Headache & Migraine

Key clinical point: Patients with migraine show higher treatment adherence and persistence to calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb), specifically to galcanezumab, over standard-of-care (SOC) migraine preventive treatments.

Major finding: At 12 months of follow-up, CGRP mAb vs. SOC initiators had significantly higher mean adherence (proportion of days covered: 55.1% vs. 35.2%; P < .001) and persistence (212.5 vs. 131.9 days; P < .001). Similarly, galcanezumab vs. SOC initiators showed significantly higher adherence (63.7% vs. 33.7%; P < .001) and persistence (252.3 vs. 127.3 days; P < .001).

Study details: This retrospective, observational, claims database study created two separate 1:1 propensity-score-matched cohorts of adult patients with migraine initiating SOC or a CGRP mAb (n = 3082 pairs) and SOC or galcanezumab (n = 421 pairs).

Disclosures: The study was funded by Eli Lilly and Company. All authors declared being current/former employees or minor shareholders of Eli Lilly or a company contracted by Eli Lilly.

Source: Varnado OJ et al. Treatment patterns for calcitonin gene-related peptide monoclonal antibodies including galcanezumab versus conventional preventive treatments for migraine: A retrospective us claims study, Patient Prefer Adherence. 2022;16:821-839 (Mar 29). Doi: 10.2147/PPA.S346660

Key clinical point: Patients with migraine show higher treatment adherence and persistence to calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb), specifically to galcanezumab, over standard-of-care (SOC) migraine preventive treatments.

Major finding: At 12 months of follow-up, CGRP mAb vs. SOC initiators had significantly higher mean adherence (proportion of days covered: 55.1% vs. 35.2%; P < .001) and persistence (212.5 vs. 131.9 days; P < .001). Similarly, galcanezumab vs. SOC initiators showed significantly higher adherence (63.7% vs. 33.7%; P < .001) and persistence (252.3 vs. 127.3 days; P < .001).

Study details: This retrospective, observational, claims database study created two separate 1:1 propensity-score-matched cohorts of adult patients with migraine initiating SOC or a CGRP mAb (n = 3082 pairs) and SOC or galcanezumab (n = 421 pairs).

Disclosures: The study was funded by Eli Lilly and Company. All authors declared being current/former employees or minor shareholders of Eli Lilly or a company contracted by Eli Lilly.

Source: Varnado OJ et al. Treatment patterns for calcitonin gene-related peptide monoclonal antibodies including galcanezumab versus conventional preventive treatments for migraine: A retrospective us claims study, Patient Prefer Adherence. 2022;16:821-839 (Mar 29). Doi: 10.2147/PPA.S346660

Key clinical point: Patients with migraine show higher treatment adherence and persistence to calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb), specifically to galcanezumab, over standard-of-care (SOC) migraine preventive treatments.

Major finding: At 12 months of follow-up, CGRP mAb vs. SOC initiators had significantly higher mean adherence (proportion of days covered: 55.1% vs. 35.2%; P < .001) and persistence (212.5 vs. 131.9 days; P < .001). Similarly, galcanezumab vs. SOC initiators showed significantly higher adherence (63.7% vs. 33.7%; P < .001) and persistence (252.3 vs. 127.3 days; P < .001).

Study details: This retrospective, observational, claims database study created two separate 1:1 propensity-score-matched cohorts of adult patients with migraine initiating SOC or a CGRP mAb (n = 3082 pairs) and SOC or galcanezumab (n = 421 pairs).

Disclosures: The study was funded by Eli Lilly and Company. All authors declared being current/former employees or minor shareholders of Eli Lilly or a company contracted by Eli Lilly.

Source: Varnado OJ et al. Treatment patterns for calcitonin gene-related peptide monoclonal antibodies including galcanezumab versus conventional preventive treatments for migraine: A retrospective us claims study, Patient Prefer Adherence. 2022;16:821-839 (Mar 29). Doi: 10.2147/PPA.S346660

Key clinical point: Real-time ultrasound-guided stellate ganglion block (SGB) can effectively ameliorate migraine pain and disability without causing any serious complications, thus improving the quality of life of patients.

Major finding: After 3 months of SGB administration, the numerical rating scale score decreased from 7.0 to 2.0 (P < .01), Migraine Disability Assessment Scale total score from 14.0 to 7.0 (P < .001), and analgesic use frequency from 6.2 ± 2.8 to 1.9 ± 1.8. No serious complications were observed.

Study details: The study enrolled 81 patients aged >18 years with migraine who received SGB on the affected side with 0.15% ropivacaine weekly 4 times.

Disclosures: The study was sponsored by a grant from the Shanghai Municipal Health Commission. The authors reported no conflicts of interest.

Source: Hou J et al. Real-time ultrasound-guided stellate ganglion block for migraine: an observational study. BMC Anesthesiol. 2022;22:78 (Mar 24). Doi: 10.1186/s12871-022-01622-8

Key clinical point: Real-time ultrasound-guided stellate ganglion block (SGB) can effectively ameliorate migraine pain and disability without causing any serious complications, thus improving the quality of life of patients.

