Tirzepatide vs. insulin glargine improves renal outcomes in T2D

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Key clinical point: Once-weekly tirzepatide vs. insulin glargine slowed estimated glomerular filtration rate (eGFR) decline, and reduced urine albumin-creatinine ratio (UACR) and the risk for composite kidney outcomes in patients with type 2 diabetes (T2D) with varying degrees of chronic kidney disease and high cardiovascular risk.

 

Major finding: Combined tirzepatide vs. insulin glargine was associated with slower annual rates of eGFR decline (between-group difference [Δ], 2.2 [95% CI, 1.6-2.8] mL/min per 1.73 m²) and reduced UACR increase (Δ, 31.9%; 95% CI, 37.7% to 25.7%) and risk for composite kidney outcomes (hazard ratio, 0.58; 95% CI, 0.43-0.80).

 

Study details: This was a post hoc analysis of SURPASS-4 trial including 2,002 patients with T2D and high cardiovascular risk who were randomly assigned to receive once-weekly tirzepatide (5, 10, or 15 mg; n=997) or insulin glargine (n=1,005).

 

Disclosures: This study was funded by Eli Lilly and Company. Some authors declared receiving research grants, contract support, payment/honoraria for speaking, and/or consulting fees from various sources, including Eli Lilly. Some authors declared being employees and shareholders of Eli Lilly.

 

Source: Heerspink HJL et al. Effects of tirzepatide versus insulin glargine on kidney outcomes in type 2 diabetes in the SURPASS-4 trial: Post-hoc analysis of an open-label, randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2022 (Sep 21). Doi: 10.1016/S2213-8587(22)00243-1.

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Key clinical point: Once-weekly tirzepatide vs. insulin glargine slowed estimated glomerular filtration rate (eGFR) decline, and reduced urine albumin-creatinine ratio (UACR) and the risk for composite kidney outcomes in patients with type 2 diabetes (T2D) with varying degrees of chronic kidney disease and high cardiovascular risk.

 

Major finding: Combined tirzepatide vs. insulin glargine was associated with slower annual rates of eGFR decline (between-group difference [Δ], 2.2 [95% CI, 1.6-2.8] mL/min per 1.73 m²) and reduced UACR increase (Δ, 31.9%; 95% CI, 37.7% to 25.7%) and risk for composite kidney outcomes (hazard ratio, 0.58; 95% CI, 0.43-0.80).

 

Study details: This was a post hoc analysis of SURPASS-4 trial including 2,002 patients with T2D and high cardiovascular risk who were randomly assigned to receive once-weekly tirzepatide (5, 10, or 15 mg; n=997) or insulin glargine (n=1,005).

 

Disclosures: This study was funded by Eli Lilly and Company. Some authors declared receiving research grants, contract support, payment/honoraria for speaking, and/or consulting fees from various sources, including Eli Lilly. Some authors declared being employees and shareholders of Eli Lilly.

 

Source: Heerspink HJL et al. Effects of tirzepatide versus insulin glargine on kidney outcomes in type 2 diabetes in the SURPASS-4 trial: Post-hoc analysis of an open-label, randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2022 (Sep 21). Doi: 10.1016/S2213-8587(22)00243-1.

Key clinical point: Once-weekly tirzepatide vs. insulin glargine slowed estimated glomerular filtration rate (eGFR) decline, and reduced urine albumin-creatinine ratio (UACR) and the risk for composite kidney outcomes in patients with type 2 diabetes (T2D) with varying degrees of chronic kidney disease and high cardiovascular risk.

 

Major finding: Combined tirzepatide vs. insulin glargine was associated with slower annual rates of eGFR decline (between-group difference [Δ], 2.2 [95% CI, 1.6-2.8] mL/min per 1.73 m²) and reduced UACR increase (Δ, 31.9%; 95% CI, 37.7% to 25.7%) and risk for composite kidney outcomes (hazard ratio, 0.58; 95% CI, 0.43-0.80).

 

Study details: This was a post hoc analysis of SURPASS-4 trial including 2,002 patients with T2D and high cardiovascular risk who were randomly assigned to receive once-weekly tirzepatide (5, 10, or 15 mg; n=997) or insulin glargine (n=1,005).

 

Disclosures: This study was funded by Eli Lilly and Company. Some authors declared receiving research grants, contract support, payment/honoraria for speaking, and/or consulting fees from various sources, including Eli Lilly. Some authors declared being employees and shareholders of Eli Lilly.

 

Source: Heerspink HJL et al. Effects of tirzepatide versus insulin glargine on kidney outcomes in type 2 diabetes in the SURPASS-4 trial: Post-hoc analysis of an open-label, randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2022 (Sep 21). Doi: 10.1016/S2213-8587(22)00243-1.

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Meta-analysis evaluates safety and efficacy of cinnarizine in migraine

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Key clinical point: Cinnarizine appeared safe and effective in migraine prophylaxis, with cinnarizine-treated patients reporting significant improvements in migraine frequency and severity.

