Endocrinology Associates, Montgomery, AL 36106, USA.
Curr Med Res Opin. 2012 Jul;28(7):1203-11. doi: 10.1185/03007995.2012.686444. Epub 2012 Jun 25.
To determine if self-titration using biphasic insulin aspart 70/30 (BIAsp 30) had a different impact on efficacy and safety across different racial/ethnic subgroups.
RESEARCH DESIGN/METHODS: This was an exploratory, post hoc analysis by race (White vs. Black/African-American) and ethnicity (Hispanic/Latino vs. non-Hispanic/Latino) of data from the INITIATEplus trial. Participants were treated twice-daily with BIAsp 30 over 24 weeks.
NCT00101751.
Efficacy endpoints included reductions in mean glycated hemoglobin (A1C) and fasting plasma glucose (FPG). Safety endpoints included hypoglycemia rates (events/patient-year) and adverse events. Body weight changes were also measured.
Glycemic control improved by a similar extent for all demographic groups. Observed mean decreases in A1C ranged from 2.4% to 2.6% after 24 weeks' treatment. Baseline-adjusted mean A1C decreases for White vs. Black/African-American subjects were 2.56% and 2.13% (p < 0.0001), and for Hispanic/Latino vs. non-Hispanic/Latino subjects were 2.45% and 2.42% (p = 0.677), respectively. Final FPG values were similar among all groups (141-146 mg/dL [7.83-8.10 m mol/L]), and baseline-adjusted FPG decreases were not significantly different (p > 0.025) between groups. Hypoglycemia was low for White, Black/African-American, Hispanic/Latino, and non-Hispanic/Latino subjects (0.08, 0.04, 0.03, and 0.07 major events/patient-year, with 0.60, 0.30, 0.37, and 0.52 minor events/patient-year, respectively). Body weight increases were 3.17 and 3.06 kg (White vs. African-American) and 2.69 and 3.19 kg (Hispanic/Latino vs. non-Hispanic/Latino). Final weight-adjusted total daily insulin doses were 0.60 U/kg for Black/African-American subjects vs. 0.78 U/kg for White subjects (p < 0.0001), and 0.71 U/kg for Hispanic/Latino subjects vs. 0.74 U/kg for non-Hispanic/Latino subjects (p = 0.42).
The trial was not designed or powered for comparisons across racial or ethnic groups, subjects were not stratified for pre-baseline medication regimens between each race and ethnic group, and unequal subject numbers and baseline A1C disparities existed between the pairs of groups being compared.
Diabetes self-management with BIAsp 30 using an easily followed self-titration algorithm produced low hypoglycemia rates. All subgroups achieved A1C reductions >2.1% and FPG declines >82 mg/dL that were similar across groups, demonstrating that self-titration of BIAsp 30 can successfully be pursued in a primary care setting by patients who had previously failed to meet ADA A1C targets under oral antidiabetes therapy, with race or ethnicity not an obstacle to achieving better glycemic control.
确定使用双相门冬胰岛素 70/30（BIAsp 30）进行自我滴定在不同种族/民族亚组中的疗效和安全性是否存在差异。
研究设计/方法：这是对 INITIATEplus 试验数据的一项探索性、事后按种族（白种人 vs. 黑种人/非裔美国人）和族裔（西班牙裔/拉丁裔 vs. 非西班牙裔/拉丁裔）进行的分析。参与者接受为期 24 周的每日两次 BIAsp 30 治疗。
NCT00101751。
疗效终点包括平均糖化血红蛋白（A1C）和空腹血浆葡萄糖（FPG）的降低。安全性终点包括低血糖发生率（事件/患者年）和不良事件。还测量了体重变化。
所有人群的血糖控制均得到相似程度的改善。治疗 24 周后，观察到的 A1C 平均降低幅度为 2.4%至 2.6%。与白种人相比，黑种人/非裔美国人受试者的基线调整后 A1C 降低幅度分别为 2.56%和 2.13%（p<0.0001），西班牙裔/拉丁裔与非西班牙裔/拉丁裔受试者分别为 2.45%和 2.42%（p=0.677）。所有组的最终 FPG 值均相似（141-146mg/dL[7.83-8.10mmol/L]），且组间基线调整后 FPG 降低无显著差异（p>0.025）。白种人、黑种人/非裔美国人、西班牙裔/拉丁裔和非西班牙裔/拉丁裔受试者的低血糖发生率较低（0.08、0.04、0.03 和 0.07 个主要事件/患者年，分别有 0.60、0.30、0.37 和 0.52 个次要事件/患者年）。体重增加分别为 3.17kg 和 3.06kg（白种人 vs. 非裔美国人）和 2.69kg 和 3.19kg（西班牙裔/拉丁裔 vs. 非西班牙裔/拉丁裔）。黑种人/非裔美国人受试者的最终体重调整后的每日胰岛素总剂量为 0.60U/kg，而白种人受试者为 0.78U/kg（p<0.0001），西班牙裔/拉丁裔受试者为 0.71U/kg，而非西班牙裔/拉丁裔受试者为 0.74U/kg（p=0.42）。
该试验并非专为比较不同种族或族裔群体而设计或赋权，每个种族和族裔群体之间的基线治疗方案没有分层，并且在比较的两组之间存在不等的受试者数量和基线 A1C 差异。
使用易于遵循的自我滴定算法进行 BIAsp 30 的自我管理可降低低血糖发生率。所有亚组的 A1C 降低幅度均>2.1%，FPG 降低幅度>82mg/dL，组间相似，这表明在初级保健环境中，先前未能通过口服抗糖尿病治疗达到 ADA A1C 目标的患者可以成功地使用 BIAsp 30 进行自我滴定，以达到更好的血糖控制，种族或民族并不是一个障碍。
