Fakhoury Walid, Lockhart Ian, Kotchie Robert W, Aagren Mark, LeReun Corinne
IMS Health, London, UK.
Pharmacology. 2008;82(2):156-63. doi: 10.1159/000149569. Epub 2008 Aug 1.
Basal insulin administered to type-2 diabetic patients with poor glycaemic control when managed with oral anti-diabetics (OADs) alone can lead to an increased risk of weight gain and hypoglycaemia. In the absence of head-to-head trials, an indirect comparison of the once-daily insulin detemir with insulin glargine was conducted on the following outcomes: weight gain, hypoglycaemic episodes, and HbA(1c).
Parallel-group randomised controlled trials of at least 20 weeks duration that compared once-daily evening glargine or detemir with a common comparator, neutral protamine Hagedorn insulin (evening), were selected. Trials focused on insulin-naïve, type-2 diabetic patients poorly controlled with OAD. Five open-label trials were identified (n = 2,092 patients; n = 1 detemir and n = 4 glargine trials), with an indirect comparison of glargine (n = 869 patients) and detemir trials (n = 169 patients) carried out using meta-regression to control for covariates. Weight gain was analysed as weighted mean differences (WMD), hypoglycaemic episodes as odds ratios (OR), and HbA(1c) at the end of study as standardised mean differences (SMD).
Patients receiving evening detemir gained significantly less weight (unadjusted WMD -1.22 kg, 95% CI -2.15, -0.29 kg; p = 0.010) and significantly fewer of them experienced hypoglycaemic episodes versus evening glargine (unadjusted OR 0.52, 95% CI 0.28, 0.98; p = 0.044). There was no significant difference between treatments for the mean HbA(1c) level at study endpoint (unadjusted SMD 0.09, 95% CI -0.16, 0.33; p = 0.480).
Once-daily use of insulin detemir resulted in significantly less weight gain and fewer hypoglycaemic episodes than glargine, while maintaining clinically appropriate HbA(1c) levels in type-2 diabetic patients currently receiving OAD.
对于仅使用口服降糖药(OADs)治疗但血糖控制不佳的2型糖尿病患者,使用基础胰岛素会导致体重增加和低血糖风险增加。在缺乏头对头试验的情况下,对每日一次的地特胰岛素和甘精胰岛素进行了间接比较,比较的结果包括:体重增加、低血糖发作次数和糖化血红蛋白(HbA1c)。
选择至少持续20周的平行组随机对照试验,这些试验将每日一次的晚间甘精胰岛素或地特胰岛素与一种共同对照药物,即低精蛋白锌胰岛素(晚间)进行比较。试验聚焦于初治的、使用OADs血糖控制不佳的2型糖尿病患者。确定了5项开放标签试验(n = 2092例患者;n = 1项地特胰岛素试验和n = 4项甘精胰岛素试验),使用meta回归控制协变量,对甘精胰岛素试验(n = 869例患者)和地特胰岛素试验(n = 169例患者)进行间接比较。体重增加分析为加权平均差(WMD),低血糖发作次数分析为比值比(OR),研究结束时的糖化血红蛋白(HbA1c)分析为标准化平均差(SMD)。
与晚间甘精胰岛素相比,接受晚间地特胰岛素治疗的患者体重增加明显更少(未调整的WMD -1.22 kg,95%CI -2.15,-0.29 kg;p = 0.010),且经历低血糖发作的患者明显更少(未调整的OR 0.52,95%CI 0.28,0.98;p = 0.044)。在研究终点时,两种治疗方法的平均糖化血红蛋白(HbA1c)水平无显著差异(未调整的SMD 0.09,95%CI -0.16,0.33;p = 0.480)。
对于目前正在接受OADs治疗的2型糖尿病患者,每日一次使用地特胰岛素比甘精胰岛素导致的体重增加明显更少,低血糖发作次数也更少,同时维持了临床上合适的糖化血红蛋白(HbA1c)水平。