Saxagliptin add-on to oral antihyperglycemic agents safe and effective in drug-naive T2D patients

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Key clinical point: Combination of saxagliptin with metformin, acarbose, or gliclazide modified release was safe and effective as an initial treatment option in patients with newly diagnosed type 2 diabetes (T2D) and poor glycemic control.

 

Major finding: At 24 weeks, the mean changes in glycated hemoglobin (A1c) levels were 2.9% (95% CI 3.1% to 2.8%), 2.6% (95% CI 2.8% to 2.5%), and 2.8% (95% CI 2.9% to 2.6%) in saxagliptin+metformin (Saxa+Met), saxagliptin+acarbose (Saxa+Aca), and saxagliptin+gliclazide (Saxa+Gli) groups, respectively. Overall, 84.9%, 74.7%, and 80.3% of participants achieved an A1c < 7.0% in Saxa+Met, Saxa+Aca, and Saxa+Gli groups, respectively (P = .05), with the rates of hypoglycemia being low across all groups.

 

Study details: Findings are from a 24-week, randomized clinical trial including 648 treatment-naive patients with T2D and high A1c level who were randomly assigned to receive Saxa+Met (n = 216), Saxa+Aca (n = 216), or Saxa+Gli (n = 216).

 

Disclosures: This study was funded by AstraZeneca Pharmaceutical Company. The authors declared no conflicts of interest.

 

Source: Chen X et al. Saxagliptin combined with additional oral antihyperglycemic agents in drug-naive diabetic patients with high glycosylated hemoglobin: A 24-week, multicenter, randomized, open-label, active parallel-controlled group clinical trial in China (SUCCESS). Diabetes Obes Metab. 2022 (Sep 13). Doi: 10.1111/dom.14873

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Key clinical point: Combination of saxagliptin with metformin, acarbose, or gliclazide modified release was safe and effective as an initial treatment option in patients with newly diagnosed type 2 diabetes (T2D) and poor glycemic control.

 

Major finding: At 24 weeks, the mean changes in glycated hemoglobin (A1c) levels were 2.9% (95% CI 3.1% to 2.8%), 2.6% (95% CI 2.8% to 2.5%), and 2.8% (95% CI 2.9% to 2.6%) in saxagliptin+metformin (Saxa+Met), saxagliptin+acarbose (Saxa+Aca), and saxagliptin+gliclazide (Saxa+Gli) groups, respectively. Overall, 84.9%, 74.7%, and 80.3% of participants achieved an A1c < 7.0% in Saxa+Met, Saxa+Aca, and Saxa+Gli groups, respectively (P = .05), with the rates of hypoglycemia being low across all groups.

 

Study details: Findings are from a 24-week, randomized clinical trial including 648 treatment-naive patients with T2D and high A1c level who were randomly assigned to receive Saxa+Met (n = 216), Saxa+Aca (n = 216), or Saxa+Gli (n = 216).

 

Disclosures: This study was funded by AstraZeneca Pharmaceutical Company. The authors declared no conflicts of interest.

 

Source: Chen X et al. Saxagliptin combined with additional oral antihyperglycemic agents in drug-naive diabetic patients with high glycosylated hemoglobin: A 24-week, multicenter, randomized, open-label, active parallel-controlled group clinical trial in China (SUCCESS). Diabetes Obes Metab. 2022 (Sep 13). Doi: 10.1111/dom.14873

Key clinical point: Combination of saxagliptin with metformin, acarbose, or gliclazide modified release was safe and effective as an initial treatment option in patients with newly diagnosed type 2 diabetes (T2D) and poor glycemic control.

 

Major finding: At 24 weeks, the mean changes in glycated hemoglobin (A1c) levels were 2.9% (95% CI 3.1% to 2.8%), 2.6% (95% CI 2.8% to 2.5%), and 2.8% (95% CI 2.9% to 2.6%) in saxagliptin+metformin (Saxa+Met), saxagliptin+acarbose (Saxa+Aca), and saxagliptin+gliclazide (Saxa+Gli) groups, respectively. Overall, 84.9%, 74.7%, and 80.3% of participants achieved an A1c < 7.0% in Saxa+Met, Saxa+Aca, and Saxa+Gli groups, respectively (P = .05), with the rates of hypoglycemia being low across all groups.

 

Study details: Findings are from a 24-week, randomized clinical trial including 648 treatment-naive patients with T2D and high A1c level who were randomly assigned to receive Saxa+Met (n = 216), Saxa+Aca (n = 216), or Saxa+Gli (n = 216).

 

Disclosures: This study was funded by AstraZeneca Pharmaceutical Company. The authors declared no conflicts of interest.

