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两种噻唑烷二酮类药物对血脂水平影响的观察性研究:罗格列酮和吡格列酮在常规临床实践中的应用

An observational study of the effect of two thiazolidinediones on blood lipid levels: Rosiglitazone and pioglitazone in routine clinical practice.

作者信息

Griffis Deborah, McLaughlin Trentnt, Dirani Riad, Thwaites Rob

机构信息

AdvancePCS, Phoenix, Arizona, USA.

NDCHealth, Phoenix, Arizona, USA.

出版信息

Curr Ther Res Clin Exp. 2004 Mar;65(2):149-60. doi: 10.1016/S0011-393X(04)90029-X.

Abstract

BACKGROUND

Rosiglitazone maleate and pioglitazone hydrochloride are established antihyperglycemic agents that are effective when used as monotherapy or in combination with other medications. However, the data regarding the effects of these agents on blood lipid levels are contradictory.

OBJECTIVE

The aim of this study was to determine whether the use of rosiglitazone and pioglitazone in clinical practice is associated with any changes in blood lipid levels.

METHODS

A retrospective chart review using electronic medical record data was conducted of patients with type 2 diabetes mellitus who were newly treated with either rosiglitazone or pioglitazone and had 1 lipid measurement within 6 months prior to and 12 months following initial thiazolidinedione (TZD) therapy. Outcome measures were mean changes in low- and high-density lipoprotein cholesterol (LDL-C and HDL-C, respectively). To control for differences in baseline characteristics and/or selection bias, the treatment cohorts were compared using multivariate statistical techniques.

RESULTS

A total of 371 patients were included in the study; the pioglitazone cohort comprised 148 patients (82 women, 66 men; mean [SD] age, 64.9 [10.8] years) and the rosiglitazone cohort comprised 223 patients (113 men, 110 women; mean [SD] age, 66.1 [11.9] years). Pioglitazone-treated patients had a statistically higher mean baseline LDL-C compared with rosiglitazone-treated patients (125.0 mg/dL vs 116.6 mg/dL; P = 0.04). On average, LDL-C levels decreased over the study period, with no significant differences between the 2 cohorts (9.9 mg/dL vs 4.3 mg/dL for pioglitazone and rosiglitazone, respectively), although changes in both cohorts were statistically significant (P < 0.001).

CONCLUSIONS

TZD therapy appears to be associated with a small decrease in LDL-C within the first 6 months after initiation. No differences in changes in LDL-C or HDL-C could be discerned between patients treated with rosiglitazone compared with pioglitazone.

摘要

背景

马来酸罗格列酮和盐酸吡格列酮是已被认可的抗高血糖药物,单独使用或与其他药物联合使用时均有效。然而,关于这些药物对血脂水平影响的数据相互矛盾。

目的

本研究旨在确定临床实践中使用罗格列酮和吡格列酮是否与血脂水平的任何变化相关。

方法

对新接受罗格列酮或吡格列酮治疗且在初始噻唑烷二酮(TZD)治疗前6个月内及治疗后12个月内进行过1次血脂测量的2型糖尿病患者,使用电子病历数据进行回顾性病历审查。观察指标为低密度脂蛋白胆固醇和高密度脂蛋白胆固醇(分别为LDL-C和HDL-C)的平均变化。为控制基线特征差异和/或选择偏倚,使用多变量统计技术对治疗队列进行比较。

结果

本研究共纳入371例患者;吡格列酮队列包括148例患者(82名女性,66名男性;平均[标准差]年龄,64.9[10.8]岁),罗格列酮队列包括223例患者(113名男性,110名女性;平均[标准差]年龄,66.1[11.9]岁)。与罗格列酮治疗的患者相比,吡格列酮治疗的患者基线LDL-C平均水平在统计学上更高(125.0mg/dL对116.6mg/dL;P = 0.04)。在研究期间,LDL-C水平平均下降,两个队列之间无显著差异(吡格列酮和罗格列酮分别为9.9mg/dL和4.3mg/dL),尽管两个队列的变化在统计学上均有显著意义(P < 0.001)。

结论

TZD治疗似乎与开始治疗后的前6个月内LDL-C略有下降有关。与吡格列酮治疗的患者相比,罗格列酮治疗的患者在LDL-C或HDL-C变化方面没有差异。

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Troglitazone: the discovery and development of a novel therapy for the treatment of Type 2 diabetes mellitus.
Adv Drug Deliv Rev. 2002 Nov 5;54(9):1173-97. doi: 10.1016/s0169-409x(02)00093-5.
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Diabetes trends in the USA.美国的糖尿病趋势。
Diabetes Metab Res Rev. 2002 Sep-Oct;18 Suppl 3:S21-6. doi: 10.1002/dmrr.289.

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