 

Major finding: Over 12 weeks, cinnarizine vs placebo significantly improved the frequency (overall mean difference [OMD] 3.10; P < .001) and intensity (OMD 1.54; P < .001) of migraine attacks per month; additionally, patients receiving cinnarizine showed better improvements in migraine intensity compared with those receiving topiramate (P < .05), but showed similar improvements when compared with those receiving propranolol or sodium valproate. The most common adverse events following cinnarizine intake were somnolence and fatigue.

 

Study details: Findings are from a systematic review and meta-analysis of 7 randomized controlled trials and 3 quasi-experimental studies including patients with migraine with or without aura who received cinnarizine, placebo, propranolol, sodium valproate, or topiramate.

 

Disclosures: This study did not report the funding source. No conflicts of interest were declared.

 

Source: Shafie'ei M et al. Application of cinnarizine in migraine prevention: A systematic review and meta-analysis. Pain Pract. 2022 (Sep 23). Doi: 10.1111/papr.13164

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Key clinical point: Cinnarizine appeared safe and effective in migraine prophylaxis, with cinnarizine-treated patients reporting significant improvements in migraine frequency and severity.

 

Major finding: Over 12 weeks, cinnarizine vs placebo significantly improved the frequency (overall mean difference [OMD] 3.10; P < .001) and intensity (OMD 1.54; P < .001) of migraine attacks per month; additionally, patients receiving cinnarizine showed better improvements in migraine intensity compared with those receiving topiramate (P < .05), but showed similar improvements when compared with those receiving propranolol or sodium valproate. The most common adverse events following cinnarizine intake were somnolence and fatigue.

 

Study details: Findings are from a systematic review and meta-analysis of 7 randomized controlled trials and 3 quasi-experimental studies including patients with migraine with or without aura who received cinnarizine, placebo, propranolol, sodium valproate, or topiramate.

 

Disclosures: This study did not report the funding source. No conflicts of interest were declared.

 

Source: Shafie'ei M et al. Application of cinnarizine in migraine prevention: A systematic review and meta-analysis. Pain Pract. 2022 (Sep 23). Doi: 10.1111/papr.13164

Key clinical point: Cinnarizine appeared safe and effective in migraine prophylaxis, with cinnarizine-treated patients reporting significant improvements in migraine frequency and severity.

 

Major finding: Over 12 weeks, cinnarizine vs placebo significantly improved the frequency (overall mean difference [OMD] 3.10; P < .001) and intensity (OMD 1.54; P < .001) of migraine attacks per month; additionally, patients receiving cinnarizine showed better improvements in migraine intensity compared with those receiving topiramate (P < .05), but showed similar improvements when compared with those receiving propranolol or sodium valproate. The most common adverse events following cinnarizine intake were somnolence and fatigue.

 

Study details: Findings are from a systematic review and meta-analysis of 7 randomized controlled trials and 3 quasi-experimental studies including patients with migraine with or without aura who received cinnarizine, placebo, propranolol, sodium valproate, or topiramate.

 

Disclosures: This study did not report the funding source. No conflicts of interest were declared.

 

Source: Shafie'ei M et al. Application of cinnarizine in migraine prevention: A systematic review and meta-analysis. Pain Pract. 2022 (Sep 23). Doi: 10.1111/papr.13164

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Risk for inpatient constipation similar with erenumab and other anti-CGRP mAb in migraine

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Key clinical point: The risk for inpatient constipation within 90 days of treatment initiation was similar in patients with migraine initiating erenumab vs other anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibodies (mAb), but was lower in those initiating erenumab vs standard of care antiepileptic drugs (AED).

 

Major finding: The risk for inpatient constipation within 90 days of treatment initiation was similar with erenumab vs other CGRP mAb (odds ratio [OR] 1.06; 95% CI 0.72-1.55), whereas the risk was lower with erenumab vs AED (OR 0.69; 95% CI0.51-0.94).

 

Study details: This retrospective cohort study included 80,803 patients with migraine who initiated erenumab (n = 17,902), other CGRP mAb (n = 13,404), or AED (n = 49,497), with erenumab initiators propensity-score matched with initiators of other CGRP mAb or AED.

 

Disclosures: This study was funded by Amgen Inc., USA. Nine authors reported being current or former employees of or owning stocks in UnitedHealth Group, Amgen, and other sources. P McAllister reported receiving personal fees and research support from various sources.

 

Source: Chomistek AK et al. Inpatient constipation among migraine patients prescribed anti-calcitonin gene-related peptide monoclonal antibodies and standard of care antiepileptic drugs: A retrospective cohort study in a United States electronic health record database. Pain Ther. 2022 (Oct 7). Doi: 10.1007/s40122-022-00440-7

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Key clinical point: The risk for inpatient constipation within 90 days of treatment initiation was similar in patients with migraine initiating erenumab vs other anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibodies (mAb), but was lower in those initiating erenumab vs standard of care antiepileptic drugs (AED).