 

Source: Chen X et al. Saxagliptin combined with additional oral antihyperglycemic agents in drug-naive diabetic patients with high glycosylated hemoglobin: A 24-week, multicenter, randomized, open-label, active parallel-controlled group clinical trial in China (SUCCESS). Diabetes Obes Metab. 2022 (Sep 13). Doi: 10.1111/dom.14873

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T2D: Bexagliflozin add-on to metformin shows antidiabetic potency equivalent to glimepiride

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Key clinical point: As an adjunct to metformin, bexagliflozin (20 mg) demonstrated antidiabetic potency equivalent to titrated glimepiride in patients with type 2 diabetes (T2D) inadequately controlled on metformin. Additional benefits were demonstrated in the form of weight loss, reduced systolic blood pressure (SBP), and fewer hypoglycemic events.

 

Major finding: At week 60, the least squares mean difference in glycated hemoglobin levels between bexagliflozin and glimepiride was 0.05% (95% CI 0.21% to 0.11%), showing noninferiority of bexagliflozin over glimepiride; however, bexagliflozin was superior to glimepiride for weight loss (P < .0001), decrease in SBP (P = .0008), and hypoglycemia incidence (P < .0001).

 

Study details: This 96-week randomized controlled trial included 426 patients with T2D (7.0% ≤ A1c ≤ 10.5%) inadequately controlled on metformin who were randomly assigned to receive bexagliflozin (n = 213) or titrated glimepiride (n = 213).

 

Disclosures: This study was funded by Theracos Sub, LLC. Some authors including the lead author were supported by a research grant to the Massachusetts General Hospital from Theracos Sub, LLC.

 

Source: Halvorsen YD et al. A 96-week, double-blind, randomized, controlled trial comparing bexagliflozin to glimepiride as an adjunct to metformin for the treatment of type 2 diabetes in adults. Diabetes Obes Metab. 2022 (Sep 30). Doi: 10.1111/dom.14875

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Key clinical point: As an adjunct to metformin, bexagliflozin (20 mg) demonstrated antidiabetic potency equivalent to titrated glimepiride in patients with type 2 diabetes (T2D) inadequately controlled on metformin. Additional benefits were demonstrated in the form of weight loss, reduced systolic blood pressure (SBP), and fewer hypoglycemic events.

 

Major finding: At week 60, the least squares mean difference in glycated hemoglobin levels between bexagliflozin and glimepiride was 0.05% (95% CI 0.21% to 0.11%), showing noninferiority of bexagliflozin over glimepiride; however, bexagliflozin was superior to glimepiride for weight loss (P < .0001), decrease in SBP (P = .0008), and hypoglycemia incidence (P < .0001).

 

Study details: This 96-week randomized controlled trial included 426 patients with T2D (7.0% ≤ A1c ≤ 10.5%) inadequately controlled on metformin who were randomly assigned to receive bexagliflozin (n = 213) or titrated glimepiride (n = 213).

 

Disclosures: This study was funded by Theracos Sub, LLC. Some authors including the lead author were supported by a research grant to the Massachusetts General Hospital from Theracos Sub, LLC.

 

Source: Halvorsen YD et al. A 96-week, double-blind, randomized, controlled trial comparing bexagliflozin to glimepiride as an adjunct to metformin for the treatment of type 2 diabetes in adults. Diabetes Obes Metab. 2022 (Sep 30). Doi: 10.1111/dom.14875

Key clinical point: As an adjunct to metformin, bexagliflozin (20 mg) demonstrated antidiabetic potency equivalent to titrated glimepiride in patients with type 2 diabetes (T2D) inadequately controlled on metformin. Additional benefits were demonstrated in the form of weight loss, reduced systolic blood pressure (SBP), and fewer hypoglycemic events.

 

Major finding: At week 60, the least squares mean difference in glycated hemoglobin levels between bexagliflozin and glimepiride was 0.05% (95% CI 0.21% to 0.11%), showing noninferiority of bexagliflozin over glimepiride; however, bexagliflozin was superior to glimepiride for weight loss (P < .0001), decrease in SBP (P = .0008), and hypoglycemia incidence (P < .0001).

 

Study details: This 96-week randomized controlled trial included 426 patients with T2D (7.0% ≤ A1c ≤ 10.5%) inadequately controlled on metformin who were randomly assigned to receive bexagliflozin (n = 213) or titrated glimepiride (n = 213).

 

Disclosures: This study was funded by Theracos Sub, LLC. Some authors including the lead author were supported by a research grant to the Massachusetts General Hospital from Theracos Sub, LLC.

