Key clinical point: Erenumab vs placebo demonstrated a similar safety profile across all age groups of patients with chronic or episodic migraine, with no increase in adverse events because of age.

Major finding: Incidence of treatment-emergent adverse events was similar with 70 and 140 mg erenumab vs placebo across age groups: <40 (44.2% and 43.7% vs 44.4%, respectively), 40-49 (42.1% and 42.9% vs 49.2%, respectively), 50-59 (43.5% and 50.6% vs 41.6%, respectively), and ≥60 (39.5% and 48.6% vs 59.4%, respectively) years. The age-stratified incidence of treatment-emergent serious adverse events was low with both erenumab doses, with none reported among patients aged ≥60 years.

Study details: Findings are from a pooled and age-stratified analysis of five phase 2 and 3 randomized controlled trials including 3345 patients with chronic or episodic migraine with or without aura who were randomly assigned to receive erenumab (70 or 140 mg) or placebo.

Disclosures: This study was funded by Novartis Pharma AG, Switzerland. Erenumab was co-developed by Novartis and Amgen. Six authors declared being current or former employees or stockholders of Novartis or Amgen. C Lampl declared receiving honoraria from Novartis.

Source: Lampl C et al. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: A pooled analysis of placebo-controlled trials. J Headache Pain. 2022;23:104 (Aug 18). Doi: 10.1186/s10194-022-01470-4

Key clinical point: Erenumab vs placebo demonstrated a similar safety profile across all age groups of patients with chronic or episodic migraine, with no increase in adverse events because of age.

Major finding: Incidence of treatment-emergent adverse events was similar with 70 and 140 mg erenumab vs placebo across age groups: <40 (44.2% and 43.7% vs 44.4%, respectively), 40-49 (42.1% and 42.9% vs 49.2%, respectively), 50-59 (43.5% and 50.6% vs 41.6%, respectively), and ≥60 (39.5% and 48.6% vs 59.4%, respectively) years. The age-stratified incidence of treatment-emergent serious adverse events was low with both erenumab doses, with none reported among patients aged ≥60 years.

Study details: Findings are from a pooled and age-stratified analysis of five phase 2 and 3 randomized controlled trials including 3345 patients with chronic or episodic migraine with or without aura who were randomly assigned to receive erenumab (70 or 140 mg) or placebo.

Disclosures: This study was funded by Novartis Pharma AG, Switzerland. Erenumab was co-developed by Novartis and Amgen. Six authors declared being current or former employees or stockholders of Novartis or Amgen. C Lampl declared receiving honoraria from Novartis.

Source: Lampl C et al. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: A pooled analysis of placebo-controlled trials. J Headache Pain. 2022;23:104 (Aug 18). Doi: 10.1186/s10194-022-01470-4

Key clinical point: Erenumab vs placebo demonstrated a similar safety profile across all age groups of patients with chronic or episodic migraine, with no increase in adverse events because of age.

Major finding: Incidence of treatment-emergent adverse events was similar with 70 and 140 mg erenumab vs placebo across age groups: <40 (44.2% and 43.7% vs 44.4%, respectively), 40-49 (42.1% and 42.9% vs 49.2%, respectively), 50-59 (43.5% and 50.6% vs 41.6%, respectively), and ≥60 (39.5% and 48.6% vs 59.4%, respectively) years. The age-stratified incidence of treatment-emergent serious adverse events was low with both erenumab doses, with none reported among patients aged ≥60 years.

Study details: Findings are from a pooled and age-stratified analysis of five phase 2 and 3 randomized controlled trials including 3345 patients with chronic or episodic migraine with or without aura who were randomly assigned to receive erenumab (70 or 140 mg) or placebo.

Disclosures: This study was funded by Novartis Pharma AG, Switzerland. Erenumab was co-developed by Novartis and Amgen. Six authors declared being current or former employees or stockholders of Novartis or Amgen. C Lampl declared receiving honoraria from Novartis.

Source: Lampl C et al. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: A pooled analysis of placebo-controlled trials. J Headache Pain. 2022;23:104 (Aug 18). Doi: 10.1186/s10194-022-01470-4

Key clinical point: Eptinezumab vs placebo significantly reduced the number of headache days with acute headache medication (AHM) use in patients with chronic migraine (CM), with the effect being greatest among those with medication-overuse headache and ≥50% response.

Major finding: Eptinezumab vs placebo resulted in a greater percentage-point reductions in the number of headache days with AHM use in the overall cohort of patients with CM (percentage-point reduction −25.1% vs −17.0%) and in patients with CM and medication-overuse headache who experienced ≥50% response (percentage-point reduction −38.3% vs −31.5%) over 24 weeks.

Study details: Findings are from a post hoc analysis of a phase 3 study, PROMISE-2, including 1072 patients with CM, of which 40.2% were diagnosed with medication-overuse headache and were randomly assigned to receive eptinezumab (100 or 300 mg) or placebo.

Disclosures: This study was funded by Lundbeck Seattle BioPharmaceuticals, Inc., USA. Four authors declared being current or former employees of Lundbeck or a subsidiary company or a company contracted by Lundbeck or owning stocks or stock options in Alder/Lundbeck. Several authors reported ties with Lundbeck or other sources.

Source: Cowan RP et al. Quantity changes in acute headache medication use among patients with chronic migraine treated with eptinezumab: Subanalysis of the PROMISE‑2 study. J Headache Pain. 2022;23:115 (Sep 6). Doi: 10.1186/s10194-022-01482-0

Key clinical point: Eptinezumab vs placebo significantly reduced the number of headache days with acute headache medication (AHM) use in patients with chronic migraine (CM), with the effect being greatest among those with medication-overuse headache and ≥50% response.

Major finding: Eptinezumab vs placebo resulted in a greater percentage-point reductions in the number of headache days with AHM use in the overall cohort of patients with CM (percentage-point reduction −25.1% vs −17.0%) and in patients with CM and medication-overuse headache who experienced ≥50% response (percentage-point reduction −38.3% vs −31.5%) over 24 weeks.

Study details: Findings are from a post hoc analysis of a phase 3 study, PROMISE-2, including 1072 patients with CM, of which 40.2% were diagnosed with medication-overuse headache and were randomly assigned to receive eptinezumab (100 or 300 mg) or placebo.

Disclosures: This study was funded by Lundbeck Seattle BioPharmaceuticals, Inc., USA. Four authors declared being current or former employees of Lundbeck or a subsidiary company or a company contracted by Lundbeck or owning stocks or stock options in Alder/Lundbeck. Several authors reported ties with Lundbeck or other sources.