Major finding: After 3 months of SGB administration, the numerical rating scale score decreased from 7.0 to 2.0 (P < .01), Migraine Disability Assessment Scale total score from 14.0 to 7.0 (P < .001), and analgesic use frequency from 6.2 ± 2.8 to 1.9 ± 1.8. No serious complications were observed.

Study details: The study enrolled 81 patients aged >18 years with migraine who received SGB on the affected side with 0.15% ropivacaine weekly 4 times.

Disclosures: The study was sponsored by a grant from the Shanghai Municipal Health Commission. The authors reported no conflicts of interest.

Source: Hou J et al. Real-time ultrasound-guided stellate ganglion block for migraine: an observational study. BMC Anesthesiol. 2022;22:78 (Mar 24). Doi: 10.1186/s12871-022-01622-8

Key clinical point: Real-time ultrasound-guided stellate ganglion block (SGB) can effectively ameliorate migraine pain and disability without causing any serious complications, thus improving the quality of life of patients.

Major finding: After 3 months of SGB administration, the numerical rating scale score decreased from 7.0 to 2.0 (P < .01), Migraine Disability Assessment Scale total score from 14.0 to 7.0 (P < .001), and analgesic use frequency from 6.2 ± 2.8 to 1.9 ± 1.8. No serious complications were observed.

Study details: The study enrolled 81 patients aged >18 years with migraine who received SGB on the affected side with 0.15% ropivacaine weekly 4 times.

Disclosures: The study was sponsored by a grant from the Shanghai Municipal Health Commission. The authors reported no conflicts of interest.

Source: Hou J et al. Real-time ultrasound-guided stellate ganglion block for migraine: an observational study. BMC Anesthesiol. 2022;22:78 (Mar 24). Doi: 10.1186/s12871-022-01622-8

Key clinical point: Migraine frequency decreases significantly in most patients with migraine on resuming preventive treatment with the same calcitonin gene-related peptide-receptor (CGRP-[R]) monoclonal antibody (mAb) after a 3-month drug holiday.

Major finding: After 9-12 weeks of therapy resumption, monthly migraine days reduced significantly (−4.5 days, P < .001) and attained a level comparable with that in the 4-week period before therapy discontinuation (P > .999).

Study details: Findings are from a longitudinal cohort study including 39 patients with episodic or chronic migraine who restarted treatment with erenumab (n = 16) or galcanezumab/fremanezumab (n = 23) after a 3-month drug holiday following the first treatment cycle with the same CGRP(-R) mAb.

Disclosures: This study did not receive any financial support. Some authors declared serving on the advisory board of or receiving consulting, speaker, or personal fees from various sources.

Source: Raffaelli B et al. Resumption of migraine preventive treatment with CGRP(-receptor) antibodies after a 3-month drug holiday: A real-world experience. J Headache Pain. 2022;23:40 (Mar 30). Doi:  10.1186/s10194-022-01417-9

Key clinical point: Migraine frequency decreases significantly in most patients with migraine on resuming preventive treatment with the same calcitonin gene-related peptide-receptor (CGRP-[R]) monoclonal antibody (mAb) after a 3-month drug holiday.

Major finding: After 9-12 weeks of therapy resumption, monthly migraine days reduced significantly (−4.5 days, P < .001) and attained a level comparable with that in the 4-week period before therapy discontinuation (P > .999).

Study details: Findings are from a longitudinal cohort study including 39 patients with episodic or chronic migraine who restarted treatment with erenumab (n = 16) or galcanezumab/fremanezumab (n = 23) after a 3-month drug holiday following the first treatment cycle with the same CGRP(-R) mAb.

Disclosures: This study did not receive any financial support. Some authors declared serving on the advisory board of or receiving consulting, speaker, or personal fees from various sources.

Source: Raffaelli B et al. Resumption of migraine preventive treatment with CGRP(-receptor) antibodies after a 3-month drug holiday: A real-world experience. J Headache Pain. 2022;23:40 (Mar 30). Doi:  10.1186/s10194-022-01417-9

Key clinical point: Migraine frequency decreases significantly in most patients with migraine on resuming preventive treatment with the same calcitonin gene-related peptide-receptor (CGRP-[R]) monoclonal antibody (mAb) after a 3-month drug holiday.

Major finding: After 9-12 weeks of therapy resumption, monthly migraine days reduced significantly (−4.5 days, P < .001) and attained a level comparable with that in the 4-week period before therapy discontinuation (P > .999).

Study details: Findings are from a longitudinal cohort study including 39 patients with episodic or chronic migraine who restarted treatment with erenumab (n = 16) or galcanezumab/fremanezumab (n = 23) after a 3-month drug holiday following the first treatment cycle with the same CGRP(-R) mAb.

Disclosures: This study did not receive any financial support. Some authors declared serving on the advisory board of or receiving consulting, speaker, or personal fees from various sources.

Source: Raffaelli B et al. Resumption of migraine preventive treatment with CGRP(-receptor) antibodies after a 3-month drug holiday: A real-world experience. J Headache Pain. 2022;23:40 (Mar 30). Doi:  10.1186/s10194-022-01417-9

Key clinical point: Topiramate in combination with monthly injections of greater occipital nerve block (GONB) is better at decreasing monthly migraine days (MMD) in chronic migraine (CM) than topiramate monotherapy at month 3 and is equally well tolerated.

