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Ipragliflozin: A novel sodium-glucose cotransporter 2 inhibitor developed in Japan

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World Journal of Diabetes 2015年第1期6卷 136-144页

作者： Tsuyoshi Ohkura Division of Cardiovascular Medicine Endocrinology and Metabolism Department of Molecular Medicine and Therapeutics Tottori University Faculty of Medicine

sodium-glucose cotransporter 2(SGLT2) inhibition induces glucosuria and decreases blood glucose levels in diabetic patients and lowers hypoglycemic risk. SGLT1 is expressed in the kidney and intestine; SGLT1 inhibition causes abdominal symptoms such as diarrhea and reduces incretin secretion. Therefore, SGLT2 selectivity is important. Ipragliflozin is highly selective for SGLT2. In type 2 diabetes mellitus(T2DM), urinaryglucose excretion increased to 90 g/24 h after 28 d of treatment with ipragliflozin 300 mg/d. Twelve weeks of ipragliflozin 50 mg/d vs placebo reduced glycated hemoglobin and body weight by 0.65% and 0.66 kg, respectively, in Western T2 DM patients, and by 1.3% and 1.89 kg, respectively, in Japanese patients. Ipragliflozin(highly selective SGLT2 inhibitor) improves glycemic control and reduces body weight and lowers hypoglycemic risk and abdominal symptoms. Ipragliflozin can be a novel anti-diabetic and antiobesity agent.

关键词： sodium-glucose cotransporter 2 inhibitor Type 2 diabetes mellitus Ipragliflozin Japan

Mechanism Underlying Increase of the Serum Magnesium Concentration Observed Following Treatment with sodium-glucose Cotransporter 2 Inhibitors

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Journal of Diabetes Mellitus 2017年第4期7卷 241-248页

作者： Yasuhiro Sasaki Keiko Koyano Shuhei Iida Tatsuo Yanagawa Department of Medicine Nerima General Hospital Tokyo Japan Public Interest Incorporated Foundation Tokyo Healthcare Foundation Institute for Healthcare Quality Improvement Tokyo Japan

Aim: The EMPA-REG OUTCOME study reported that the sodium-glucose cotransporter 2 inhibitor (SGLT2-i) suppressed cardiovascular (CV) events in patients with type 2 diabetes;we recently suggested that increase of the serum magnesium (Mg) by SGLT2-i’s can, in part, explain this reduction. The objective of this study was to elucidate the mechanism underlying the elevation of the serum Mg level induced by treatment with SGLT2-i’s. Methods: We analyzed the data of 37 patients with type 2 diabetes who underwent clinical evaluation and laboratory assessment at baseline and the end of 3 months. To investigate the relationship between the changes in the serum Mg concentrations during 3 months’ treatment (ΔMg) and other variables, we carried out simple linear regression analysis and multiple linear regression analysis. Results: Three months’ treatment with the SGLT2-i resulted in a significant improvement of the body weight (BW), BMI, hemoglobin A1c (HbA1c), and fasting plasma glucose levels. The serum Mg increased significantly. Simple linear regression analysis revealed an association between the ΔMg and the serum triglyceride, serum Mg at baseline, change of the BW (ΔBW), and change of the HbA1c. Multiple linear regression analysis revealed a significant association between the ΔMg and the serum Mg level at the baseline (r = -0.55, P Conclusion: Our study revealed that a lower serum Mg level at the baseline and BW reduction were significantly associated with an increase in the serum Mg following 3 months’ treatment with SGLT2-i’s.