Source: Cowan RP et al. Quantity changes in acute headache medication use among patients with chronic migraine treated with eptinezumab: Subanalysis of the PROMISE‑2 study. J Headache Pain. 2022;23:115 (Sep 6). Doi: 10.1186/s10194-022-01482-0

Key clinical point: Eptinezumab vs placebo significantly reduced the number of headache days with acute headache medication (AHM) use in patients with chronic migraine (CM), with the effect being greatest among those with medication-overuse headache and ≥50% response.

Major finding: Eptinezumab vs placebo resulted in a greater percentage-point reductions in the number of headache days with AHM use in the overall cohort of patients with CM (percentage-point reduction −25.1% vs −17.0%) and in patients with CM and medication-overuse headache who experienced ≥50% response (percentage-point reduction −38.3% vs −31.5%) over 24 weeks.

Study details: Findings are from a post hoc analysis of a phase 3 study, PROMISE-2, including 1072 patients with CM, of which 40.2% were diagnosed with medication-overuse headache and were randomly assigned to receive eptinezumab (100 or 300 mg) or placebo.

Disclosures: This study was funded by Lundbeck Seattle BioPharmaceuticals, Inc., USA. Four authors declared being current or former employees of Lundbeck or a subsidiary company or a company contracted by Lundbeck or owning stocks or stock options in Alder/Lundbeck. Several authors reported ties with Lundbeck or other sources.

Source: Cowan RP et al. Quantity changes in acute headache medication use among patients with chronic migraine treated with eptinezumab: Subanalysis of the PROMISE‑2 study. J Headache Pain. 2022;23:115 (Sep 6). Doi: 10.1186/s10194-022-01482-0

Key clinical point: Patients with migraine without aura who experienced transient visual disturbance (MwTVD) had worse headache, higher migraine-related disability, more psychiatric comorbidities, and a higher risk for chronic migraine than those with migraine with visual aura (MA).

Major finding: MwTVD vs MA group had a higher prevalence of chronic migraine (41.9% vs 11.8%; P < .001) and higher mean Migraine Disability Assessment, anxiety, and depression scores (all P < .001), with transient visual disturbance being a significant risk factor for chronic migraine even after adjusting for confounding factors (adjusted odds ratio 4.75; P < .001).

Study details: This was a post hoc analysis of previously collected data of 2551 patients with migraine, of which 743 had MA and 1808 had MwTVD.

Disclosures: This study was supported by Brain Research Center, the Ministry of Education in Taiwan, and other sources. The authors declared no conflicts of interest.

Source: Tsao Y-C et al. Non-aura visual disturbance with high visual aura rating scale scores has stronger association with migraine chronification than typical aura. Cephalalgia. 2022 (Sep 6). Doi: 10.1177/03331024221123074

Key clinical point: Patients with migraine without aura who experienced transient visual disturbance (MwTVD) had worse headache, higher migraine-related disability, more psychiatric comorbidities, and a higher risk for chronic migraine than those with migraine with visual aura (MA).

Major finding: MwTVD vs MA group had a higher prevalence of chronic migraine (41.9% vs 11.8%; P < .001) and higher mean Migraine Disability Assessment, anxiety, and depression scores (all P < .001), with transient visual disturbance being a significant risk factor for chronic migraine even after adjusting for confounding factors (adjusted odds ratio 4.75; P < .001).

Study details: This was a post hoc analysis of previously collected data of 2551 patients with migraine, of which 743 had MA and 1808 had MwTVD.

Disclosures: This study was supported by Brain Research Center, the Ministry of Education in Taiwan, and other sources. The authors declared no conflicts of interest.

Source: Tsao Y-C et al. Non-aura visual disturbance with high visual aura rating scale scores has stronger association with migraine chronification than typical aura. Cephalalgia. 2022 (Sep 6). Doi: 10.1177/03331024221123074

Key clinical point: Patients with migraine without aura who experienced transient visual disturbance (MwTVD) had worse headache, higher migraine-related disability, more psychiatric comorbidities, and a higher risk for chronic migraine than those with migraine with visual aura (MA).

Major finding: MwTVD vs MA group had a higher prevalence of chronic migraine (41.9% vs 11.8%; P < .001) and higher mean Migraine Disability Assessment, anxiety, and depression scores (all P < .001), with transient visual disturbance being a significant risk factor for chronic migraine even after adjusting for confounding factors (adjusted odds ratio 4.75; P < .001).

Study details: This was a post hoc analysis of previously collected data of 2551 patients with migraine, of which 743 had MA and 1808 had MwTVD.

Disclosures: This study was supported by Brain Research Center, the Ministry of Education in Taiwan, and other sources. The authors declared no conflicts of interest.

Source: Tsao Y-C et al. Non-aura visual disturbance with high visual aura rating scale scores has stronger association with migraine chronification than typical aura. Cephalalgia. 2022 (Sep 6). Doi: 10.1177/03331024221123074

Key clinical point: Poor sleep quality significantly increased the risk of developing migraine and migraine-related burden.

Major finding: Poor sleep quality was more prevalent in patients with migraine vs healthy controls (66.9% vs 24.3%; P < .001), with the risk for migraine being 3.981-times higher in those with poor vs good sleep quality (P  =  .001). Poor sleep quality in patients with migraine was significantly associated with increases in total pain burden, decreased quality of life, and increased anxiety and depression (all P_trend < .05).

Study details: Findings are from a case-control and cross-sectional analysis including 134 patients with migraine with or without aura and 70 sex- and age-matched healthy controls.

Disclosures: This study was supported by the Elite Medical Professionals project of China-Japan Friendship Hospital. The authors declared no conflicts of interest.

Source: Duan S et al. Association between sleep quality, migraine and migraine burden. Front Neurol. 2022 (Aug 26). Doi: 10.3389/fneur.2022.955298

Key clinical point: Poor sleep quality significantly increased the risk of developing migraine and migraine-related burden.

Major finding: Poor sleep quality was more prevalent in patients with migraine vs healthy controls (66.9% vs 24.3%; P < .001), with the risk for migraine being 3.981-times higher in those with poor vs good sleep quality (P  =  .001). Poor sleep quality in patients with migraine was significantly associated with increases in total pain burden, decreased quality of life, and increased anxiety and depression (all P_trend < .05).

Study details: Findings are from a case-control and cross-sectional analysis including 134 patients with migraine with or without aura and 70 sex- and age-matched healthy controls.

