PDF(Pubmed)
Abstract：
UNASSIGNED: To report the safety and side effects associated with taking verapamil for beta-cell preservation in children with newly-diagnosed T1D.
UNASSIGNED: Eighty-eight participants aged 8.5 to 17.9 years weighing ≥ 30 kg were randomly assigned to verapamil (N = 47) or placebo (N = 41) within 31 days of T1D diagnosis and followed for 12 months from diagnosis, main CLVer study. Drug dosing was weight-based with incremental increases to full dosage. Side effect monitoring included serial measurements of pulse, blood pressure, liver enzymes, and electrocardiograms (ECGs). At study end, participants were enrolled in an observational extension study (CLVerEx), which is ongoing. No study drug is provided during the extension, but participants may use verapamil if prescribed by their diabetes care team.
UNASSIGNED: Overall rates of adverse events were low and comparable between verapamil and placebo groups. There was no difference in the frequency of liver function abnormalities. Three CLVer participants reduced or discontinued medication due to asymptomatic ECG changes. One CLVerEx participant (18 years old), treated with placebo during CLVer, who had not had a monitoring ECG, experienced complete AV block with a severe hypotensive episode 6 weeks after reaching his maximum verapamil dose following an inadvertent double dose on the day of the event.
UNASSIGNED: The use of verapamil in youth newly-diagnosed with T1D appears generally safe and well tolerated with appropriate monitoring. We strongly recommend monitoring for potential side effects including an ECG at screening and an additional ECG once full dosage is reached.ClinicalTrials.gov number: NCT04233034.
UNASSIGNED: Eighty-eight participants aged 8.5 to 17.9 years weighing ≥ 30 kg were randomly assigned to verapamil (N = 47) or placebo (N = 41) within 31 days of T1D diagnosis and followed for 12 months from diagnosis, main CLVer study. Drug dosing was weight-based with incremental increases to full dosage. Side effect monitoring included serial measurements of pulse, blood pressure, liver enzymes, and electrocardiograms (ECGs). At study end, participants were enrolled in an observational extension study (CLVerEx), which is ongoing. No study drug is provided during the extension, but participants may use verapamil if prescribed by their diabetes care team.
UNASSIGNED: Overall rates of adverse events were low and comparable between verapamil and placebo groups. There was no difference in the frequency of liver function abnormalities. Three CLVer participants reduced or discontinued medication due to asymptomatic ECG changes. One CLVerEx participant (18 years old), treated with placebo during CLVer, who had not had a monitoring ECG, experienced complete AV block with a severe hypotensive episode 6 weeks after reaching his maximum verapamil dose following an inadvertent double dose on the day of the event.
UNASSIGNED: The use of verapamil in youth newly-diagnosed with T1D appears generally safe and well tolerated with appropriate monitoring. We strongly recommend monitoring for potential side effects including an ECG at screening and an additional ECG once full dosage is reached.ClinicalTrials.gov number: NCT04233034.
摘要：
■报告在新诊断的T1D儿童中服用维拉帕米进行β细胞保存的安全性和副作用。
88名年龄在8.5至17.9岁，体重≥30公斤的参与者在T1D诊断后31天内被随机分配到维拉帕米（N=47）或安慰剂（N=41），并从诊断后随访12个月。主要CLVer研究。药物剂量是基于体重的,增加至全剂量。副作用监测包括脉冲的串行测量，血压,肝酶，心电图（ECG）。在研究结束时，参与者参加了一项观察性扩展研究(CLVerEx)，正在进行中。延期期间没有提供研究药物，但参与者可以使用维拉帕米，如果他们的糖尿病护理团队规定。
■维拉帕米和安慰剂组之间的不良事件总体发生率较低，具有可比性。肝功能异常的频率没有差异。由于无症状的ECG变化，三名CLVer参与者减少或停药。一名CLVerEx参与者（18岁），在CLVer期间用安慰剂治疗，没有心电图监测的人，在事件发生当天意外双倍剂量后达到最大剂量的维拉帕米后6周出现完全房室传导阻滞并出现严重低血压事件.
■在新诊断为T1D的年轻人中使用维拉帕米似乎通常是安全的，并且在适当的监测下耐受性良好。我们强烈建议监测潜在的副作用，包括筛查时的心电图和达到全剂量后的额外心电图。ClinicalTrials.gov编号：NCT04233034。
88名年龄在8.5至17.9岁，体重≥30公斤的参与者在T1D诊断后31天内被随机分配到维拉帕米（N=47）或安慰剂（N=41），并从诊断后随访12个月。主要CLVer研究。药物剂量是基于体重的,增加至全剂量。副作用监测包括脉冲的串行测量，血压,肝酶，心电图（ECG）。在研究结束时，参与者参加了一项观察性扩展研究(CLVerEx)，正在进行中。延期期间没有提供研究药物，但参与者可以使用维拉帕米，如果他们的糖尿病护理团队规定。
■维拉帕米和安慰剂组之间的不良事件总体发生率较低，具有可比性。肝功能异常的频率没有差异。由于无症状的ECG变化，三名CLVer参与者减少或停药。一名CLVerEx参与者（18岁），在CLVer期间用安慰剂治疗，没有心电图监测的人，在事件发生当天意外双倍剂量后达到最大剂量的维拉帕米后6周出现完全房室传导阻滞并出现严重低血压事件.
■在新诊断为T1D的年轻人中使用维拉帕米似乎通常是安全的，并且在适当的监测下耐受性良好。我们强烈建议监测潜在的副作用，包括筛查时的心电图和达到全剂量后的额外心电图。ClinicalTrials.gov编号：NCT04233034。
