% satisfaction level with the medication.

When CGRP acute medications were first approved, there was concern about the use of a mAb together with an oral antagonist. It was thought that CGRP medications would be associated with fewer benefits than when these medications were used alone, due to the belief that only a specific amount of CGRP could be blocked at any specific time. This trial shows that the efficacy of CGRP acute medications is not affected by concomitant use of mAb. Many patients who respond well to CGRP mAb will benefit significantly from the additional abortive use of oral antagonists.

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Which migraine medications are most effective?

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For relief of acute migraine, triptans, ergots, and antiemetics are two to five times more effective than ibuprofen, and acetaminophen is the least effective medication, new results from large, real-world analysis of self-reported patient data show. 

METHODOLOGY: 

  • Researchers analyzed nearly 11 million migraine attack records extracted from Migraine Buddy, an e-diary smartphone app, over a 6-year period. 
  • They evaluated self-reported treatment effectiveness for 25 acute migraine medications among seven classes: acetaminophen, NSAIDs, triptans, combination analgesics, ergots, antiemetics, and opioids. 
  • A two-level nested multivariate logistic regression model adjusted for within-subject dependency and for concomitant medications taken within each analyzed migraine attack. 
  • The final analysis included nearly 5 million medication-outcome pairs from 3.1 million migraine attacks in 278,000 medication users. 

TAKEAWAY:

  • Using ibuprofen as the reference, triptans, ergots, and antiemetics were the top three medication classes with the highest effectiveness (mean odds ratios [OR] 4.80, 3.02, and 2.67, respectively). 
  • The next most effective medication classes were opioids (OR, 2.49), NSAIDs other than ibuprofen (OR, 1.94), combination analgesics acetaminophen/acetylsalicylic acid/caffeine (OR, 1.69), and others (OR, 1.49).
  • Acetaminophen (OR, 0.83) was considered to be the least effective.
  • The most effective individual medications were eletriptan (Relpax) (OR, 6.1); zolmitriptan (Zomig) (OR, 5.7); and sumatriptan (Imitrex) (OR, 5.2).

IN PRACTICE:

“Our findings that triptans, ergots, and antiemetics are the most effective classes of medications align with the guideline recommendations and offer generalizable insights to complement clinical practice,” the authors wrote. 

laflor/gettyimages

SOURCE:

The study, with first author Chia-Chun Chiang, MD, Department of Neurology, Mayo Clinic, Rochester, Minnesota, was published online November 29 in Neurology.

LIMITATIONS:

The findings are based on subjective user-reported ratings of effectiveness and information on side effects, dosages, and formulations were not available. The newer migraine medication classes, gepants and ditans, were not included due to the relatively lower number of treated attacks. The regression model did not include age, gender, pain intensity, and other migraine-associated symptoms, which could potentially affect treatment effectiveness. 

DISCLOSURES: 

Funding for the study was provided by the Kanagawa University of Human Service research fund. A full list of author disclosures can be found with the original article.

A version of this article first appeared on Medscape.com.

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For relief of acute migraine, triptans, ergots, and antiemetics are two to five times more effective than ibuprofen, and acetaminophen is the least effective medication, new results from large, real-world analysis of self-reported patient data show. 

METHODOLOGY: 

  • Researchers analyzed nearly 11 million migraine attack records extracted from Migraine Buddy, an e-diary smartphone app, over a 6-year period. 
  • They evaluated self-reported treatment effectiveness for 25 acute migraine medications among seven classes: acetaminophen, NSAIDs, triptans, combination analgesics, ergots, antiemetics, and opioids. 
  • A two-level nested multivariate logistic regression model adjusted for within-subject dependency and for concomitant medications taken within each analyzed migraine attack. 
  • The final analysis included nearly 5 million medication-outcome pairs from 3.1 million migraine attacks in 278,000 medication users. 

