Article

Getahun D, Fassett MJ, Jacobsen SJ, et al. Perinatal outcomes after bariatric surgery. Am J Obstet Gynecol. 2021;S0002-9378(21)00771-7. doi: 10.1016/j.ajog.2021 .06.087.

EXPERT COMMENTARY

Prepregnancy obesity continues to rise in the United States, with a prevalence of 29% among reproductive-age women in 2019, an 11% increase from 2016.¹ Pregnant patients with obesity are at increased risk for multiple adverse perinatal outcomes, including gestational diabetes and preeclampsia. Bariatric surgery is effective for weight loss and has been shown to improve comorbidities associated with obesity,² and it may have potential benefits for pregnancy outcomes, such as reducing rates of gestational diabetes and preeclampsia.^3-5 However, little was known about other outcomes as well as other potential factors before a recent study in which investigators examined perinatal outcomes after bariatric surgery.

Details of the study

Getahun and colleagues conducted a population-based, retrospective study of pregnant patients who were eligible for bariatric surgery (body mass index [BMI] ≥40 kg/m² with no comorbidities or a BMI between 35 and 40 kg/m² with obesity-related comorbidities, such as diabetes). They aimed to evaluate the association of bariatric surgery with adverse perinatal outcomes.

Results. In a large sample of pregnant patients eligible for bariatric surgery (N = 20,213), the authors found that patients who had bariatric surgery (n = 1,886) had a reduced risk of macrosomia (aOR, 0.24), preeclampsia (aOR, 0.53), gestational diabetes (aOR, 0.60), and cesarean delivery (aOR, 0.65) compared with those who did not have bariatric surgery (n = 18,327). They also found that patients who had bariatric surgery had an increased risk of small-for-gestational age neonates (aOR, 2.46) and postpartum hemorrhage (aOR, 1.79).

These results remained after adjusting for other potential confounders. The authors evaluated the outcomes based on the timing of surgery and the patients’ pregnancy (<1 year, 1-1.5 years, 1.5-2 years, >2 years). The outcomes were more favorable among the patients who had the bariatric surgery regardless of the time interval of surgery to pregnancy than those who did not have the surgery. In addition, the benefits of bariatric surgery did not differ between the 2 most common types of bariatric surgery (Roux-en-Y gastric bypass and vertical sleeve gastrectomy) performed in this study, and both had better outcomes than those who did not have the surgery. Finally, patients with chronic hypertension and pregestational diabetes who had bariatric surgery also had lower risks of adverse outcomes than those without bariatric surgery.

Study strengths and limitations

Given the study’s retrospective design, uncertainties and important confounders could not be addressed, such as why certain eligible patients had the surgery and others did not. However, with its large sample size and an appropriate comparison group, the study findings further support the perinatal benefits of bariatric surgery in obese patients. Of note, this study also had a large sample of Black and Hispanic patients, populations known to have higher rates of obesity¹ and pregnancy complications. Subgroup analyses within each racial/ethnic group revealed that those who had the surgery had lower risks of adverse perinatal outcomes than those who did not.

Patients who had the bariatric surgery had an increased risk of postpartum hemorrhage; however, there is no physiologic basis or theory to explain this finding, so further studies are needed. Lastly, although patients who had bariatric surgery had an increased risk of small-for-gestational-age babies and the study was not powered for the risk of stillbirth, the patients who had the surgery had a reduced risk of neonates admitted to the neonatal intensive care unit. More data would have been beneficial to assess if these small-for-gestational-age babies were healthy. In general, obese patients tend to have larger and unhealthy babies; thus, healthier babies, even if small for gestational age, would not be an adverse outcome.

Benefits of bariatric surgery extend to perinatal outcomes

This study reinforces current practice that includes eligible patients being counseled about the health-related benefits of bariatric surgery, which now includes more perinatal outcomes. The finding of the increased risk of small-for-gestational-age fetuses supports the practice of a screening growth ultrasound exam in patients who had bariatric surgery. ●

Getahun D, Fassett MJ, Jacobsen SJ, et al. Perinatal outcomes after bariatric surgery. Am J Obstet Gynecol. 2021;S0002-9378(21)00771-7. doi: 10.1016/j.ajog.2021 .06.087.

EXPERT COMMENTARY

Prepregnancy obesity continues to rise in the United States, with a prevalence of 29% among reproductive-age women in 2019, an 11% increase from 2016.¹ Pregnant patients with obesity are at increased risk for multiple adverse perinatal outcomes, including gestational diabetes and preeclampsia. Bariatric surgery is effective for weight loss and has been shown to improve comorbidities associated with obesity,² and it may have potential benefits for pregnancy outcomes, such as reducing rates of gestational diabetes and preeclampsia.^3-5 However, little was known about other outcomes as well as other potential factors before a recent study in which investigators examined perinatal outcomes after bariatric surgery.