Major finding: At month 3, greater reductions in MMD were observed in patients receiving topiramate and GONB with lidocaine+methylprednisolone (−9.6 vs. −7.3 days; P = .003) and topiramate and GONB with only lidocaine (−10.1 vs. −7.3 days; P < .001) compared with patients receiving topiramate monotherapy. Tolerability between the groups was comparable.

Study details: Findings are from a parallel group, three-arm study including 125 adult patients with CM who were randomly assigned to receive topiramate alone (n = 41), topiramate and GONB with lidocaine+methylprednisolone in month 1 followed by monthly lidocaine injections (n = 44), or topiramate and GONB with monthly lidocaine injections (n = 40) for 3 months.

Disclosures: The study received no financial support. The authors declared no conflicts of interest.

Source: Chowdhury D et al. Efficacy and tolerability of combination treatment of topiramate and greater occipital nerve block versus topiramate monotherapy for the preventive treatment of chronic migraine: A randomized controlled trial. Cephalalgia. 2022 (Mar 8). Doi: 10.1177/03331024221082077

Key clinical point: Topiramate in combination with monthly injections of greater occipital nerve block (GONB) is better at decreasing monthly migraine days (MMD) in chronic migraine (CM) than topiramate monotherapy at month 3 and is equally well tolerated.

Major finding: At month 3, greater reductions in MMD were observed in patients receiving topiramate and GONB with lidocaine+methylprednisolone (−9.6 vs. −7.3 days; P = .003) and topiramate and GONB with only lidocaine (−10.1 vs. −7.3 days; P < .001) compared with patients receiving topiramate monotherapy. Tolerability between the groups was comparable.

Study details: Findings are from a parallel group, three-arm study including 125 adult patients with CM who were randomly assigned to receive topiramate alone (n = 41), topiramate and GONB with lidocaine+methylprednisolone in month 1 followed by monthly lidocaine injections (n = 44), or topiramate and GONB with monthly lidocaine injections (n = 40) for 3 months.

Disclosures: The study received no financial support. The authors declared no conflicts of interest.

Source: Chowdhury D et al. Efficacy and tolerability of combination treatment of topiramate and greater occipital nerve block versus topiramate monotherapy for the preventive treatment of chronic migraine: A randomized controlled trial. Cephalalgia. 2022 (Mar 8). Doi: 10.1177/03331024221082077

Key clinical point: Topiramate in combination with monthly injections of greater occipital nerve block (GONB) is better at decreasing monthly migraine days (MMD) in chronic migraine (CM) than topiramate monotherapy at month 3 and is equally well tolerated.

Major finding: At month 3, greater reductions in MMD were observed in patients receiving topiramate and GONB with lidocaine+methylprednisolone (−9.6 vs. −7.3 days; P = .003) and topiramate and GONB with only lidocaine (−10.1 vs. −7.3 days; P < .001) compared with patients receiving topiramate monotherapy. Tolerability between the groups was comparable.

Study details: Findings are from a parallel group, three-arm study including 125 adult patients with CM who were randomly assigned to receive topiramate alone (n = 41), topiramate and GONB with lidocaine+methylprednisolone in month 1 followed by monthly lidocaine injections (n = 44), or topiramate and GONB with monthly lidocaine injections (n = 40) for 3 months.

Disclosures: The study received no financial support. The authors declared no conflicts of interest.

Source: Chowdhury D et al. Efficacy and tolerability of combination treatment of topiramate and greater occipital nerve block versus topiramate monotherapy for the preventive treatment of chronic migraine: A randomized controlled trial. Cephalalgia. 2022 (Mar 8). Doi: 10.1177/03331024221082077

Key clinical point: External trigeminal nerve stimulation (e-TNS) for 2 consecutive hours is an effective, safe, nonpharmacological, and noninvasive acute treatment option for a migraine attack with or without aura.

Major finding: A significantly higher percentage of patients experienced pain freedom (25.5% vs. 18.3%; P < .05) and showed resolution of the most bothersome migraine symptoms (56.4% vs. 42.3%; P < .01) with e-TNS vs. sham treatment, effectuating a therapeutic gain of 7.2% and 14.1%, respectively.

Study details: The intention-to-treat population in this multicenter, prospective, phase 3 study, TEAM, consisted of 538 adult patients with episodic migraine with or without aura who were randomly assigned to receive active (n = 259) or sham (n = 279) stimulation for 2 hours.

Disclosures: The study was sponsored by Cefaly Technology, Belgium. Some authors reported receiving consulting fees, advisory board honoraria, or research grants from various sources. MAL Johnson is the Global Director of Medical Affairs for Cefaly.

Source: Kuruvilla DE et al. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022;12:5110 (Mar 24). Doi: 10.1038/s41598-022-09071-6

Key clinical point: External trigeminal nerve stimulation (e-TNS) for 2 consecutive hours is an effective, safe, nonpharmacological, and noninvasive acute treatment option for a migraine attack with or without aura.

Major finding: A significantly higher percentage of patients experienced pain freedom (25.5% vs. 18.3%; P < .05) and showed resolution of the most bothersome migraine symptoms (56.4% vs. 42.3%; P < .01) with e-TNS vs. sham treatment, effectuating a therapeutic gain of 7.2% and 14.1%, respectively.

