Efficacy and safety of external concurrent occipital and trigeminal neurostimulation in migraine treatment

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Key clinical point: External concurrent occipital and trigeminal neurostimulation (eCOT-NS) was well tolerated, safe, and an effective treatment that provided fast and durable relief and freedom from pain in patients with migraine with or without aura.

Major finding: A significantly higher proportion of patients in the active vs sham eCOT-NS arm reported pain relief after 2 hours of treatment initiation (60% vs 37%; P  =  .018), freedom from pain at 2 hours after treatment initiation without any rescue medication (46% vs 12%; P < .001), and improvement in their most bothersome symptom (81% vs 60%; P  =  .047). No serious adverse events were reported.

Study details: Findings are from the RIME study, a randomized, double-blind, sham-controlled study including 187 adults with migraine with or without aura who were randomly assigned to receive active (n = 94) or sham (n = 93) eCOT-NS.

Disclosures: This study was supported by Neurolief Ltd. Several authors reported receiving research grants or honoraria or serving as consultants or advisory board members for various sources, including Neurolief Ltd.

Source: Tepper SJ et al. Migraine treatment with external concurrent occipital and trigeminal neurostimulation—A randomized controlled trial. Headache. 2022 (Jun 24). Doi:  10.1111/head.14350

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Key clinical point: External concurrent occipital and trigeminal neurostimulation (eCOT-NS) was well tolerated, safe, and an effective treatment that provided fast and durable relief and freedom from pain in patients with migraine with or without aura.

Major finding: A significantly higher proportion of patients in the active vs sham eCOT-NS arm reported pain relief after 2 hours of treatment initiation (60% vs 37%; P  =  .018), freedom from pain at 2 hours after treatment initiation without any rescue medication (46% vs 12%; P < .001), and improvement in their most bothersome symptom (81% vs 60%; P  =  .047). No serious adverse events were reported.

Study details: Findings are from the RIME study, a randomized, double-blind, sham-controlled study including 187 adults with migraine with or without aura who were randomly assigned to receive active (n = 94) or sham (n = 93) eCOT-NS.

Disclosures: This study was supported by Neurolief Ltd. Several authors reported receiving research grants or honoraria or serving as consultants or advisory board members for various sources, including Neurolief Ltd.

Source: Tepper SJ et al. Migraine treatment with external concurrent occipital and trigeminal neurostimulation—A randomized controlled trial. Headache. 2022 (Jun 24). Doi:  10.1111/head.14350

Key clinical point: External concurrent occipital and trigeminal neurostimulation (eCOT-NS) was well tolerated, safe, and an effective treatment that provided fast and durable relief and freedom from pain in patients with migraine with or without aura.

Major finding: A significantly higher proportion of patients in the active vs sham eCOT-NS arm reported pain relief after 2 hours of treatment initiation (60% vs 37%; P  =  .018), freedom from pain at 2 hours after treatment initiation without any rescue medication (46% vs 12%; P < .001), and improvement in their most bothersome symptom (81% vs 60%; P  =  .047). No serious adverse events were reported.

Study details: Findings are from the RIME study, a randomized, double-blind, sham-controlled study including 187 adults with migraine with or without aura who were randomly assigned to receive active (n = 94) or sham (n = 93) eCOT-NS.

Disclosures: This study was supported by Neurolief Ltd. Several authors reported receiving research grants or honoraria or serving as consultants or advisory board members for various sources, including Neurolief Ltd.

Source: Tepper SJ et al. Migraine treatment with external concurrent occipital and trigeminal neurostimulation—A randomized controlled trial. Headache. 2022 (Jun 24). Doi:  10.1111/head.14350

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Vitamin D3 supplementation to topiramate therapy shows promise for pediatric migraine

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Key clinical point: Vitamin D3 (5000 IU daily) supplementation as an adjuvant therapy to topiramate was well tolerated and safe, and an effective strategy for pediatric migraine prophylaxis.

Major finding: After 16 weeks of treatment, the monthly headache frequency (6.23 vs 9.79 attacks/month; P  =  .01) and disability from headache score (17.56 vs 25.18; P  =  .04) were significantly lower in the vitamin D3 supplementation vs placebo group, with >50% decrease in the monthly headache attack frequency being reported by a significantly higher proportion of patients receiving vitamin D3 supplementation vs placebo (75.0% vs 53.5%; P  =  .01) and no serious adverse events being reported.