Details of the study

Getahun and colleagues conducted a population-based, retrospective study of pregnant patients who were eligible for bariatric surgery (body mass index [BMI] ≥40 kg/m² with no comorbidities or a BMI between 35 and 40 kg/m² with obesity-related comorbidities, such as diabetes). They aimed to evaluate the association of bariatric surgery with adverse perinatal outcomes.

Results. In a large sample of pregnant patients eligible for bariatric surgery (N = 20,213), the authors found that patients who had bariatric surgery (n = 1,886) had a reduced risk of macrosomia (aOR, 0.24), preeclampsia (aOR, 0.53), gestational diabetes (aOR, 0.60), and cesarean delivery (aOR, 0.65) compared with those who did not have bariatric surgery (n = 18,327). They also found that patients who had bariatric surgery had an increased risk of small-for-gestational age neonates (aOR, 2.46) and postpartum hemorrhage (aOR, 1.79).

These results remained after adjusting for other potential confounders. The authors evaluated the outcomes based on the timing of surgery and the patients’ pregnancy (<1 year, 1-1.5 years, 1.5-2 years, >2 years). The outcomes were more favorable among the patients who had the bariatric surgery regardless of the time interval of surgery to pregnancy than those who did not have the surgery. In addition, the benefits of bariatric surgery did not differ between the 2 most common types of bariatric surgery (Roux-en-Y gastric bypass and vertical sleeve gastrectomy) performed in this study, and both had better outcomes than those who did not have the surgery. Finally, patients with chronic hypertension and pregestational diabetes who had bariatric surgery also had lower risks of adverse outcomes than those without bariatric surgery.

Study strengths and limitations

Given the study’s retrospective design, uncertainties and important confounders could not be addressed, such as why certain eligible patients had the surgery and others did not. However, with its large sample size and an appropriate comparison group, the study findings further support the perinatal benefits of bariatric surgery in obese patients. Of note, this study also had a large sample of Black and Hispanic patients, populations known to have higher rates of obesity¹ and pregnancy complications. Subgroup analyses within each racial/ethnic group revealed that those who had the surgery had lower risks of adverse perinatal outcomes than those who did not.

Patients who had the bariatric surgery had an increased risk of postpartum hemorrhage; however, there is no physiologic basis or theory to explain this finding, so further studies are needed. Lastly, although patients who had bariatric surgery had an increased risk of small-for-gestational-age babies and the study was not powered for the risk of stillbirth, the patients who had the surgery had a reduced risk of neonates admitted to the neonatal intensive care unit. More data would have been beneficial to assess if these small-for-gestational-age babies were healthy. In general, obese patients tend to have larger and unhealthy babies; thus, healthier babies, even if small for gestational age, would not be an adverse outcome.

Benefits of bariatric surgery extend to perinatal outcomes

This study reinforces current practice that includes eligible patients being counseled about the health-related benefits of bariatric surgery, which now includes more perinatal outcomes. The finding of the increased risk of small-for-gestational-age fetuses supports the practice of a screening growth ultrasound exam in patients who had bariatric surgery. ●

Getahun D, Fassett MJ, Jacobsen SJ, et al. Perinatal outcomes after bariatric surgery. Am J Obstet Gynecol. 2021;S0002-9378(21)00771-7. doi: 10.1016/j.ajog.2021 .06.087.

EXPERT COMMENTARY

Prepregnancy obesity continues to rise in the United States, with a prevalence of 29% among reproductive-age women in 2019, an 11% increase from 2016.¹ Pregnant patients with obesity are at increased risk for multiple adverse perinatal outcomes, including gestational diabetes and preeclampsia. Bariatric surgery is effective for weight loss and has been shown to improve comorbidities associated with obesity,² and it may have potential benefits for pregnancy outcomes, such as reducing rates of gestational diabetes and preeclampsia.^3-5 However, little was known about other outcomes as well as other potential factors before a recent study in which investigators examined perinatal outcomes after bariatric surgery.

Details of the study

Getahun and colleagues conducted a population-based, retrospective study of pregnant patients who were eligible for bariatric surgery (body mass index [BMI] ≥40 kg/m² with no comorbidities or a BMI between 35 and 40 kg/m² with obesity-related comorbidities, such as diabetes). They aimed to evaluate the association of bariatric surgery with adverse perinatal outcomes.

Results. In a large sample of pregnant patients eligible for bariatric surgery (N = 20,213), the authors found that patients who had bariatric surgery (n = 1,886) had a reduced risk of macrosomia (aOR, 0.24), preeclampsia (aOR, 0.53), gestational diabetes (aOR, 0.60), and cesarean delivery (aOR, 0.65) compared with those who did not have bariatric surgery (n = 18,327). They also found that patients who had bariatric surgery had an increased risk of small-for-gestational age neonates (aOR, 2.46) and postpartum hemorrhage (aOR, 1.79).

