Dutta Deep, Nagendra Lakshmi, Raizada Nishant, Bhattacharya Saptarshi, Sharma Meha
Department of Endocrinology, Center for Endocrinology Diabetes Arthritis and Rheumatism (CEDAR) Superspeciality Healthcare, Dwarka, New Delhi, India.
Department of Endocrinology, JSS Academy of Higher Education and Research, Mysore, Karnataka, India.
Indian J Endocrinol Metab. 2023 May-Jun;27(3):192-200. doi: 10.4103/ijem.ijem_122_23. Epub 2023 Jun 26.
Meta-analysis studying the role of verapamil in improving C-peptide in people with recent-onset type-1 diabetes (T1DM) has not been conducted to date. We undertook this meta-analysis to address this knowledge gap. Electronic databases were systematically reviewed for RCTs having individuals with T1DM receiving verapamil in the treatment arm and placebo in the control arm over the standard of care. The primary outcome was to evaluate changes in the C-peptide area under the curve (AUC) at a one-year follow-up. Secondary outcomes were to assess alterations in C-peptide AUC, glycated hemoglobin (HbA1c), blood pressure, heart rate, and side effects at different time intervals over a one-year follow-up. From the initially screened 27 articles, data from two RCTs (112 patients) satisfied the inclusion criteria and were analyzed. Compared to placebo, C-peptide AUC in individuals receiving verapamil was not different at three months [MD 0.17 nmol/L (95%CI: -0.05-0.38); = 0.13; I = 86%] but significantly higher at 1-year [MD 0.27 nmol/L (95%CI: 0.19-0.35); < 0.01; I = 12%]. The verapamil arm showed similar changes in HbA1C at three months [MD 0.23% (95%CI: -0.43-0.90); = 0.49; I = 88%] and 1-year [MD 0.18% (95% CI: -0.74 - 1.10); = 0.70; I = 89%] compared to placebo. Occurrence of treatment-emergent adverse events [Risk ratio (RR) 1.90 (95%CI: 0.52-6.91); = 0.33; I = 63%], serious adverse events [RR 1.40 (95%CI: 0.50-3.93); = 0.53], constipation [RR4.11 (95%CI: 0.93-18.13); = 0.06; I = 0%], headache [RR0.48 (95%CI: 0.16-1.43); = 0.19; I = 0%], severe hypoglycemia [RR 0.87 (95%CI: 0.06 - 13.51); = 0.92] were comparable across groups. Verapamil was well tolerated, and its use over one year was associated with significant improvements in C-peptide AUC though the HbA1c remained unchanged.
迄今为止,尚未进行关于维拉帕米在改善近期发病的1型糖尿病(T1DM)患者C肽水平方面作用的荟萃分析。我们进行这项荟萃分析以填补这一知识空白。我们系统检索了电子数据库,查找将T1DM患者纳入治疗组并给予维拉帕米、纳入对照组并给予安慰剂(超过标准治疗)的随机对照试验(RCT)。主要结局是评估一年随访时C肽曲线下面积(AUC)的变化。次要结局是评估一年随访期间不同时间点C肽AUC、糖化血红蛋白(HbA1c)、血压、心率及副作用的改变。从最初筛选的27篇文章中,来自两项RCT(112例患者)的数据符合纳入标准并进行了分析。与安慰剂相比,接受维拉帕米治疗的患者在3个月时C肽AUC无差异[平均差(MD)0.17 nmol/L(95%置信区间:-0.05 - 0.38);P = 0.13;I² = 86%],但在1年时显著更高[MD 0.27 nmol/L(95%置信区间:0.19 - 0.35);P < 0.01;I² = 12%]。维拉帕米组在3个月[MD 0.23%(95%置信区间:-0.43 - 0.90);P = 0.49;I² = 88%]和1年时[MD 0.18%(95%置信区间:-0.74 - 1.10);P = 0.70;I² = 89%]与安慰剂相比,HbA1c的变化相似。治疗中出现的不良事件发生率[风险比(RR)1.90(95%置信区间:0.52 - 6.91);P = 0.33;I² = 63%]、严重不良事件[RR 1.40(95%置信区间:0.50 - 3.93);P = 0.53]、便秘[RR 4.11(95%置信区间:0.93 - 18.13);P = 0.06;I² = 0%]、头痛[RR 0.48(95%置信区间:0.16 - 1.43);P = 0.19;I² = 0%]、严重低血糖[RR 0.87(95%置信区间:0.06 - 13.51);P = 0.92]在各组间相当。维拉帕米耐受性良好,虽然HbA1c保持不变,但使用一年与C肽AUC显著改善相关。