Study details: The findings are from a double-blind, prospective case-control study including 60 children and adolescents (aged 5-14 years) with migraine who were randomly assigned to receive topiramate with vitamin D3 supplementation or placebo.

Disclosures: This study did not receive any financial support. The authors declared no competing interests.

Source: Elmala MK et al. The impact of vitamin D3 supplementation to topiramate therapy on pediatric migraine prophylaxis. J Child Neurol. 2022 (Jun 22). Doi: 10.1177/08830738221092882

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Key clinical point: Vitamin D3 (5000 IU daily) supplementation as an adjuvant therapy to topiramate was well tolerated and safe, and an effective strategy for pediatric migraine prophylaxis.

Major finding: After 16 weeks of treatment, the monthly headache frequency (6.23 vs 9.79 attacks/month; P  =  .01) and disability from headache score (17.56 vs 25.18; P  =  .04) were significantly lower in the vitamin D3 supplementation vs placebo group, with >50% decrease in the monthly headache attack frequency being reported by a significantly higher proportion of patients receiving vitamin D3 supplementation vs placebo (75.0% vs 53.5%; P  =  .01) and no serious adverse events being reported.

Study details: The findings are from a double-blind, prospective case-control study including 60 children and adolescents (aged 5-14 years) with migraine who were randomly assigned to receive topiramate with vitamin D3 supplementation or placebo.

Disclosures: This study did not receive any financial support. The authors declared no competing interests.

Source: Elmala MK et al. The impact of vitamin D3 supplementation to topiramate therapy on pediatric migraine prophylaxis. J Child Neurol. 2022 (Jun 22). Doi: 10.1177/08830738221092882

Key clinical point: Vitamin D3 (5000 IU daily) supplementation as an adjuvant therapy to topiramate was well tolerated and safe, and an effective strategy for pediatric migraine prophylaxis.

Major finding: After 16 weeks of treatment, the monthly headache frequency (6.23 vs 9.79 attacks/month; P  =  .01) and disability from headache score (17.56 vs 25.18; P  =  .04) were significantly lower in the vitamin D3 supplementation vs placebo group, with >50% decrease in the monthly headache attack frequency being reported by a significantly higher proportion of patients receiving vitamin D3 supplementation vs placebo (75.0% vs 53.5%; P  =  .01) and no serious adverse events being reported.

Study details: The findings are from a double-blind, prospective case-control study including 60 children and adolescents (aged 5-14 years) with migraine who were randomly assigned to receive topiramate with vitamin D3 supplementation or placebo.

Disclosures: This study did not receive any financial support. The authors declared no competing interests.

Source: Elmala MK et al. The impact of vitamin D3 supplementation to topiramate therapy on pediatric migraine prophylaxis. J Child Neurol. 2022 (Jun 22). Doi: 10.1177/08830738221092882

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Acute migraine: Favorable safety profile of oral CGRP receptor antagonists vs triptans

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Key clinical point: Oral calcitonin gene-related peptide (CGRP) receptor antagonists appeared to be safer and better tolerated than triptans for the treatment of acute migraine and could be a viable option for patients who experience overall triptan-associated adverse events (AE).

Major finding: Oral CGRP receptor antagonists were safer than triptans in terms of any AE (risk ratio [RR] 0.78; P  =  .03) and treatment-related AE (RR 0.68; P < .00001), with the incidence of dizziness (RR 0.69; P  =  .01), dry mouth (RR 0.72; P  =  .02), fatigue (RR 0.52; P  =  .001), paresthesia (RR 0.34; P < .0001), and somnolence (RR 0.65; P  =  .004) being lower with oral CGRP receptor antagonists vs triptans.

Study details: The data come from a meta-analysis of 15 trials including 13,270 patients who received oral CGRP receptor antagonists (n = 8240), placebo (n = 4253), or triptans (n = 777) for the treatment of acute migraine.

Disclosures: This study was funded by a National Research Foundation of Korea grant funded by the Korea government. The authors declared no competing interests.

Source: Lee S et al. Safety evaluation of oral calcitonin-gene–related peptide receptor antagonists in patients with acute migraine: A systematic review and meta-analysis. Eur J Clin Pharmacol. 2022 (Jun 22). Doi: 10.1007/s00228-022-03347-6

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Key clinical point: Oral calcitonin gene-related peptide (CGRP) receptor antagonists appeared to be safer and better tolerated than triptans for the treatment of acute migraine and could be a viable option for patients who experience overall triptan-associated adverse events (AE).

