Endocrinology, diabetes & metabolism · 2021
Tolerability of eptinezumab in overweight, obese or type 1 diabetes patients.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Baker Brian, Schaeffler Barbara, Hirman Joe, Hompesch Marcus, Pederson Susan, Smith Jeff
Аннотация
INTRODUCTION: In addition to its role in the pathogenesis of migraine, calcitonin gene-related peptide (CGRP) is implicated in the regulation of insulin secretion. However, there are limited data on the use of CGRP inhibitor monoclonal antibodies in individuals who are overweight/obese and those with diabetes.
METHODS: Two randomized, double-blind, placebo-controlled trials were conducted to assess the safety and metabolic effects of eptinezumab in non-migraine overweight/obese patients (study 1) and patients with type 1 diabetes (T1D; study 2). The primary end-point in overweight/obese patients was safety and changes in basal metabolic rate (BMR), defined as the energy expenditure during the fasting and resting states. In patients with T1D, the primary end-points were safety and insulin sensitivity as assessed by the bodyweight and insulin concentration corrected glucose infusion rate (M/I).
RESULTS: A total of 24 patients were enrolled in study 1, and 21 patients were enrolled in study 2. In overweight/obese patients, there was no significant difference in the least squares (LS) mean change in BMR between the eptinezumab- and placebo-treated patients from baseline to day 7 (6.4 vs -25.2 Kcal/day; LS mean difference 31.6 [95% confidence interval -90.6, 153.8]). In patients with T1D, there was no significant difference in insulin sensitivity between the eptinezumab and placebo groups. Eptinezumab was well tolerated in both studies with a similar rate of adverse events between treatment groups, and no new safety signals were identified.
CONCLUSION: Eptinezumab was well tolerated and not associated with adverse metabolic effects in patients who were overweight/obese or had T1D, providing ongoing support for the use of eptinezumab in these subgroups of patients with migraine.
METHODS: Two randomized, double-blind, placebo-controlled trials were conducted to assess the safety and metabolic effects of eptinezumab in non-migraine overweight/obese patients (study 1) and patients with type 1 diabetes (T1D; study 2). The primary end-point in overweight/obese patients was safety and changes in basal metabolic rate (BMR), defined as the energy expenditure during the fasting and resting states. In patients with T1D, the primary end-points were safety and insulin sensitivity as assessed by the bodyweight and insulin concentration corrected glucose infusion rate (M/I).
RESULTS: A total of 24 patients were enrolled in study 1, and 21 patients were enrolled in study 2. In overweight/obese patients, there was no significant difference in the least squares (LS) mean change in BMR between the eptinezumab- and placebo-treated patients from baseline to day 7 (6.4 vs -25.2 Kcal/day; LS mean difference 31.6 [95% confidence interval -90.6, 153.8]). In patients with T1D, there was no significant difference in insulin sensitivity between the eptinezumab and placebo groups. Eptinezumab was well tolerated in both studies with a similar rate of adverse events between treatment groups, and no new safety signals were identified.
CONCLUSION: Eptinezumab was well tolerated and not associated with adverse metabolic effects in patients who were overweight/obese or had T1D, providing ongoing support for the use of eptinezumab in these subgroups of patients with migraine.