 

Major finding: The risk for inpatient constipation within 90 days of treatment initiation was similar with erenumab vs other CGRP mAb (odds ratio [OR] 1.06; 95% CI 0.72-1.55), whereas the risk was lower with erenumab vs AED (OR 0.69; 95% CI0.51-0.94).

 

Study details: This retrospective cohort study included 80,803 patients with migraine who initiated erenumab (n = 17,902), other CGRP mAb (n = 13,404), or AED (n = 49,497), with erenumab initiators propensity-score matched with initiators of other CGRP mAb or AED.

 

Disclosures: This study was funded by Amgen Inc., USA. Nine authors reported being current or former employees of or owning stocks in UnitedHealth Group, Amgen, and other sources. P McAllister reported receiving personal fees and research support from various sources.

 

Source: Chomistek AK et al. Inpatient constipation among migraine patients prescribed anti-calcitonin gene-related peptide monoclonal antibodies and standard of care antiepileptic drugs: A retrospective cohort study in a United States electronic health record database. Pain Ther. 2022 (Oct 7). Doi: 10.1007/s40122-022-00440-7

Key clinical point: The risk for inpatient constipation within 90 days of treatment initiation was similar in patients with migraine initiating erenumab vs other anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibodies (mAb), but was lower in those initiating erenumab vs standard of care antiepileptic drugs (AED).

 

Major finding: The risk for inpatient constipation within 90 days of treatment initiation was similar with erenumab vs other CGRP mAb (odds ratio [OR] 1.06; 95% CI 0.72-1.55), whereas the risk was lower with erenumab vs AED (OR 0.69; 95% CI0.51-0.94).

 

Study details: This retrospective cohort study included 80,803 patients with migraine who initiated erenumab (n = 17,902), other CGRP mAb (n = 13,404), or AED (n = 49,497), with erenumab initiators propensity-score matched with initiators of other CGRP mAb or AED.

 

Disclosures: This study was funded by Amgen Inc., USA. Nine authors reported being current or former employees of or owning stocks in UnitedHealth Group, Amgen, and other sources. P McAllister reported receiving personal fees and research support from various sources.

 

Source: Chomistek AK et al. Inpatient constipation among migraine patients prescribed anti-calcitonin gene-related peptide monoclonal antibodies and standard of care antiepileptic drugs: A retrospective cohort study in a United States electronic health record database. Pain Ther. 2022 (Oct 7). Doi: 10.1007/s40122-022-00440-7

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Preventive treatment improves cognition and QoL in patients with chronic migraine

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Key clinical point: Patients with chronic migraine vs healthy controls had highly impaired cognition and worsened quality of life (QoL), which improved after 3 months of treatment with botulinum toxin or oral drugs.

 

Major finding: Patients with chronic migraine had worse scores than healthy controls for cognition, QoL, and emotional status at baseline (P < .0001), but showed significant improvements in Rey-Osterrieth Complex Figure test memory task (P < .0001), Trail Making Test A attention test (P  =  .007), and 36-item Short Form Health Survey based QoL measures for bodily pain (P  =  .040) and general health (P  =  .003) after 3 months of preventive treatment.

 

Study details: This observational study analyzed 46 patients with chronic migraine and 50 age- and sex-matched healthy controls for mood, cognition, and QoL before and 3 months after receiving preventive treatment with botulinum toxin or oral drugs.

 

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

 

Source: González-Mingot C et al. Preventive treatment can reverse cognitive impairment in chronic migraine. J Headache Pain. 2022;23:121 (Sep 15). Doi: 10.1186/s10194-022-01486-w

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Key clinical point: Patients with chronic migraine vs healthy controls had highly impaired cognition and worsened quality of life (QoL), which improved after 3 months of treatment with botulinum toxin or oral drugs.

 

Major finding: Patients with chronic migraine had worse scores than healthy controls for cognition, QoL, and emotional status at baseline (P < .0001), but showed significant improvements in Rey-Osterrieth Complex Figure test memory task (P < .0001), Trail Making Test A attention test (P  =  .007), and 36-item Short Form Health Survey based QoL measures for bodily pain (P  =  .040) and general health (P  =  .003) after 3 months of preventive treatment.

 

Study details: This observational study analyzed 46 patients with chronic migraine and 50 age- and sex-matched healthy controls for mood, cognition, and QoL before and 3 months after receiving preventive treatment with botulinum toxin or oral drugs.

 

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

 

Source: González-Mingot C et al. Preventive treatment can reverse cognitive impairment in chronic migraine. J Headache Pain. 2022;23:121 (Sep 15). Doi: 10.1186/s10194-022-01486-w

Key clinical point: Patients with chronic migraine vs healthy controls had highly impaired cognition and worsened quality of life (QoL), which improved after 3 months of treatment with botulinum toxin or oral drugs.