Study details: The intention-to-treat population in this multicenter, prospective, phase 3 study, TEAM, consisted of 538 adult patients with episodic migraine with or without aura who were randomly assigned to receive active (n = 259) or sham (n = 279) stimulation for 2 hours.

Disclosures: The study was sponsored by Cefaly Technology, Belgium. Some authors reported receiving consulting fees, advisory board honoraria, or research grants from various sources. MAL Johnson is the Global Director of Medical Affairs for Cefaly.

Source: Kuruvilla DE et al. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022;12:5110 (Mar 24). Doi: 10.1038/s41598-022-09071-6

Key clinical point: External trigeminal nerve stimulation (e-TNS) for 2 consecutive hours is an effective, safe, nonpharmacological, and noninvasive acute treatment option for a migraine attack with or without aura.

Major finding: A significantly higher percentage of patients experienced pain freedom (25.5% vs. 18.3%; P < .05) and showed resolution of the most bothersome migraine symptoms (56.4% vs. 42.3%; P < .01) with e-TNS vs. sham treatment, effectuating a therapeutic gain of 7.2% and 14.1%, respectively.

Study details: The intention-to-treat population in this multicenter, prospective, phase 3 study, TEAM, consisted of 538 adult patients with episodic migraine with or without aura who were randomly assigned to receive active (n = 259) or sham (n = 279) stimulation for 2 hours.

Disclosures: The study was sponsored by Cefaly Technology, Belgium. Some authors reported receiving consulting fees, advisory board honoraria, or research grants from various sources. MAL Johnson is the Global Director of Medical Affairs for Cefaly.

Source: Kuruvilla DE et al. Phase 3 randomized, double-blind, sham-controlled Trial of e-TNS for the Acute treatment of Migraine (TEAM). Sci Rep. 2022;12:5110 (Mar 24). Doi: 10.1038/s41598-022-09071-6

Key clinical point: Fremanezumab lowers the pain and neurological symptom days in patients with episodic migraine (EM) or chronic migraine (CM) with associated neurological dysfunction and inadequate response to 2-4 prior classes of prophylactic medications.

Major finding: Quarterly and monthly fremanezumab vs. placebo significantly reduced monthly mean days with neurological symptoms (least square mean difference −1.7 days and −1.8 days vs. −0.5 days; both P ≤ .01) and monthly migraine days (P < .0001) over 12 weeks.

Study details: This post hoc analysis included 837 patients with difficult-to-treat EM or CM from the phase 3b FOCUS study who received quarterly fremanezumab, monthly fremanezumab, or placebo over 12 weeks and were categorized into patients with (n = 493) and without (n = 344) associated neurological dysfunction.

Disclosures: This study was funded by Teva Branded Pharmaceutical Products R&D, Inc., USA. Some authors declared serving as consultants, speakers, or principal clinical trial investigators for or receiving personal fees from various sources, including Teva, and other authors are employees or stockholders of Teva.

Source: Lampl C et al. Efficacy and quality-of-life improvements with fremanezumab treatment in patients with difficult-to-treat migraine with associated neurological dysfunction. Eur J Neurol. 2022 (Mar 18). Doi: 10.1111/ene.15328

Key clinical point: Fremanezumab lowers the pain and neurological symptom days in patients with episodic migraine (EM) or chronic migraine (CM) with associated neurological dysfunction and inadequate response to 2-4 prior classes of prophylactic medications.

Major finding: Quarterly and monthly fremanezumab vs. placebo significantly reduced monthly mean days with neurological symptoms (least square mean difference −1.7 days and −1.8 days vs. −0.5 days; both P ≤ .01) and monthly migraine days (P < .0001) over 12 weeks.

Study details: This post hoc analysis included 837 patients with difficult-to-treat EM or CM from the phase 3b FOCUS study who received quarterly fremanezumab, monthly fremanezumab, or placebo over 12 weeks and were categorized into patients with (n = 493) and without (n = 344) associated neurological dysfunction.

Disclosures: This study was funded by Teva Branded Pharmaceutical Products R&D, Inc., USA. Some authors declared serving as consultants, speakers, or principal clinical trial investigators for or receiving personal fees from various sources, including Teva, and other authors are employees or stockholders of Teva.

Source: Lampl C et al. Efficacy and quality-of-life improvements with fremanezumab treatment in patients with difficult-to-treat migraine with associated neurological dysfunction. Eur J Neurol. 2022 (Mar 18). Doi: 10.1111/ene.15328

Key clinical point: Fremanezumab lowers the pain and neurological symptom days in patients with episodic migraine (EM) or chronic migraine (CM) with associated neurological dysfunction and inadequate response to 2-4 prior classes of prophylactic medications.

Major finding: Quarterly and monthly fremanezumab vs. placebo significantly reduced monthly mean days with neurological symptoms (least square mean difference −1.7 days and −1.8 days vs. −0.5 days; both P ≤ .01) and monthly migraine days (P < .0001) over 12 weeks.

