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老年人糖尿病减药:一项随机临床试验。

Diabetes Deprescribing in Older Adults: A Randomized Clinical Trial.

作者信息

Grant Richard W, Peterson Ilana, McCloskey Jodi M, Lipska Kasia J, Nugent Joshua, Karter Andrew J, Gilliam Lisa K

机构信息

Division of Research, Kaiser Permanente Northern California, Pleasanton.

Section of Endocrinology, Department of Medicine, Yale School of Medicine, New Haven, Connecticut.

出版信息

JAMA Intern Med. 2025 Jun 23. doi: 10.1001/jamainternmed.2025.2015.

Abstract

IMPORTANCE

Medication-related hypoglycemia is the leading cause of iatrogenic complications among older adults with type 2 diabetes.

OBJECTIVE

To compare physician academic detailing (AD) with or without patient previsit activation for insulin and/or sulfonylurea deprescribing in older patients with diabetes.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted from September 2020 to March 2024 with 6 and 12 months of follow-up in a large integrated health care system in Northern California. Primary care physicians (PCPs) and their patients with type 2 diabetes who were 75 years and older, had hemoglobin A1c of 8.0% or lower, and were treated with insulin and/or sulfonylureas were included.

INTERVENTIONS

Participating PCPs attended at least 1 AD session that provided evidence to support diabetes medication reassessment and potential deprescribing strategies in older patients with type 2 diabetes. Prior to their visit with a participating PCP, trial patients were randomly assigned to receive either a previsit activation deprescribing handout (AD plus previsit arm) or an attention control healthy lifestyle handout (AD-only arm).

MAIN OUTCOMES AND MEASURES

Primary outcomes (assessed at 6 months) were diabetes medication deprescribing (an aggregate measure) and any patient-reported severe hypoglycemia episodes.

RESULTS

A total of 211 PCPs were able to attend at least 1 AD session and treated 450 eligible patients (mean [SD] age, 79.9 [4.0] years; 223 [49.6%] female; mean [SD] concurrent chronic conditions, 6.2 [3.6]; and mean [SD] hemoglobin A1c, 7.5% [1.1%]). At 6 months, there was a statistically significant higher diabetes medication deprescribing rate in the AD plus previsit activation arm compared with the AD-only arm (36 of 232 patients [15.8%] vs 19 of 218 patients [9.0%]; adjusted risk difference [RD], 7.5%; 95% CI, 1.5%-13.6%; P = .01); this difference persisted at 12 months (50 of 232 patients [22.8%] vs 33 of 218 patients [16.3%]; adjusted RD, 7.9%; 95% CI, 0.4%-15.5%; P = .04). There was not a statistically significant difference in severe self-reported hypoglycemia at 6 months between the AD plus previsit and AD-only arms (10 of 232 patients [4.7%] vs 13 of 218 patients [6.5%]; adjusted RD, -2.3%; 95% CI, -7.1% to 2.5%; P = .04).

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial, AD with previsit activation was a simple and effective strategy for increasing diabetes medication deprescribing in older patients with type 2 diabetes.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04585191.

摘要

重要性

药物相关低血糖是老年2型糖尿病患者医源性并发症的主要原因。

目的

比较有或没有患者就诊前激活措施的医生学术推广(AD)对老年糖尿病患者停用胰岛素和/或磺脲类药物的效果。

设计、地点和参与者:这项随机临床试验于2020年9月至2024年3月进行,在北加利福尼亚州的一个大型综合医疗系统中进行了6个月和12个月的随访。纳入了75岁及以上、糖化血红蛋白(HbA1c)为8.0%或更低、正在接受胰岛素和/或磺脲类药物治疗的初级保健医生(PCP)及其2型糖尿病患者。

干预措施

参与的初级保健医生参加至少1次AD会议,该会议提供证据支持对老年2型糖尿病患者进行糖尿病药物重新评估和潜在的减药策略。在与参与的初级保健医生就诊前,试验患者被随机分配接受就诊前激活减药手册(AD加就诊前组)或注意力控制健康生活方式手册(仅AD组)。

主要结局和测量指标

主要结局(在6个月时评估)为糖尿病药物减药(一项综合指标)和任何患者报告的严重低血糖发作。

结果

共有211名初级保健医生能够参加至少1次AD会议,并治疗了450名符合条件的患者(平均[标准差]年龄,79.9[4.0]岁;223名[49.6%]为女性;平均[标准差]并发慢性病,6.2[3.6];平均[标准差]糖化血红蛋白,7.5%[1.1%])。在6个月时,AD加就诊前激活组的糖尿病药物减药率在统计学上显著高于仅AD组(232名患者中的36名[15.8%]对218名患者中的19名[9.0%];调整风险差异[RD],7.5%;95%置信区间,1.5%-13.6%;P = 0.01);这种差异在12个月时仍然存在(232名患者中的50名[22.8%]对218名患者中的33名[16.3%];调整RD,7.9%;95%置信区间,0.4%-15.5%;P = 0.04)。AD加就诊前组和仅AD组在6个月时自我报告的严重低血糖方面没有统计学上的显著差异(232名患者中的10名[4.7%]对218名患者中的13名[6.5%];调整RD,-2.3%;95%置信区间,-7.1%至2.5%;P = 0.04)。

结论和相关性

在这项随机临床试验中,有就诊前激活措施的AD是增加老年2型糖尿病患者糖尿病药物减药的一种简单有效的策略。

试验注册

ClinicalTrials.gov标识符:NCT04585191。

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