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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Pharmacokinetics and pharmacodynamics of extended-release glipizide GITS compared with immediate-release glipizide in patients with type II diabetes mellitus.
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Pharmacokinetics and pharmacodynamics of extended-release glipizide GITS compared with immediate-release glipizide in patients with type II diabetes mellitus.

机译：与II型糖尿病患者相比，缓释格列吡嗪GITS与速释格列吡嗪的药代动力学和药效学。

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摘要

This study was designed to compare the pharmacokinetic and short-term pharmacodynamic profile of extended-release glipizide GITS (Glucotrol XL) given in a dosage of 20 mg once daily with that of immediate-release glipizide (Glucotrol) 10mg twice daily in patients with type II diabetes mellitus. In an open-label, randomized, two-way crossover study, each glipizide formulation was administered for 5 days. Serial blood samples were drawn at baseline and on the 5th day of each treatment phase for measurement of glipizide, glucose, insulin, and C-peptide concentrations. At steady state, the mean Cmax after immediate-release glipizide was significantly greater than after glipizide GITS, and the tmax was considerably shorter. Although the mean Cmin with glipizide GITS was about 80% higher than with immediate-release glipizide, the mean AUC0-24 was significantly lower. Despite the lower plasma concentrations with glipizide GITS in this short-term study, the two formulations had similar effects on serum concentrations of glucose, insulin, and C-peptide. The absence of a pronounced peak plasma concentration with the GITS formulation might confer advantages in terms of maintaining clinical effectiveness and reducing the potential to cause adverse effects.
机译：这项研究旨在比较2型糖尿病患者每天两次剂量的缓释格列吡嗪GITS（Glucotrol XL）与每天两次的速释格列吡嗪（Glucotrol）10mg的药代动力学和短期药效学特征II型糖尿病。在开放标签，随机，双向交叉研究中，每种格列吡嗪制剂给药5天。在每个治疗阶段的基线和第5天抽取连续血样，以测量格列吡嗪，葡萄糖，胰岛素和C肽的浓度。在稳态下，速释格列吡嗪后的平均Cmax明显大于格列吡嗪GITS后的平均Cmax，tmax则短得多。尽管格列吡嗪GITS的平均Cmin比速释格列吡嗪的Cmin高约80％，但平均AUC0-24却低得多。尽管在这项短期研究中使用格列吡嗪GITS降低了血浆浓度，但两种制剂对血清葡萄糖，胰岛素和C肽的浓度具有相似的影响。 GITS制剂不存在明显的峰值血浆浓度可能在保持临床有效性和减少引起不良反应的可能性方面具有优势。

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