关键词： Diabetes Magnesium Cardiovascular Events sodium-glucose Cotransporter 2 Inhibitors The EMPA-REG OUTCOME Study

Effects of glucose-lowering agents on cardiorespiratory fitness

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World Journal of Diabetes 2018年第12期9卷 230-238页

作者： Hidetaka Hamasaki Endocrinology and Metabolism Internal Medicine Hamasaki Clinic

Exercise therapy is essential for the management of type 2 diabetes(T2 D). However, patients with T2 D show lower physical activity and reduced cardiorespiratory fitness than healthy individuals. It would be ideal for clinicians to co-prescribe glucose-lowering agents that improve cardiorespiratory fitness or exercise capacity in conjunction with exercise therapy. Metformin does not improve cardiorespiratory fitness and may attenuate any beneficial effect of exercise in patients with T2 D. In contrast, thiazolidinediones appear to improve cardiorespiratory fitness in patients with T2 D. Although evidence is limited, sodium–glucose cotransporter 2(SGLT2) inhibitors may improve cardiorespiratory fitness in patients with heart failure, and the effect of glucagon-like peptide-1(GLP-1) receptor agonists on cardiorespiratory fitness is controversial. Recent clinical trials have shown that both SGLT2 inhibitors and GLP-1 receptor agonists exert a favorable effect on cardiovascular disease. It becomes more important to choose drugs that have beneficial effects on the cardiovascular system beyond glucose-lowering effects. Further studies are warranted to determine an ideal glucose-lowering agent combined with exercise therapy for the treatment of T2 D.

关键词： Type 2 diabetes Glucagon-like peptide l receptor agonist Cardiorespiratory fitness Exercise capacity Metformin Thiazolidinedione sodium-glucose cotransporter 2 inhibitors

Novel pharmacological therapy in type 2 diabetes mellitus with established cardiovascular disease: Current evidence

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World Journal of Diabetes 2019年第5期10卷 291-303页

作者： Leonardo Pozo Fatimah Bello Andres Suarez Francisco E Ochoa-Martinez Yamely Mendez Chelsea H Chang Salim Surani University of Texas Rio Grande Valley-Doctors Hospital at Renaissance Internal Medicine Residency Program Faculty of Medicine Universidad Autonoma de Nuevo LeonUniversity Hospital "Dr. José Eleuterio González" Faculty of Medicine "Dr. Alberto Romo Caballero" Universidad Autonoma de Tamaulipas Medical Critical Care Services Christus Spohn Hospitals-Corpus Christi

Cardiovascular diseases(CVDs) remain the leading cause of death in the world and in most developed countries. Patients with type 2 diabetes mellitus(T2DM)suffer from both microvascular and macrovascular diseases and therefore have higher rates of morbidity and mortality compared to those without T2DM. If current trends continue, the Center for Disease Control and Prevention estimates that 1 in 3 Americans will have T2DM by year 2050. As a consequence of the controversy surrounding rosiglitazone and the increasing prevalence of diabetes and CVDs, in 2008 the Food and Drug Administration(FDA) established new expectations for the evaluation of new antidiabetic agents, advising for pre and,in some cases, post-marketing data on major cardiovascular events. As a direct consequence, there has been a paradigm shift in new antidiabetic agents that has given birth to the recently published American Diabetes Association/European Association for the Study of Diabetes consensus statement recommending sodium-glucose cotransporter-2 inhibitors(SGLT2i) and glucagon like peptide-1 receptor agonists(GLP-1RA) in patients with T2DM and established CVD. As a result of over a decade of randomized placebo controlled cardiovascular outcome trials, the aforementioned drugs have received FDA approval for risk reduction of cardiovascular(CV) events in patients with T2DM and established CV ***2i have been shown to have a stronger benefit in patients with congestiveheart failure and diabetic kidney disease when compared to their GLP-1RA counterparts. These benefits are not withstanding additional considerations such as cost and the multiple FDA Black Box warnings. This topic is currently an emerging research area and this mini-review paper examines the role of these two novel classes of drugs in patients with T2DM with both confirmed, and at risk for, CVD.

关键词： Type 2 diabetes mellitus Glucagon-like-peptide 1 agonists sodium-glucose cotransporter-2 inhibitor Cardiovascular disease Major adverse cardiovascular event

Using real world data to assess cardiovascular outcomes of two antidiabetic treatment classes

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World Journal of Diabetes 2018年第12期9卷 252-257页

作者： Manfred Paul Stapff CMO TriNetX Inc.