Major finding: Oral CGRP receptor antagonists were safer than triptans in terms of any AE (risk ratio [RR] 0.78; P  =  .03) and treatment-related AE (RR 0.68; P < .00001), with the incidence of dizziness (RR 0.69; P  =  .01), dry mouth (RR 0.72; P  =  .02), fatigue (RR 0.52; P  =  .001), paresthesia (RR 0.34; P < .0001), and somnolence (RR 0.65; P  =  .004) being lower with oral CGRP receptor antagonists vs triptans.

Study details: The data come from a meta-analysis of 15 trials including 13,270 patients who received oral CGRP receptor antagonists (n = 8240), placebo (n = 4253), or triptans (n = 777) for the treatment of acute migraine.

Disclosures: This study was funded by a National Research Foundation of Korea grant funded by the Korea government. The authors declared no competing interests.

Source: Lee S et al. Safety evaluation of oral calcitonin-gene–related peptide receptor antagonists in patients with acute migraine: A systematic review and meta-analysis. Eur J Clin Pharmacol. 2022 (Jun 22). Doi: 10.1007/s00228-022-03347-6

Key clinical point: Oral calcitonin gene-related peptide (CGRP) receptor antagonists appeared to be safer and better tolerated than triptans for the treatment of acute migraine and could be a viable option for patients who experience overall triptan-associated adverse events (AE).

Major finding: Oral CGRP receptor antagonists were safer than triptans in terms of any AE (risk ratio [RR] 0.78; P  =  .03) and treatment-related AE (RR 0.68; P < .00001), with the incidence of dizziness (RR 0.69; P  =  .01), dry mouth (RR 0.72; P  =  .02), fatigue (RR 0.52; P  =  .001), paresthesia (RR 0.34; P < .0001), and somnolence (RR 0.65; P  =  .004) being lower with oral CGRP receptor antagonists vs triptans.

Study details: The data come from a meta-analysis of 15 trials including 13,270 patients who received oral CGRP receptor antagonists (n = 8240), placebo (n = 4253), or triptans (n = 777) for the treatment of acute migraine.

Disclosures: This study was funded by a National Research Foundation of Korea grant funded by the Korea government. The authors declared no competing interests.

Source: Lee S et al. Safety evaluation of oral calcitonin-gene–related peptide receptor antagonists in patients with acute migraine: A systematic review and meta-analysis. Eur J Clin Pharmacol. 2022 (Jun 22). Doi: 10.1007/s00228-022-03347-6

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Levetiracetam shows some potential as prophylactic treatment of episodic migraine

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Key clinical point: Levetiracetam reduced attack frequency, headache days, and days with acute drug intake as the prophylactic treatment for episodic migraine along with an overall tolerable safety profile.

Major finding: During the last 4 weeks of treatment, levetiracetam significantly reduced the number of migraine attacks (P < .001), days with migraine (P  =  .001), and use of acute drugs for migraine attack (P < .001), with 46.0% of patients showing at least 50% reduction in migraine attack frequency and the mean number of migraine attacks decreasing from 5.2 ± 2.1 to 3.4 ± 2.7.

Study details: The data come from a prospective, open-label study including 50 patients with episodic migraine who received 1000 mg levetiracetam (starting dose 500 mg) twice a day for 12 weeks.

Disclosures: This study was supported by UCB Chemie GmbH Germany. Some authors declared serving as consultants for various sources.

Source: Evers S et al. Levetiracetam in the prophylactic treatment of episodic migraine: A prospective open label study. Cephalalgia. 2022 (May 27). Doi: 10.1177/03331024221103815

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Key clinical point: Levetiracetam reduced attack frequency, headache days, and days with acute drug intake as the prophylactic treatment for episodic migraine along with an overall tolerable safety profile.

Major finding: During the last 4 weeks of treatment, levetiracetam significantly reduced the number of migraine attacks (P < .001), days with migraine (P  =  .001), and use of acute drugs for migraine attack (P < .001), with 46.0% of patients showing at least 50% reduction in migraine attack frequency and the mean number of migraine attacks decreasing from 5.2 ± 2.1 to 3.4 ± 2.7.

Study details: The data come from a prospective, open-label study including 50 patients with episodic migraine who received 1000 mg levetiracetam (starting dose 500 mg) twice a day for 12 weeks.