These results remained after adjusting for other potential confounders. The authors evaluated the outcomes based on the timing of surgery and the patients’ pregnancy (<1 year, 1-1.5 years, 1.5-2 years, >2 years). The outcomes were more favorable among the patients who had the bariatric surgery regardless of the time interval of surgery to pregnancy than those who did not have the surgery. In addition, the benefits of bariatric surgery did not differ between the 2 most common types of bariatric surgery (Roux-en-Y gastric bypass and vertical sleeve gastrectomy) performed in this study, and both had better outcomes than those who did not have the surgery. Finally, patients with chronic hypertension and pregestational diabetes who had bariatric surgery also had lower risks of adverse outcomes than those without bariatric surgery.

Study strengths and limitations

Given the study’s retrospective design, uncertainties and important confounders could not be addressed, such as why certain eligible patients had the surgery and others did not. However, with its large sample size and an appropriate comparison group, the study findings further support the perinatal benefits of bariatric surgery in obese patients. Of note, this study also had a large sample of Black and Hispanic patients, populations known to have higher rates of obesity¹ and pregnancy complications. Subgroup analyses within each racial/ethnic group revealed that those who had the surgery had lower risks of adverse perinatal outcomes than those who did not.

Patients who had the bariatric surgery had an increased risk of postpartum hemorrhage; however, there is no physiologic basis or theory to explain this finding, so further studies are needed. Lastly, although patients who had bariatric surgery had an increased risk of small-for-gestational-age babies and the study was not powered for the risk of stillbirth, the patients who had the surgery had a reduced risk of neonates admitted to the neonatal intensive care unit. More data would have been beneficial to assess if these small-for-gestational-age babies were healthy. In general, obese patients tend to have larger and unhealthy babies; thus, healthier babies, even if small for gestational age, would not be an adverse outcome.

Benefits of bariatric surgery extend to perinatal outcomes

This study reinforces current practice that includes eligible patients being counseled about the health-related benefits of bariatric surgery, which now includes more perinatal outcomes. The finding of the increased risk of small-for-gestational-age fetuses supports the practice of a screening growth ultrasound exam in patients who had bariatric surgery. ●

Key clinical point: Ubrogepant was effective and safe in patients with migraine, regardless of prior or concomitant preventive medication use.

Major finding: Ubrogepant vs. placebo was associated with significantly higher responder rates for pain freedom (P £ .005), absence of most bothersome symptom (50 mg ubrogepant vs. placebo; P £ .001), and pain relief (P £ .011) at 2 hours, with the responder rates not being significantly different among patients with vs. without preventive medication use (all P > .05). No serious or treatment-related adverse events were reported.

Study details: Findings are from a pooled analysis of ACHIEVE I and ACHIEVE II phase 3 trials (n = 2,247) and the long-term safety extension trial (n = 813) including patients with migraine with or without a history of preventive medication use.

Disclosures: This study was funded by Allergan (before its acquisition by AbbVie). Some investigators, including the lead author, reported advising or consulting for; being a speaker, on the board of directors, or a contributing author for; receiving grants, research support, and honoraria from; holding stocks or patents with; or employment with various sources including Allergan and AbbVie.

Source: Blumenfeld AM et al. Add Ther. 2021 (Dec 7). Doi: 10.1007/s12325-021-01923-3.

Key clinical point: Ubrogepant was effective and safe in patients with migraine, regardless of prior or concomitant preventive medication use.

Major finding: Ubrogepant vs. placebo was associated with significantly higher responder rates for pain freedom (P £ .005), absence of most bothersome symptom (50 mg ubrogepant vs. placebo; P £ .001), and pain relief (P £ .011) at 2 hours, with the responder rates not being significantly different among patients with vs. without preventive medication use (all P > .05). No serious or treatment-related adverse events were reported.

Study details: Findings are from a pooled analysis of ACHIEVE I and ACHIEVE II phase 3 trials (n = 2,247) and the long-term safety extension trial (n = 813) including patients with migraine with or without a history of preventive medication use.

Disclosures: This study was funded by Allergan (before its acquisition by AbbVie). Some investigators, including the lead author, reported advising or consulting for; being a speaker, on the board of directors, or a contributing author for; receiving grants, research support, and honoraria from; holding stocks or patents with; or employment with various sources including Allergan and AbbVie.

Source: Blumenfeld AM et al. Add Ther. 2021 (Dec 7). Doi: 10.1007/s12325-021-01923-3.

Key clinical point: Ubrogepant was effective and safe in patients with migraine, regardless of prior or concomitant preventive medication use.

Major finding: Ubrogepant vs. placebo was associated with significantly higher responder rates for pain freedom (P £ .005), absence of most bothersome symptom (50 mg ubrogepant vs. placebo; P £ .001), and pain relief (P £ .011) at 2 hours, with the responder rates not being significantly different among patients with vs. without preventive medication use (all P > .05). No serious or treatment-related adverse events were reported.

