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在炎热潮湿的印度夏季,评估卡格列净 100mg 起始治疗 2 型糖尿病患者的短期疗效、安全性和耐受性的真实世界研究。

Real world study of short term efficacy, safety, and tolerability of canagliflozin 100 mg initiation in type 2 diabetes mellitus patients during hot humid Indian summer.

机构信息

Department of Endocrinology, KPC Medical College & Hospital, Kolkata, India.

Department of Endocrinology, KPC Medical College & Hospital, Kolkata, India.

出版信息

Diabetes Metab Syndr. 2021 Jan-Feb;15(1):385-389. doi: 10.1016/j.dsx.2021.01.011. Epub 2021 Jan 22.

DOI:10.1016/j.dsx.2021.01.011
PMID:33548908
Abstract

BACKGROUND AND AIM

To assess short term (3 months) efficacy, safety, and tolerability of canagliflozin 100 mg among type 2 diabetes mellitus (T2DM) initiated during hot humid Indian summer.

METHODS

A prospective, observational, multi-center study of 300 T2DM patients with inadequate glycemic control (i.e., HbA1c of ≥6.5%) with or without other antihyperglycemic agents (AHA) were enrolled in the study in the month of March. The objective of the study was to assess the efficacy that is changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), blood pressure (BP), lipid profile, body mass index (BMI) and safety of canagliflozin with regards to genitourinary infection, fall, diabetic keto acidosis (DKA) episodes, blood ketone and beta-hydroxybutyrate levels. All patients were initiated on canagliflozin 100 mg once daily for 12 weeks, irrespective of background medications.

RESULTS

At 12 weeks, a significant reduction was observed in all the glycemic parameters,BMI, BP, total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C). However, a nonsignificant reduction in estimated glomerular filtration rate (eGFR) was observed at 12 weeks. A total of 9 adverse events were reported including 2 episodes of urinary tract infection (UTI) and 4 episodes of genital infection. The blood ketone, beta-hydroxybutyrate levels were found to be within normal limits and no episode of DKA was reported at 12 weeks. None of our patients had reported any volume depletion related adverse events viz. postural hypotension, giddiness etc. CONCLUSION: Canagliflozin 100 mg can be safely initiated in type 2 diabetes patients during hot humid Indian summer, irrespective of background medications and is effective and well tolerated.

摘要

背景和目的

评估卡格列净 100mg 在炎热潮湿的印度夏季起始治疗 2 型糖尿病(T2DM)的短期(3 个月)疗效、安全性和耐受性。

方法

这是一项前瞻性、观察性、多中心研究,共纳入 300 例血糖控制不佳(即 HbA1c≥6.5%)的 T2DM 患者,这些患者正在接受或未接受其他降糖药物(AHA)治疗。该研究的目的是评估卡格列净的疗效,即糖化血红蛋白(HbA1c)、空腹血糖(FPG)、餐后血糖(PPG)、血压(BP)、血脂谱、体重指数(BMI)的变化,以及卡格列净在尿路感染、跌倒、糖尿病酮症酸中毒(DKA)发作、血酮和β-羟丁酸水平方面的安全性。所有患者均起始接受卡格列净 100mg 每日一次治疗 12 周,无论背景药物如何。

结果

在 12 周时,所有血糖参数、BMI、BP、总胆固醇(TC)和低密度脂蛋白胆固醇(LDL-C)均显著降低。然而,在 12 周时观察到估算肾小球滤过率(eGFR)的非显著性降低。共报告了 9 例不良事件,包括 2 例尿路感染(UTI)和 4 例生殖器感染。血酮、β-羟丁酸水平均在正常范围内,在 12 周时未报告 DKA 发作。我们的患者均未报告任何与容量不足相关的不良事件,如体位性低血压、头晕等。

结论

卡格列净 100mg 可在炎热潮湿的印度夏季起始用于 2 型糖尿病患者,无论背景药物如何,且安全有效,耐受性良好。

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