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首页> 外文期刊>The Journal of pharmacy technology: jPT : official publication of the Association of Pharmacy Technicians >An Update of Recent Trials with Vildagliptin, a Dipeptidyl Peptidase-4 Inhibitor for the Treatment of Type 2 Diabetes
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An Update of Recent Trials with Vildagliptin, a Dipeptidyl Peptidase-4 Inhibitor for the Treatment of Type 2 Diabetes

机译:维拉格列汀,二肽肽酶-4抑制剂治疗2型糖尿病的最新试验的更新。

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摘要

Objective: To review the clinical efficacy and tolerability of vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, for the treatment of type 2 diabetes, based on recent Phase 3 trials. Data Sources: Primary literature and review articles were obtained via a MEDLINE search (2005-November 2007) using the search terms diabetes, vildagliptin, and LAF-237. Additional data from abstracts presented at clinical meetings were included when appropriate. Study Selection: Nine double-blind, randomized, multicenter, parallel-group trials and vildagliptin studies were identified and reviewed. Data Synthesis: Vildagliptin, a selective DPP-4 inhibitor, has been shown to produce clinically significant reductions in hemoglobin A_(1c) (A1C) levels when used as monotherapy (0.6-1%) or in combination with other glucose-lowering agents (mean decrease 0.7%). Phase 3 trials indicated a 24- to 52-week sustained effect on reduction of blood glucose in patients with type 2 diabetes. The primary endpoint for all trials was change from baseline A1C. In the intent-to-treat population, baseline A1C was compared with end-of-study A1C. More than 2,500 patients with type 2 diabetes enrolled in monotherapy trials; an additional 2,119 participated in combination therapy trials. Males outnumbered females, and all groups included obese patients. The most common adverse effects reported were nasopharyngiris, headache, and dizziness. Vildagliptin was weight-neutral and produced a rate of hypoglycemia similar to that of placebo. Conclusions: Vildagliptin appears to be a promising agent for the management of type 2 diabetes.
机译:目的:基于最近的3期临床试验,综述二肽基肽酶4(DPP-4)抑制剂维格列汀治疗2型糖尿病的临床疗效和耐受性。数据来源:主要文献和评论文章是通过MEDLINE搜索(2005年11月至2007年11月)使用搜索词糖尿病,维达列汀和LAF-237获得的。在适当的时候,还包括在临床会议上发表的摘要的其他数据。研究选择:鉴定并审查了9项双盲,随机,多中心,平行组试验和维格列汀研究。数据综合:维尔达列汀,一种选择性DPP-4抑制剂,已显示在单药治疗(0.6-1%)或与其他降糖药联合使用时,会产生血红蛋白A_(1c)(A1C)水平的临床显着降低(平均下降0.7%)。 3期试验表明,对2型糖尿病患者的血糖降低具有24至52周的持续作用。所有试验的主要终点是基线A1C的变化。在意向性治疗人群中,将基线A1C与研究结束时的A1C进行了比较。超过2500名2型糖尿病患者参加了单药治疗试验;另外2119人参加了联合疗法试验。男性多于女性,并且所有组均包括肥胖患者。报告的最常见不良反应是鼻咽,头痛和头晕。维格列汀是体重中性的,产生的低血糖发生率与安慰剂相似。结论:维格列汀似乎是治疗2型糖尿病的有前途的药物。

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