Study details: This post hoc analysis included 837 patients with difficult-to-treat EM or CM from the phase 3b FOCUS study who received quarterly fremanezumab, monthly fremanezumab, or placebo over 12 weeks and were categorized into patients with (n = 493) and without (n = 344) associated neurological dysfunction.

Disclosures: This study was funded by Teva Branded Pharmaceutical Products R&D, Inc., USA. Some authors declared serving as consultants, speakers, or principal clinical trial investigators for or receiving personal fees from various sources, including Teva, and other authors are employees or stockholders of Teva.

Source: Lampl C et al. Efficacy and quality-of-life improvements with fremanezumab treatment in patients with difficult-to-treat migraine with associated neurological dysfunction. Eur J Neurol. 2022 (Mar 18). Doi: 10.1111/ene.15328

Key clinical point: Consistent with the overall study population results, eptinezumab therapy demonstrated favorable efficacy and safety in patients with episodic migraine (EM) or chronic migraine (CM) and self-reported aura from the PROMISE studies.

Major finding: Over weeks 1-12, monthly migraine days decreased with 100 mg and 300 mg eptinezumab vs. placebo in patients with EM (100 mg, −3.9 days; 300 mg, −4.2 days vs. −3.3 days) and CM (100 mg, −7.1 days; 300 mg, −7.6 days vs. −5.9 days) with aura. Treatment-emergent adverse event rates were similar across treatment groups.

Study details: Of 1741 patients with EM/CM from the PROMISE-1 and PROMISE-2 trials, this post hoc analysis included 877 patients who self-reported migraine with aura at screening and received eptinezumab (n = 583) or placebo (n = 294).

Disclosures: Lundbeck Seattle BioPharmaceuticals, Inc., USA, funded the study. Some authors declared serving as consultants, speakers, advisors, or as a primary trial investigator for and receiving personal fees and research support from various sources, including Lundbeck. Some authors are current or former employees of Lundbeck or its subsidiary company.

Source: Ashina M et al. Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2. Cephalalgia. 2022 (Mar 18). Doi: 10.1177/03331024221077646

Key clinical point: Consistent with the overall study population results, eptinezumab therapy demonstrated favorable efficacy and safety in patients with episodic migraine (EM) or chronic migraine (CM) and self-reported aura from the PROMISE studies.

Major finding: Over weeks 1-12, monthly migraine days decreased with 100 mg and 300 mg eptinezumab vs. placebo in patients with EM (100 mg, −3.9 days; 300 mg, −4.2 days vs. −3.3 days) and CM (100 mg, −7.1 days; 300 mg, −7.6 days vs. −5.9 days) with aura. Treatment-emergent adverse event rates were similar across treatment groups.

Study details: Of 1741 patients with EM/CM from the PROMISE-1 and PROMISE-2 trials, this post hoc analysis included 877 patients who self-reported migraine with aura at screening and received eptinezumab (n = 583) or placebo (n = 294).

Disclosures: Lundbeck Seattle BioPharmaceuticals, Inc., USA, funded the study. Some authors declared serving as consultants, speakers, advisors, or as a primary trial investigator for and receiving personal fees and research support from various sources, including Lundbeck. Some authors are current or former employees of Lundbeck or its subsidiary company.

Source: Ashina M et al. Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2. Cephalalgia. 2022 (Mar 18). Doi: 10.1177/03331024221077646

Key clinical point: Consistent with the overall study population results, eptinezumab therapy demonstrated favorable efficacy and safety in patients with episodic migraine (EM) or chronic migraine (CM) and self-reported aura from the PROMISE studies.

Major finding: Over weeks 1-12, monthly migraine days decreased with 100 mg and 300 mg eptinezumab vs. placebo in patients with EM (100 mg, −3.9 days; 300 mg, −4.2 days vs. −3.3 days) and CM (100 mg, −7.1 days; 300 mg, −7.6 days vs. −5.9 days) with aura. Treatment-emergent adverse event rates were similar across treatment groups.

Study details: Of 1741 patients with EM/CM from the PROMISE-1 and PROMISE-2 trials, this post hoc analysis included 877 patients who self-reported migraine with aura at screening and received eptinezumab (n = 583) or placebo (n = 294).

Disclosures: Lundbeck Seattle BioPharmaceuticals, Inc., USA, funded the study. Some authors declared serving as consultants, speakers, advisors, or as a primary trial investigator for and receiving personal fees and research support from various sources, including Lundbeck. Some authors are current or former employees of Lundbeck or its subsidiary company.

Source: Ashina M et al. Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2. Cephalalgia. 2022 (Mar 18). Doi: 10.1177/03331024221077646

Key clinical point: Galcanezumab is an effective and safe long-term treatment option for chronic migraine.

Major finding: At month 12, patients in the placebo, 120 mg galcanezumab, and 240 mg galcanezumab groups showed a mean change of −8.5, −9.0, and −8.0 days in monthly migraine days from the beginning of the double-blind period, respectively (all within-group P < .001). No new safety concerns emerged with extended treatment.

Study details: Findings are from the 9-month open-label extension of the REGAIN trial including 1022 patients with chronic migraine who completed the preceding 3-month double-blind treatment (501, 259, and 262 patients assigned to the placebo, 120 mg galcanezumab, and 240 mg galcanezumab groups, respectively) and received a 240-mg galcanezumab loading dose, followed by 120 mg in the next month and flexible dosing thereafter.