Disclosures: This study was supported by UCB Chemie GmbH Germany. Some authors declared serving as consultants for various sources.

Source: Evers S et al. Levetiracetam in the prophylactic treatment of episodic migraine: A prospective open label study. Cephalalgia. 2022 (May 27). Doi: 10.1177/03331024221103815

Key clinical point: Levetiracetam reduced attack frequency, headache days, and days with acute drug intake as the prophylactic treatment for episodic migraine along with an overall tolerable safety profile.

Major finding: During the last 4 weeks of treatment, levetiracetam significantly reduced the number of migraine attacks (P < .001), days with migraine (P  =  .001), and use of acute drugs for migraine attack (P < .001), with 46.0% of patients showing at least 50% reduction in migraine attack frequency and the mean number of migraine attacks decreasing from 5.2 ± 2.1 to 3.4 ± 2.7.

Study details: The data come from a prospective, open-label study including 50 patients with episodic migraine who received 1000 mg levetiracetam (starting dose 500 mg) twice a day for 12 weeks.

Disclosures: This study was supported by UCB Chemie GmbH Germany. Some authors declared serving as consultants for various sources.

Source: Evers S et al. Levetiracetam in the prophylactic treatment of episodic migraine: A prospective open label study. Cephalalgia. 2022 (May 27). Doi: 10.1177/03331024221103815

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Atogepant safe and effective for prevention of episodic migraine

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Key clinical point: Once-daily oral atogepant was overall safe and effective for the prevention of episodic migraine in adults.

Major finding: The reduction in the mean number of migraine days across the 12-week treatment period was significantly greater with 10 mg atogepant (mean difference [MD] 1.16; P < .001), 30 mg (MD 1.15; P < .001), or 60 mg (MD 1.20; P  =  .016) vs placebo. Overall, the relative risk for any adverse event with atogepant vs placebo treatment was 1.07 (P  =  .630).

Study details: The data come from a systematic review and meta-analysis of 2 randomized controlled trials including 1550 patients with episodic migraine who were randomly assigned to receive 10 mg atopegant (n = 314), 30 mg atogepant (n = 411), 60 mg atopegant (n = 417), or placebo (n = 408).

Disclosures: This study did not receive any funding. Some authors declared receiving grants or serving as speakers, consultants, or on advisory boards for various sources.

Source: Lattanzi S et al. Atogepant for the prevention of episodic migraine in adults: A systematic review and meta-analysis of efficacy and safety. Neurol Ther. 2022 (Jun 15). Doi:  10.1007/s40120-022-00370-8

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Key clinical point: Once-daily oral atogepant was overall safe and effective for the prevention of episodic migraine in adults.

Major finding: The reduction in the mean number of migraine days across the 12-week treatment period was significantly greater with 10 mg atogepant (mean difference [MD] 1.16; P < .001), 30 mg (MD 1.15; P < .001), or 60 mg (MD 1.20; P  =  .016) vs placebo. Overall, the relative risk for any adverse event with atogepant vs placebo treatment was 1.07 (P  =  .630).

Study details: The data come from a systematic review and meta-analysis of 2 randomized controlled trials including 1550 patients with episodic migraine who were randomly assigned to receive 10 mg atopegant (n = 314), 30 mg atogepant (n = 411), 60 mg atopegant (n = 417), or placebo (n = 408).

Disclosures: This study did not receive any funding. Some authors declared receiving grants or serving as speakers, consultants, or on advisory boards for various sources.

Source: Lattanzi S et al. Atogepant for the prevention of episodic migraine in adults: A systematic review and meta-analysis of efficacy and safety. Neurol Ther. 2022 (Jun 15). Doi:  10.1007/s40120-022-00370-8

Key clinical point: Once-daily oral atogepant was overall safe and effective for the prevention of episodic migraine in adults.

Major finding: The reduction in the mean number of migraine days across the 12-week treatment period was significantly greater with 10 mg atogepant (mean difference [MD] 1.16; P < .001), 30 mg (MD 1.15; P < .001), or 60 mg (MD 1.20; P  =  .016) vs placebo. Overall, the relative risk for any adverse event with atogepant vs placebo treatment was 1.07 (P  =  .630).

Study details: The data come from a systematic review and meta-analysis of 2 randomized controlled trials including 1550 patients with episodic migraine who were randomly assigned to receive 10 mg atopegant (n = 314), 30 mg atogepant (n = 411), 60 mg atopegant (n = 417), or placebo (n = 408).