AIM To evaluate the effect on cardiovascular outcomes of sodium-glucose co-transporter-2(SGLT2) inhibitors in a real world setting by analyzing electronic medical *** We used Tri Net X, a global federated research network providing statistics on electronic health records(EHR). The analytics subset contained EHR from approximately 38 Million patients in 35 Health Care Organizations in the United States. The records of 46,909 patients who had taken SGLT2 inhibitors were compared to 189,120 patients with dipeptidyl peptidase(DPP) 4 inhibitors. We identified five potential confounding factors and built respective strata: elderly, hypertension, chronic kidney disease(CKD), and co-medication with either insulin or metformin. Cardiovascular events were countedas stroke(ICD10 code: I63) or myocardial infarction(ICD10: I21) occurring within three years after the first instance of the respective medication in the patients' *** Of the 46909 patients with SGLT2 inhibitors in their EHR, 1667 patients(3.6%) had an ICD code for stroke or for myocardial infarction within the first three years after the first instance of the medication. In the control group, there were 10680 events of 189120 patients(5.6%), which represents a risk ratio of 0.63(95%CI: 0.60-0.66). The overall incidence of stroke or myocardial infarction in the strata with a potential confounding risk factor reached from 4.9% in patients taking metformin to 12.5% in the stratum with the highest risk(concomitant CKD). In all strata, the difference in risk of experiencing a cardiovascular event was similarly in favor of SGLT2 vs control, with Risk Ratio ranging from 0.62 to *** Real world data replicated the results from randomized clinical trials, confirmed the cardiovascular advantages of SGLT2 inhibitors, and showed its applicability to the US population.

关键词： sodium-glucose co-transporter-2 inhibitors Cardiovascular events Clinical trials Electronic medical records Dipeptidyl peptidase 4 inhibitors Real world evidence Diabetes

Prevention of macrovascular complications in patients with type 2 diabetes mellitus: Review of cardiovascular safety and efficacy of newer diabetes medications

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World Journal of Diabetes 2019年第6期10卷 324-332页

作者： Ravi Kant Kashif M Munir Arshpreet Kaur Vipin Verma Division of Endocrinology Diabetes and Nutrition Medical University of South Carolina/Anmed Campus Anderson SC 29621 United States Division of Endocrinology Diabetes and Nutrition University of Maryland School of Medicine Baltimore MD 21201 United States Division of Endocrinology Diabetes and Nutrition Sinai Hospital Baltimore MD 21215 United States Department of Medicine Medical University of South Carolina/Anmed Campus Anderson SC 29621 United States

Lack of conclusive beneficial effects of strict glycemic control on macrovascular complications has been very frustrating for clinicians involved in care of patients with diabetes mellitus (DM). Highly publicized controversy surrounding cardiovascular (CV) safety of rosiglitazone resulted in major changes in United States Food and Drug Administration policy in 2008 regarding approval process of new antidiabetic medications, which has resulted in revolutionary data from several large CV outcome trials over the last few years. All drugs in glucagon-like peptide-1 receptor agonist (GLP-1 RA) and sodium-glucose cotransporter-2 (SGLT-2) inhibitor classes have shown to be CV safe with heterogeneous results on CV efficacy. Given twofold higher CV disease mortality in patients with DM than without DM, GLP-1 RAs and SGLT-2-inhibitors are important additions to clinician’s armamentarium and should be second line-therapy particularly in patients with T2DM and established atherosclerotic CV disease or high risks for CV disease. Abundance of data and heterogeneity in CV outcome trials results can make it difficult for clinicians, particularly primary care physicians, to stay updated with all the recent evidence. The scope of this comprehensive review will focus on all major CV outcome studies evaluating CV safety and efficacy of GLP-1 RAs and SGLT-2 inhibitors.