Study details: Findings are from a pooled analysis of ACHIEVE I and ACHIEVE II phase 3 trials (n = 2,247) and the long-term safety extension trial (n = 813) including patients with migraine with or without a history of preventive medication use.

Disclosures: This study was funded by Allergan (before its acquisition by AbbVie). Some investigators, including the lead author, reported advising or consulting for; being a speaker, on the board of directors, or a contributing author for; receiving grants, research support, and honoraria from; holding stocks or patents with; or employment with various sources including Allergan and AbbVie.

Source: Blumenfeld AM et al. Add Ther. 2021 (Dec 7). Doi: 10.1007/s12325-021-01923-3.

Key clinical point: Fremanezumab was effective and well tolerated over 12 weeks in older patients with chronic or episodic migraine.

Major finding: Quarterly and monthly fremanezumab vs. placebo showed greater reduction in monthly average migraine days (least-squares mean change from baseline [D] −4.3 and −4.6 vs. −2.3), headache days of at least moderate severity (D −3.9 and −4.2 vs. −2.1), and acute medication use (D −3.7 and −4.0 vs. −1.3) over 12 weeks (all P < .05). Adverse events were similar across groups.

Study details: Findings are pooled subgroup analysis of 3 phase 3 studies (HALO CM, HALO EM, and FOCUS) including 246 participants aged ≥60 years with chronic or episodic migraine with an inadequate response to 2-4 prior migraine preventives. They were randomly assigned to quarterly fremanezumab, monthly fremanezumab, or matched monthly placebo.

Disclosures: This study was funded by Teva Pharmaceuticals Ltd. Some investigators, including the lead author, reported participating in clinical trials and receiving honoraria, research support, and legal or personal fees from and being former or current employees of various sources, including Teva Pharmaceuticals.

Source: Nahas SJ et al. J Headache Pain. 2021;22:141 (Nov 24). Doi: 10.1186/s10194-021-01351-2.

Key clinical point: Fremanezumab was effective and well tolerated over 12 weeks in older patients with chronic or episodic migraine.

Major finding: Quarterly and monthly fremanezumab vs. placebo showed greater reduction in monthly average migraine days (least-squares mean change from baseline [D] −4.3 and −4.6 vs. −2.3), headache days of at least moderate severity (D −3.9 and −4.2 vs. −2.1), and acute medication use (D −3.7 and −4.0 vs. −1.3) over 12 weeks (all P < .05). Adverse events were similar across groups.

Study details: Findings are pooled subgroup analysis of 3 phase 3 studies (HALO CM, HALO EM, and FOCUS) including 246 participants aged ≥60 years with chronic or episodic migraine with an inadequate response to 2-4 prior migraine preventives. They were randomly assigned to quarterly fremanezumab, monthly fremanezumab, or matched monthly placebo.

Disclosures: This study was funded by Teva Pharmaceuticals Ltd. Some investigators, including the lead author, reported participating in clinical trials and receiving honoraria, research support, and legal or personal fees from and being former or current employees of various sources, including Teva Pharmaceuticals.

Source: Nahas SJ et al. J Headache Pain. 2021;22:141 (Nov 24). Doi: 10.1186/s10194-021-01351-2.

Key clinical point: Fremanezumab was effective and well tolerated over 12 weeks in older patients with chronic or episodic migraine.

Major finding: Quarterly and monthly fremanezumab vs. placebo showed greater reduction in monthly average migraine days (least-squares mean change from baseline [D] −4.3 and −4.6 vs. −2.3), headache days of at least moderate severity (D −3.9 and −4.2 vs. −2.1), and acute medication use (D −3.7 and −4.0 vs. −1.3) over 12 weeks (all P < .05). Adverse events were similar across groups.

Study details: Findings are pooled subgroup analysis of 3 phase 3 studies (HALO CM, HALO EM, and FOCUS) including 246 participants aged ≥60 years with chronic or episodic migraine with an inadequate response to 2-4 prior migraine preventives. They were randomly assigned to quarterly fremanezumab, monthly fremanezumab, or matched monthly placebo.

Disclosures: This study was funded by Teva Pharmaceuticals Ltd. Some investigators, including the lead author, reported participating in clinical trials and receiving honoraria, research support, and legal or personal fees from and being former or current employees of various sources, including Teva Pharmaceuticals.

Source: Nahas SJ et al. J Headache Pain. 2021;22:141 (Nov 24). Doi: 10.1186/s10194-021-01351-2.

Key clinical point: Patients with migraine are more likely to suffer from dry eye than patients without migraine.

Major finding: The prevalence of dry eye was significantly higher in patients with vs. without migraine (odds ratio, 1.55; P < .001).

Study details: Findings are from a meta-analysis of 7 case-control or cross-sectional studies including a total population of 1,033,288 individuals with or without migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China and Fundamental Research Funds of the State Key Laboratory of Ophthalmology. The authors declared no conflict of interests.

