Achieving comparability in glycemic control between antidiabetic treatment strategies in pregnancy when using real world data.

Achieving comparability in glycemic control between antidiabetic treatment strategies in pregnancy when using real world data.
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使用真实世界数据时,实现妊娠期抗糖尿病治疗策略之间血糖控制的可比性。

DOI:
10.1002/pds.5665
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发表时间:
2023
影响因子:
2.6
通讯作者:
Patorno,Elisabetta
Patorno,Elisabetta
中科院分区:
医学4区
文献类型:
--
作者:
Cesta,CarolynE;Hernández-Díaz,Sonia;Huybrechts,KristaF;Bateman,BrianT;Vine,Seanna;Seely,EllenW;Patorno,Elisabetta

文献摘要

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目的医疗利用数据库通常缺乏血糖控制信息,这是研究降糖治疗安全性时的一个关键混杂因素,因为控制较差的患者被引导至二线药物,特别是胰岛素,而不是一线药物,如二甲双胍。我们评估了调整测量的特征是否达到平衡血糖控制时,比较抗糖尿病治疗策略的孕妇与妊娠前2型糖尿病(T2DM)methodsIn美国保险索赔数据库,我们确定了3360名妇女与T2DM怀孕2004年和2015年之间,其中一个子集的996血红蛋白A1c(HbA1c)水平的数据。我们仅选择胰岛素作为对照组,并使用倾向评分(PS)匹配合并症和糖尿病严重程度的代理,但不使用HbA1c,以调整混杂因素。我们使用标准化差异(st.diff)来评估基于索赔的协变量和亚组中平均HbA1c(% ± SD)的平衡。结果在PS匹配之前,基于索赔的协变量存在不平衡,当两种治疗策略都包括胰岛素时,差异较小。PS匹配后,大多数基于声明的协变量达到平衡(st.diff <0.1)。当两种治疗均包括胰岛素时,PS匹配前后的平均HbA1c相似(例如,7.1二甲双胍+胰岛素与仅胰岛素分别为± 1.5 vs. 7.7 ± 1.8和7.1 ± 1.5 vs. 7.5 ± 1.7)。当非胰岛素治疗与包括胰岛素的治疗相比时,PS匹配后平均HbA1的差异增加(例如,6.3± 1.1 vs. 7.6 ± 1.7(二甲双胍单药vs.胰岛素单药)。结论在将人群限制为T2DM女性并比较适用于糖尿病严重程度相似患者的治疗策略后,获得了基于声明的特征和血糖控制的平衡。当比较联合与不联合胰岛素的治疗策略时,即使在其他测量特征达到平衡时,PS匹配后血糖控制的差异仍然存在。
PurposeHealthcare utilization databases often lack information on glycemic control, a key confounder when studying the safety of antidiabetic treatments, since patients with worse control are channeled to second‐line agents, in particular insulin, versus first‐line agents such as metformin. We evaluated whether adjustment for measured characteristics attains balance in glycemic control when comparing antidiabetic treatment strategies in pregnant women with pregestational type 2 diabetes (T2DM).MethodsIn a US insurance claims database, we identified 3360 women with T2DM pregnant between 2004 and 2015, of whom a subset of 996 had data on hemoglobin A1c(HbA1c) levels. We selectedinsulin onlyas the comparator group and used propensity score (PS)‐matching on comorbidities and proxies of diabetes severity, but not on HbA1c, to adjust for confounding. We used standardized differences (st.diff) to assess balance in claims‐based covariates and mean HbA1c(% ± SD) in the subset.ResultsThere were imbalances in claims‐based covariates before PS‐matching, with smaller differences when both treatment strategies included insulin. After PS‐matching, balance was achieved in most claims‐based covariates (st.diff <0.1). Mean HbA1cwas similar before and after PS‐matching when both treatments included insulin (e.g., 7.1 ± 1.5 vs. 7.7 ± 1.8 and 7.1 ± 1.5 vs. 7.5 ± 1.7, respectively, formetformin + insulinvs.insulin only). Differences in mean HbA1cremained after PS‐matching when non‐insulin treatments were compared to treatments including insulin (e.g., 6.3 ± 1.1 vs. 7.6 ± 1.7 formetformin onlyvs.insulin only).ConclusionsBalance in both claims‐based characteristics and glycemic control was attained after restricting the population to women with T2DM and comparing treatment strategies indicated for patients with similar diabetes severity. When comparing treatment strategies with versus without insulin, differences in glycemic control persisted after PS‐matching even when balance was attained for other measured characteristics.