 

Source: Halvorsen YD et al. A 96-week, double-blind, randomized, controlled trial comparing bexagliflozin to glimepiride as an adjunct to metformin for the treatment of type 2 diabetes in adults. Diabetes Obes Metab. 2022 (Sep 30). Doi: 10.1111/dom.14875

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T2D: Increased risk for ventricular arrhythmia or sudden cardiac death with sulfonylurea vs metformin

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Key clinical point: Patients with type 2 diabetes (T2D) who used sulfonylurea were at a higher risk for ventricular arrhythmia or sudden cardiac death (VA/SCD) compared with those who used metformin, irrespective of the severity of diabetes or history of coronary heart disease.

 

Major finding: Patients receiving sulfonylurea vs metformin had a significantly higher risk for VA/SCD (hazard ratio [HR] 1.90; 95% CI 1.73-2.08), with the results being consistent in both insulin users (HR 1.82; 95% CI 1.52-2.18) and nonusers (HR 1.92; 95% CI 1.73-2.13) and patients with (HR 1.64; 95% CI 1.34-2.02) and without (HR 1.95; 95% CI 1.76-2.16) coronary heart disease.

 

Study details: Findings are from a population-based cohort study including patients with T2D receiving metformin (n = 16,596) who were matched with those receiving sulfonylurea (n = 16,596) using propensity score matching.

 

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

 

Source: Lee TTL et al. Sulfonylurea is associated with higher risks of ventricular arrhythmia or sudden cardiac death compared with metformin: A population-based cohort study. J Am Heart Assoc. 2022;11(18):e026289 (Sep 14). Doi: 10.1161/JAHA.122.026289

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Key clinical point: Patients with type 2 diabetes (T2D) who used sulfonylurea were at a higher risk for ventricular arrhythmia or sudden cardiac death (VA/SCD) compared with those who used metformin, irrespective of the severity of diabetes or history of coronary heart disease.

 

Major finding: Patients receiving sulfonylurea vs metformin had a significantly higher risk for VA/SCD (hazard ratio [HR] 1.90; 95% CI 1.73-2.08), with the results being consistent in both insulin users (HR 1.82; 95% CI 1.52-2.18) and nonusers (HR 1.92; 95% CI 1.73-2.13) and patients with (HR 1.64; 95% CI 1.34-2.02) and without (HR 1.95; 95% CI 1.76-2.16) coronary heart disease.

 

Study details: Findings are from a population-based cohort study including patients with T2D receiving metformin (n = 16,596) who were matched with those receiving sulfonylurea (n = 16,596) using propensity score matching.

 

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

 

Source: Lee TTL et al. Sulfonylurea is associated with higher risks of ventricular arrhythmia or sudden cardiac death compared with metformin: A population-based cohort study. J Am Heart Assoc. 2022;11(18):e026289 (Sep 14). Doi: 10.1161/JAHA.122.026289

Key clinical point: Patients with type 2 diabetes (T2D) who used sulfonylurea were at a higher risk for ventricular arrhythmia or sudden cardiac death (VA/SCD) compared with those who used metformin, irrespective of the severity of diabetes or history of coronary heart disease.

 

Major finding: Patients receiving sulfonylurea vs metformin had a significantly higher risk for VA/SCD (hazard ratio [HR] 1.90; 95% CI 1.73-2.08), with the results being consistent in both insulin users (HR 1.82; 95% CI 1.52-2.18) and nonusers (HR 1.92; 95% CI 1.73-2.13) and patients with (HR 1.64; 95% CI 1.34-2.02) and without (HR 1.95; 95% CI 1.76-2.16) coronary heart disease.

 

Study details: Findings are from a population-based cohort study including patients with T2D receiving metformin (n = 16,596) who were matched with those receiving sulfonylurea (n = 16,596) using propensity score matching.

 

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

 

Source: Lee TTL et al. Sulfonylurea is associated with higher risks of ventricular arrhythmia or sudden cardiac death compared with metformin: A population-based cohort study. J Am Heart Assoc. 2022;11(18):e026289 (Sep 14). Doi: 10.1161/JAHA.122.026289

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Antidiabetic drugs influence fracture risk in T2D

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Key clinical point: Glucagon-like peptide-1 receptor agonists (GLP1-RAs) and sulfonylureas (SUs) provide better protection against fractures in patients with type 2 diabetes (T2D) compared with thiazolidinedione (TZD). Sodium-glucose cotransporter-2 inhibitors (SGLT-2is) and dipeptidyl peptidase-4 inhibitors (DPP-4is) increase fracture risk vs. GLP1-RAs.