Source: Chen H et al. Cornea. 2021 (Nov 6). Doi: 10.1097/ICO.0000000000002851.

Key clinical point: Patients with migraine are more likely to suffer from dry eye than patients without migraine.

Major finding: The prevalence of dry eye was significantly higher in patients with vs. without migraine (odds ratio, 1.55; P < .001).

Study details: Findings are from a meta-analysis of 7 case-control or cross-sectional studies including a total population of 1,033,288 individuals with or without migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China and Fundamental Research Funds of the State Key Laboratory of Ophthalmology. The authors declared no conflict of interests.

Source: Chen H et al. Cornea. 2021 (Nov 6). Doi: 10.1097/ICO.0000000000002851.

Key clinical point: Patients with migraine are more likely to suffer from dry eye than patients without migraine.

Major finding: The prevalence of dry eye was significantly higher in patients with vs. without migraine (odds ratio, 1.55; P < .001).

Study details: Findings are from a meta-analysis of 7 case-control or cross-sectional studies including a total population of 1,033,288 individuals with or without migraine.

Disclosures: This study was supported by the National Natural Science Foundation of China and Fundamental Research Funds of the State Key Laboratory of Ophthalmology. The authors declared no conflict of interests.

Source: Chen H et al. Cornea. 2021 (Nov 6). Doi: 10.1097/ICO.0000000000002851.

Key clinical point: Prevalence of migraine was higher in patients with celiac disease (CD) vs. healthy controls, with patients with CD and migraine showing worse gastrointestinal symptoms compared with those without migraine.

Major finding: The prevalence of migraine was higher in patients with vs. without CD (20.7% vs. 11.9%; P < .001). Patients with CD with vs. without migraine headache had a higher prevalence of abdominal pain (80.1% vs. 71.8%; P = .025), constipation (47.8% vs. 35.5%; P = .011), and diarrhea (60.8% vs. 45.9%; P = .002).

Study details: This case-control cross-sectional study included 1,000 adult patients with CD and 1,000 healthy controls.

Disclosures: No funding was received for this study. The authors declared no conflict of interests.

Source: Fanaeian MM et al. PLoS One. 2021;16(11):e0259502 (Nov 17). Doi:  10.1371/journal.pone.0259502.

Key clinical point: Prevalence of migraine was higher in patients with celiac disease (CD) vs. healthy controls, with patients with CD and migraine showing worse gastrointestinal symptoms compared with those without migraine.

Major finding: The prevalence of migraine was higher in patients with vs. without CD (20.7% vs. 11.9%; P < .001). Patients with CD with vs. without migraine headache had a higher prevalence of abdominal pain (80.1% vs. 71.8%; P = .025), constipation (47.8% vs. 35.5%; P = .011), and diarrhea (60.8% vs. 45.9%; P = .002).

Study details: This case-control cross-sectional study included 1,000 adult patients with CD and 1,000 healthy controls.

Disclosures: No funding was received for this study. The authors declared no conflict of interests.

Source: Fanaeian MM et al. PLoS One. 2021;16(11):e0259502 (Nov 17). Doi:  10.1371/journal.pone.0259502.

Key clinical point: Prevalence of migraine was higher in patients with celiac disease (CD) vs. healthy controls, with patients with CD and migraine showing worse gastrointestinal symptoms compared with those without migraine.

Major finding: The prevalence of migraine was higher in patients with vs. without CD (20.7% vs. 11.9%; P < .001). Patients with CD with vs. without migraine headache had a higher prevalence of abdominal pain (80.1% vs. 71.8%; P = .025), constipation (47.8% vs. 35.5%; P = .011), and diarrhea (60.8% vs. 45.9%; P = .002).

Study details: This case-control cross-sectional study included 1,000 adult patients with CD and 1,000 healthy controls.

Disclosures: No funding was received for this study. The authors declared no conflict of interests.

Source: Fanaeian MM et al. PLoS One. 2021;16(11):e0259502 (Nov 17). Doi:  10.1371/journal.pone.0259502.

Key clinical point: The frequency of occipital bending (OB) was 2-fold higher in patients with migraine with visual aura than those without visual aura.

Major finding: Overall, the prevalence of OB was 33.3% and was significantly higher in patients with migraine with vs. without visual aura (57.1% vs. 25.4%; odds ratio 3.9; P = .015).

Study details: Findings are from a retrospective analysis of 84 patients with migraine with (n = 21) or without visual aura (n = 63).

Disclosures: No source of funding was identified. The authors declared no conflict of interests.

Source: Özkan E et al. Headache. 2021 (Nov 28). Doi: 10.1111/head.14240.

Key clinical point: The frequency of occipital bending (OB) was 2-fold higher in patients with migraine with visual aura than those without visual aura.

