Department of Epidemiology, Pharmatelligence, Cardiff, United Kingdom.
Clin Ther. 2011 Jan;33(1):27-35. doi: 10.1016/j.clinthera.2011.01.023.
Premixed, or biphasic, insulins containing varying proportions of rapid- and intermediate-acting insulin components have been developed to limit the number of daily injections for patients who require both prandial and basal insulin injections.
This study was conducted to determine whether there were differences in glycosylated hemoglobin (HbA(1c)), weight change, hypoglycemia occurrence, and treatment discontinuation between patients treated with biphasic insulin aspart 30 (BIAsp-30) or biphasic human insulin 30 (BHI-30) in UK general practice.
Data were from >350 general practices from the United Kingdom. Patients were stratified by treatment regimen, diabetes type, and insulin status (naive or experienced). Changes in HbA(1c) and weight were compared from baseline (the date of the first prescription for either insulin) through 180 days of follow-up using ANCOVA. Hypoglycemia incidence rate ratios were compared, and the adjusted likelihood of hypoglycemia was evaluated by logistic regression. Rates of treatment discontinuation were compared using the Cox proportional hazards model.
The study included data from 7720 patients, of whom 1333 (17.3%) had type 1 diabetes and 4457 (57.7%) were male. Patients' mean (SD) age was 57.9 (19.8) years, and their mean body mass index was 29.5 (6.2) kg/m(2). The difference in HbA(1c) reduction was significant for BIAsp-30 compared with BHI-30 in insulin-naive patients with type 1 diabetes (0.57%; P = 0.045), insulin-naive patients with type 2 diabetes (-0.17%; P = 0.003), and insulin-experienced patients with type 2 diabetes (-0.23%; P = 0.007). The difference between insulins was not significant in insulin-experienced patients with type 1 diabetes. Five hundred ninety-four patients (7.7%) experienced at least one hypoglycemic event. The incidence rate ratio for reported hypoglycemia was significantly lower with BIAsp-30 compared with BHI-30 in insulin-naive patients with type 2 diabetes (0.74; 95% CI, 0.62-0.89; P = 0.001); the difference between insulins was not significant in the other groups. The adjusted hazard ratio for treatment discontinuation was significant for BIAsp-30 versus BHI-30 in insulin-experienced patients with type 2 diabetes (0.693; 95% CI, 0.543-0.884; P = 0.003), whereas the hazard ratios for the other groups did not reach statistical significance. There were no significant differences in weight change between BIAsp-30 and BHI-30 in any of the groups.
In this analysis, BIAsp-30 was associated with improved glycemic control (HbA(1c)) compared with BHI-30 in insulin-naive patients with type 1 or type 2 diabetes and insulin-experienced patients with type 2 diabetes. BIAsp-30 was associated with reduced hypoglycemia in insulin-naive patients with type 2 diabetes and lower rates of treatment discontinuation in insulin-experienced patients with type 2 diabetes. Cambridgeshire Research Ethics Committee: REC 08/H0305/47.
含有不同比例速效和中效胰岛素成分的预混、双相胰岛素已被开发出来，以减少需要同时进行餐时和基础胰岛素注射的患者的每日注射次数。
本研究旨在确定在英国普通实践中，使用双相门冬胰岛素 30（BIAsp-30）或双相人胰岛素 30（BHI-30）治疗的患者在糖化血红蛋白（HbA（1c））、体重变化、低血糖发生和治疗停药方面是否存在差异。
数据来自英国的 350 多家普通诊所。根据治疗方案、糖尿病类型和胰岛素状态（初治或经验丰富）对患者进行分层。使用 ANCOVA 比较从基线（首次使用胰岛素的日期）到 180 天随访期间 HbA（1c）和体重的变化。比较低血糖发生率比，并通过 logistic 回归评估低血糖调整后的可能性。使用 Cox 比例风险模型比较治疗停药率。
该研究纳入了 7720 名患者的数据，其中 1333 名（17.3%）患有 1 型糖尿病，4457 名（57.7%）为男性。患者的平均（SD）年龄为 57.9（19.8）岁，平均体重指数为 29.5（6.2）kg/m2。在初治的 1 型糖尿病患者（0.57%；P=0.045）、初治的 2 型糖尿病患者（-0.17%；P=0.003）和经验丰富的 2 型糖尿病患者（-0.23%；P=0.007）中，BIAsp-30 与 BHI-30 相比，HbA（1c）降低的差异有统计学意义。在经验丰富的 1 型糖尿病患者中，两种胰岛素之间的差异无统计学意义。594 名患者（7.7%）至少经历过一次低血糖事件。在初治的 2 型糖尿病患者中，报告的低血糖发生率与 BIAsp-30 相比显著降低（BHI-30；0.74；95%CI，0.62-0.89；P=0.001）；在其他组中，两种胰岛素之间的差异无统计学意义。在经验丰富的 2 型糖尿病患者中，BIAsp-30 与 BHI-30 相比，治疗停药的调整后危险比显著降低（0.693；95%CI，0.543-0.884；P=0.003），而其他组的危险比未达到统计学意义。在任何一组中，BIAsp-30 与 BHI-30 相比，体重变化均无显著差异。
在这项分析中，与 BHI-30 相比，BIAsp-30 在初治的 1 型或 2 型糖尿病患者和经验丰富的 2 型糖尿病患者中与改善血糖控制（HbA（1c））相关。与 BHI-30 相比，BIAsp-30 与 2 型糖尿病初治患者的低血糖发生率降低和经验丰富的 2 型糖尿病患者的治疗停药率降低相关。剑桥郡研究伦理委员会：REC 08/H0305/47。
