门冬胰岛素30治疗口服降糖药疗效不佳的2型糖尿病患者可改善血糖控制：PRESENT研究结果

Improved Glycaemic Control with Biphasic Insulin Aspart 30 in Type 2 Diabetes Patients Failing Oral Antidiabetic Drugs: PRESENT Study Results.

作者信息

Güler Serdar, Sharma Surendra Kumar, Almustafa Majeed, Kim Chong Hwa, Azar Sami, Danciulescu Rucsandra, Shestakova Marina, Khutsoane Duma, Bech Ole Molskov

出版信息

Arch Drug Inf. 2009 Jun;2(2):23-33. doi: 10.1111/j.1753-5174.2008.00015.x.

DOI:10.1111/j.1753-5174.2008.00015.x

PMID:19684847

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2721962/

Abstract

AIMS

This paper presents the treatment outcomes for patients intiated on biphasic insulin aspart 30 (BIAsp 30) treatment: BIAsp 30-only, BIAsp 30 + sulphonylureas (SU), BIAsp 30 + biguanides (BI), BIAsp 30 + SU + BI, BIAsp 30 + alpha-glucosidase inhibitors (GI), and BIAsp 30 + BI + thiazolidinediones (TZD) after failing oral antidiabetic drugs (OADs) treatment. METHODS: This was a multi-national, multi-centre, six-month, prospective, open-labelled, uncontrolled, clinical experience evaluation study, with the exception of a three-month study in one country (China) ("all exclude China" and "China"). Initiation and discontinuation of BIAsp 30 treatment were entirely at the discretion of the attending physicians. RESULTS: Mean HbA(1c), FPG and PPPG were significantly reduced from baseline at three and six months in all groups (P < 0.001). In "all exclude China", reductions in mean HbA(1c), FPG and PPPG at six months were as follows: BIAsp 30-only group (-2.12 +/- 1.76% points; -4.82 +/- 3.86 mmol/L; -6.89 +/- 4.74 mmol/L), BIAsp 30 + BI group (-2.24 +/- 1.77% points; -4.48 +/- 3.68 mmol/L; -6.66 +/- 4.55 mmol/L), BIAsp 30 + SU group (-1.95 +/- 1.59% points; -3.98 +/- 3.19 mmol/L; -6.25 +/- 4.45 mmol/L) and BIAsp 30 + SU + BI group (-1.78 +/- 1.20% points; -3.57 +/- 2.78 mmol/L; -5.89 +/- 3.98 mmol/L). The only serious adverse drug reaction was reported by the BIAsp 30-only group. In the "China" group, reductions in mean HbA(1c), FPG and PPPG at three months were: BIAsp 30-only group (-2.16 +/- 1.52% points; -3.34 +/- 2.49 mmol/L; -6.29 +/- 3.92 mmol/L), BIAsp 30 + BI group (-2.44 +/- 1.52% points; -4.01 +/- 2.50 mmol/L; -7.10 +/- 3.96 mmol/L), BIAsp 30 + GI group (-2.33 +/- 1.41% points; -4.34 +/- 2.52 mmol/L; -7.97 +/- 3.99 mmol/L) and BIAsp 30 + BI + TZD group (-1.21 +/- 1.60% points; -3.50 +/- 2.29 mmol/L; -5.97 +/- 3.39 mmol/L). No serious ADR were reported in China. The most frequent hypoglycaemic episodes were diurnal and minor in nature. CONCLUSIONS: BIAsp 30 treatment in a clinical setting improved glycaemic control in type 2 diabetes patients failing OADs.

摘要

目的

本文介绍了起始使用双相门冬胰岛素30（BIAsp 30）治疗的患者的治疗结果：仅使用BIAsp 30、BIAsp 30+磺脲类药物（SU）、BIAsp 30+双胍类药物（BI）、BIAsp 30+SU+BI、BIAsp 30+α-葡萄糖苷酶抑制剂（GI）以及BIAsp 30+BI+噻唑烷二酮类药物（TZD），这些患者均为口服抗糖尿病药物（OADs）治疗失败后。方法：这是一项多国、多中心、为期6个月的前瞻性、开放标签、非对照临床经验评估研究，但在中国的一项为期3个月的研究除外（“所有不包括中国”和“中国”）。BIAsp 30治疗的起始和终止完全由主治医生自行决定。结果：所有组在3个月和6个月时，平均糖化血红蛋白（HbA1c）、空腹血糖（FPG）和餐后血糖（PPPG）均较基线显著降低（P<0.001）。在“所有不包括中国”组中，6个月时平均HbA1c、FPG和PPPG的降低情况如下：仅使用BIAsp 30组（-2.12±1.76个百分点；-4.82±3.86 mmol/L；-6.89±4.74 mmol/L），BIAsp 30+BI组（-2.24±1.77个百分点；-4.48±3.68 mmol/L；-6.66±4.55 mmol/L），BIAsp 30+SU组（-1.95±1.59个百分点；-3.98±3.19 mmol/L；-6.25±4.45 mmol/L）以及BIAsp 30+SU+BI组（-1.78±1.20个百分点；-3.57±2.78 mmol/L；-5.89±3.98 mmol/L）。仅使用BIAsp 30组报告了唯一的严重药物不良反应。在“中国”组中，3个月时平均HbA1c、FPG和PPPG的降低情况为：仅使用BIAsp 30组（-2.16±1.52个百分点；-3.34±2.49 mmol/L；-6.29±3.92 mmol/L），BIAsp 30+BI组（-2.44±1.52个百分点；-4.01±2.50 mmol/L；-7.10±3.96 mmol/L），BIAsp 30+GI组（-2.33±1.41个百分点；-4.34±2.52 mmol/L；-7.97±3.99 mmol/L）以及BIAsp 30+BI+TZD组（-1.21±1.60个百分点；-3.50±2.29 mmol/L；-5.97±3.39 mmol/L）。中国未报告严重不良事件。最常见的低血糖发作是日间发作且程度较轻。结论：在临床环境中，BIAsp 30治疗改善了OADs治疗失败的2型糖尿病患者的血糖控制。