2 型糖尿病患者的下肢事件：利尿剂使用相关风险增加的证据。
Lower limb events in individuals with type 2 diabetes: evidence for an increased risk associated with diuretic use.
机构信息
Department of Diabetology, Endocrinology and Nutrition, Bichat Hospital, Assistance Publique - Hôpitaux de Paris, DHU FIRE, 46 rue Henri Huchard 75877, Paris Cedex 18, France.
UFR de Médecine, Paris Diderot University, Sorbonne Paris Cité, Paris, France.
出版信息
Diabetologia. 2019 Jun;62(6):939-947. doi: 10.1007/s00125-019-4835-z. Epub 2019 Feb 26.
AIMS/HYPOTHESIS: Recently, safety data signalled an increased risk of amputations in people taking canagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor. If this side effect is due to drug-induced hypovolaemia, diuretics should also increase that risk. The aim of this study was to analyse the association between diuretic use and the risk of lower limb events (LLEs) in people with type 2 diabetes.
METHODS
SURDIAGENE (SUivi Rénal, DIAbète de type 2 et GENEtique) is a prospective observational cohort that includes people with type 2 diabetes enrolled from 2002 to 2012 and followed-up until onset of LLE, death or 31 December 2015, whichever came first. Primary outcome was the first occurrence of LLE, a composite of lower limb amputation (LLA) and lower limb revascularisation (LLR). The rates of primary outcome were compared between participants taking and not taking diuretics at baseline in a Cox-adjusted model.
RESULTS
At baseline, of the 1459 participants included, 670 were taking diuretics. In participants with and without diuretics, the mean ages were 67.1 and 62.9 years and 55.8% and 59.8% were men, respectively. During a median follow-up of 7.1 years, the incidence of LLE was 1.80 per 100 patient-years in diuretic users vs 1.00 in non-users (p < 0.001). The HR for LLE in users vs non-users was 2.08 (95% CI 1.49, 2.93), p < 0.001. This association remained significant in a multivariable-adjusted model (1.49 [1.01, 2.19]; p = 0.04) and similar after considering death as a competing risk (subhazard ratio 1.89 [1.35, 2.64]; p < 0.001). When separated, LLA but not LLR, was associated with the use of diuretics: 2.01 (1.14, 3.54), p = 0.02 and 1.05 (0.67, 1.64), p = 0.84, respectively, in the multivariable-adjusted model.
CONCLUSIONS/INTERPRETATION: Among people with type 2 diabetes treated with diuretics, there was a significant increase in the risk of LLE, predominantly in the risk of LLA.
目的/假设：最近，安全性数据表明，服用钠-葡萄糖共转运蛋白 2（SGLT2）抑制剂卡格列净的患者截肢风险增加。如果这种副作用是由于药物引起的血容量不足引起的，那么利尿剂也应该增加这种风险。本研究的目的是分析 2 型糖尿病患者使用利尿剂与下肢事件（LLE）风险之间的关系。
方法
SURDIAGENE（SUivi Rénal，DIAbète de type 2 et GENEtique）是一项前瞻性观察队列研究，纳入了 2002 年至 2012 年间招募的 2 型糖尿病患者，并随访至 LLE 发作、死亡或 2015 年 12 月 31 日（以先发生者为准）。主要结局是 LLE 的首次发生，这是下肢截肢（LLA）和下肢血运重建（LLR）的复合结局。在 Cox 调整模型中，比较了基线时服用和未服用利尿剂的参与者之间的主要结局发生率。
结果
在基线时，纳入的 1459 名参与者中，670 名正在服用利尿剂。在服用和未服用利尿剂的参与者中，平均年龄分别为 67.1 岁和 62.9 岁，分别有 55.8%和 59.8%为男性。在中位随访 7.1 年期间，利尿剂使用者的 LLE 发生率为每 100 患者-年 1.80 例，而非使用者为 1.00 例（p<0.001）。与非使用者相比，使用者的 LLE 风险比（HR）为 2.08（95%CI 1.49，2.93），p<0.001。在多变量调整模型中，这种关联仍然显著（1.49 [1.01，2.19]；p=0.04），在考虑死亡为竞争风险后也相似（亚危险比 1.89 [1.35，2.64]；p<0.001）。在多变量调整模型中，当单独考虑时，仅 LLA，而不是 LLR，与利尿剂的使用相关：2.01（1.14，3.54），p=0.02 和 1.05（0.67，1.64），p=0.84。
结论/解释：在接受利尿剂治疗的 2 型糖尿病患者中，LLE 的风险显著增加，主要是 LLA 的风险增加。
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