Disclosures: This study was supported by the Elite Medical Professionals project of China-Japan Friendship Hospital. The authors declared no conflicts of interest.

Source: Duan S et al. Association between sleep quality, migraine and migraine burden. Front Neurol. 2022 (Aug 26). Doi: 10.3389/fneur.2022.955298

Key clinical point: Poor sleep quality significantly increased the risk of developing migraine and migraine-related burden.

Major finding: Poor sleep quality was more prevalent in patients with migraine vs healthy controls (66.9% vs 24.3%; P < .001), with the risk for migraine being 3.981-times higher in those with poor vs good sleep quality (P  =  .001). Poor sleep quality in patients with migraine was significantly associated with increases in total pain burden, decreased quality of life, and increased anxiety and depression (all P_trend < .05).

Study details: Findings are from a case-control and cross-sectional analysis including 134 patients with migraine with or without aura and 70 sex- and age-matched healthy controls.

Disclosures: This study was supported by the Elite Medical Professionals project of China-Japan Friendship Hospital. The authors declared no conflicts of interest.

Source: Duan S et al. Association between sleep quality, migraine and migraine burden. Front Neurol. 2022 (Aug 26). Doi: 10.3389/fneur.2022.955298

Key clinical point: Participants, especially women and those aged 50-85 years, who had a high intake of dietary thiamine were less likely to develop severe headache or migraine.

Major finding: Dietary thiamine intake was associated with a reduced risk for migraine or headache (adjusted odds ratio [aOR] 0.93; P  =  .046), particularly among women (aOR 0.90; P  =  .022) and those aged 50-85 years (aOR 0.86; P  =  .023).

Study details: Findings are from a cross-sectional study including 13,439 American adults, of which 2745 experienced migraine or severe headache in the past 3 months.

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

Source: Li D et al. Dietary intake of thiamine and riboflavin in relation to severe headache or migraine: A cross-sectional survey. Headache. 2022 (Sep 1). Doi: 10.1111/head.14384

Key clinical point: Participants, especially women and those aged 50-85 years, who had a high intake of dietary thiamine were less likely to develop severe headache or migraine.

Major finding: Dietary thiamine intake was associated with a reduced risk for migraine or headache (adjusted odds ratio [aOR] 0.93; P  =  .046), particularly among women (aOR 0.90; P  =  .022) and those aged 50-85 years (aOR 0.86; P  =  .023).

Study details: Findings are from a cross-sectional study including 13,439 American adults, of which 2745 experienced migraine or severe headache in the past 3 months.

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

Source: Li D et al. Dietary intake of thiamine and riboflavin in relation to severe headache or migraine: A cross-sectional survey. Headache. 2022 (Sep 1). Doi: 10.1111/head.14384

Key clinical point: Participants, especially women and those aged 50-85 years, who had a high intake of dietary thiamine were less likely to develop severe headache or migraine.

Major finding: Dietary thiamine intake was associated with a reduced risk for migraine or headache (adjusted odds ratio [aOR] 0.93; P  =  .046), particularly among women (aOR 0.90; P  =  .022) and those aged 50-85 years (aOR 0.86; P  =  .023).

Study details: Findings are from a cross-sectional study including 13,439 American adults, of which 2745 experienced migraine or severe headache in the past 3 months.

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

Source: Li D et al. Dietary intake of thiamine and riboflavin in relation to severe headache or migraine: A cross-sectional survey. Headache. 2022 (Sep 1). Doi: 10.1111/head.14384

Key clinical point: Fremanezumab vs placebo demonstrated significant and clinically meaningful improvements in migraine- and headache-related disability in patients with chronic and episodic migraine, including those with difficult-to-treat migraine.

Major finding: At 12 weeks of treatment, a significantly higher proportion of patients receiving quarterly and monthly fremanezumab vs placebo reported ≥5-point reduction in 6-item Headache Impact Test scores (53% and 55% vs 39%, respectively; both P < .0001) and ≥30% reduction in Migraine Disability Assessment scores among patients with severe disability (69% and 79% vs 58%, respectively; both P < .001).

Study details: Findings are from a pooled analysis of three phase 3 trials including 3660 patients with episodic or chronic migraine with or without aura who were randomly assigned to receive quarterly or monthly fremanezumab or placebo.

Disclosures: This study was funded by Teva Pharmaceuticals. Five authors declared being current or former employees of Teva Pharmaceuticals. P McAllister reported receiving research support and serving as a consultant for Teva Pharmaceuticals and other sources.

Source: McAllister P et al. Impact of fremanezumab on disability outcomes in patients with episodic and chronic migraine: A pooled analysis of phase 3 studies. J Headache Pain. 2022;23:112 (Aug 29). Doi: 10.1186/s10194-022-01438-4

Key clinical point: Fremanezumab vs placebo demonstrated significant and clinically meaningful improvements in migraine- and headache-related disability in patients with chronic and episodic migraine, including those with difficult-to-treat migraine.

Major finding: At 12 weeks of treatment, a significantly higher proportion of patients receiving quarterly and monthly fremanezumab vs placebo reported ≥5-point reduction in 6-item Headache Impact Test scores (53% and 55% vs 39%, respectively; both P < .0001) and ≥30% reduction in Migraine Disability Assessment scores among patients with severe disability (69% and 79% vs 58%, respectively; both P < .001).

Study details: Findings are from a pooled analysis of three phase 3 trials including 3660 patients with episodic or chronic migraine with or without aura who were randomly assigned to receive quarterly or monthly fremanezumab or placebo.

Disclosures: This study was funded by Teva Pharmaceuticals. Five authors declared being current or former employees of Teva Pharmaceuticals. P McAllister reported receiving research support and serving as a consultant for Teva Pharmaceuticals and other sources.

Source: McAllister P et al. Impact of fremanezumab on disability outcomes in patients with episodic and chronic migraine: A pooled analysis of phase 3 studies. J Headache Pain. 2022;23:112 (Aug 29). Doi: 10.1186/s10194-022-01438-4

Key clinical point: Fremanezumab vs placebo demonstrated significant and clinically meaningful improvements in migraine- and headache-related disability in patients with chronic and episodic migraine, including those with difficult-to-treat migraine.

Major finding: At 12 weeks of treatment, a significantly higher proportion of patients receiving quarterly and monthly fremanezumab vs placebo reported ≥5-point reduction in 6-item Headache Impact Test scores (53% and 55% vs 39%, respectively; both P < .0001) and ≥30% reduction in Migraine Disability Assessment scores among patients with severe disability (69% and 79% vs 58%, respectively; both P < .001).

