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在现实环境中评估口服抗糖尿病药物控制不佳患者的血糖控制情况:评估2型糖尿病强化治疗的合适时机(ATTAIN)的结果。

Evaluating glycaemic control in patients poorly controlled on oral antidiabetic drugs in real-world setting: Results from assessing the Appropriate Timing of Type 2 diAbetes INtensification (ATTAIN).

作者信息

Jude Edward B, O'Leary Caroline, Myland Melissa, Nixon Mark, Gooch Nick, Shaunik Alka, Lew Elisheva

机构信息

Diabetes Centre Tameside General Hospital Ashton-under-Lyne UK.

IQVIA London UK.

出版信息

Endocrinol Diabetes Metab. 2019 Sep 29;3(1):e00094. doi: 10.1002/edm2.94. eCollection 2020 Jan.

Abstract

INTRODUCTION

Many patients with type 2 diabetes mellitus (DM) fail to achieve glycaemic control despite recommended treatment strategies to reduce glycated haemoglobin (HbA1c). This real-world retrospective cohort study compared HbA1c change and treatment patterns between those intensifying and not intensifying therapy with oral antidiabetic drugs (OADs).

MATERIALS AND METHODS

Patients suboptimally controlled on OADs (>58 mmol/mol [>7.5%] or >64 mmol/mol [>8.0%] for high risk, index 1) were included from IQVIA Medical Research Data. Intensifiers within 12 months of index 1 were matched (1:1) to nonintensifiers. Primary outcomes were HbA1c change and proportion of participants achieving HbA1c targets 6 and 12 months post-index 2 (date of intensification [intensifiers] or pseudodate [nonintensifiers]). Therapy adherence was also assessed.

RESULTS

A total of 10 832 participants (5539 intensifiers and 5293 nonintensifiers) were included. Mean HbA1c decrease from baseline to 6 months was -1.13% (intensifiers) vs -0.75% (nonintensifiers), with no substantial further change at 12 months. Cox proportional hazards (PH) analysis suggested a nearly 20% greater chance of target achievement at 6 months for intensifiers vs nonintensifiers (hazard ratio [HR]: 0.79 [95% confidence interval [CI]: 0.73-0.86]), which was similar at 12 months (HR: 0.80 [95% CI: 0.74-0.86]). Intensifiers tended towards greater adherence to baseline therapy (90% [standard deviation (SD): 14.9] vs nonintensifiers 87% [SD: 16.0]), which decreased following intensification.

CONCLUSIONS

Significant reductions in HbA1c were evident at 6 months and were greater in intensifiers vs nonintensifiers. Little additional clinical benefit was seen 12 months postintensification. Despite good treatment adherence, many participants failed to achieve target HbA1c; actions beyond improved adherence are needed to improve suboptimal HbA1c.

摘要

引言

尽管有推荐的治疗策略来降低糖化血红蛋白(HbA1c),但许多2型糖尿病(DM)患者仍未能实现血糖控制。这项真实世界的回顾性队列研究比较了使用口服抗糖尿病药物(OADs)强化治疗和未强化治疗患者的HbA1c变化及治疗模式。

材料与方法

从IQVIA医学研究数据中纳入OADs治疗效果欠佳(高危患者HbA1c>58 mmol/mol[>7.5%]或>64 mmol/mol[>8.0%],索引1)的患者。索引1后12个月内的强化治疗患者与未强化治疗患者进行1:1匹配。主要结局为索引2后6个月和12个月(强化治疗日期[强化治疗组]或虚拟日期[未强化治疗组])的HbA1c变化以及达到HbA1c目标的参与者比例。同时评估治疗依从性。

结果

共纳入10832名参与者(5539名强化治疗组和5293名未强化治疗组)。从基线到6个月,强化治疗组HbA1c平均下降1.13%,未强化治疗组为0.75%,12个月时无显著进一步变化。Cox比例风险(PH)分析表明,强化治疗组在6个月时达到目标的可能性比未强化治疗组高近20%(风险比[HR]:0.79[95%置信区间[CI]:0.73 - 0.86]),12个月时情况相似(HR:0.80[95%CI:0.74 - 0.86])。强化治疗组对基线治疗的依从性更高(90%[标准差(SD):14.9],未强化治疗组为(87%[SD:16.0]),强化治疗后依从性下降。

结论

强化治疗组在6个月时HbA1c显著降低,且降幅大于未强化治疗组。强化治疗12个月后临床获益增加不多。尽管治疗依从性良好,但许多参与者仍未达到目标HbA1c;需要采取除改善依从性之外的措施来改善欠佳的HbA1c水平。

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