口服降糖药无效的2型糖尿病患者使用双相胰岛素aspart30改善血糖控制:目前的研究结果

Archives of Drug Information Pub Date : 2009-06-01 DOI:10.1111/j.1753-5174.2008.00015.x

Serdar Güler MD, Surendra Kumar Sharma MD, Majeed Almustafa MD, ChB, MRCP (UK), FRCP (Ed.), Chong Hwa Kim MD, PhD, Sami Azar MD, FACP, Rucsandra Danciulescu MD, PhD, Marina Shestakova MD, PhD, Duma Khutsoane MD, MMed Intern(ufs), FCP(SA), Ole Molskov Bech MD, MBA

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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 HbA1c, 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 HbA1c, 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. 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引用次数: 6

摘要

目标本文介绍了在口服降糖药(OADs)治疗失败后开始双相胰岛素-天冬氨酸30 (BIAsp 30)治疗的患者的治疗结果:仅BIAsp 30、BIAsp 30 +磺脲类(SU)、BIAsp 30 +双胍类(BI)、BIAsp 30 + SU + BI、BIAsp 30 + α -葡萄糖苷酶抑制剂(GI)、BIAsp 30 + BI +噻唑烷二酮类(TZD)。这是一项多国、多中心、为期6个月、前瞻性、开放标签、非对照、临床经验评估研究，除了在一个国家(中国)进行的为期3个月的研究(“全部排除中国”和“中国”)。BIAsp 30治疗的开始和终止完全由主治医师决定。在3个月和6个月时，各组平均HbA1c、FPG和PPPG均较基线显著降低(P < 0.001)。在“全部排除中国”的情况下，6个月时平均HbA1c、FPG和PPPG的下降如下:仅BIAsp 30组(- 2.12±1.76%点;−4.82±3.86 mmol/L;−6.89±4.74更易/ L), BIAsp 30 + BI集团(−2.24±1.77%;−4.48±3.68 mmol/L;−6.66±4.55更易/ L), BIAsp 30 +苏集团(−1.95±1.59%;−3.98±3.19 mmol/L;−6.25±4.45更易/ L)和苏BIAsp 30 + + BI集团(−1.78±1.20%;−3.57±2.78 mmol/L;−5.89±3.98 mmol/L)。仅BIAsp 30组报告了唯一的严重药物不良反应。在“中国”组中，三个月时平均HbA1c、FPG和PPPG的下降为:仅BIAsp 30组(- 2.16±1.52%点;−3.34±2.49 mmol/L;−6.29±3.92更易/ L), BIAsp 30 + BI集团(−2.44±1.52%;−4.01±2.50 mmol/L;−7.10±3.96更易/ L), BIAsp 30 + GI组(−2.33±1.41%;−4.34±2.52 mmol/L;−7.97±3.99更易/ L)和BIAsp 30 + BI + TZD集团(−1.21±1.60%;−3.50±2.29 mmol/L;−5.97±3.39 mmol/L)。在中国没有严重的不良反应报告。最常见的低血糖发作发生在白天，性质轻微。BIAsp 30治疗可改善oad失败的2型糖尿病患者的血糖控制。

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

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.

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