与卡格列净相关的药物不良事件:随机、安慰剂对照试验的荟萃分析

M. Shawaqfeh, M. M. Bhinder, Amin Saleh Halum, C. Harrington, S. Muflih, T. Do
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引用次数: 1

摘要

Canagliflozin是一种钠-葡萄糖共转运蛋白2 (SGLT2)抑制剂,最近在美国被批准用于联合饮食和运动治疗2型糖尿病。批准了两种剂量,100毫克和300毫克。美国标签警告300mg剂量时,与容量消耗相关的不良反应会随剂量增加而增加。本荟萃分析的目的是评估卡格列净对安全性和耐受性结果的剂量反应。通过MEDLINE、EMBASE和Cochrane文库进行检索,比较卡格列净与安慰剂或主动对照的临床试验。关键词:卡格列净,meta分析。相关文章的参考书目也被用作来源。两位审稿人提取数据并评估相关研究。收集、验证并进一步分析研究特征、感兴趣的安全结局和偏倚风险。2项试验(n=270)研究了Canagliflozin作为单一疗法,10项研究(n=2525)研究了Canagliflozin作为附加疗法。其中10项研究纳入了选定安全性结果的分析。干预时间为12至52周。所有的研究都是随机的,与安慰剂或积极对照进行比较。加格列净治疗增加了外阴阴道真菌感染的风险(RR 4.11;可信区间3.01 - -5.60;P<0.01), polakiuria (RR 2.89, CI 1.84- 4.53),多尿症(RR 3.87;CI 1.66-9.05),低血糖(RR 1.22;CI 1.10-1.35)和低血容量(RR 2.04;Ci 1.13- 3.68)。在观察到的安全性结果中,除生殖器感染外,没有显著的剂量反应(RR 4.12;可信区间2.47 - -6.87)。此外,与对照组相比,卡格列净治疗组严重不良事件减少24% (RR 0.76;0.62 - -0.93;P < 0.01)。本荟萃分析未显示卡格列净对治疗2型糖尿病突发不良事件的剂量反应效应。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Adverse Drug Events Related to Canagliflozin: A Meta-Analysis of Randomized, Placebo-Controlled Trials
Canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, was recently approved in United States for the treatment of type 2 diabetes mellitus in combination with diet and exercise. Two strengths were approved, 100 mg and 300 mg. The US label warns of a dose-dependent increase in volume depletion-related adverse reactions on the 300 mg dose. The purpose of this meta-analysis was to assess the dose response of canaglifozin on safety and tolerability outcomes. A search was performed through MEDLINE, EMBASE, and Cochrane Library for clinical trials comparing canagliflozin with placebo or active controls. Keywords include canagliflozin, and meta-analysis. Reference lists of relevant articles were also used as sources. Two reviewers extracted data and evaluated pertinent studies. Study characteristics, safety outcomes of interest, and risk of bias were collected, verified and further analyzed. Canagliflozin was studied as monotherapy in 2 trials (n=270) and as an add-on therapy in 10 studies (n=2525). Ten of the studies were included in the analysis of selected safety outcomes. Length of intervention ranged from 12 to 52 weeks. All studies were randomized, comparative to either placebo or active controls. Canagliflozin treatment, , increased the risk of vulvovaginal mycotic infection (RR 4.11; CI 3.01-5.60; P<0.01), pollakiuria (RR 2.89, CI 1.84- 4.53), polyuria (RR 3.87; CI 1.66-9.05), hypoglycemia (RR 1.22; CI 1.10-1.35) and hypovolemia (RR 2.04; CI 1.13- 3.68). There were no significant dose responses among observed safety outcomes with the exception of genital infections (RR 4.12; CI 2.47-6.87). Additionally, the canagliflozin treatment group experienced a 24% reduction in serious adverse events when compared to controls (RR 0.76; 0.62-0.93; P<0.01). This meta-analysis did not show a dose response effect of canaglifozin on treatment emergent adverse events in type 2 diabetics.
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