Study details: Findings are from a pooled analysis of three phase 3 trials including 3660 patients with episodic or chronic migraine with or without aura who were randomly assigned to receive quarterly or monthly fremanezumab or placebo.

Disclosures: This study was funded by Teva Pharmaceuticals. Five authors declared being current or former employees of Teva Pharmaceuticals. P McAllister reported receiving research support and serving as a consultant for Teva Pharmaceuticals and other sources.

Source: McAllister P et al. Impact of fremanezumab on disability outcomes in patients with episodic and chronic migraine: A pooled analysis of phase 3 studies. J Headache Pain. 2022;23:112 (Aug 29). Doi: 10.1186/s10194-022-01438-4

Key clinical point: Treatment of a migraine attack with 50 or 100 mg ubrogepant leads to more favorable treatment outcomes when pain is mild vs moderate or severe.

Major finding: At 2 hours after ubrogepant treatment, the rates of freedom from pain (50 mg: odds ratio [OR] 2.89; 100 mg: OR 3.50; both P < .0001) and migraine symptoms (all P < .001) were higher when pain was mild vs moderate or severe.

Study details: Findings are from a post hoc analysis of a phase 3, long-term extension trial including patients with migraine with or without aura who were randomly assigned to receive 50 mg ubrogepant (n = 401), 100 mg ubrogepant (n = 407), or usual care (n = 417).

Disclosures: This study was sponsored by AbbVie Six authors reported being current or former employees or stockholders of AbbVie. Several authors including the lead author reported serving as consultants or advisory board members or receiving honoraria or research support from various sources.

Source: Lipton RB et al. Efficacy of ubrogepant in the acute treatment of migraine with mild pain versus moderate or severe pain. Neurology. 2022 (Aug 17). Doi:  10.1212/WNL.0000000000201031

Key clinical point: Treatment of a migraine attack with 50 or 100 mg ubrogepant leads to more favorable treatment outcomes when pain is mild vs moderate or severe.

Major finding: At 2 hours after ubrogepant treatment, the rates of freedom from pain (50 mg: odds ratio [OR] 2.89; 100 mg: OR 3.50; both P < .0001) and migraine symptoms (all P < .001) were higher when pain was mild vs moderate or severe.

Study details: Findings are from a post hoc analysis of a phase 3, long-term extension trial including patients with migraine with or without aura who were randomly assigned to receive 50 mg ubrogepant (n = 401), 100 mg ubrogepant (n = 407), or usual care (n = 417).

Disclosures: This study was sponsored by AbbVie Six authors reported being current or former employees or stockholders of AbbVie. Several authors including the lead author reported serving as consultants or advisory board members or receiving honoraria or research support from various sources.

Source: Lipton RB et al. Efficacy of ubrogepant in the acute treatment of migraine with mild pain versus moderate or severe pain. Neurology. 2022 (Aug 17). Doi:  10.1212/WNL.0000000000201031

Key clinical point: Treatment of a migraine attack with 50 or 100 mg ubrogepant leads to more favorable treatment outcomes when pain is mild vs moderate or severe.

Major finding: At 2 hours after ubrogepant treatment, the rates of freedom from pain (50 mg: odds ratio [OR] 2.89; 100 mg: OR 3.50; both P < .0001) and migraine symptoms (all P < .001) were higher when pain was mild vs moderate or severe.

Study details: Findings are from a post hoc analysis of a phase 3, long-term extension trial including patients with migraine with or without aura who were randomly assigned to receive 50 mg ubrogepant (n = 401), 100 mg ubrogepant (n = 407), or usual care (n = 417).

Disclosures: This study was sponsored by AbbVie Six authors reported being current or former employees or stockholders of AbbVie. Several authors including the lead author reported serving as consultants or advisory board members or receiving honoraria or research support from various sources.

Source: Lipton RB et al. Efficacy of ubrogepant in the acute treatment of migraine with mild pain versus moderate or severe pain. Neurology. 2022 (Aug 17). Doi:  10.1212/WNL.0000000000201031

Key clinical point: A combined manual therapeutic approach that included soft-tissue and articulatory manual therapy techniques was more effective in reducing migraine impact than either technique alone.

Major finding: After 4 weeks of intervention, the improvement in pain intensity was greater with combined soft-tissue and articulatory manual therapy vs only soft-tissue (P < .001) or articulatory (P = .014) manual therapy. Reduction in migraine duration was significant with combined vs soft-tissue therapy (P  =  .02), with improvements maintained through a  4-week follow-up. No serious side-effects were reported.

Study details: Findings are from a randomized controlled trial including 75 patients with chronic or episodic migraine who were randomly assigned to receive soft-tissue therapy, articulatory therapy, or combination of both manual therapies.

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

Source: Muñoz-Gómez E et al. Potential add-on effects of manual therapy techniques in migraine patients: A randomised controlled trial. J Clin Med. 2022;11(16):4686 (Aug 11). Doi: 10.3390/jcm11164686

Key clinical point: A combined manual therapeutic approach that included soft-tissue and articulatory manual therapy techniques was more effective in reducing migraine impact than either technique alone.

Major finding: After 4 weeks of intervention, the improvement in pain intensity was greater with combined soft-tissue and articulatory manual therapy vs only soft-tissue (P < .001) or articulatory (P = .014) manual therapy. Reduction in migraine duration was significant with combined vs soft-tissue therapy (P  =  .02), with improvements maintained through a  4-week follow-up. No serious side-effects were reported.

Study details: Findings are from a randomized controlled trial including 75 patients with chronic or episodic migraine who were randomly assigned to receive soft-tissue therapy, articulatory therapy, or combination of both manual therapies.

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

Source: Muñoz-Gómez E et al. Potential add-on effects of manual therapy techniques in migraine patients: A randomised controlled trial. J Clin Med. 2022;11(16):4686 (Aug 11). Doi: 10.3390/jcm11164686

Key clinical point: A combined manual therapeutic approach that included soft-tissue and articulatory manual therapy techniques was more effective in reducing migraine impact than either technique alone.

Major finding: After 4 weeks of intervention, the improvement in pain intensity was greater with combined soft-tissue and articulatory manual therapy vs only soft-tissue (P < .001) or articulatory (P = .014) manual therapy. Reduction in migraine duration was significant with combined vs soft-tissue therapy (P  =  .02), with improvements maintained through a  4-week follow-up. No serious side-effects were reported.