 

Major finding: Patients with chronic migraine had worse scores than healthy controls for cognition, QoL, and emotional status at baseline (P < .0001), but showed significant improvements in Rey-Osterrieth Complex Figure test memory task (P < .0001), Trail Making Test A attention test (P  =  .007), and 36-item Short Form Health Survey based QoL measures for bodily pain (P  =  .040) and general health (P  =  .003) after 3 months of preventive treatment.

 

Study details: This observational study analyzed 46 patients with chronic migraine and 50 age- and sex-matched healthy controls for mood, cognition, and QoL before and 3 months after receiving preventive treatment with botulinum toxin or oral drugs.

 

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

 

Source: González-Mingot C et al. Preventive treatment can reverse cognitive impairment in chronic migraine. J Headache Pain. 2022;23:121 (Sep 15). Doi: 10.1186/s10194-022-01486-w

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Changes in gastrointestinal motility with galcanezumab and erenumab in episodic migraine

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Key clinical point: Treatments with galcanezumab and erenumab increase constipation-related gastrointestinal discomfort, while erenumab also worsens stool form and bowel habits in patients with episodic migraine.

 

Major finding: An increase in the gastrointestinal symptom rating scale-constipation domain score was observed with both galcanezumab (least squares mean change [LSMC] 0.4; P  =  .002) and erenumab (LSMC 0.3; P  =  .016); additionally, erenumab significantly reduced Bristol Stool Form Scale (LSMC 0.5; P  =  .004) and spontaneous bowel movement (LSMC 1.2; P  =  .012) scores. No severe treatment-emergent adverse events were reported.

 

Study details: This phase 4 clinical trial included 65 patients with episodic migraine with or without aura and without significant gastrointestinal symptoms who were randomized to receive galcanezumab or erenumab.

 

Disclosures: This study was funded by Eli Lilly and Company. Six authors declared being full-time employees or minor shareholders or statistical contractors at Eli Lilly. Some authors reported receiving grants, contracts, consulting fees, or payment for speaker’s bureaus from various sources, including Eli Lilly.

 

Source: Kudrow D et al. A phase IV clinical trial of gastrointestinal motility in adult patients with migraine before and after initiation of a calcitonin gene-related peptide ligand (galcanezumab) or receptor (erenumab) antagonist. Headache. 2022 (Sep 16). Doi: 10.1111/head.14390

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Key clinical point: Treatments with galcanezumab and erenumab increase constipation-related gastrointestinal discomfort, while erenumab also worsens stool form and bowel habits in patients with episodic migraine.

 

Major finding: An increase in the gastrointestinal symptom rating scale-constipation domain score was observed with both galcanezumab (least squares mean change [LSMC] 0.4; P  =  .002) and erenumab (LSMC 0.3; P  =  .016); additionally, erenumab significantly reduced Bristol Stool Form Scale (LSMC 0.5; P  =  .004) and spontaneous bowel movement (LSMC 1.2; P  =  .012) scores. No severe treatment-emergent adverse events were reported.

 

Study details: This phase 4 clinical trial included 65 patients with episodic migraine with or without aura and without significant gastrointestinal symptoms who were randomized to receive galcanezumab or erenumab.

 

Disclosures: This study was funded by Eli Lilly and Company. Six authors declared being full-time employees or minor shareholders or statistical contractors at Eli Lilly. Some authors reported receiving grants, contracts, consulting fees, or payment for speaker’s bureaus from various sources, including Eli Lilly.

 

Source: Kudrow D et al. A phase IV clinical trial of gastrointestinal motility in adult patients with migraine before and after initiation of a calcitonin gene-related peptide ligand (galcanezumab) or receptor (erenumab) antagonist. Headache. 2022 (Sep 16). Doi: 10.1111/head.14390

Key clinical point: Treatments with galcanezumab and erenumab increase constipation-related gastrointestinal discomfort, while erenumab also worsens stool form and bowel habits in patients with episodic migraine.

 

Major finding: An increase in the gastrointestinal symptom rating scale-constipation domain score was observed with both galcanezumab (least squares mean change [LSMC] 0.4; P  =  .002) and erenumab (LSMC 0.3; P  =  .016); additionally, erenumab significantly reduced Bristol Stool Form Scale (LSMC 0.5; P  =  .004) and spontaneous bowel movement (LSMC 1.2; P  =  .012) scores. No severe treatment-emergent adverse events were reported.

 

Study details: This phase 4 clinical trial included 65 patients with episodic migraine with or without aura and without significant gastrointestinal symptoms who were randomized to receive galcanezumab or erenumab.

 

Disclosures: This study was funded by Eli Lilly and Company. Six authors declared being full-time employees or minor shareholders or statistical contractors at Eli Lilly. Some authors reported receiving grants, contracts, consulting fees, or payment for speaker’s bureaus from various sources, including Eli Lilly.