Disclosures: This study was sponsored by Eli Lilly and Company. Some authors declared receiving speaker, consultant, or advisory board member honoraria from various sources, including Eli Lilly. Two authors reported being full-time employees and minor stockholders of Eli Lilly.

Source: Pozo-Rosich P et al. Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. 2022 (Apr 8). Doi:   10.1080/03007995.2022.2059975

Key clinical point: Galcanezumab is an effective and safe long-term treatment option for chronic migraine.

Major finding: At month 12, patients in the placebo, 120 mg galcanezumab, and 240 mg galcanezumab groups showed a mean change of −8.5, −9.0, and −8.0 days in monthly migraine days from the beginning of the double-blind period, respectively (all within-group P < .001). No new safety concerns emerged with extended treatment.

Study details: Findings are from the 9-month open-label extension of the REGAIN trial including 1022 patients with chronic migraine who completed the preceding 3-month double-blind treatment (501, 259, and 262 patients assigned to the placebo, 120 mg galcanezumab, and 240 mg galcanezumab groups, respectively) and received a 240-mg galcanezumab loading dose, followed by 120 mg in the next month and flexible dosing thereafter.

Disclosures: This study was sponsored by Eli Lilly and Company. Some authors declared receiving speaker, consultant, or advisory board member honoraria from various sources, including Eli Lilly. Two authors reported being full-time employees and minor stockholders of Eli Lilly.

Source: Pozo-Rosich P et al. Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. 2022 (Apr 8). Doi:   10.1080/03007995.2022.2059975

Key clinical point: Galcanezumab is an effective and safe long-term treatment option for chronic migraine.

Major finding: At month 12, patients in the placebo, 120 mg galcanezumab, and 240 mg galcanezumab groups showed a mean change of −8.5, −9.0, and −8.0 days in monthly migraine days from the beginning of the double-blind period, respectively (all within-group P < .001). No new safety concerns emerged with extended treatment.

Study details: Findings are from the 9-month open-label extension of the REGAIN trial including 1022 patients with chronic migraine who completed the preceding 3-month double-blind treatment (501, 259, and 262 patients assigned to the placebo, 120 mg galcanezumab, and 240 mg galcanezumab groups, respectively) and received a 240-mg galcanezumab loading dose, followed by 120 mg in the next month and flexible dosing thereafter.

Disclosures: This study was sponsored by Eli Lilly and Company. Some authors declared receiving speaker, consultant, or advisory board member honoraria from various sources, including Eli Lilly. Two authors reported being full-time employees and minor stockholders of Eli Lilly.

Source: Pozo-Rosich P et al. Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. 2022 (Apr 8). Doi:   10.1080/03007995.2022.2059975

A 35-year-old man comes to clinic for evaluation of new, severe headaches. He reports that these started 3 days ago. His headache is worse when he stands, and resolves when he lies down. Valsalva maneuver makes the headache much worse. The headaches are present in the occipital region. He also has noticed the onset of tinnitus. A physical exam reveals that his blood pressure is 110/70 mm Hg, his pulse is 60 beats per minute, and his temperature is 36.4° C. His standing BP is 105/60 mm Hg and standing pulse is 66 bpm. Both his neurologic exam and noncontrast head CT scan are normal.


Which of the following is the most likely diagnosis?

A) Subarachnoid hemorrhage

B) POTS (Postural orthostatic tachycardia syndrome)

C) Hypnic headache

D) Spontaneous intracranial hypotension (SIH)

E) Acoustic neuroma

The most likely cause for this patient’s headaches given his set of symptoms is spontaneous intracranial hypotension. Orthostatic headaches are common with POTS, but the absence of tachycardia with standing makes this diagnosis unlikely.

Spontaneous intracranial hypotension has symptoms that we are all familiar with in the post–lumbar puncture patient. In patients with post-LP headache, the positional nature makes it easy to diagnose. Patients who have had a lumbar puncture have a clear reason they have a cerebrospinal fluid (CSF) leak, leading to intracranial hypotension. Those with SIH do not.
 

Related research

Schievink summarized a lot of useful information in a review of patients with spontaneous intracranial hypotension.¹ The incidence is about 5/100,000, with the most common age around 40 years old. The most common symptom is orthostatic headache. The headache usually occurs within 15 minutes upon standing, and many patients have the onset of headache rapidly upon standing.

Usually the headache improves with lying down, and it is often brought on with Valsalva maneuver. Many patients report headaches that are worse in the second half of the day.