Study details: Findings are from a randomized controlled trial including 75 patients with chronic or episodic migraine who were randomly assigned to receive soft-tissue therapy, articulatory therapy, or combination of both manual therapies.

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

Source: Muñoz-Gómez E et al. Potential add-on effects of manual therapy techniques in migraine patients: A randomised controlled trial. J Clin Med. 2022;11(16):4686 (Aug 11). Doi: 10.3390/jcm11164686

Key clinical point: Treatment of perimenstrual migraine attacks with lasmiditan was associated with early and sustained freedom from migraine-related pain.

Major finding: Women who received 200 mg lasmiditan vs placebo during perimenstrual migraine attacks were more likely to report freedom from migraine-related pain (odds ratio [OR] 6.04; P < .001) and pain relief (OR 2.29; P  =  .007) at 2 hours and sustained freedom from pain at 24 hours (OR 11.67; P  =  .001).

Study details: Findings are from a post hoc analysis of the phase 2 MONONOFU and phase 3 CENTURION trials including 303 women with migraine with or without aura who had ≥1 perimenstrual migraine attacks and were randomly assigned to receive lasmiditan (50, 100, or 200 mg) or placebo.

Disclosures: This study was funded by Eli Lilly and Company. Four authors declared being employees and minor stockholders of Eli Lilly and Company. The other authors reported ties with various sources, including Eli Lilly and Company.

Source: MacGregor EA et al. Efficacy of lasmiditan for the acute treatment of perimenstrual migraine. Cephalalgia. 2022 (Aug 18). Doi: 10.1177/03331024221118929

Key clinical point: Treatment of perimenstrual migraine attacks with lasmiditan was associated with early and sustained freedom from migraine-related pain.

Major finding: Women who received 200 mg lasmiditan vs placebo during perimenstrual migraine attacks were more likely to report freedom from migraine-related pain (odds ratio [OR] 6.04; P < .001) and pain relief (OR 2.29; P  =  .007) at 2 hours and sustained freedom from pain at 24 hours (OR 11.67; P  =  .001).

Study details: Findings are from a post hoc analysis of the phase 2 MONONOFU and phase 3 CENTURION trials including 303 women with migraine with or without aura who had ≥1 perimenstrual migraine attacks and were randomly assigned to receive lasmiditan (50, 100, or 200 mg) or placebo.

Disclosures: This study was funded by Eli Lilly and Company. Four authors declared being employees and minor stockholders of Eli Lilly and Company. The other authors reported ties with various sources, including Eli Lilly and Company.

Source: MacGregor EA et al. Efficacy of lasmiditan for the acute treatment of perimenstrual migraine. Cephalalgia. 2022 (Aug 18). Doi: 10.1177/03331024221118929

Key clinical point: Treatment of perimenstrual migraine attacks with lasmiditan was associated with early and sustained freedom from migraine-related pain.

Major finding: Women who received 200 mg lasmiditan vs placebo during perimenstrual migraine attacks were more likely to report freedom from migraine-related pain (odds ratio [OR] 6.04; P < .001) and pain relief (OR 2.29; P  =  .007) at 2 hours and sustained freedom from pain at 24 hours (OR 11.67; P  =  .001).

Study details: Findings are from a post hoc analysis of the phase 2 MONONOFU and phase 3 CENTURION trials including 303 women with migraine with or without aura who had ≥1 perimenstrual migraine attacks and were randomly assigned to receive lasmiditan (50, 100, or 200 mg) or placebo.

Disclosures: This study was funded by Eli Lilly and Company. Four authors declared being employees and minor stockholders of Eli Lilly and Company. The other authors reported ties with various sources, including Eli Lilly and Company.

Source: MacGregor EA et al. Efficacy of lasmiditan for the acute treatment of perimenstrual migraine. Cephalalgia. 2022 (Aug 18). Doi: 10.1177/03331024221118929

Treatment of people with obesity but without diabetes with the glucagon-like peptide-1 (GLP-1) agonist semaglutide (Wegovy) – hailed at its approval in 2021 as a “game changer” for the treatment of obesity – led to beneficial changes in body mass index (BMI), glycemic control, and other clinical measures.

This collectively cut the calculated risk for possible future development of type 2 diabetes in study participants by more than half, based on post-hoc analysis of data from two pivotal trials that compared semaglutide with placebo.

The findings “suggest that semaglutide could help prevent type 2 diabetes in people with overweight or obesity,” said W. Timothy Garvey, MD, in a presentation at the annual meeting of the European Association for the Study of Diabetes.

Asked to comment, Rodolfo J. Galindo, MD, said: “We devote a significant amount of effort to treating people with diabetes but very little effort for diabetes prevention. We hope that further scientific findings showing the benefits of weight loss, as illustrated by [Dr.] Garvey [and colleagues], for diabetes prevention will change the pandemic of adiposity-based chronic disease.”
 

GLP-1 agonists as complication-reducing agents

Finding a link between treatment with semaglutide and a reduced future risk of developing type 2 diabetes is important because it shows that this regimen is not just a BMI-centric approach to treating people with obesity but is also a way to potentially reduce complications of obesity such as diabetes onset, explained Dr. Garvey, a professor and director of the Diabetes Research Center at the University of Alabama at Birmingham.

Recent obesity-management recommendations have focused on interventions aimed at avoiding complications, as in 2016 guidelines from the American Association of Clinical Endocrinologists and the American College of Endocrinology, he noted.

Having evidence that treatment with a GLP-1 agonist such as semaglutide can reduce the incidence of diabetes in people with obesity might also help convince payers to more uniformly reimburse for this type of obesity intervention, which up to now has commonly faced coverage limitations, especially in the United States, he said in an interview.

Dr. Garvey added that evidence for a reduction in the incidence of cardiovascular disease complications such as myocardial infarction and stroke may need to join diabetes prevention as proven effects from obesity intervention before coverage decisions change.

He cited the SELECT trial, which is testing the hypothesis that semaglutide treatment of people with overweight or obesity can reduce the incidence of cardiovascular events in about 17,500 participants and with expected completion toward the end of 2023.

“A complication-centric approach to management of people with obesity needs prediction tools that allow a focus on prevention strategies for people with obesity who are at increased risk of developing diabetes,” commented Dr. Galindo, an endocrinologist at Emory University, Atlanta, in an interview.
 