Disclosures: This study did not receive any funding. Some authors declared receiving grants or serving as speakers, consultants, or on advisory boards for various sources.

Source: Lattanzi S et al. Atogepant for the prevention of episodic migraine in adults: A systematic review and meta-analysis of efficacy and safety. Neurol Ther. 2022 (Jun 15). Doi:  10.1007/s40120-022-00370-8

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CGRP and PACAP-38 as effective biomarkers for pediatric migraine

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Key clinical point: Calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) could serve as effective diagnostic biomarkers for pediatric migraine.

Major finding: The plasma levels of CGRP and PACAP-38 were significantly higher in patients with migraine in the ictal and interictal periods and with and without aura compared with healthy controls (P < .001), with PACAP-38 (adjusted odds ratio [aOR] 1.331; P < .001) and CGRP (aOR 1.113; P < .001) being independent risk factors for the diagnosis of pediatric migraine.

Study details: This was a prospective study of 76 patients aged 4-18 years with migraine and 77 age-matched healthy controls.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Liu J et al. CGRP and PACAP-38 play an important role in diagnosing pediatric migraine. J Headache Pain. 2022;23:68 (Jun 13). Doi: 10.1186/s10194-022-01435-7

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Key clinical point: Calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) could serve as effective diagnostic biomarkers for pediatric migraine.

Major finding: The plasma levels of CGRP and PACAP-38 were significantly higher in patients with migraine in the ictal and interictal periods and with and without aura compared with healthy controls (P < .001), with PACAP-38 (adjusted odds ratio [aOR] 1.331; P < .001) and CGRP (aOR 1.113; P < .001) being independent risk factors for the diagnosis of pediatric migraine.

Study details: This was a prospective study of 76 patients aged 4-18 years with migraine and 77 age-matched healthy controls.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Liu J et al. CGRP and PACAP-38 play an important role in diagnosing pediatric migraine. J Headache Pain. 2022;23:68 (Jun 13). Doi: 10.1186/s10194-022-01435-7

Key clinical point: Calcitonin gene-related peptide (CGRP) and pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) could serve as effective diagnostic biomarkers for pediatric migraine.

Major finding: The plasma levels of CGRP and PACAP-38 were significantly higher in patients with migraine in the ictal and interictal periods and with and without aura compared with healthy controls (P < .001), with PACAP-38 (adjusted odds ratio [aOR] 1.331; P < .001) and CGRP (aOR 1.113; P < .001) being independent risk factors for the diagnosis of pediatric migraine.

Study details: This was a prospective study of 76 patients aged 4-18 years with migraine and 77 age-matched healthy controls.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Liu J et al. CGRP and PACAP-38 play an important role in diagnosing pediatric migraine. J Headache Pain. 2022;23:68 (Jun 13). Doi: 10.1186/s10194-022-01435-7

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Presence of migraine and ocular motor cranial nerve palsy: Is there a link?

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Key clinical point: Migraine was significantly associated with the incidence of ocular motor cranial nerve palsy (OMCNP), with the risk being particularly high among patients with migraine who smoked or had diabetes mellitus.

 

Major finding: The incidence of OMCNP was significantly higher in patients with vs without migraine (adjusted hazard ratio [aHR] 1.166; 95% CI 1.013-1.343), with the association being strongest among those who smoked (aHR 1.426; 95% CI 1.127-1.803) and had diabetes mellitus (aHR 1.378; 95% CI 1.045-1.378).

 

Study details: This was a population-based, observational, retrospective cohort study including 4,053,824 medical beneficiaries; of which 5806 developed OMCNP and 4,048,018 did not develop OMCNP (control population). A subgroup of 111,853 patients had migraine.

 

Disclosures: This study was supported by a National Research Foundation of Korea grant funded by the Korea government and others. The authors declared no conflicts of interest.

 

Source: Rhiu S et al. Association between migraine and risk of ocular motor cranial nerve palsy. Sci Rep. 2022;12:10512 (Jun 22). Doi: 10.1038/s41598-022-14621-z

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Key clinical point: Migraine was significantly associated with the incidence of ocular motor cranial nerve palsy (OMCNP), with the risk being particularly high among patients with migraine who smoked or had diabetes mellitus.

