Orozco-Beltrán Domingo, Artola-Menéndez Sara
Unidad de Docencia e Investigación, Departamento de Medicina Clínica, Universidad Miguel Hernández. Hospital Universitario de Sant Joan d'Alacant, Sant Joan d'Alacant, Alicante, España.
Especialista en Medicina Interna, Coordinadora de la Red de Grupos de Estudio de la Diabetes en Atención Primaria (RedGDPS), Centro de Salud M. J. Hereza, Leganés, Madrid, España.
Aten Primaria. 2016 Feb;48(2):95-101. doi: 10.1016/j.aprim.2015.02.010. Epub 2015 Jun 6.
Describe the experience in the primary care setting with insulin detemir in patients with poorly controlled type2 diabetes mellitus that need to add-on insulin to their oral antidiabetic drug therapy.
Prospective observational study of 6 months of follow up, performed in 10 countries. In Spain, participating sites were only from the primary care setting. Eligible patients were those with poorly controlled type2 diabetes mellitus adding-on once-daily insulin detemir to their existing oral antidiabetic therapy in the month prior to their enrollment. The change of Hb1Ac and of weight at the end of the study and the incidence of hypoglycemia and adverse reactions, were analyzed. We report the results obtained in the Spanish cohort.
Overall 17,374 patients were included, 973 in Spain [mean age 64.8 years (SE 12); duration of diabetes 9.4 years (SE 6.2); Hb1Ac 8.9% (DE 1.4)]. In the sample analyzed for efficacy (n=474) the mean change of Hb1Ac was -1.6% (95%CI: -1.75 to -1.42; P<.001), mean change of weight was -2.9 kg (95%CI: -3.72 to -2.08; P<.001). Only one episode of severe hypoglycemia was reported, which was also the only serious adverse reaction reported in the study. The incidence rate of non-severe hypoglycemia was 2.44 events/patient-year.
In this cohort of patients with type 2 diabetes mellitus receiving newly initiated insulin therapy, once-daily detemir improved the glycemic control, with low incidence of hypoglycemia and a significant reduction of the weight.
描述在基层医疗环境中，德谷胰岛素用于2型糖尿病控制不佳且需要在口服降糖药物治疗基础上加用胰岛素的患者的治疗经验。
在10个国家进行了为期6个月随访的前瞻性观察研究。在西班牙，参与研究的机构仅来自基层医疗环境。符合条件的患者为2型糖尿病控制不佳，在入组前一个月开始在现有口服降糖治疗基础上加用每日一次德谷胰岛素的患者。分析了研究结束时糖化血红蛋白（Hb1Ac）和体重的变化以及低血糖和不良反应的发生率。我们报告了西班牙队列中获得的结果。
共纳入17374例患者，其中973例来自西班牙[平均年龄64.8岁（标准误12）；糖尿病病程9.4年（标准误6.2）；Hb1Ac为8.9%（标准差1.4）]。在分析疗效的样本（n = 474）中，Hb1Ac的平均变化为-1.6%（95%置信区间：-1.75至-1.42；P <.001），体重的平均变化为-2.9 kg（95%置信区间：-3.72至-2.08；P <.001）。仅报告了1例严重低血糖事件，这也是该研究中报告的唯一严重不良反应。非严重低血糖的发生率为2.44次事件/患者年。
在这组新开始胰岛素治疗的2型糖尿病患者中，每日一次德谷胰岛素改善了血糖控制，低血糖发生率低且体重显著减轻。