Combined analysis of STEP 1 and STEP 4 data

The analysis conducted by Dr. Garvey and colleagues used data from the STEP 1 trial, which compared semaglutide 2.4 mg subcutaneous once weekly with placebo for weight loss in more than 1,500 people predominantly with obesity (about 6% were overweight) and showed that after 68 weeks semaglutide cut the calculated risk of developing type 2 diabetes over the subsequent 10 years from 18% at baseline to 7%, compared with a drop from 18% at baseline to 16% among those who received placebo.

A second, similar analysis of data from people predominantly with obesity in the STEP 4 trial – which treated around 800 people with semaglutide 2.4 mg for 20 weeks and then randomized them to placebo or continued semaglutide treatment – showed that semaglutide treatment cut their calculated 10-year risk for incident type 2 diabetes from 20% at baseline to about 11% after 20 weeks. The risk rebounded in the study participants who then switched from semaglutide to placebo. Among those randomized to remain on semaglutide for a total of 68 weeks, the 10-year risk fell further to 8%.

Dr. Garvey and associates used a validated prognostic formula, the cardiometabolic disease staging (CMDS) tool, they had previously developed and reported to calculate 10-year risk for development of type 2 diabetes based on three unmodifiable factors (age, sex, and race) and five modifiable factors (BMI, blood pressure, glucose level, HDL cholesterol, and triglycerides). They applied the analysis to data from 1,561 of the STEP 1 participants and 766 participants in the STEP 4 study.

“There is no better tool I know of to predict diabetes incidence,” commented Michael A. Nauck, MD, professor and chief of clinical research, diabetes division, St. Josef Hospital, Bochum, Germany.

In his opinion, the CMDS tool is appropriate for estimating the risk of developing incident type 2 diabetes in populations but not in specific individuals.

The new analyses also showed that, in STEP 1, the impact of semaglutide on reducing future risk of developing type 2 diabetes was roughly the same regardless of whether participants entered the study with prediabetes or were normoglycemic at entry.

Blood glucose changes confer the biggest effect

The biggest contributor among the five modifiable components of the CMDS tool for altering the predicted risk for incident diabetes was the reduction in blood glucose produced by semaglutide treatment, which influenced just under half of the change in predicted risk, Dr. Garvey said. The four other modifiable components had roughly similar individual effects on predicted risk, with change in BMI influencing about 15% of the observed effect.

“Our analysis shows that semaglutide treatment is preventing diabetes via several mechanisms. It’s not just a reduction in glucose,” Dr. Garvey said.

Dr. Nauck cautioned, however, that it is hard to judge the efficacy of an intervention like semaglutide for preventing incident diabetes when one of its effects is to dampen down hyperglycemia, the signal indicator of diabetes onset.

Indeed, semaglutide was first approved as a treatment for type 2 diabetes (known as Ozempic, Novo Nordisk) at slightly lower doses than it is approved for obesity. It is also available as an oral agent to treat diabetes (Rybelsus).  

Dr. Nauck also noted that the results from at least one previously reported study had already shown the same relationship between treatment with the GLP-1 agonist liraglutide as an anti-obesity agent (3.0 mg dose daily, known as Saxenda) and a reduced subsequent incidence of type 2 diabetes but using actual clinical outcomes during 3 years of follow-up rather than a calculated projection of diabetes likelihood.

The SCALE Obesity and Prediabetes trial randomized 2,254 people with prediabetes and overweight or obesity to weekly treatment with 3.0 mg of liraglutide or placebo. After 160 weeks on treatment, the cumulative incidence of type 2 diabetes was 2% in those who received liraglutide and 6% among those on placebo, with a significant hazard ratio reduction of 79% in the incidence of diabetes on liraglutide treatment.

The STEP 1 and STEP 4 trials were sponsored by Novo Nordisk, the company that markets semaglutide (Wegovy). Dr. Garvey has reported serving as an advisor without compensation to Novo Nordisk as well as Boehringer Ingelheim, Eli Lilly, Jazz, and Pfizer. He is also a site principal investigator for multicentered clinical trials sponsored by the University of Alabama at Birmingham and funded by Novo Nordisk, Eli Lilly, Epitomee, and Pfizer. Dr .Galindo has reported being a consultant or advisor for Boehringer Ingelheim, Eli Lilly, Pfizer, Sanofi, and Weight Watchers and receiving research funding from Dexcom, Eli Lilly, and Novo Nordisk. Dr. Nauck has reported being an advisor or consultant to Novo Nordisk as well as to Boehringer Ingelheim, Eli Lilly, Menarini/Berlin Chemie, MSD, Regor, and ShouTi/Gasherbrum, receiving research funding from MSD, being a member of a data monitoring and safety board for Inventiva, and being a speaker on behalf of Novo Nordisk as well as for Eli Lilly, Menarini/Berlin Chemie, MSD, and Sun Pharmaceuticals.

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

Treatment of people with obesity but without diabetes with the glucagon-like peptide-1 (GLP-1) agonist semaglutide (Wegovy) – hailed at its approval in 2021 as a “game changer” for the treatment of obesity – led to beneficial changes in body mass index (BMI), glycemic control, and other clinical measures.

This collectively cut the calculated risk for possible future development of type 2 diabetes in study participants by more than half, based on post-hoc analysis of data from two pivotal trials that compared semaglutide with placebo.

The findings “suggest that semaglutide could help prevent type 2 diabetes in people with overweight or obesity,” said W. Timothy Garvey, MD, in a presentation at the annual meeting of the European Association for the Study of Diabetes.

Asked to comment, Rodolfo J. Galindo, MD, said: “We devote a significant amount of effort to treating people with diabetes but very little effort for diabetes prevention. We hope that further scientific findings showing the benefits of weight loss, as illustrated by [Dr.] Garvey [and colleagues], for diabetes prevention will change the pandemic of adiposity-based chronic disease.”
 

GLP-1 agonists as complication-reducing agents

Finding a link between treatment with semaglutide and a reduced future risk of developing type 2 diabetes is important because it shows that this regimen is not just a BMI-centric approach to treating people with obesity but is also a way to potentially reduce complications of obesity such as diabetes onset, explained Dr. Garvey, a professor and director of the Diabetes Research Center at the University of Alabama at Birmingham.

Recent obesity-management recommendations have focused on interventions aimed at avoiding complications, as in 2016 guidelines from the American Association of Clinical Endocrinologists and the American College of Endocrinology, he noted.

Having evidence that treatment with a GLP-1 agonist such as semaglutide can reduce the incidence of diabetes in people with obesity might also help convince payers to more uniformly reimburse for this type of obesity intervention, which up to now has commonly faced coverage limitations, especially in the United States, he said in an interview.

