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卡格列净治疗2型糖尿病的疗效与安全性:随机对照试验的系统评价

Efficacy and safety of canagliflozin in type 2 diabetes mellitus: systematic review of randomized controlled trials.

作者信息

Parveen Rizwana, Agarwal Nidhi Bharal, Kaushal Neelam, Mali Ghanshyam, Raisuddin Sheikh

机构信息

a Centre for Translational and Clinical Research , Jamia Hamdard , New Delhi 110062 , India.

b Medical Affairs and Clinical Research , Sun Pharma Industries Ltd. , Gurgaon 122001 , India.

出版信息

Expert Opin Pharmacother. 2016;17(1):105-15. doi: 10.1517/14656566.2016.1109629. Epub 2015 Dec 9.

DOI:10.1517/14656566.2016.1109629
PMID:26650511
Abstract

BACKGROUND

Currently available antihyperglycemic agents (AHAs), despite being effective, do not provide adequate glycemic control in some cases and are associated with side effects. A sodium glucose co-transporter 2 inhibitor, canagliflozin, is a newer AHA, which acts by decreasing the reabsorption of filtered glucose thereby elevating the urinary glucose excretion in diabetics.

AREAS COVERED

This systematic review was completed to assess the clinical effectiveness and safety of canagliflozin in T2DM. A literature search in PubMed, MEDLINE, Cochrane and ClinicalTrials.gov was conducted for randomized clinical trials of canagliflozin as an AHA by applying predetermined inclusion and exclusion criteria. Total 13 studies were included in the systematic review. The main outcomes assessed were change in HbA1c and fasting plasma glucose.

EXPERT OPINION

Canagliflozin monotherapy or combination therapy has the potential to decrease inadequately controlled hyperglycemia in T2DM. It acts by a novel insulin independent mechanism which complements the action of the existing AHA and improves glycemic control and decreases the body weight. Safety profile of canagliflozin indicates lower number of hypoglycemic episodes. Some manageable adverse events include genital mycotic infections, urinary tract infections, osmotic diuresis-related events etc. These findings affirm the utility of canagliflozin in T2DM; however, data on long-term safety and efficacy are needed.

摘要

背景

目前可用的抗高血糖药物(AHAs)尽管有效,但在某些情况下并不能提供足够的血糖控制,且伴有副作用。钠-葡萄糖协同转运蛋白2抑制剂卡格列净是一种较新的抗高血糖药物,其作用机制是减少滤过葡萄糖的重吸收,从而增加糖尿病患者的尿糖排泄。

涵盖领域

本系统评价旨在评估卡格列净在2型糖尿病(T2DM)中的临床有效性和安全性。通过应用预先确定的纳入和排除标准,在PubMed、MEDLINE、Cochrane和ClinicalTrials.gov上检索了卡格列净作为抗高血糖药物的随机临床试验。系统评价共纳入13项研究。评估的主要结局是糖化血红蛋白(HbA1c)和空腹血糖的变化。

专家观点

卡格列净单药治疗或联合治疗有可能降低T2DM中控制不佳的高血糖。它通过一种新的非胰岛素依赖机制发挥作用,补充了现有抗高血糖药物的作用,改善了血糖控制并减轻了体重。卡格列净的安全性表明低血糖发作次数较少。一些可管理的不良事件包括生殖器霉菌感染、尿路感染、渗透性利尿相关事件等。这些发现证实了卡格列净在T2DM中的效用;然而,仍需要长期安全性和有效性的数据。

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