 

Source: Kudrow D et al. A phase IV clinical trial of gastrointestinal motility in adult patients with migraine before and after initiation of a calcitonin gene-related peptide ligand (galcanezumab) or receptor (erenumab) antagonist. Headache. 2022 (Sep 16). Doi: 10.1111/head.14390

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Association between CGRP-LI levels and migraine treatment outcomes with erenumab

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Key clinical point: Patients with migraine and low serum levels of calcitonin gene-related peptide-like immunoreactivity (CGRP-LI) at 2-4 weeks after initiating erenumab experienced a greater reduction in monthly migraine days (MMD) at 3 months after treatment initiation; however, CGRP-LI levels at treatment initiation showed no effect on clinical response.

 

Major finding: Absolute reduction in MMD after 3 months of initiating erenumab was significantly associated with serum CGRP-LI levels after 2-4 weeks of erenumab treatment (β 2.13; P  =  .003) but not with those before starting erenumab treatment (β 0.80; P  =  .24).

 

Study details: Findings are from a study including 94 patients with episodic or chronic migraine with/without aura who previously failed 4 migraine prophylactics and were treated with erenumab (70 mg) once every 4 weeks.

 

Disclosures: This study was supported by Vici grant from the Dutch Research Council. Two authors declared receiving consultancy or industry grant support or independent support from various sources, including Dutch Research Council.

 

Source: de Vries Lentsch S et al. Serum CGRP in migraine patients using erenumab as preventive treatment. J Headache Pain. 2022;23:120 (Sep 12). Doi: 10.1186/s10194-022-01483-z

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Key clinical point: Patients with migraine and low serum levels of calcitonin gene-related peptide-like immunoreactivity (CGRP-LI) at 2-4 weeks after initiating erenumab experienced a greater reduction in monthly migraine days (MMD) at 3 months after treatment initiation; however, CGRP-LI levels at treatment initiation showed no effect on clinical response.

 

Major finding: Absolute reduction in MMD after 3 months of initiating erenumab was significantly associated with serum CGRP-LI levels after 2-4 weeks of erenumab treatment (β 2.13; P  =  .003) but not with those before starting erenumab treatment (β 0.80; P  =  .24).

 

Study details: Findings are from a study including 94 patients with episodic or chronic migraine with/without aura who previously failed 4 migraine prophylactics and were treated with erenumab (70 mg) once every 4 weeks.

 

Disclosures: This study was supported by Vici grant from the Dutch Research Council. Two authors declared receiving consultancy or industry grant support or independent support from various sources, including Dutch Research Council.

 

Source: de Vries Lentsch S et al. Serum CGRP in migraine patients using erenumab as preventive treatment. J Headache Pain. 2022;23:120 (Sep 12). Doi: 10.1186/s10194-022-01483-z

Key clinical point: Patients with migraine and low serum levels of calcitonin gene-related peptide-like immunoreactivity (CGRP-LI) at 2-4 weeks after initiating erenumab experienced a greater reduction in monthly migraine days (MMD) at 3 months after treatment initiation; however, CGRP-LI levels at treatment initiation showed no effect on clinical response.

 

Major finding: Absolute reduction in MMD after 3 months of initiating erenumab was significantly associated with serum CGRP-LI levels after 2-4 weeks of erenumab treatment (β 2.13; P  =  .003) but not with those before starting erenumab treatment (β 0.80; P  =  .24).

 

Study details: Findings are from a study including 94 patients with episodic or chronic migraine with/without aura who previously failed 4 migraine prophylactics and were treated with erenumab (70 mg) once every 4 weeks.

 

Disclosures: This study was supported by Vici grant from the Dutch Research Council. Two authors declared receiving consultancy or industry grant support or independent support from various sources, including Dutch Research Council.

 

Source: de Vries Lentsch S et al. Serum CGRP in migraine patients using erenumab as preventive treatment. J Headache Pain. 2022;23:120 (Sep 12). Doi: 10.1186/s10194-022-01483-z

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Benefit-risk profiles of lasmiditan, rimegepant, and ubrogepant for acute treatment of migraine

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Key clinical point: Doses of 200 mg lasmiditan and 75 mg rimegepant had the lowest numbers needed to treat (NNT) to achieve immediate and sustained pain freedom, respectively, whereas 25 mg ubrogepant had higher numbers needed to harm (NNH) for nausea and dizziness in acute treatment for migraine.

 

Major finding: Compared with placebo, 200 mg lasmiditan had the lowest NNT for immediate pain freedom at 2 hours (NNT 7; 95% credible interval [CrI] 5-9) and 75 mg rimegepant had the lowest NNT for sustained pain freedom at 2-24 hours (NNT 7; 95% CrI 5-12); although statistically insignificant, 25 mg ubrogepant had a high NNH for dizziness and nausea.