Dr. Garvey added that evidence for a reduction in the incidence of cardiovascular disease complications such as myocardial infarction and stroke may need to join diabetes prevention as proven effects from obesity intervention before coverage decisions change.

He cited the SELECT trial, which is testing the hypothesis that semaglutide treatment of people with overweight or obesity can reduce the incidence of cardiovascular events in about 17,500 participants and with expected completion toward the end of 2023.

“A complication-centric approach to management of people with obesity needs prediction tools that allow a focus on prevention strategies for people with obesity who are at increased risk of developing diabetes,” commented Dr. Galindo, an endocrinologist at Emory University, Atlanta, in an interview.
 

Combined analysis of STEP 1 and STEP 4 data

The analysis conducted by Dr. Garvey and colleagues used data from the STEP 1 trial, which compared semaglutide 2.4 mg subcutaneous once weekly with placebo for weight loss in more than 1,500 people predominantly with obesity (about 6% were overweight) and showed that after 68 weeks semaglutide cut the calculated risk of developing type 2 diabetes over the subsequent 10 years from 18% at baseline to 7%, compared with a drop from 18% at baseline to 16% among those who received placebo.

A second, similar analysis of data from people predominantly with obesity in the STEP 4 trial – which treated around 800 people with semaglutide 2.4 mg for 20 weeks and then randomized them to placebo or continued semaglutide treatment – showed that semaglutide treatment cut their calculated 10-year risk for incident type 2 diabetes from 20% at baseline to about 11% after 20 weeks. The risk rebounded in the study participants who then switched from semaglutide to placebo. Among those randomized to remain on semaglutide for a total of 68 weeks, the 10-year risk fell further to 8%.

Dr. Garvey and associates used a validated prognostic formula, the cardiometabolic disease staging (CMDS) tool, they had previously developed and reported to calculate 10-year risk for development of type 2 diabetes based on three unmodifiable factors (age, sex, and race) and five modifiable factors (BMI, blood pressure, glucose level, HDL cholesterol, and triglycerides). They applied the analysis to data from 1,561 of the STEP 1 participants and 766 participants in the STEP 4 study.

“There is no better tool I know of to predict diabetes incidence,” commented Michael A. Nauck, MD, professor and chief of clinical research, diabetes division, St. Josef Hospital, Bochum, Germany.

In his opinion, the CMDS tool is appropriate for estimating the risk of developing incident type 2 diabetes in populations but not in specific individuals.

The new analyses also showed that, in STEP 1, the impact of semaglutide on reducing future risk of developing type 2 diabetes was roughly the same regardless of whether participants entered the study with prediabetes or were normoglycemic at entry.

Blood glucose changes confer the biggest effect

The biggest contributor among the five modifiable components of the CMDS tool for altering the predicted risk for incident diabetes was the reduction in blood glucose produced by semaglutide treatment, which influenced just under half of the change in predicted risk, Dr. Garvey said. The four other modifiable components had roughly similar individual effects on predicted risk, with change in BMI influencing about 15% of the observed effect.

“Our analysis shows that semaglutide treatment is preventing diabetes via several mechanisms. It’s not just a reduction in glucose,” Dr. Garvey said.

Dr. Nauck cautioned, however, that it is hard to judge the efficacy of an intervention like semaglutide for preventing incident diabetes when one of its effects is to dampen down hyperglycemia, the signal indicator of diabetes onset.

Indeed, semaglutide was first approved as a treatment for type 2 diabetes (known as Ozempic, Novo Nordisk) at slightly lower doses than it is approved for obesity. It is also available as an oral agent to treat diabetes (Rybelsus).  

Dr. Nauck also noted that the results from at least one previously reported study had already shown the same relationship between treatment with the GLP-1 agonist liraglutide as an anti-obesity agent (3.0 mg dose daily, known as Saxenda) and a reduced subsequent incidence of type 2 diabetes but using actual clinical outcomes during 3 years of follow-up rather than a calculated projection of diabetes likelihood.

The SCALE Obesity and Prediabetes trial randomized 2,254 people with prediabetes and overweight or obesity to weekly treatment with 3.0 mg of liraglutide or placebo. After 160 weeks on treatment, the cumulative incidence of type 2 diabetes was 2% in those who received liraglutide and 6% among those on placebo, with a significant hazard ratio reduction of 79% in the incidence of diabetes on liraglutide treatment.

The STEP 1 and STEP 4 trials were sponsored by Novo Nordisk, the company that markets semaglutide (Wegovy). Dr. Garvey has reported serving as an advisor without compensation to Novo Nordisk as well as Boehringer Ingelheim, Eli Lilly, Jazz, and Pfizer. He is also a site principal investigator for multicentered clinical trials sponsored by the University of Alabama at Birmingham and funded by Novo Nordisk, Eli Lilly, Epitomee, and Pfizer. Dr .Galindo has reported being a consultant or advisor for Boehringer Ingelheim, Eli Lilly, Pfizer, Sanofi, and Weight Watchers and receiving research funding from Dexcom, Eli Lilly, and Novo Nordisk. Dr. Nauck has reported being an advisor or consultant to Novo Nordisk as well as to Boehringer Ingelheim, Eli Lilly, Menarini/Berlin Chemie, MSD, Regor, and ShouTi/Gasherbrum, receiving research funding from MSD, being a member of a data monitoring and safety board for Inventiva, and being a speaker on behalf of Novo Nordisk as well as for Eli Lilly, Menarini/Berlin Chemie, MSD, and Sun Pharmaceuticals.

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

Treatment of people with obesity but without diabetes with the glucagon-like peptide-1 (GLP-1) agonist semaglutide (Wegovy) – hailed at its approval in 2021 as a “game changer” for the treatment of obesity – led to beneficial changes in body mass index (BMI), glycemic control, and other clinical measures.

This collectively cut the calculated risk for possible future development of type 2 diabetes in study participants by more than half, based on post-hoc analysis of data from two pivotal trials that compared semaglutide with placebo.

The findings “suggest that semaglutide could help prevent type 2 diabetes in people with overweight or obesity,” said W. Timothy Garvey, MD, in a presentation at the annual meeting of the European Association for the Study of Diabetes.

Asked to comment, Rodolfo J. Galindo, MD, said: “We devote a significant amount of effort to treating people with diabetes but very little effort for diabetes prevention. We hope that further scientific findings showing the benefits of weight loss, as illustrated by [Dr.] Garvey [and colleagues], for diabetes prevention will change the pandemic of adiposity-based chronic disease.”
 

