Cystic Fibrosis Centre Copenhagen, Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark.
Cystic Fibrosis Centre Copenhagen, Department of Infectious Diseases, Copenhagen University Hospital - Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark; Department of Nutrition, Exercise and Sports, University of Copenhagen, Nørre Allé 51, Frederiksberg C, Denmark.
J Cyst Fibros. 2024 Jan;23(1):103-108. doi: 10.1016/j.jcf.2023.11.005. Epub 2023 Nov 21.
Elexacaftor/tezacaftor/ivacaftor (ETI) has improved the clinical status of individuals with cystic fibrosis (CF), however, whether ETI impacts glucose tolerance remains unknown. We aimed to study the change in glycated hemoglobin (HbA1c) and CF related diabetes (CFRD) status after initiation of ETI.
We included individuals ≥12 years treated with ETI in Denmark in a longitudinal observational study. HbA1c was measured at baseline, 3, 6, 9 and 12 months after treatment initiation. Change in HbA1c was assessed in mixed models adjusted for age, sex, glucose tolerance and prior CFTR modulator treatment. In a sub-population with CFRD, we assessed the change in insulin usage, hypoglycemic events and the 30-day continuous glucose monitoring (CGM) parameters (i.e., average blood glucose, time below (≤3.9 mM) and above (>10.0 mM) normal range, and the variation in glucose) after 12 months of treatment.
Among 321 individuals with CF, HbA1c declined by 2.1 mmol/mol [95 % confidence interval (CI): -2.6; -1.5 mmol/mol] after 3 months and by 2.3 mmol/mol [95 %CI: -2.8; -1.9 mmol/mol] after 12 months of ETI treatment. The decline was independent of glucose tolerance status at baseline. In 26 individuals with CFRD at baseline, the mean decline in HbA1c was 3.6 mmol/mol [95 %CI: -6.9; -0.4 mmol/mol] after 12 months, but we did not observe any change in insulin usage, weekly number of hypoglycemic events or CGM parameters.
In the Danish CF cohort, HbA1c declined over 12 months of ETI treatment, however, among a subset with CFRD, we observed no change in insulin usage and CGM glucose levels.
依伐卡托/泰它卡托/维加特（ETI）改善了囊性纤维化（CF）患者的临床状况，但 ETI 是否影响葡萄糖耐量尚不清楚。我们旨在研究 ETI 治疗后糖化血红蛋白（HbA1c）和 CF 相关糖尿病（CFRD）状态的变化。
我们纳入了丹麦接受 ETI 治疗的≥12 岁的个体进行了一项纵向观察性研究。在治疗开始后 3、6、9 和 12 个月测量 HbA1c。采用混合模型调整年龄、性别、葡萄糖耐量和既往 CFTR 调节剂治疗后评估 HbA1c 的变化。在 CFRD 亚组中，我们评估了治疗 12 个月后胰岛素使用、低血糖事件和 30 天连续血糖监测（CGM）参数（即平均血糖、低于（≤3.9 mM）和高于（>10.0 mM）正常范围的时间以及血糖变化）的变化。
在 321 名 CF 患者中，ETI 治疗 3 个月后 HbA1c 下降 2.1 mmol/mol[95%置信区间（CI）：-2.6；-1.5 mmol/mol]，治疗 12 个月后下降 2.3 mmol/mol[95%CI：-2.8；-1.9 mmol/mol]。这种下降与基线时的葡萄糖耐量状态无关。在基线时有 CFRD 的 26 名患者中，12 个月后 HbA1c 的平均下降为 3.6 mmol/mol[95%CI：-6.9；-0.4 mmol/mol]，但我们没有观察到胰岛素使用、每周低血糖事件或 CGM 参数的任何变化。
在丹麦 CF 队列中，ETI 治疗 12 个月后 HbA1c 下降，但在 CFRD 亚组中，我们没有观察到胰岛素使用和 CGM 血糖水平的变化。