 

Study details: Findings are from a fixed-effects Bayesian network meta-analysis of five phase 3 randomized controlled trials including 10,060 patients with migraine who received lasmiditan, rimegepant, ubrogepant, or placebo for acute treatment.

 

Disclosures: This study was supported by Biohaven Pharmaceuticals. Seven authors declared being employees of and owning stock or stock options in Biohaven or a company funded by Biohaven.

 

Source: Johnston K et al. Rimegepant, ubrogepant, and lasmiditan in the acute treatment of migraine examining the benefit-risk profile using number needed to treat/harm. Clin J Pain. 2022;38(11):680-685  (Sep 26). Doi: 10.1097/AJP.0000000000001072

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Key clinical point: Doses of 200 mg lasmiditan and 75 mg rimegepant had the lowest numbers needed to treat (NNT) to achieve immediate and sustained pain freedom, respectively, whereas 25 mg ubrogepant had higher numbers needed to harm (NNH) for nausea and dizziness in acute treatment for migraine.

 

Major finding: Compared with placebo, 200 mg lasmiditan had the lowest NNT for immediate pain freedom at 2 hours (NNT 7; 95% credible interval [CrI] 5-9) and 75 mg rimegepant had the lowest NNT for sustained pain freedom at 2-24 hours (NNT 7; 95% CrI 5-12); although statistically insignificant, 25 mg ubrogepant had a high NNH for dizziness and nausea.

 

Study details: Findings are from a fixed-effects Bayesian network meta-analysis of five phase 3 randomized controlled trials including 10,060 patients with migraine who received lasmiditan, rimegepant, ubrogepant, or placebo for acute treatment.

 

Disclosures: This study was supported by Biohaven Pharmaceuticals. Seven authors declared being employees of and owning stock or stock options in Biohaven or a company funded by Biohaven.

 

Source: Johnston K et al. Rimegepant, ubrogepant, and lasmiditan in the acute treatment of migraine examining the benefit-risk profile using number needed to treat/harm. Clin J Pain. 2022;38(11):680-685  (Sep 26). Doi: 10.1097/AJP.0000000000001072

Key clinical point: Doses of 200 mg lasmiditan and 75 mg rimegepant had the lowest numbers needed to treat (NNT) to achieve immediate and sustained pain freedom, respectively, whereas 25 mg ubrogepant had higher numbers needed to harm (NNH) for nausea and dizziness in acute treatment for migraine.

 

Major finding: Compared with placebo, 200 mg lasmiditan had the lowest NNT for immediate pain freedom at 2 hours (NNT 7; 95% credible interval [CrI] 5-9) and 75 mg rimegepant had the lowest NNT for sustained pain freedom at 2-24 hours (NNT 7; 95% CrI 5-12); although statistically insignificant, 25 mg ubrogepant had a high NNH for dizziness and nausea.

 

Study details: Findings are from a fixed-effects Bayesian network meta-analysis of five phase 3 randomized controlled trials including 10,060 patients with migraine who received lasmiditan, rimegepant, ubrogepant, or placebo for acute treatment.

 

Disclosures: This study was supported by Biohaven Pharmaceuticals. Seven authors declared being employees of and owning stock or stock options in Biohaven or a company funded by Biohaven.

 

Source: Johnston K et al. Rimegepant, ubrogepant, and lasmiditan in the acute treatment of migraine examining the benefit-risk profile using number needed to treat/harm. Clin J Pain. 2022;38(11):680-685  (Sep 26). Doi: 10.1097/AJP.0000000000001072

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Overlapping initial symptoms demand careful differential diagnosis of migraine and ischemic stroke

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Mon, 11/21/2022 - 13:13

Key clinical point: At the onset of attack, many patients with migraine with aura (MwA) experience stroke-like symptoms, whereas many patients with acute ischemic stroke (AIS) experience migraine-like symptoms, highlighting the need for additional clinical investigation for careful differential diagnosis.

 

Major finding: Migraine-like irritative sensations were experienced by 32.1% and 35.2% of patients with stroke who experienced visual disturbances and sensory disturbances, respectively, whereas stroke-like symptoms were reported by 12.0% and 31.4% of patients with MwA who experienced visual disturbances and sensory disturbances, respectively.

 

Study details: Findings are from a questionnaire-based observational study including 343 patients with MwA and 350 patients with AIS.

 

Disclosures: This study was supported by Swiss Heart Foundation. Several authors reported receiving research support, grants, personal fees, speaker fees, consulting or advisory support from Swiss Heart Foundation or other sources.

 

Source: Scutelnic A et al. Migraine aura-like symptoms at onset of stroke and stroke-like symptoms in migraine with aura. Front Neurol. 2022;13:1004058 (Sep 14). Doi: 10.3389/fneur.2022.1004058

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Key clinical point: At the onset of attack, many patients with migraine with aura (MwA) experience stroke-like symptoms, whereas many patients with acute ischemic stroke (AIS) experience migraine-like symptoms, highlighting the need for additional clinical investigation for careful differential diagnosis.