Orthostatic headache occurs in almost all patients with spontaneous intracranial hypotension, but in one series it occurred only in 77% of patients with SIH.² The patients who did not have typical headaches are more likely to have auditory symptoms such as tinnitus and muffled hearing.³

When you suspect SIH, appropriate workup is to start with brain MR imaging with contrast. Krantz and colleagues found dural enhancement was present in 83% of cases of SIH, venous distention sign in 75%, and brain sagging in 61%.⁴

About 10% of patients with SIH have normal brain imaging, so if the clinical features strongly suggest the diagnosis, moving on to spinal imaging with CT myelography or spinal MR are appropriate next steps.⁵

The causes of SIH are meningeal diverticula (usually in the thoracic or upper lumbar regions), ventral dural tears (usually from osteophytes), and cerebrospinal fluid–venous fistulas. Treatment of SIH has traditionally included a conservative approach of bed rest, oral hydration, and caffeine. The effectiveness of this is unknown, and, in one small series, 61% had headache symptoms at 6 months.⁶

Epidural blood patches are likely more rapidly effective than conservative therapy. In one study comparing the two treatments, Chung and colleagues found that 77% of the patients who received an epidural blood patch had complete headache relief at 4 weeks, compared with 40% of those who received conservative measures (P < .05).⁷
 

Clinical pearls

• Strongly consider SIH in patients with positional headache.
• Brain MR should be the first diagnostic test.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as 3rd-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. Schievink WI. Spontaneous spinal cerebrospinal fluid leaks and intracranial hypotension. JAMA. 2006;295:2286-96.

2. Mea E et al. Headache attributed to spontaneous intracranial hypotension. Neurol Sci. 2008;29:164-65.

3. Krantz PG et al. Spontaneous Intracranial Hypotension: 10 Myths and Misperceptions. Headache. 2018;58:948-59.

4. Krantz PG et. al. Imaging signs in spontaneous intracranial hypotension: prevalence and relationship to CSF pressure. AJNR Am J Neuroradiol. 2016;37:1374-8.

5. Krantz PG et al. Spontaneous intracranial hypotension: Pathogenesis, diagnosis, and treatment. Neuroimaging Clin N Am. 2019;29:581-94.

6. Kong D-S et. al. Clinical features and long-term results of spontaneous intracranial hypotension. Neurosurgery. 2005;57:91-6.

7. Chung SJ et al. Short- and long-term outcomes of spontaneous CSF hypovolemia. Eur Neurol. 2005;54:63-7.

A 35-year-old man comes to clinic for evaluation of new, severe headaches. He reports that these started 3 days ago. His headache is worse when he stands, and resolves when he lies down. Valsalva maneuver makes the headache much worse. The headaches are present in the occipital region. He also has noticed the onset of tinnitus. A physical exam reveals that his blood pressure is 110/70 mm Hg, his pulse is 60 beats per minute, and his temperature is 36.4° C. His standing BP is 105/60 mm Hg and standing pulse is 66 bpm. Both his neurologic exam and noncontrast head CT scan are normal.


Which of the following is the most likely diagnosis?

A) Subarachnoid hemorrhage

B) POTS (Postural orthostatic tachycardia syndrome)

C) Hypnic headache

D) Spontaneous intracranial hypotension (SIH)

E) Acoustic neuroma

The most likely cause for this patient’s headaches given his set of symptoms is spontaneous intracranial hypotension. Orthostatic headaches are common with POTS, but the absence of tachycardia with standing makes this diagnosis unlikely.

Spontaneous intracranial hypotension has symptoms that we are all familiar with in the post–lumbar puncture patient. In patients with post-LP headache, the positional nature makes it easy to diagnose. Patients who have had a lumbar puncture have a clear reason they have a cerebrospinal fluid (CSF) leak, leading to intracranial hypotension. Those with SIH do not.
 

Related research

Schievink summarized a lot of useful information in a review of patients with spontaneous intracranial hypotension.¹ The incidence is about 5/100,000, with the most common age around 40 years old. The most common symptom is orthostatic headache. The headache usually occurs within 15 minutes upon standing, and many patients have the onset of headache rapidly upon standing.

Usually the headache improves with lying down, and it is often brought on with Valsalva maneuver. Many patients report headaches that are worse in the second half of the day.

Orthostatic headache occurs in almost all patients with spontaneous intracranial hypotension, but in one series it occurred only in 77% of patients with SIH.² The patients who did not have typical headaches are more likely to have auditory symptoms such as tinnitus and muffled hearing.³

When you suspect SIH, appropriate workup is to start with brain MR imaging with contrast. Krantz and colleagues found dural enhancement was present in 83% of cases of SIH, venous distention sign in 75%, and brain sagging in 61%.⁴

About 10% of patients with SIH have normal brain imaging, so if the clinical features strongly suggest the diagnosis, moving on to spinal imaging with CT myelography or spinal MR are appropriate next steps.⁵

The causes of SIH are meningeal diverticula (usually in the thoracic or upper lumbar regions), ventral dural tears (usually from osteophytes), and cerebrospinal fluid–venous fistulas. Treatment of SIH has traditionally included a conservative approach of bed rest, oral hydration, and caffeine. The effectiveness of this is unknown, and, in one small series, 61% had headache symptoms at 6 months.⁶

Epidural blood patches are likely more rapidly effective than conservative therapy. In one study comparing the two treatments, Chung and colleagues found that 77% of the patients who received an epidural blood patch had complete headache relief at 4 weeks, compared with 40% of those who received conservative measures (P < .05).⁷
 

Clinical pearls

• Strongly consider SIH in patients with positional headache.
• Brain MR should be the first diagnostic test.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as 3rd-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. Schievink WI. Spontaneous spinal cerebrospinal fluid leaks and intracranial hypotension. JAMA. 2006;295:2286-96.

