Irene Romera , Francisco Javier Ampudia-Blasco , Antonio Pérez , Bernat Ariño , Egon Pfarr , Sanja Giljanovic Kis , Ebrahim Naderali
{"title":"恩帕列嗪联合其他口服降糖药治疗2型糖尿病的疗效和安全性","authors":"Irene Romera , Francisco Javier Ampudia-Blasco , Antonio Pérez , Bernat Ariño , Egon Pfarr , Sanja Giljanovic Kis , Ebrahim Naderali","doi":"10.1016/j.endoen.2016.11.001","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>To analyze the efficacy and safety of empagliflozin combined with other oral hypoglycemic agents in patients with type 2 diabetes mellitus.</p></div><div><h3>Methods</h3><p>Pooled analysis of three phase <span>III</span> trials in patients with type 2 diabetes mellitus (n<!--> <!-->=<!--> <!-->1801) who received placebo or empagliflozin 10 or 25<!--> <!-->mg once daily for 24 weeks, in combination with metformin, metformin<!--> <!-->+<!--> <!-->sulphonylurea or pioglitazone<!--> <!-->±<!--> <!-->metformin.</p></div><div><h3>Results</h3><p>Empagliflozin significantly decreased HbA1c (adjusted mean reduction vs placebo with empagliflozin 10<!--> <!-->mg: −0.58% [95% CI: −0.66; −0.49]; <em>p</em> <!--><<!--> <!-->0.0001, and with empagliflozin 25<!--> <!-->mg: −0.62% [95% CI: −0.70; −0.53], <em>p</em> <!--><<!--> <!-->0.0001), weight (adjusted mean reduction vs placebo with empagliflozin 10<!--> <!-->mg: −1.77<!--> <!-->kg [95% CI: −2.05; −1.48]; <em>p</em> <!--><<!--> <!-->0.0001, and with empagliflozin 25<!--> <!-->mg: −1.96<!--> <!-->kg [95% CI: −2.24; −1.67], <em>p</em> <!--><<!--> <!-->0.0001), and systolic and diastolic blood pressure (SBP/DBP). Adverse effect rates were 64% with placebo, 63.9% with empagliflozin 10<!--> <!-->mg, and 60.9% with empagliflozin 25<!--> <!-->mg. Documented episodes of hypoglycemia (≤70<!--> <!-->mg/dL and/or requiring care) occurred in 3.9% of patients with placebo, 6.9% of patients with empagliflozin 10<!--> <!-->mg, and 5.3% of patients with empagliflozin 25<!--> <!-->mg. Urinary tract infections developed in 9.4% of patients with placebo, 10.2% of patients with empagliflozin 10<!--> <!-->mg, and 8.3% of patients with empagliflozin 25<!--> <!-->mg. Genital infections were reported in 1.0% of patients with placebo, 4.6% of patients with empagliflozin 10<!--> <!-->mg, and 3.5% of patients with empagliflozin 25<!--> <!-->mg.</p></div><div><h3>Conclusions</h3><p>Empagliflozin combined with other oral treatments decreased HbA1c, body weight, and SBP/DBP as compared to placebo, with a good safety and tolerability profile.</p></div>","PeriodicalId":48670,"journal":{"name":"Endocrinologia Y Nutricion","volume":"63 10","pages":"Pages 519-526"},"PeriodicalIF":0.0000,"publicationDate":"2016-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.endoen.2016.11.001","citationCount":"3","resultStr":"{\"title\":\"Efficacy and safety of empagliflozin in combination with other oral hypoglycemic agents in patients with type 2 diabetes mellitus\",\"authors\":\"Irene Romera , Francisco Javier Ampudia-Blasco , Antonio Pérez , Bernat Ariño , Egon Pfarr , Sanja Giljanovic Kis , Ebrahim Naderali\",\"doi\":\"10.1016/j.endoen.2016.11.001\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>To analyze the efficacy and safety of empagliflozin combined with other oral hypoglycemic agents in patients with type 2 diabetes mellitus.</p></div><div><h3>Methods</h3><p>Pooled analysis of three phase <span>III</span> trials in patients with type 2 diabetes mellitus (n<!--> <!-->=<!--> <!-->1801) who received placebo or empagliflozin 10 or 25<!--> <!-->mg once daily for 24 weeks, in combination with metformin, metformin<!--> <!-->+<!--> <!-->sulphonylurea or pioglitazone<!--> <!-->±<!--> <!-->metformin.</p></div><div><h3>Results</h3><p>Empagliflozin significantly decreased HbA1c (adjusted mean reduction vs placebo with empagliflozin 10<!--> <!-->mg: −0.58% [95% CI: −0.66; −0.49]; <em>p</em> <!