TAKEAWAY:

  • Using ibuprofen as the reference, triptans, ergots, and antiemetics were the top three medication classes with the highest effectiveness (mean odds ratios [OR] 4.80, 3.02, and 2.67, respectively). 
  • The next most effective medication classes were opioids (OR, 2.49), NSAIDs other than ibuprofen (OR, 1.94), combination analgesics acetaminophen/acetylsalicylic acid/caffeine (OR, 1.69), and others (OR, 1.49).
  • Acetaminophen (OR, 0.83) was considered to be the least effective.
  • The most effective individual medications were eletriptan (Relpax) (OR, 6.1); zolmitriptan (Zomig) (OR, 5.7); and sumatriptan (Imitrex) (OR, 5.2).

IN PRACTICE:

“Our findings that triptans, ergots, and antiemetics are the most effective classes of medications align with the guideline recommendations and offer generalizable insights to complement clinical practice,” the authors wrote. 

laflor/gettyimages

SOURCE:

The study, with first author Chia-Chun Chiang, MD, Department of Neurology, Mayo Clinic, Rochester, Minnesota, was published online November 29 in Neurology.

LIMITATIONS:

The findings are based on subjective user-reported ratings of effectiveness and information on side effects, dosages, and formulations were not available. The newer migraine medication classes, gepants and ditans, were not included due to the relatively lower number of treated attacks. The regression model did not include age, gender, pain intensity, and other migraine-associated symptoms, which could potentially affect treatment effectiveness. 

DISCLOSURES: 

Funding for the study was provided by the Kanagawa University of Human Service research fund. A full list of author disclosures can be found with the original article.

A version of this article first appeared on Medscape.com.

 

For relief of acute migraine, triptans, ergots, and antiemetics are two to five times more effective than ibuprofen, and acetaminophen is the least effective medication, new results from large, real-world analysis of self-reported patient data show. 

METHODOLOGY: 

  • Researchers analyzed nearly 11 million migraine attack records extracted from Migraine Buddy, an e-diary smartphone app, over a 6-year period. 
  • They evaluated self-reported treatment effectiveness for 25 acute migraine medications among seven classes: acetaminophen, NSAIDs, triptans, combination analgesics, ergots, antiemetics, and opioids. 
  • A two-level nested multivariate logistic regression model adjusted for within-subject dependency and for concomitant medications taken within each analyzed migraine attack. 
  • The final analysis included nearly 5 million medication-outcome pairs from 3.1 million migraine attacks in 278,000 medication users. 

TAKEAWAY:

  • Using ibuprofen as the reference, triptans, ergots, and antiemetics were the top three medication classes with the highest effectiveness (mean odds ratios [OR] 4.80, 3.02, and 2.67, respectively). 
  • The next most effective medication classes were opioids (OR, 2.49), NSAIDs other than ibuprofen (OR, 1.94), combination analgesics acetaminophen/acetylsalicylic acid/caffeine (OR, 1.69), and others (OR, 1.49).
  • Acetaminophen (OR, 0.83) was considered to be the least effective.
  • The most effective individual medications were eletriptan (Relpax) (OR, 6.1); zolmitriptan (Zomig) (OR, 5.7); and sumatriptan (Imitrex) (OR, 5.2).

IN PRACTICE:

“Our findings that triptans, ergots, and antiemetics are the most effective classes of medications align with the guideline recommendations and offer generalizable insights to complement clinical practice,” the authors wrote. 

laflor/gettyimages

SOURCE:

The study, with first author Chia-Chun Chiang, MD, Department of Neurology, Mayo Clinic, Rochester, Minnesota, was published online November 29 in Neurology.

LIMITATIONS:

The findings are based on subjective user-reported ratings of effectiveness and information on side effects, dosages, and formulations were not available. The newer migraine medication classes, gepants and ditans, were not included due to the relatively lower number of treated attacks. The regression model did not include age, gender, pain intensity, and other migraine-associated symptoms, which could potentially affect treatment effectiveness. 

DISCLOSURES: 

Funding for the study was provided by the Kanagawa University of Human Service research fund. A full list of author disclosures can be found with the original article.

A version of this article first appeared on Medscape.com.

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