Major finding: Overall, the prevalence of OB was 33.3% and was significantly higher in patients with migraine with vs. without visual aura (57.1% vs. 25.4%; odds ratio 3.9; P = .015).

Study details: Findings are from a retrospective analysis of 84 patients with migraine with (n = 21) or without visual aura (n = 63).

Disclosures: No source of funding was identified. The authors declared no conflict of interests.

Source: Özkan E et al. Headache. 2021 (Nov 28). Doi: 10.1111/head.14240.

Key clinical point: The frequency of occipital bending (OB) was 2-fold higher in patients with migraine with visual aura than those without visual aura.

Major finding: Overall, the prevalence of OB was 33.3% and was significantly higher in patients with migraine with vs. without visual aura (57.1% vs. 25.4%; odds ratio 3.9; P = .015).

Study details: Findings are from a retrospective analysis of 84 patients with migraine with (n = 21) or without visual aura (n = 63).

Disclosures: No source of funding was identified. The authors declared no conflict of interests.

Source: Özkan E et al. Headache. 2021 (Nov 28). Doi: 10.1111/head.14240.

Key clinical point: Unilateral pain, fewer failed preventives, good response to triptans, and medication overuse at baseline were associated with a persistent positive response to galcanezumab during the first 3 months of therapy in patients with chronic migraine.

Major finding: Overall, 41.7% of patients had a persistent 3-month 50% responder rate in headache days of at least moderate intensity. Responders vs. nonresponders had lower number of failed preventives (odds ratio [OR] 0.733; P = .041), frequent unilateral pain (OR 3.686; P = .041), medication overuse at baseline (OR 4.575; P = .012), and good response to triptans (OR 3.248; P = .028).

Study details: This observational study included 156 adult patients with chronic migraine from the GARLIT study who had a galcanezumab prescription.

Disclosures: This study was funded by Campus Bio-Medico University. Some investigators including the lead author received grants, travel expenses, and honoraria for advisory boards, speaker panels, or clinical investigation studies from various pharmaceutical companies.

Source: Vernieri F et al. Eur J Neurol. 2021 (Nov 26). Doi: 10.1111/ene.15197.

Key clinical point: Unilateral pain, fewer failed preventives, good response to triptans, and medication overuse at baseline were associated with a persistent positive response to galcanezumab during the first 3 months of therapy in patients with chronic migraine.

Major finding: Overall, 41.7% of patients had a persistent 3-month 50% responder rate in headache days of at least moderate intensity. Responders vs. nonresponders had lower number of failed preventives (odds ratio [OR] 0.733; P = .041), frequent unilateral pain (OR 3.686; P = .041), medication overuse at baseline (OR 4.575; P = .012), and good response to triptans (OR 3.248; P = .028).

Study details: This observational study included 156 adult patients with chronic migraine from the GARLIT study who had a galcanezumab prescription.

Disclosures: This study was funded by Campus Bio-Medico University. Some investigators including the lead author received grants, travel expenses, and honoraria for advisory boards, speaker panels, or clinical investigation studies from various pharmaceutical companies.

Source: Vernieri F et al. Eur J Neurol. 2021 (Nov 26). Doi: 10.1111/ene.15197.

Key clinical point: Unilateral pain, fewer failed preventives, good response to triptans, and medication overuse at baseline were associated with a persistent positive response to galcanezumab during the first 3 months of therapy in patients with chronic migraine.

Major finding: Overall, 41.7% of patients had a persistent 3-month 50% responder rate in headache days of at least moderate intensity. Responders vs. nonresponders had lower number of failed preventives (odds ratio [OR] 0.733; P = .041), frequent unilateral pain (OR 3.686; P = .041), medication overuse at baseline (OR 4.575; P = .012), and good response to triptans (OR 3.248; P = .028).

Study details: This observational study included 156 adult patients with chronic migraine from the GARLIT study who had a galcanezumab prescription.

Disclosures: This study was funded by Campus Bio-Medico University. Some investigators including the lead author received grants, travel expenses, and honoraria for advisory boards, speaker panels, or clinical investigation studies from various pharmaceutical companies.

Source: Vernieri F et al. Eur J Neurol. 2021 (Nov 26). Doi: 10.1111/ene.15197.

Key clinical point: Lasmiditan was associated with mild-to-moderate central nervous system (CNS)-related adverse events (AE), mostly transient in duration.

Major finding: Treatment-emergent serious AEs occurred in 0.4%, 0.2%, and 0.4% of patients treated with placebo, 100 mg lasmiditan, and 200 mg lasmiditan, respectively. The most common treatment-emergent AEs with lasmiditan were dizziness, nausea, paresthesia, fatigue, somnolence, and vertigo, with mostly mild-to-moderate severity. No deaths were reported.

Study details: Findings are from safety analysis of the phase 3 CENTURION trial that assessed 4,494 attacks across 1,471 patients with migraine with and without aura who were randomly assigned to either 200 mg lasmiditan or 100 mg lasmiditan for 4 attacks or placebo for 3 attacks and 50 mg lasmiditan for the third/fourth attack.