 

Major finding: The incidence of OMCNP was significantly higher in patients with vs without migraine (adjusted hazard ratio [aHR] 1.166; 95% CI 1.013-1.343), with the association being strongest among those who smoked (aHR 1.426; 95% CI 1.127-1.803) and had diabetes mellitus (aHR 1.378; 95% CI 1.045-1.378).

 

Study details: This was a population-based, observational, retrospective cohort study including 4,053,824 medical beneficiaries; of which 5806 developed OMCNP and 4,048,018 did not develop OMCNP (control population). A subgroup of 111,853 patients had migraine.

 

Disclosures: This study was supported by a National Research Foundation of Korea grant funded by the Korea government and others. The authors declared no conflicts of interest.

 

Source: Rhiu S et al. Association between migraine and risk of ocular motor cranial nerve palsy. Sci Rep. 2022;12:10512 (Jun 22). Doi: 10.1038/s41598-022-14621-z

Key clinical point: Migraine was significantly associated with the incidence of ocular motor cranial nerve palsy (OMCNP), with the risk being particularly high among patients with migraine who smoked or had diabetes mellitus.

 

Major finding: The incidence of OMCNP was significantly higher in patients with vs without migraine (adjusted hazard ratio [aHR] 1.166; 95% CI 1.013-1.343), with the association being strongest among those who smoked (aHR 1.426; 95% CI 1.127-1.803) and had diabetes mellitus (aHR 1.378; 95% CI 1.045-1.378).

 

Study details: This was a population-based, observational, retrospective cohort study including 4,053,824 medical beneficiaries; of which 5806 developed OMCNP and 4,048,018 did not develop OMCNP (control population). A subgroup of 111,853 patients had migraine.

 

Disclosures: This study was supported by a National Research Foundation of Korea grant funded by the Korea government and others. The authors declared no conflicts of interest.

 

Source: Rhiu S et al. Association between migraine and risk of ocular motor cranial nerve palsy. Sci Rep. 2022;12:10512 (Jun 22). Doi: 10.1038/s41598-022-14621-z

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Migraine: Efficacy outcomes and adverse effects of lasmiditan are highly interlinked

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Key clinical point: Treatment of a single migraine attack with 200 mg lasmiditan demonstrated a strong association between achieving freedom from pain and central nervous system common treatment-emergent adverse events (CTEAE).

 

Major finding: Significantly higher proportion of patients treated with 200 mg lasmiditan who were pain-free vs those who experienced moderate-to-severe pain at 2 hours post-dose reported 1 CTEAE (48.2% vs 28.7%; P < .001). A significantly higher proportion of patients reporting 1 vs 0 CTEAE were pain-free at 2 hours (39.0% vs 30.2%; P < .001). However, the absence of CTAE did not translate to the lack of efficacy.

 

Study details: This was a post hoc analysis of 4 randomized phase 2/3 trials including 6602 patients with migraine with or without aura who received lasmiditan (50, 100, or 200 mg) or placebo.

 

Disclosures: This study was funded by Eli Lilly and Company. Six authors reported being employees and minor stockholders of Eli Lilly. RB Lipton reported ties with Eli Lilly and other sources and owning stock or stock options in 3 companies.

 

Source: Doty EG et al. The association between the occurrence of common treatment-emergent adverse events and efficacy outcomes after lasmiditan treatment of a single migraine attack: Secondary analyses from four pooled randomized clinical trials. CNS Drugs. 2022;36:771–783 (Jul 2). Doi: 10.1007/s40263-022-00928-y

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Key clinical point: Treatment of a single migraine attack with 200 mg lasmiditan demonstrated a strong association between achieving freedom from pain and central nervous system common treatment-emergent adverse events (CTEAE).

 

Major finding: Significantly higher proportion of patients treated with 200 mg lasmiditan who were pain-free vs those who experienced moderate-to-severe pain at 2 hours post-dose reported 1 CTEAE (48.2% vs 28.7%; P < .001). A significantly higher proportion of patients reporting 1 vs 0 CTEAE were pain-free at 2 hours (39.0% vs 30.2%; P < .001). However, the absence of CTAE did not translate to the lack of efficacy.

 

Study details: This was a post hoc analysis of 4 randomized phase 2/3 trials including 6602 patients with migraine with or without aura who received lasmiditan (50, 100, or 200 mg) or placebo.

 

Disclosures: This study was funded by Eli Lilly and Company. Six authors reported being employees and minor stockholders of Eli Lilly. RB Lipton reported ties with Eli Lilly and other sources and owning stock or stock options in 3 companies.

