Impact of breakthrough trials on prescription trends of sodium‐glucose cotransporter‐2 inhibitors in Japan: An interrupted time‐series analysis
Impact of breakthrough trials on prescription trends of sodium‐glucose cotransporter‐2 inhibitors in Japan: An interrupted time‐series analysis
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日本突破性试验对钠-葡萄糖协同转运蛋白-2 抑制剂处方趋势的影响：间断时间序列分析
DOI：
10.1111/jcpt.13768
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发表时间：
2022
影响因子：
2
通讯作者：
Imai Shinobu
中科院分区：
文献类型：
--
作者：
Iketani Ryo;Imai Shinobu
钠-葡萄糖协同转运蛋白-2抑制剂（SGLT-2 is）越来越多地被用于治疗2型糖尿病（T2 DM）。我们的目的是研究临床试验对SGLT-2 is处方的显著影响，以及SGLT-2 is突破性试验的影响和普遍性之间的关系。方法这项回顾性队列研究涉及日本医疗数据中心健康保险数据库中至少处方一种降糖药物的32，949例T2 DM患者。从2014年4月至2020年3月，每月计算SGLT-2 is的处方率。我们评价了亚洲亚组EMPA‐REG OUTCOME研究对恩格列净处方率的影响，以及CANVAS/CANVAS‐R研究对卡格列净处方率的影响。在总人群、有心血管疾病史的亚组中，使用准泊松回归模型估计发生率比（IRR）和95%置信区间（CI）（高危人群），无心血管疾病史和危险因素的亚组（低风险组）结果和讨论针对亚洲亚组的EMPA‐REG OUTCOME研究导致恩格列净的处方率在发表后3个月增加，总体人群和高风险组，但低风险组中没有（IRR [95% CI]：分别为1.40 [1.17-1.66]、1.39 [1.05-1.84]和1.00 [0.79-1.27]）。增加高风险组可能是适当的，因为本研究仅纳入了有心血管疾病史的患者。CANVAS/CANVAS-R研究导致总体人群、高风险组和低风险组中卡格列净的处方率在发表后3个月增加（IRR [95% CI]分别为1.52 [1.06-2.19]、1.39 [1.06-1.83]和1.81 [1.20-2.75]）。增加低风险组可能是不合适的，因为这项研究没有包括没有心血管疾病史或危险因素的患者。什么是新的和结论突破性试验增加处方率不仅对患者的试验结果可以推断，但也为那些在试验中的好处是不确定的。我们的研究结果表明，突破性试验的信息可能需要与试验结果的普遍性数据一起提供沿着。
What is Known and ObjectiveSodium‐glucose cotransporter‐2 inhibitors (SGLT‐2is) have been increasingly prescribed for the treatment of type 2 diabetes mellitus (T2DM). We aimed to investigate the impact of clinical trials presenting remarkable results on the prescription of SGLT‐2is and the relationship between the impact and generalisability of the breakthrough trials on SGLT‐2is.MethodsThis retrospective cohort study involved 32,949 patients with T2DM who were prescribed at least one antidiabetic agent in the Japan Medical Data Center health insurance database. Prescription rates of SGLT‐2is were calculated monthly from April 2014 to March 2020. We evaluated the impact of the EMPA‐REG OUTCOME study for an Asian subgroup on the prescription rate of empagliflozin and the impact of the CANVAS/CANVAS‐R study on the prescription rate of canagliflozin. Incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were estimated using the quasi‐Poisson regression model in the overall population, subgroup with a history of cardiovascular disease (high‐risk group), and subgroup without a history and risk factors of cardiovascular disease (low‐risk group).Results and DiscussionThe EMPA‐REG OUTCOME study for the Asian subgroup led to increased prescription rates of empagliflozin 3 months after its publication in the overall population and high‐risk group but not in low‐risk group (IRR [95% CI]: 1.40 [1.17–1.66], 1.39 [1.05–1.84], and 1.00 [0.79–1.27], respectively). The increase in high‐risk group may be appropriate because this study included patients with a history of cardiovascular disease only. The CANVAS/CANVAS‐R study led to increased prescription rates of canagliflozin 3 months after its publication in the overall population, high‐risk group, and low‐risk group (IRR [95% CI]: 1.52 [1.06–2.19], 1.39 [1.06–1.83], and 1.81 [1.20–2.75], respectively). The increase in low‐risk group may not be appropriate because this study did not include patients without a history or risk factors of cardiovascular disease.What is New and ConclusionThe breakthrough trials increased prescription rates not only for patients to whom the trial results could be extrapolated but also for those in whom trial benefits were not certain. Our findings suggest that information about breakthrough trials may need to be provided along with data on trial result generalisability.
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数据资源概况：JMDC声称来自健康保险协会的数据库。
影响因子：
1.6
作者：
Nagai K;Tanaka T;Kodaira N;Kimura S;Takahashi Y;Nakayama T
通讯作者：
Nakayama T
回顾性全国范围内关于日本2型糖尿病患者一线抗糖尿病药物的趋势的研究。
影响因子：
3.2
作者：
Bouchi R;Sugiyama T;Goto A;Imai K;Ihana-Sugiyama N;Ohsugi M;Yamauchi T;Kadowaki T;Ueki K
通讯作者：
Ueki K
影响因子：
8.2
作者：
Davies, Melanie J.;D'Alessio, David A.;Buse, John B.
通讯作者：
Buse, John B.
影响因子：
4.1
作者：
Engler, Clemens;Leo, Marco;Ebenbichler, Christoph
通讯作者：
Ebenbichler, Christoph
DOI：
10.1111/dom.14245
发表时间：
2021-03
期刊：
Diabetes, obesity & metabolism
影响因子：
--
作者：
Funck KL;Knudsen JS;Hansen TK;Thomsen RW;Grove EL
通讯作者：
Grove EL