 

Major finding: Migraine-like irritative sensations were experienced by 32.1% and 35.2% of patients with stroke who experienced visual disturbances and sensory disturbances, respectively, whereas stroke-like symptoms were reported by 12.0% and 31.4% of patients with MwA who experienced visual disturbances and sensory disturbances, respectively.

 

Study details: Findings are from a questionnaire-based observational study including 343 patients with MwA and 350 patients with AIS.

 

Disclosures: This study was supported by Swiss Heart Foundation. Several authors reported receiving research support, grants, personal fees, speaker fees, consulting or advisory support from Swiss Heart Foundation or other sources.

 

Source: Scutelnic A et al. Migraine aura-like symptoms at onset of stroke and stroke-like symptoms in migraine with aura. Front Neurol. 2022;13:1004058 (Sep 14). Doi: 10.3389/fneur.2022.1004058

Key clinical point: At the onset of attack, many patients with migraine with aura (MwA) experience stroke-like symptoms, whereas many patients with acute ischemic stroke (AIS) experience migraine-like symptoms, highlighting the need for additional clinical investigation for careful differential diagnosis.

 

Major finding: Migraine-like irritative sensations were experienced by 32.1% and 35.2% of patients with stroke who experienced visual disturbances and sensory disturbances, respectively, whereas stroke-like symptoms were reported by 12.0% and 31.4% of patients with MwA who experienced visual disturbances and sensory disturbances, respectively.

 

Study details: Findings are from a questionnaire-based observational study including 343 patients with MwA and 350 patients with AIS.

 

Disclosures: This study was supported by Swiss Heart Foundation. Several authors reported receiving research support, grants, personal fees, speaker fees, consulting or advisory support from Swiss Heart Foundation or other sources.

 

Source: Scutelnic A et al. Migraine aura-like symptoms at onset of stroke and stroke-like symptoms in migraine with aura. Front Neurol. 2022;13:1004058 (Sep 14). Doi: 10.3389/fneur.2022.1004058

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Real-world efficacy of galcanezumab in high frequency episodic and chronic migraine

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Key clinical point: Galcanezumab demonstrated persistent efficacy in improving migraine features and disability scores and was well tolerated over 1 year in real-life patients with high frequency episodic migraine (HFEM) or chronic migraine (CM).

 

Major finding: The monthly migraine days (MMD) significantly reduced in patients with HFEM (from 11.5 ± 3.5 to 5.5 ± 5.5) and CM (from 19.3 ± 5.8 to 7.4 ± 5.9; both P < .00001) over 12 months along with a significant decrease in pain intensity, monthly acute medication intake, Headache Impact Test-6, and Migraine Disability Assessment questionnaire scores (all P < .00001). Overall, 56.5% of patients presented with a response rate of ≥50% reduction in MMD for 9 cumulative months. No serious adverse events were reported.

Study details: Findings are from a prospective ongoing study including 191 patients with HFEM or CM who received galcanezumab and completed the 12 months of observation since galcanezumab initiation.

 

Disclosures: This study was supported by Campus Bio-Medico University. Several authors reported receiving grants or honoraria from various sources.

 

Source: Vernieri F et al for the GARLIT Study Group. Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study. Eur J Neurol. 2022 (Sep 13). Doi: 10.1111/ene.15563

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Key clinical point: Galcanezumab demonstrated persistent efficacy in improving migraine features and disability scores and was well tolerated over 1 year in real-life patients with high frequency episodic migraine (HFEM) or chronic migraine (CM).

 

Major finding: The monthly migraine days (MMD) significantly reduced in patients with HFEM (from 11.5 ± 3.5 to 5.5 ± 5.5) and CM (from 19.3 ± 5.8 to 7.4 ± 5.9; both P < .00001) over 12 months along with a significant decrease in pain intensity, monthly acute medication intake, Headache Impact Test-6, and Migraine Disability Assessment questionnaire scores (all P < .00001). Overall, 56.5% of patients presented with a response rate of ≥50% reduction in MMD for 9 cumulative months. No serious adverse events were reported.

Study details: Findings are from a prospective ongoing study including 191 patients with HFEM or CM who received galcanezumab and completed the 12 months of observation since galcanezumab initiation.

 

Disclosures: This study was supported by Campus Bio-Medico University. Several authors reported receiving grants or honoraria from various sources.

 

Source: Vernieri F et al for the GARLIT Study Group. Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study. Eur J Neurol. 2022 (Sep 13). Doi: 10.1111/ene.15563

Key clinical point: Galcanezumab demonstrated persistent efficacy in improving migraine features and disability scores and was well tolerated over 1 year in real-life patients with high frequency episodic migraine (HFEM) or chronic migraine (CM).