 

Source: Doty EG et al. The association between the occurrence of common treatment-emergent adverse events and efficacy outcomes after lasmiditan treatment of a single migraine attack: Secondary analyses from four pooled randomized clinical trials. CNS Drugs. 2022;36:771–783 (Jul 2). Doi: 10.1007/s40263-022-00928-y

Key clinical point: Treatment of a single migraine attack with 200 mg lasmiditan demonstrated a strong association between achieving freedom from pain and central nervous system common treatment-emergent adverse events (CTEAE).

 

Major finding: Significantly higher proportion of patients treated with 200 mg lasmiditan who were pain-free vs those who experienced moderate-to-severe pain at 2 hours post-dose reported 1 CTEAE (48.2% vs 28.7%; P < .001). A significantly higher proportion of patients reporting 1 vs 0 CTEAE were pain-free at 2 hours (39.0% vs 30.2%; P < .001). However, the absence of CTAE did not translate to the lack of efficacy.

 

Study details: This was a post hoc analysis of 4 randomized phase 2/3 trials including 6602 patients with migraine with or without aura who received lasmiditan (50, 100, or 200 mg) or placebo.

 

Disclosures: This study was funded by Eli Lilly and Company. Six authors reported being employees and minor stockholders of Eli Lilly. RB Lipton reported ties with Eli Lilly and other sources and owning stock or stock options in 3 companies.

 

Source: Doty EG et al. The association between the occurrence of common treatment-emergent adverse events and efficacy outcomes after lasmiditan treatment of a single migraine attack: Secondary analyses from four pooled randomized clinical trials. CNS Drugs. 2022;36:771–783 (Jul 2). Doi: 10.1007/s40263-022-00928-y

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Galcanezumab leads to conversion from chronic to episodic migraine in real world

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Key clinical point: Long-term treatment with galcanezumab led to three-quarters of patients with chronic migraine (CM) reverting to episodic migraine (EM), with more than half persistently reverting to episodic migraine (EM) under real-life conditions.

 

Major finding: Over 1 year, approximately 75% of patients reverted from CM to EM at each visit, with persistent reversion from CM to EM and medium-to-low frequency EM being reported by 52.3% and 20.6% of patients, respectively. Older age at onset (P  =  .01) and less frequent baseline monthly migraine days (P  =  .005) significantly increased the reversion frequency to EM.

 

Study details: Findings are from a 12-month observational, longitudinal cohort study, GARLIT, including 155 patients with CM who received galcanezumab.

 

Disclosures: This study did not receive any specific funding. Several authors reported receiving grants or honoraria from various sources.

 

Source: Altamura C et al for the GARLIT Study Group. Conversion from chronic to episodic migraine in patients treated with galcanezumab in real life in Italy: The 12-month observational, longitudinal, cohort multicenter GARLIT experience. J Neurol. 2022 (Jun 28). Doi: 10.1007/s00415-022-11226-4

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Key clinical point: Long-term treatment with galcanezumab led to three-quarters of patients with chronic migraine (CM) reverting to episodic migraine (EM), with more than half persistently reverting to episodic migraine (EM) under real-life conditions.

 

Major finding: Over 1 year, approximately 75% of patients reverted from CM to EM at each visit, with persistent reversion from CM to EM and medium-to-low frequency EM being reported by 52.3% and 20.6% of patients, respectively. Older age at onset (P  =  .01) and less frequent baseline monthly migraine days (P  =  .005) significantly increased the reversion frequency to EM.

 

Study details: Findings are from a 12-month observational, longitudinal cohort study, GARLIT, including 155 patients with CM who received galcanezumab.

 

Disclosures: This study did not receive any specific funding. Several authors reported receiving grants or honoraria from various sources.

 

Source: Altamura C et al for the GARLIT Study Group. Conversion from chronic to episodic migraine in patients treated with galcanezumab in real life in Italy: The 12-month observational, longitudinal, cohort multicenter GARLIT experience. J Neurol. 2022 (Jun 28). Doi: 10.1007/s00415-022-11226-4

Key clinical point: Long-term treatment with galcanezumab led to three-quarters of patients with chronic migraine (CM) reverting to episodic migraine (EM), with more than half persistently reverting to episodic migraine (EM) under real-life conditions.

