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:Carolyn R. Harley、Avanish Mishra、Scott E. Cantor、Michael Nelson、Alexander M. Walker
DOI:10.2165/00044011-200222090-00002
日期:——
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. 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. 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. 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). 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.
本研究比较了刚接受商业保险的 2 型糖尿病患者对格列吡嗪胃肠道治疗系统 (GITS)、格列吡嗪速释 (IR) 和格列本脲(格列本脲)治疗的持续性和依从性。该研究的目的是确定三种第二代磺脲类药物之间的持久性和依从性是否存在差异。这是对八个独立实践模式健康计划中的商业参与者的回顾性纵向索赔数据分析。研究受试者年龄在 25 岁或以上,在 1996 年 1 月 1 日至 1999 年 12 月 31 日期间首次开具研究药物处方。所有受试者均刚刚接受糖尿病药物治疗,并开始接受单一疗法。要纳入研究,受试者必须在指数声明前 6 个月以及指数声明后至少 30 天连续参加其健康计划。持续性定义为从索引处方配药日期到终止、转换或增加治疗的总天数。依从性定义为治疗期间提供的天数与总天数的比率。用于测量依从性的治疗期定义为从指数处方配药日期到指数药物最后配药处方的供应天数用完的时间段。 Cox比例风险分析用于比较持久性的差异,多元回归用于评估依从性的差异。在 24 311 名受试者中,35% 的人首次处方格列吡嗪 GITS,15% 的人服用格列吡嗪 IR,50% 的人服用格列吡嗪。超过一半的研究对象是男性,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。到研究结束时,79% 的受试者已经终止了指数药物的治疗。 Cox 比例风险分析显示,服用格列吡嗪 IR 的患者改变治疗的可能性高出 1.33 倍 [95% 置信区间 (CI) 1.25 至 1.42],而服用格列本脲的患者改变治疗的可能性高出 1.16 倍(95% CI 1.11 至 1.42)。 1.22)与开始治疗后 90 天内服用格列吡嗪 GITS 的患者进行比较。在指数处方后 1620 天的后续分析中也发现了类似的结果。依从性分析表明,与服用格列吡嗪 GITS 的患者相比,服用格列吡嗪 IR 或格列本脲的患者对治疗的依从性较差 (p < 0.001)。与格列吡嗪 IR 和格列本脲相比,格列吡嗪 GITS 在治疗的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。缺乏持久性和依从性会产生潜在的临床和经济后果。