Ramirez Alejandro, Weare-Regales Natalia, Domingo Anthony, Villafranca Arnaldo, Valdez Krystal A, Velez C Marcela, Foulis Philip, Gomez-Daspet Joaquin
is Assistant Chief of Endocrinology; is a staff endocrinologist; is Chief, Pathology Informatics, Pathology and Laboratory Medicine service; and is Chief of Endocrinology, Diabetes, and Metabolism section, all at the James A. Haley Veterans' Hospital in Tampa, Florida. Alejandro Ramirez and Natalia Weare-Regales are Assistant Professors, and Joaquin Gomez-Daspet is Associate Professor and Director of the Endocrinology, Diabetes and Metabolism Fellowship Training program, all at University of South Florida Morsani College of Medicine. is a Founder and Physician at Miami Endocrinology Specialists in Aventura, Florida. is a Founder and Physician at Team Endocrine in Pembroke Pines, Florida. is an Endocrinologist at First California Physician Partners in Templeton. is a Clinical Epidemiology Professor at Facultad de Medicina at Universidad de Antioquia in Medellin, Colombia.
Fed Pract. 2021 Mar;38(3):e15-e21. doi: 10.12788/fp.0105.
The prevalence of obesity and diabetes mellitus (DM) has each increased drastically according to the Centers for Disease Control and Prevention. Growth of severe insulinresistant DM is predicted. U-500 insulin is highly concentrated and can replace less concentrated formulations in patients that need high insulin dosages. The aim of this study was to compare clinical outcomes of U-500 and U-100 insulin regimens in veterans with obesity and insulin resistance.
A single-site retrospective chart analysis of adult subjects was conducted from July 2002 to June 2011. Data for repeated measures spanned a period from 3 months before the intervention (baseline) through 12 months afterward. The main outcome was the variation in hemoglobin A (HbA). Other outcomes included incidence of severe hypoglycemia, weight changes, cardiovascular events, and number of injections.
A total of 142 subjects (68 taking U-500 and 74 taking U-100) were included. Baseline characteristics were similar between the groups, except for weight, which was higher among U-500 subjects. Mean HbA was reduced by 0.84% and 0.56% in U-500 and U-100, respectively ( = .003). Severe hypoglycemia occurred in 5 subjects in the U-500 group and 1 in the U-100 group ( = .08). No significant difference was noted in the number of cardiovascular events. The mean number of daily injections was 2 in the U-500 group, and 4 in the U-100 group ( < .001).
U-500 insulin, when compared with U-100 insulin regimens, led to a statistically significant reduction in HbA and number of insulin injections. Additional research is necessary to assess the risk of severe hypoglycemia in U-500 users. Neither regimen was associated with increased cardiovascular risk.
根据疾病控制与预防中心的数据，肥胖症和糖尿病（DM）的患病率均急剧上升。预计重度胰岛素抵抗性糖尿病会增加。U-500胰岛素高度浓缩，可替代需要高剂量胰岛素的患者使用的低浓度制剂。本研究的目的是比较U-500和U-100胰岛素方案在肥胖和胰岛素抵抗退伍军人中的临床疗效。
对2002年7月至2011年6月的成年受试者进行单中心回顾性病历分析。重复测量的数据涵盖干预前3个月（基线）至干预后12个月的时间段。主要结局是糖化血红蛋白（HbA）的变化。其他结局包括严重低血糖的发生率、体重变化、心血管事件和注射次数。
共纳入142名受试者（68名使用U-500，74名使用U-100）。两组的基线特征相似，但U-500组受试者的体重较高。U-500组和U-100组的平均HbA分别降低了0.84%和0.56%（P = 0.003）。U-500组有5名受试者发生严重低血糖，U-100组有1名受试者发生严重低血糖（P = 0.08）。心血管事件的数量没有显著差异。U-500组每日平均注射次数为2次，U-100组为4次（P < 0.001）。
与U-100胰岛素方案相比，U-500胰岛素可使HbA和胰岛素注射次数在统计学上显著降低。有必要进行更多研究以评估U-500使用者发生严重低血糖的风险。两种方案均未增加心血管风险。