 

Major finding: Over 1 year, approximately 75% of patients reverted from CM to EM at each visit, with persistent reversion from CM to EM and medium-to-low frequency EM being reported by 52.3% and 20.6% of patients, respectively. Older age at onset (P  =  .01) and less frequent baseline monthly migraine days (P  =  .005) significantly increased the reversion frequency to EM.

 

Study details: Findings are from a 12-month observational, longitudinal cohort study, GARLIT, including 155 patients with CM who received galcanezumab.

 

Disclosures: This study did not receive any specific funding. Several authors reported receiving grants or honoraria from various sources.

 

Source: Altamura C et al for the GARLIT Study Group. Conversion from chronic to episodic migraine in patients treated with galcanezumab in real life in Italy: The 12-month observational, longitudinal, cohort multicenter GARLIT experience. J Neurol. 2022 (Jun 28). Doi: 10.1007/s00415-022-11226-4

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Significant preventive effects of eptinezumab in patients with previous unsuccessful migraine treatment

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Key clinical point: Eptinezumab (100 and 300 mg) was efficacious compared with placebo with an acceptable safety and tolerability profile in patients with episodic and chronic migraine and 2-4 previous unsuccessful preventive treatments.

 

Major finding: In 1-12 weeks, 100 and 300 mg eptinezumab vs placebo led to a significantly higher reduction in mean monthly migraine days (difference from placebo 2.7 and 3.2, respectively; both P < .0001) and higher odds of 75% migraine responder rates (odds ratio 9.2 and 11.4, respectively; both P < .0001), with comparable treatment-emergent adverse events.

 

Study details: Findings are from the phase 3b DELIVER trial including 892 patients with episodic and chronic migraine and 2-4 previous unsuccessful preventive treatments who were randomly assigned to receive eptinezumab (100 or 300 mg) or placebo.

 

Disclosures: This study was supported by H Lundbeck. Five authors reported being full-time employees or owning stock or stock options in H Lundbeck or its subsidiaries. Several authors reported ties with various sources and scientific journals.

 

Source: Ashina M et al. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): A multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022;21(7):597-607 (Jul 1). Doi: 10.1016/S1474-4422(22)00185-5

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Key clinical point: Eptinezumab (100 and 300 mg) was efficacious compared with placebo with an acceptable safety and tolerability profile in patients with episodic and chronic migraine and 2-4 previous unsuccessful preventive treatments.

 

Major finding: In 1-12 weeks, 100 and 300 mg eptinezumab vs placebo led to a significantly higher reduction in mean monthly migraine days (difference from placebo 2.7 and 3.2, respectively; both P < .0001) and higher odds of 75% migraine responder rates (odds ratio 9.2 and 11.4, respectively; both P < .0001), with comparable treatment-emergent adverse events.

 

Study details: Findings are from the phase 3b DELIVER trial including 892 patients with episodic and chronic migraine and 2-4 previous unsuccessful preventive treatments who were randomly assigned to receive eptinezumab (100 or 300 mg) or placebo.

 

Disclosures: This study was supported by H Lundbeck. Five authors reported being full-time employees or owning stock or stock options in H Lundbeck or its subsidiaries. Several authors reported ties with various sources and scientific journals.

 

Source: Ashina M et al. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): A multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022;21(7):597-607 (Jul 1). Doi: 10.1016/S1474-4422(22)00185-5

Key clinical point: Eptinezumab (100 and 300 mg) was efficacious compared with placebo with an acceptable safety and tolerability profile in patients with episodic and chronic migraine and 2-4 previous unsuccessful preventive treatments.

 

Major finding: In 1-12 weeks, 100 and 300 mg eptinezumab vs placebo led to a significantly higher reduction in mean monthly migraine days (difference from placebo 2.7 and 3.2, respectively; both P < .0001) and higher odds of 75% migraine responder rates (odds ratio 9.2 and 11.4, respectively; both P < .0001), with comparable treatment-emergent adverse events.

 

Study details: Findings are from the phase 3b DELIVER trial including 892 patients with episodic and chronic migraine and 2-4 previous unsuccessful preventive treatments who were randomly assigned to receive eptinezumab (100 or 300 mg) or placebo.

 

Disclosures: This study was supported by H Lundbeck. Five authors reported being full-time employees or owning stock or stock options in H Lundbeck or its subsidiaries. Several authors reported ties with various sources and scientific journals.

 

Source: Ashina M et al. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): A multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022;21(7):597-607 (Jul 1). Doi: 10.1016/S1474-4422(22)00185-5

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