GLP-1 agonists as complication-reducing agents

Finding a link between treatment with semaglutide and a reduced future risk of developing type 2 diabetes is important because it shows that this regimen is not just a BMI-centric approach to treating people with obesity but is also a way to potentially reduce complications of obesity such as diabetes onset, explained Dr. Garvey, a professor and director of the Diabetes Research Center at the University of Alabama at Birmingham.

Recent obesity-management recommendations have focused on interventions aimed at avoiding complications, as in 2016 guidelines from the American Association of Clinical Endocrinologists and the American College of Endocrinology, he noted.

Having evidence that treatment with a GLP-1 agonist such as semaglutide can reduce the incidence of diabetes in people with obesity might also help convince payers to more uniformly reimburse for this type of obesity intervention, which up to now has commonly faced coverage limitations, especially in the United States, he said in an interview.

Dr. Garvey added that evidence for a reduction in the incidence of cardiovascular disease complications such as myocardial infarction and stroke may need to join diabetes prevention as proven effects from obesity intervention before coverage decisions change.

He cited the SELECT trial, which is testing the hypothesis that semaglutide treatment of people with overweight or obesity can reduce the incidence of cardiovascular events in about 17,500 participants and with expected completion toward the end of 2023.

“A complication-centric approach to management of people with obesity needs prediction tools that allow a focus on prevention strategies for people with obesity who are at increased risk of developing diabetes,” commented Dr. Galindo, an endocrinologist at Emory University, Atlanta, in an interview.
 

Combined analysis of STEP 1 and STEP 4 data

The analysis conducted by Dr. Garvey and colleagues used data from the STEP 1 trial, which compared semaglutide 2.4 mg subcutaneous once weekly with placebo for weight loss in more than 1,500 people predominantly with obesity (about 6% were overweight) and showed that after 68 weeks semaglutide cut the calculated risk of developing type 2 diabetes over the subsequent 10 years from 18% at baseline to 7%, compared with a drop from 18% at baseline to 16% among those who received placebo.

A second, similar analysis of data from people predominantly with obesity in the STEP 4 trial – which treated around 800 people with semaglutide 2.4 mg for 20 weeks and then randomized them to placebo or continued semaglutide treatment – showed that semaglutide treatment cut their calculated 10-year risk for incident type 2 diabetes from 20% at baseline to about 11% after 20 weeks. The risk rebounded in the study participants who then switched from semaglutide to placebo. Among those randomized to remain on semaglutide for a total of 68 weeks, the 10-year risk fell further to 8%.

Dr. Garvey and associates used a validated prognostic formula, the cardiometabolic disease staging (CMDS) tool, they had previously developed and reported to calculate 10-year risk for development of type 2 diabetes based on three unmodifiable factors (age, sex, and race) and five modifiable factors (BMI, blood pressure, glucose level, HDL cholesterol, and triglycerides). They applied the analysis to data from 1,561 of the STEP 1 participants and 766 participants in the STEP 4 study.

“There is no better tool I know of to predict diabetes incidence,” commented Michael A. Nauck, MD, professor and chief of clinical research, diabetes division, St. Josef Hospital, Bochum, Germany.

In his opinion, the CMDS tool is appropriate for estimating the risk of developing incident type 2 diabetes in populations but not in specific individuals.

The new analyses also showed that, in STEP 1, the impact of semaglutide on reducing future risk of developing type 2 diabetes was roughly the same regardless of whether participants entered the study with prediabetes or were normoglycemic at entry.

Blood glucose changes confer the biggest effect

The biggest contributor among the five modifiable components of the CMDS tool for altering the predicted risk for incident diabetes was the reduction in blood glucose produced by semaglutide treatment, which influenced just under half of the change in predicted risk, Dr. Garvey said. The four other modifiable components had roughly similar individual effects on predicted risk, with change in BMI influencing about 15% of the observed effect.

“Our analysis shows that semaglutide treatment is preventing diabetes via several mechanisms. It’s not just a reduction in glucose,” Dr. Garvey said.

Dr. Nauck cautioned, however, that it is hard to judge the efficacy of an intervention like semaglutide for preventing incident diabetes when one of its effects is to dampen down hyperglycemia, the signal indicator of diabetes onset.

Indeed, semaglutide was first approved as a treatment for type 2 diabetes (known as Ozempic, Novo Nordisk) at slightly lower doses than it is approved for obesity. It is also available as an oral agent to treat diabetes (Rybelsus).  

Dr. Nauck also noted that the results from at least one previously reported study had already shown the same relationship between treatment with the GLP-1 agonist liraglutide as an anti-obesity agent (3.0 mg dose daily, known as Saxenda) and a reduced subsequent incidence of type 2 diabetes but using actual clinical outcomes during 3 years of follow-up rather than a calculated projection of diabetes likelihood.

The SCALE Obesity and Prediabetes trial randomized 2,254 people with prediabetes and overweight or obesity to weekly treatment with 3.0 mg of liraglutide or placebo. After 160 weeks on treatment, the cumulative incidence of type 2 diabetes was 2% in those who received liraglutide and 6% among those on placebo, with a significant hazard ratio reduction of 79% in the incidence of diabetes on liraglutide treatment.

The STEP 1 and STEP 4 trials were sponsored by Novo Nordisk, the company that markets semaglutide (Wegovy). Dr. Garvey has reported serving as an advisor without compensation to Novo Nordisk as well as Boehringer Ingelheim, Eli Lilly, Jazz, and Pfizer. He is also a site principal investigator for multicentered clinical trials sponsored by the University of Alabama at Birmingham and funded by Novo Nordisk, Eli Lilly, Epitomee, and Pfizer. Dr .Galindo has reported being a consultant or advisor for Boehringer Ingelheim, Eli Lilly, Pfizer, Sanofi, and Weight Watchers and receiving research funding from Dexcom, Eli Lilly, and Novo Nordisk. Dr. Nauck has reported being an advisor or consultant to Novo Nordisk as well as to Boehringer Ingelheim, Eli Lilly, Menarini/Berlin Chemie, MSD, Regor, and ShouTi/Gasherbrum, receiving research funding from MSD, being a member of a data monitoring and safety board for Inventiva, and being a speaker on behalf of Novo Nordisk as well as for Eli Lilly, Menarini/Berlin Chemie, MSD, and Sun Pharmaceuticals.

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