Disclosures: This study was sponsored by Eli Lilly and Company. Some investigators, including the lead author, reported receiving research grants, institutional payments, or fees for advisory boards and scientific lecturing; being an employee of; owning shares in; or consulting for various sources, including Eli Lilly and Company.

Source: Tassorelli C et al. J Headache Pain. 2021;22:132 (Nov 6). Doi: 10.1186/s10194-021-01343-2.

Key clinical point: Lasmiditan was associated with mild-to-moderate central nervous system (CNS)-related adverse events (AE), mostly transient in duration.

Major finding: Treatment-emergent serious AEs occurred in 0.4%, 0.2%, and 0.4% of patients treated with placebo, 100 mg lasmiditan, and 200 mg lasmiditan, respectively. The most common treatment-emergent AEs with lasmiditan were dizziness, nausea, paresthesia, fatigue, somnolence, and vertigo, with mostly mild-to-moderate severity. No deaths were reported.

Study details: Findings are from safety analysis of the phase 3 CENTURION trial that assessed 4,494 attacks across 1,471 patients with migraine with and without aura who were randomly assigned to either 200 mg lasmiditan or 100 mg lasmiditan for 4 attacks or placebo for 3 attacks and 50 mg lasmiditan for the third/fourth attack.

Disclosures: This study was sponsored by Eli Lilly and Company. Some investigators, including the lead author, reported receiving research grants, institutional payments, or fees for advisory boards and scientific lecturing; being an employee of; owning shares in; or consulting for various sources, including Eli Lilly and Company.

Source: Tassorelli C et al. J Headache Pain. 2021;22:132 (Nov 6). Doi: 10.1186/s10194-021-01343-2.

Key clinical point: Lasmiditan was associated with mild-to-moderate central nervous system (CNS)-related adverse events (AE), mostly transient in duration.

Major finding: Treatment-emergent serious AEs occurred in 0.4%, 0.2%, and 0.4% of patients treated with placebo, 100 mg lasmiditan, and 200 mg lasmiditan, respectively. The most common treatment-emergent AEs with lasmiditan were dizziness, nausea, paresthesia, fatigue, somnolence, and vertigo, with mostly mild-to-moderate severity. No deaths were reported.

Study details: Findings are from safety analysis of the phase 3 CENTURION trial that assessed 4,494 attacks across 1,471 patients with migraine with and without aura who were randomly assigned to either 200 mg lasmiditan or 100 mg lasmiditan for 4 attacks or placebo for 3 attacks and 50 mg lasmiditan for the third/fourth attack.

Disclosures: This study was sponsored by Eli Lilly and Company. Some investigators, including the lead author, reported receiving research grants, institutional payments, or fees for advisory boards and scientific lecturing; being an employee of; owning shares in; or consulting for various sources, including Eli Lilly and Company.

Source: Tassorelli C et al. J Headache Pain. 2021;22:132 (Nov 6). Doi: 10.1186/s10194-021-01343-2.

Key clinical point: Greater occipital nerve (GON) blockade with local anesthetics reduced the severity and duration of headaches in patients with episodic migraine without aura, with the headache frequency reducing significantly among patients receiving lidocaine alone or in combination with triamcinolone.

Major finding: GON block with triamcinolone, lidocaine, lidocaine+triamcinolone, or only normal saline significantly reduced the severity (P < .001) and duration (P = .001) of headaches, with no injection being superior to placebo. Headache frequency reduced in patients who received lidocaine (5.81 attacks per month; 95% CI of the difference −2.52 to −9.09) and lidocaine+triamcinolone (5.69 attacks per month; 95% CI of the difference −1.11 to −10.27).

Study details: This placebo-controlled clinical trial randomly assigned 55 adult patients with episodic migraine without aura to triamcinolone (n = 10), lidocaine (n = 16), lidocaine+triamcinolone (n = 13), or normal saline only (n = 16) groups.

Disclosures: This work was supported by the Iranian Center of Neurological Research in affiliation with Tehran University of Medical Sciences. The authors declared no conflict of interests.

Source: Malekian N et al. Cephalalgia. 2021 (Nov 17). Doi: 10.1177/03331024211058182.

Key clinical point: Greater occipital nerve (GON) blockade with local anesthetics reduced the severity and duration of headaches in patients with episodic migraine without aura, with the headache frequency reducing significantly among patients receiving lidocaine alone or in combination with triamcinolone.

Major finding: GON block with triamcinolone, lidocaine, lidocaine+triamcinolone, or only normal saline significantly reduced the severity (P < .001) and duration (P = .001) of headaches, with no injection being superior to placebo. Headache frequency reduced in patients who received lidocaine (5.81 attacks per month; 95% CI of the difference −2.52 to −9.09) and lidocaine+triamcinolone (5.69 attacks per month; 95% CI of the difference −1.11 to −10.27).