 

Major finding: The monthly migraine days (MMD) significantly reduced in patients with HFEM (from 11.5 ± 3.5 to 5.5 ± 5.5) and CM (from 19.3 ± 5.8 to 7.4 ± 5.9; both P < .00001) over 12 months along with a significant decrease in pain intensity, monthly acute medication intake, Headache Impact Test-6, and Migraine Disability Assessment questionnaire scores (all P < .00001). Overall, 56.5% of patients presented with a response rate of ≥50% reduction in MMD for 9 cumulative months. No serious adverse events were reported.

Study details: Findings are from a prospective ongoing study including 191 patients with HFEM or CM who received galcanezumab and completed the 12 months of observation since galcanezumab initiation.

 

Disclosures: This study was supported by Campus Bio-Medico University. Several authors reported receiving grants or honoraria from various sources.

 

Source: Vernieri F et al for the GARLIT Study Group. Maintenance of response and predictive factors of 1-year GalcanezumAb treatment in real-life migraine patients in Italy: The multicenter prospective cohort GARLIT study. Eur J Neurol. 2022 (Sep 13). Doi: 10.1111/ene.15563

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Meta-analysis corroborates evidence on efficacy of onabotulinumtoxinA for chronic migraine

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Key clinical point: Meta-analysis on 10 years of real-world data confirmed the efficacy of onabotulinumtoxinA as a preventive treatment for chronic migraine.

 

Major finding: At week 24, onabotulinumtoxinA reduced the number of headache days per month (mean change from baseline [MCFB] 10.64; 95% CI 12.31 to 8.97), with a 50% reduction in migraine days response rate of 46.57% (95% CI 29.50%-63.65%) and improvements in total Headache Impact Test-6 score (MCFB 11.70; 95% CI 13.86 to 9.54) and Migraine-Specific Quality of Life v2.1 score (MCFB 23.60; 95% CI 21.56-25.64). The improvements were maintained till 52 weeks.

Study details: Findings are from a systematic review and meta-analysis of 44 studies including patients with chronic migraine who received onabotulinumtoxinA.

 

Disclosures: This study was supported by AbbVie. M Lanteri-Minet reported receiving personal fees and grants from various sources. Four authors declared being employees of AbbVie or working for a consultancy company commissioned by AbbVie or holding stock options in GSK and AbbVie.

 

Source: Lanteri-Minet M et al. Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data. Cephalalgia. 2022 (Sep 8). Doi: 10.1177/03331024221123058

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Key clinical point: Meta-analysis on 10 years of real-world data confirmed the efficacy of onabotulinumtoxinA as a preventive treatment for chronic migraine.

 

Major finding: At week 24, onabotulinumtoxinA reduced the number of headache days per month (mean change from baseline [MCFB] 10.64; 95% CI 12.31 to 8.97), with a 50% reduction in migraine days response rate of 46.57% (95% CI 29.50%-63.65%) and improvements in total Headache Impact Test-6 score (MCFB 11.70; 95% CI 13.86 to 9.54) and Migraine-Specific Quality of Life v2.1 score (MCFB 23.60; 95% CI 21.56-25.64). The improvements were maintained till 52 weeks.

Study details: Findings are from a systematic review and meta-analysis of 44 studies including patients with chronic migraine who received onabotulinumtoxinA.

 

Disclosures: This study was supported by AbbVie. M Lanteri-Minet reported receiving personal fees and grants from various sources. Four authors declared being employees of AbbVie or working for a consultancy company commissioned by AbbVie or holding stock options in GSK and AbbVie.

 

Source: Lanteri-Minet M et al. Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data. Cephalalgia. 2022 (Sep 8). Doi: 10.1177/03331024221123058

Key clinical point: Meta-analysis on 10 years of real-world data confirmed the efficacy of onabotulinumtoxinA as a preventive treatment for chronic migraine.

 

Major finding: At week 24, onabotulinumtoxinA reduced the number of headache days per month (mean change from baseline [MCFB] 10.64; 95% CI 12.31 to 8.97), with a 50% reduction in migraine days response rate of 46.57% (95% CI 29.50%-63.65%) and improvements in total Headache Impact Test-6 score (MCFB 11.70; 95% CI 13.86 to 9.54) and Migraine-Specific Quality of Life v2.1 score (MCFB 23.60; 95% CI 21.56-25.64). The improvements were maintained till 52 weeks.

Study details: Findings are from a systematic review and meta-analysis of 44 studies including patients with chronic migraine who received onabotulinumtoxinA.

 

Disclosures: This study was supported by AbbVie. M Lanteri-Minet reported receiving personal fees and grants from various sources. Four authors declared being employees of AbbVie or working for a consultancy company commissioned by AbbVie or holding stock options in GSK and AbbVie.

 

Source: Lanteri-Minet M et al. Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data. Cephalalgia. 2022 (Sep 8). Doi: 10.1177/03331024221123058

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