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对2型糖尿病患者在管理式医疗中使用格列吡嗪控释片、格列吡嗪普通片和格列本脲的持续性和依从性的“真实世界”分析。

A 'Real-World' Analysis of Persistence on and Adherence to Glipizide GITS, Glipizide IR and Glibenclamide in Managed Care among Patients with Type 2 Diabetes Mellitus.

作者信息

Hurley Carolyn R, Mishra Avanish, Cantor Scott E, Nelson Michael, Walker Alexander M

机构信息

Ingenix Inc., 12125 Technology Drive, MN002-0258, Eden Prairie, Minnesota, 55344, USA.

Pfizer Inc., New York, USA.

出版信息

Clin Drug Investig. 2002 Sep;22(9):575-584. doi: 10.2165/00044011-200222090-00002.

Abstract

OBJECTIVE

This study compared persistence on and adherence to therapy with glipizide gastrointestinal therapeutic system (GITS), glipizide immediate release (IR) and glibenclamide (glyburide) in commercially insured patients newly treated for type 2 diabetes mellitus. The objective of the study was to determine if there were differences in persistence and adherence between the three second-generation sulphonylureas.

STUDY DESIGN

This was a retrospective longitudinal claims data analysis for commercial enrollees in eight independent practice model health plans. Study subjects were 25 years of age or older with a first prescription for a study drug from 1 January 1996 through 31 December 1999. All subjects were newly treated with medication for diabetes mellitus, and were initiated on monotherapy. To be included in the study, subjects had to be continuously enrolled in their health plan 6 months prior to their index claim and at least 30 days following the index claim.

METHODS AND SUBJECTS

Persistence was defined as the total days from the index prescription fill date until termination, switch or augmentation of therapy. Adherence was defined as the ratio of days supplied to total days in the treatment period. The treatment period for the measurement of adherence was defined as the period from index prescription fill date to run-out of days supplied of the last filled prescription for the index drug. Cox proportional hazards analysis was used to compare differences in persistence, and multivariate regression was used to assess differences in adherence. Of the 24 311 subjects, 35% filled a first prescription for glipizide GITS, 15% for glipizide IR, and 50% for glibenclamide. Over one-half of study subjects were male, and the average age was between 51 years for the glipizide GITS cohort and 53 years for the glibenclamide cohort.

MAIN OUTCOMES AND RESULTS

By the end of the study, 79% of subjects had terminated therapy with their index drug. Cox proportional hazards analysis showed that patients taking glipizide IR were 1.33 times more likely to experience treatment change [95% confidence interval (CI) 1.25 to 1.42], and patients taking glibenclamide were 1.16 times more likely to change therapy (95% CI 1.11 to 1.22) compared with patients taking glipizide GITS in the first 90 days following initiation of therapy. Similar results were found upon subsequent analysis in the 1620 days following the index prescription. The analysis of adherence showed that patients taking glipizide IR or glibenclamide were less adherent to therapy compared with patients taking glipizide GITS (p < 0.001).

CONCLUSIONS

Glipizide GITS appears to have an advantage in persistence on and adherence to therapy compared with glipizide IR and glibenclamide. These differences may be related to administration frequency. Lack of persistence and adherence has potential clinical and economic consequences.

摘要

目的

本研究比较了格列吡嗪胃肠治疗系统(GITS)、速释格列吡嗪(IR)和格列本脲(优降糖)在新接受治疗的2型糖尿病商业保险患者中的治疗持续性和依从性。本研究的目的是确定这三种第二代磺酰脲类药物在持续性和依从性方面是否存在差异。

研究设计

这是一项针对八个独立执业模式健康计划中的商业参保者的回顾性纵向索赔数据分析。研究对象为1996年1月1日至1999年12月31日首次开具研究药物处方的25岁及以上人群。所有受试者均为新接受糖尿病药物治疗,并开始接受单一疗法。要纳入本研究,受试者必须在其索引索赔前6个月及索引索赔后至少30天持续参加其健康计划。

方法和受试者

持续性定义为从索引处方配药日期到治疗终止、换药或增加药物的总天数。依从性定义为供应天数与治疗期总天数的比值。测量依从性的治疗期定义为从索引处方配药日期到索引药物最后一次配药的供应天数用完的时间段。采用Cox比例风险分析比较持续性差异,采用多元回归评估依从性差异。在24311名受试者中,35%的人首次开具了格列吡嗪GITS处方,15%的人开具了速释格列吡嗪处方,50%的人开具了格列本脲处方。超过一半的研究受试者为男性,格列吡嗪GITS队列的平均年龄为51岁,格列本脲队列的平均年龄为53岁。

主要结局和结果

到研究结束时,79%的受试者终止了其索引药物治疗。Cox比例风险分析显示,与开始治疗后的前90天内服用格列吡嗪GITS的患者相比,服用速释格列吡嗪的患者发生治疗改变的可能性高1.33倍[95%置信区间(CI)1.25至1.42],服用格列本脲的患者发生治疗改变的可能性高1.16倍(95%CI 1.11至1.22)。在索引处方后的1620天进行后续分析时也发现了类似结果。依从性分析显示,与服用格列吡嗪GITS的患者相比,服用速释格列吡嗪或格列本脲的患者治疗依从性较差(p<0.001)。

结论

与速释格列吡嗪和格列本脲相比,格列吡嗪GITS在治疗持续性和依从性方面似乎具有优势。这些差异可能与给药频率有关。缺乏持续性和依从性具有潜在的临床和经济后果。

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