2. Mea E et al. Headache attributed to spontaneous intracranial hypotension. Neurol Sci. 2008;29:164-65.

3. Krantz PG et al. Spontaneous Intracranial Hypotension: 10 Myths and Misperceptions. Headache. 2018;58:948-59.

4. Krantz PG et. al. Imaging signs in spontaneous intracranial hypotension: prevalence and relationship to CSF pressure. AJNR Am J Neuroradiol. 2016;37:1374-8.

5. Krantz PG et al. Spontaneous intracranial hypotension: Pathogenesis, diagnosis, and treatment. Neuroimaging Clin N Am. 2019;29:581-94.

6. Kong D-S et. al. Clinical features and long-term results of spontaneous intracranial hypotension. Neurosurgery. 2005;57:91-6.

7. Chung SJ et al. Short- and long-term outcomes of spontaneous CSF hypovolemia. Eur Neurol. 2005;54:63-7.

A 35-year-old man comes to clinic for evaluation of new, severe headaches. He reports that these started 3 days ago. His headache is worse when he stands, and resolves when he lies down. Valsalva maneuver makes the headache much worse. The headaches are present in the occipital region. He also has noticed the onset of tinnitus. A physical exam reveals that his blood pressure is 110/70 mm Hg, his pulse is 60 beats per minute, and his temperature is 36.4° C. His standing BP is 105/60 mm Hg and standing pulse is 66 bpm. Both his neurologic exam and noncontrast head CT scan are normal.


Which of the following is the most likely diagnosis?

A) Subarachnoid hemorrhage

B) POTS (Postural orthostatic tachycardia syndrome)

C) Hypnic headache

D) Spontaneous intracranial hypotension (SIH)

E) Acoustic neuroma

The most likely cause for this patient’s headaches given his set of symptoms is spontaneous intracranial hypotension. Orthostatic headaches are common with POTS, but the absence of tachycardia with standing makes this diagnosis unlikely.

Spontaneous intracranial hypotension has symptoms that we are all familiar with in the post–lumbar puncture patient. In patients with post-LP headache, the positional nature makes it easy to diagnose. Patients who have had a lumbar puncture have a clear reason they have a cerebrospinal fluid (CSF) leak, leading to intracranial hypotension. Those with SIH do not.
 

Related research

Schievink summarized a lot of useful information in a review of patients with spontaneous intracranial hypotension.¹ The incidence is about 5/100,000, with the most common age around 40 years old. The most common symptom is orthostatic headache. The headache usually occurs within 15 minutes upon standing, and many patients have the onset of headache rapidly upon standing.

Usually the headache improves with lying down, and it is often brought on with Valsalva maneuver. Many patients report headaches that are worse in the second half of the day.

Orthostatic headache occurs in almost all patients with spontaneous intracranial hypotension, but in one series it occurred only in 77% of patients with SIH.² The patients who did not have typical headaches are more likely to have auditory symptoms such as tinnitus and muffled hearing.³

When you suspect SIH, appropriate workup is to start with brain MR imaging with contrast. Krantz and colleagues found dural enhancement was present in 83% of cases of SIH, venous distention sign in 75%, and brain sagging in 61%.⁴

About 10% of patients with SIH have normal brain imaging, so if the clinical features strongly suggest the diagnosis, moving on to spinal imaging with CT myelography or spinal MR are appropriate next steps.⁵

The causes of SIH are meningeal diverticula (usually in the thoracic or upper lumbar regions), ventral dural tears (usually from osteophytes), and cerebrospinal fluid–venous fistulas. Treatment of SIH has traditionally included a conservative approach of bed rest, oral hydration, and caffeine. The effectiveness of this is unknown, and, in one small series, 61% had headache symptoms at 6 months.⁶

Epidural blood patches are likely more rapidly effective than conservative therapy. In one study comparing the two treatments, Chung and colleagues found that 77% of the patients who received an epidural blood patch had complete headache relief at 4 weeks, compared with 40% of those who received conservative measures (P < .05).⁷
 

Clinical pearls

• Strongly consider SIH in patients with positional headache.
• Brain MR should be the first diagnostic test.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and serves as 3rd-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. Schievink WI. Spontaneous spinal cerebrospinal fluid leaks and intracranial hypotension. JAMA. 2006;295:2286-96.

2. Mea E et al. Headache attributed to spontaneous intracranial hypotension. Neurol Sci. 2008;29:164-65.

3. Krantz PG et al. Spontaneous Intracranial Hypotension: 10 Myths and Misperceptions. Headache. 2018;58:948-59.

4. Krantz PG et. al. Imaging signs in spontaneous intracranial hypotension: prevalence and relationship to CSF pressure. AJNR Am J Neuroradiol. 2016;37:1374-8.

5. Krantz PG et al. Spontaneous intracranial hypotension: Pathogenesis, diagnosis, and treatment. Neuroimaging Clin N Am. 2019;29:581-94.

6. Kong D-S et. al. Clinical features and long-term results of spontaneous intracranial hypotension. Neurosurgery. 2005;57:91-6.

7. Chung SJ et al. Short- and long-term outcomes of spontaneous CSF hypovolemia. Eur Neurol. 2005;54:63-7.

Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

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

Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

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

Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

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