--><<!--> <!-->0.0001, and with empagliflozin 25<!--> <!-->mg: −0.62% [95% CI: −0.70; −0.53], <em>p</em> <!--><<!--> <!-->0.0001), weight (adjusted mean reduction vs placebo with empagliflozin 10<!--> <!-->mg: −1.77<!--> <!-->kg [95% CI: −2.05; −1.48]; <em>p</em> <!--><<!--> <!-->0.0001, and with empagliflozin 25<!--> <!-->mg: −1.96<!--> <!-->kg [95% CI: −2.24; −1.67], <em>p</em> <!--><<!--> <!-->0.0001), and systolic and diastolic blood pressure (SBP/DBP). Adverse effect rates were 64% with placebo, 63.9% with empagliflozin 10<!--> <!-->mg, and 60.9% with empagliflozin 25<!--> <!-->mg. Documented episodes of hypoglycemia (≤70<!--> <!-->mg/dL and/or requiring care) occurred in 3.9% of patients with placebo, 6.9% of patients with empagliflozin 10<!--> <!-->mg, and 5.3% of patients with empagliflozin 25<!--> <!-->mg. Urinary tract infections developed in 9.4% of patients with placebo, 10.2% of patients with empagliflozin 10<!--> <!-->mg, and 8.3% of patients with empagliflozin 25<!--> <!-->mg. Genital infections were reported in 1.0% of patients with placebo, 4.6% of patients with empagliflozin 10<!--> <!-->mg, and 3.5% of patients with empagliflozin 25<!--> <!-->mg.</p></div><div><h3>Conclusions</h3><p>Empagliflozin combined with other oral treatments decreased HbA1c, body weight, and SBP/DBP as compared to placebo, with a good safety and tolerability profile.</p></div>\",\"PeriodicalId\":48670,\"journal\":{\"name\":\"Endocrinologia Y Nutricion\",\"volume\":\"63 10\",\"pages\":\"Pages 519-526\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2016-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1016/j.endoen.2016.11.001\",\"citationCount\":\"3\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Endocrinologia Y Nutricion\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2173509316301167\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Endocrinologia Y Nutricion","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2173509316301167","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Efficacy and safety of empagliflozin in combination with other oral hypoglycemic agents in patients with type 2 diabetes mellitus
Introduction
To analyze the efficacy and safety of empagliflozin combined with other oral hypoglycemic agents in patients with type 2 diabetes mellitus.
Methods
Pooled analysis of three phase III trials in patients with type 2 diabetes mellitus (n = 1801) who received placebo or empagliflozin 10 or 25 mg once daily for 24 weeks, in combination with metformin, metformin + sulphonylurea or pioglitazone ± metformin.
Results
Empagliflozin significantly decreased HbA1c (adjusted mean reduction vs placebo with empagliflozin 10 mg: −0.58% [95% CI: −0.66; −0.49]; p < 0.0001, and with empagliflozin 25 mg: −0.62% [95% CI: −0.70; −0.53], p < 0.0001), weight (adjusted mean reduction vs placebo with empagliflozin 10 mg: −1.77 kg [95% CI: −2.05; −1.48]; p < 0.0001, and with empagliflozin 25 mg: −1.96 kg [95% CI: −2.24; −1.67], p < 0.0001), and systolic and diastolic blood pressure (SBP/DBP). Adverse effect rates were 64% with placebo, 63.9% with empagliflozin 10 mg, and 60.9% with empagliflozin 25 mg. Documented episodes of hypoglycemia (≤70 mg/dL and/or requiring care) occurred in 3.9% of patients with placebo, 6.9% of patients with empagliflozin 10 mg, and 5.3% of patients with empagliflozin 25 mg. Urinary tract infections developed in 9.4% of patients with placebo, 10.2% of patients with empagliflozin 10 mg, and 8.3% of patients with empagliflozin 25 mg. Genital infections were reported in 1.0% of patients with placebo, 4.6% of patients with empagliflozin 10 mg, and 3.5% of patients with empagliflozin 25 mg.
Conclusions
Empagliflozin combined with other oral treatments decreased HbA1c, body weight, and SBP/DBP as compared to placebo, with a good safety and tolerability profile.