Study details: This placebo-controlled clinical trial randomly assigned 55 adult patients with episodic migraine without aura to triamcinolone (n = 10), lidocaine (n = 16), lidocaine+triamcinolone (n = 13), or normal saline only (n = 16) groups.

Disclosures: This work was supported by the Iranian Center of Neurological Research in affiliation with Tehran University of Medical Sciences. The authors declared no conflict of interests.

Source: Malekian N et al. Cephalalgia. 2021 (Nov 17). Doi: 10.1177/03331024211058182.

Key clinical point: Greater occipital nerve (GON) blockade with local anesthetics reduced the severity and duration of headaches in patients with episodic migraine without aura, with the headache frequency reducing significantly among patients receiving lidocaine alone or in combination with triamcinolone.

Major finding: GON block with triamcinolone, lidocaine, lidocaine+triamcinolone, or only normal saline significantly reduced the severity (P < .001) and duration (P = .001) of headaches, with no injection being superior to placebo. Headache frequency reduced in patients who received lidocaine (5.81 attacks per month; 95% CI of the difference −2.52 to −9.09) and lidocaine+triamcinolone (5.69 attacks per month; 95% CI of the difference −1.11 to −10.27).

Study details: This placebo-controlled clinical trial randomly assigned 55 adult patients with episodic migraine without aura to triamcinolone (n = 10), lidocaine (n = 16), lidocaine+triamcinolone (n = 13), or normal saline only (n = 16) groups.

Disclosures: This work was supported by the Iranian Center of Neurological Research in affiliation with Tehran University of Medical Sciences. The authors declared no conflict of interests.

Source: Malekian N et al. Cephalalgia. 2021 (Nov 17). Doi: 10.1177/03331024211058182.

Key clinical point: Intranasal ketorolac was not inferior to intravenous ketorolac in reducing pain intensity 60 min postmedication in children with migraine headaches of moderate-to-severe pain intensity.

Major finding: The difference in mean pain reduction at 60 min between intranasal and intravenous ketorolac groups was 0.2 (95% CI −0.9 to 1.3), with intranasal ketorolac being noninferior to intravenous ketorolac (P < .001). No serious adverse events were reported.

Study details: Findings are from a phase 3 clinical trial including 59 children (age 8-17 years) with migraine headache of moderate-to-severe pain intensity requiring any intravenous analgesic. They were randomly assigned to receive either intranasal ketorolac (1 mg/kg) or intravenous ketorolac (0.5 mg/kg).

Disclosures: This study was funded by the Columbia University’s CTSA grant from NCATS/NIH and Migraine Research Foundation. The authors declared no conflict of interests.

Source: Tsze DS et al. Acad Emerg Med. 2021 (Nov 25). Doi: 10.1111/acem.14422.

Key clinical point: Intranasal ketorolac was not inferior to intravenous ketorolac in reducing pain intensity 60 min postmedication in children with migraine headaches of moderate-to-severe pain intensity.

Major finding: The difference in mean pain reduction at 60 min between intranasal and intravenous ketorolac groups was 0.2 (95% CI −0.9 to 1.3), with intranasal ketorolac being noninferior to intravenous ketorolac (P < .001). No serious adverse events were reported.

Study details: Findings are from a phase 3 clinical trial including 59 children (age 8-17 years) with migraine headache of moderate-to-severe pain intensity requiring any intravenous analgesic. They were randomly assigned to receive either intranasal ketorolac (1 mg/kg) or intravenous ketorolac (0.5 mg/kg).

Disclosures: This study was funded by the Columbia University’s CTSA grant from NCATS/NIH and Migraine Research Foundation. The authors declared no conflict of interests.

Source: Tsze DS et al. Acad Emerg Med. 2021 (Nov 25). Doi: 10.1111/acem.14422.

Key clinical point: Intranasal ketorolac was not inferior to intravenous ketorolac in reducing pain intensity 60 min postmedication in children with migraine headaches of moderate-to-severe pain intensity.

Major finding: The difference in mean pain reduction at 60 min between intranasal and intravenous ketorolac groups was 0.2 (95% CI −0.9 to 1.3), with intranasal ketorolac being noninferior to intravenous ketorolac (P < .001). No serious adverse events were reported.

Study details: Findings are from a phase 3 clinical trial including 59 children (age 8-17 years) with migraine headache of moderate-to-severe pain intensity requiring any intravenous analgesic. They were randomly assigned to receive either intranasal ketorolac (1 mg/kg) or intravenous ketorolac (0.5 mg/kg).

Disclosures: This study was funded by the Columbia University’s CTSA grant from NCATS/NIH and Migraine Research Foundation. The authors declared no conflict of interests.

Source: Tsze DS et al. Acad Emerg Med. 2021 (Nov 25). Doi: 10.1111/acem.14422.