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首页> 外文期刊>Therapeutic advances in drug safety. >Sodium-glucose cotransporter-2 inhibitors and risk for genitourinary infections in older adults with type 2 diabetes
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Sodium-glucose cotransporter-2 inhibitors and risk for genitourinary infections in older adults with type 2 diabetes

机译：钠葡萄糖COTRANSPORTER-2抑制剂和患有2型糖尿病的老年人泌尿病感染的风险

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Background and aims: Although landmark clinical trials have demonstrated an increased risk for genitourinary infection (GUI) after initiation of sodium-glucose cotransporter-2 inhibitor (SGLT2i) therapy that led to an FDA label warning, real world findings have been inconsistent and evidence specifically in older adults is lacking. The objective of the study was to examine the incidence of GUI in patients aged 65?years or older initiated on SGLT2i compared with glucagon-like peptide-1 receptor agonist (GLP1-RA) therapy at a large academic health system. Methods: A retrospective population-based cohort study was conducted using electronic health records of patients aged 65?years and older with a diagnosis of type 2 diabetes mellitus. Patients newly initiated on SGLT2i or GLP1-RA therapy with estimated glomerular filtration rate (eGFR) ?30?mL/min per 1.73 m2 and active within the health system for at least 1?year prior to initiation were included. We compared the incidence of inpatient, emergency room, or outpatient diagnosis of GUI (bacterial and mycotic) within 6?months of SGLT2i or GLP1-RA initiation. A chi-square or Fisher’s exact test were used to analyze between-group differences for categorical variables, while a t-test was used for continuous variables. A Cox proportional hazards model was used to estimate the impact of confounding variables on the primary outcome. Results: One hundred and thirty-three patients were initiated on SGLT2i therapy and 341 patients newly initiated on GLP1-RA therapy. After adjusting for differences in age, A1c, body mass index, eGFR, race and sex, there was no statistically significant difference in GUI incidence within 6?months of SGLT2i versus GLP1-RA initiation (3.8% versus 6.5%, adjusted hazard ratio: 0.784, 95% confidence interval 0.260–2.367). Conclusion: We found no increased risk of composite GUI within 6?months of initiating SGLT2i compared with GLP1-RA therapy. These real-world data in older adults add to previous findings, which suggest no increased risk of urinary tract infection with SGLT2i initiation. Plain language summary A class of antidiabetic medications and risk for genitourinary infections in older adults with type 2 diabetes Older adults with type 2 diabetes often benefit from a class of antidiabetic medications known as sodium-glucose cotransporter-2 inhibitors (SGLT2is) which help to lower blood glucose, decrease risk for cardiovascular disease and prevent kidney disease progression. However, there is concern that these medications may increase risk for urinary tract infections and/or genital fungal infections in older adults based on clinical trial evidence. Our study evaluated the real-world occurrence of these safety events in patients aged 65?years or older who were newly started on these medications. We compared these patients with a group of patients newly started on an alternative class of antidiabetic agents which are not expected to increase risk for infections, known as glucagon-like peptide-1 receptor agonists (GLP1-RA). In our study, we included 133 patients who started an SGLT2i and 341 patients who started a GLP1-RA at a large teaching hospital. We evaluated the occurrence of infection up to 6?months after initiation of these mediations. We found no significant difference in infection rate between these two groups. We conclude in the study that the use of SGLT2i in older adults was not associated with increased risk for urinary tract infections or genital fungal infections when compared with GLP1-RA use.
机译：背景和宗旨：虽然具有里程碑意义的临床试验已经证明了导致FDA标签警告的钠 - 葡萄糖Cot转储-2抑制剂（SGLT2i）治疗后泌尿病感染的风险增加（GUI），但是现实世界发现的现实发现是不一致的和证据在老年人缺乏。该研究的目的是探讨65岁的患者的GUI的发病率，与大型学术卫生系统的胰高血糖素肽-1受体激动剂（GLP1-RA）治疗相比，在SGRT2i上发起的患者。方法：采用65岁及以上的患者的电子健康记录进行了一种基于回顾性的人口的群组研究，患有2型糖尿病的诊断。在SGLT2i或GLP1-RA治疗上进行新发起的患者，估计肾小球过滤速率（EGFR）？每1.73m 2 30？ml / min，并在卫生系统内活跃至少1〜1〜1年。我们将住院患者，急诊室或门诊室外诊断的发病率与6？多月份的SGLT2i或GLP1-RA启动中的愈合（细菌和毒性）的发生率。 Chi-Square或Fisher的确切试验用于分析分类变量的组间差异，而T检验用于连续变量。 COX比例危险模型用于估计混淆变量对主要结果的影响。结果：在SGLT2i治疗中启动了一百三十三名患者，并在GLP1-RA治疗中新发起的341名患者。调整年龄差异后，A1C，体重指数，EGFR，种族和性别，3月6岁以下的GUI发病率没有统计学意义差异与GLP1-RA启动（3.8％对6.5％，调整后的危险比率： 0.784,95％置信区间0.260-2.367）。结论：与GLP1-RA疗法相比，我们发现在6岁的时间内没有增加复合GUI的风险。老年人的这些现实世界数据添加到以前的发现，这表明尿路感染的风险增加了SGLT2i启动。简单语言概述一类抗糖尿病药物和患有2型糖尿病患者的糖尿病患者患有2型糖尿病的糖尿病患者的风险通常受益于一类称为葡萄糖Cotroansporter-2抑制剂（SGLT2）的抗糖尿病药物，这有助于降低血糖，降低心血管疾病的风险，预防肾病进展。然而，担心这些药物可能会增加基于临床试验证据的老年人尿路感染和/或生殖器真菌感染的风险。我们的研究评估了65岁的患者的现实世界发生这些安全事件，这些患者是新开始这些药物的岁月或以上。我们将这些患者与一组新开始的患者进行了比较替代类抗糖尿病药物，该抗糖尿病药物不会增加感染风险，称为胰高血糖素肽-1受体激动剂（GLP1-RA）。在我们的研究中，我们包括133名开始SGLT2i和341名在一个大型教学医院开始GLP1-RA的患者。我们评估了在启动这些调解后6月6日的感染的发生。我们发现这两组之间的感染率没有显着差异。我们在研究中得出结论，在与GLP1-RA使用相比，在老年人中使用尿路感染或生殖器真菌感染的风险增加无关。

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