 

Major finding: Compared with TZD, the risk for fracture was significantly lower with GLP1-RA (risk ratio [RR], 0.50; 95% CI, 0.31-0.79) and sulfonylurea (RR, 0.56; 95% CI, 0.41-0.77); however, the risk was significantly higher with DPP-4i (RR, 1.76; 95% CI, 1.21-2.55) and SGLT-2i (RR, 1.50; 95% CI, 1.05-2.16) vs. GLP1-RA.

 

Study details: The data come from a meta-analysis of 161 trials including 191,361 patients with T2D who reported 2,916 fractures.

 

Disclosures: This study received no specific funding. The authors declared no conflicts of interest.

 

Source: Tsai WH et al. Risk of fracture caused by anti-diabetic drugs in individuals with type 2 diabetes: A network meta-analysis. Diabetes Res Clin Pract. 2022;192:110082  (Sep 16). Doi: 10.1016/j.diabres.2022.110082.

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Key clinical point: Glucagon-like peptide-1 receptor agonists (GLP1-RAs) and sulfonylureas (SUs) provide better protection against fractures in patients with type 2 diabetes (T2D) compared with thiazolidinedione (TZD). Sodium-glucose cotransporter-2 inhibitors (SGLT-2is) and dipeptidyl peptidase-4 inhibitors (DPP-4is) increase fracture risk vs. GLP1-RAs.

 

Major finding: Compared with TZD, the risk for fracture was significantly lower with GLP1-RA (risk ratio [RR], 0.50; 95% CI, 0.31-0.79) and sulfonylurea (RR, 0.56; 95% CI, 0.41-0.77); however, the risk was significantly higher with DPP-4i (RR, 1.76; 95% CI, 1.21-2.55) and SGLT-2i (RR, 1.50; 95% CI, 1.05-2.16) vs. GLP1-RA.

 

Study details: The data come from a meta-analysis of 161 trials including 191,361 patients with T2D who reported 2,916 fractures.

 

Disclosures: This study received no specific funding. The authors declared no conflicts of interest.

 

Source: Tsai WH et al. Risk of fracture caused by anti-diabetic drugs in individuals with type 2 diabetes: A network meta-analysis. Diabetes Res Clin Pract. 2022;192:110082  (Sep 16). Doi: 10.1016/j.diabres.2022.110082.

Key clinical point: Glucagon-like peptide-1 receptor agonists (GLP1-RAs) and sulfonylureas (SUs) provide better protection against fractures in patients with type 2 diabetes (T2D) compared with thiazolidinedione (TZD). Sodium-glucose cotransporter-2 inhibitors (SGLT-2is) and dipeptidyl peptidase-4 inhibitors (DPP-4is) increase fracture risk vs. GLP1-RAs.

 

Major finding: Compared with TZD, the risk for fracture was significantly lower with GLP1-RA (risk ratio [RR], 0.50; 95% CI, 0.31-0.79) and sulfonylurea (RR, 0.56; 95% CI, 0.41-0.77); however, the risk was significantly higher with DPP-4i (RR, 1.76; 95% CI, 1.21-2.55) and SGLT-2i (RR, 1.50; 95% CI, 1.05-2.16) vs. GLP1-RA.

 

Study details: The data come from a meta-analysis of 161 trials including 191,361 patients with T2D who reported 2,916 fractures.

 

Disclosures: This study received no specific funding. The authors declared no conflicts of interest.

 

Source: Tsai WH et al. Risk of fracture caused by anti-diabetic drugs in individuals with type 2 diabetes: A network meta-analysis. Diabetes Res Clin Pract. 2022;192:110082  (Sep 16). Doi: 10.1016/j.diabres.2022.110082.

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Tirzepatide vs. insulin glargine improves renal outcomes in T2D

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

 

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

 

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

 

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

 

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

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

 

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

 

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

 

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

 

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

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

 

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

 

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

 

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

 

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

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Meta-analysis evaluates safety and efficacy of cinnarizine in migraine

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

 

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

 

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

 

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

 

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

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

 

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

 

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

 

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

 

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

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

 

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

 

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

 

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

 

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

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

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

 

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

 

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

 

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

 

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

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

 

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

 

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

 

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

 

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

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

 

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

 

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

 

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

 

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

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Preventive treatment improves cognition and QoL in patients with chronic migraine

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

 

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

 

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

 

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

 

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

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

 

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

 

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

 

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

 

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

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

 

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

 

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

 

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

 

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

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Changes in gastrointestinal motility with galcanezumab and erenumab in episodic migraine

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

 

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

 

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

 

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

 

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

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

 

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

 

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

 

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

 

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

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

 

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

 

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

 

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

 

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

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

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

 

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

 

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

 

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

 

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

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

 

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

 

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

 

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

 

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

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

 

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

 

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

 

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

 

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

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