关键词： Newer antidiabetic medications Glucagon-like peptide-1 receptor agonist sodium-glucose cotransporter-2 inhibitors Type 2 diabetes mellitus Macrovascular complications Cardiovascular outcome trials Major cardiovascular events Heart failure Prevention of heart disease

Efficacy and Safety of SGLT2 Inhibitors in Patients with Type 1 Diabetes:A Meta-analysis of Randomized Controlled Trials

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Chinese Medical Sciences Journal 2017年第1期32卷 22-27页

作者： Yingying Yang Hui Pan Bo Wang Shi Chen Huijuan Zhu Department of Endocrinology Key Laboratory of Endocrinology of Ministry of HealthPeking Union Medical College HospitalChinese Academy of Medical Sciences & Peking Union Medical College Health Science Popularization Research Center Chinese Academy of Medical Sciences & Peking Union Medical College

Objective To assess the efficiency and safety of a novel sodium-glucose co-transporter 2(SGLT2) inhibitor—SGLT2 inhibitors,in combination with insulin for type 1 diabetes mellitus(T1DM). Methods We searched Medline,Embase,and the Cochrane Collaboration Library to identify the eligible studies published between January 2010 and July 2016 without restriction of language. The Food and Drug Administration(FDA) data and Clinical Trials(http://***) were also searched. The included studies met the following criteria:randomized controlled trials; T1DM patients aged between 18 and 65 years old; patients were treated with insulin plus SGLT2 inhibitors for more than 2 weeks; patients' glycosylated hemoglobin(HbA1c) levels were between 7% and 12%. The SGLT2 inhibitors group was treated with SGLT2 inhibitors plus insulin,and the placebo group received placebo plus insulin treatment. The outcomes should include one of the following items:fasting blood glucose,HbA1c,glycosuria,or adverse effects. Data were analyzed by two physicians independently. The risk of bias was evaluated by using the Cochrane Collaboration's Risk of Bias tool and heterogeneity among studies was assessed using Chi-square test. Random effect model was used to analyze the treatment effects with Revman 5.3. Results Three trials including 178 patients were enrolled. As compared to the placebo group,SGLT2 inhibitor absolutely decreased fasting blood glucose [mean differences(MD)-2.47 mmol/L,95% confidence interval(CI)-3.65 to-1.28,Pglucose(MD 131.09 g/24 h,95%CI 91.79 to 170.39,P<0.001). There were no significant differences in the incidences of hyperglycemia [odds ratio(OR) 1.82,95%CI 0.63 to 5.29,P=0.27],urinary tract infection(OR 0.95,95%CI 0.19 to 4.85,P=0.95),genital tract infection(OR 0.27,95%CI 0.01 to 7.19,P=0.43),and diabetic ketoacidosis(OR 6.03,95

关键词： sodium-glucose co-transporter 2 type 1 diabetes mellitus meta analysis fasting blood glucose urine glucose insulin dose adverse reaction

SGLT-2 inhibitors in non-alcoholic fatty liver disease patients with type 2 diabetes mellitus: A systematic review

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World Journal of Diabetes 2019年第2期10卷 114-132页

作者： Henith Raj Harsh Durgia Rajan Palui Sadishkumar Kamalanathan Sandhiya Selvarajan Sitanshu Sekhar Kar Jayaprakash Sahoo Department of Endocrinology Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry 605006 India Department of Clinical Pharmacology Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry 605006 India Department of Preventive and Social Medicine Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry 605006 India

BACKGROUND Non-alcoholic fatty liver disease(NAFLD)is a common comorbidity with type 2 *** existing therapeutic options for NAFLD are not *** diet and exercise is the cornerstone of therapy in *** is the only drug recommended in diabetes patients with biopsy proven non-alcoholic *** frequent coexistence of NAFLD and type 2 diabetes with their combined adverse health consequences and inadequate therapeutic options makes it necessary to search for newer *** To assess the effect of sodium glucose cotransporter-2(SGLT-2)inhibitors on liver enzymes in type 2 diabetes patients with *** We searched PubMed/MEDLINE,Cochrane library,Google scholar,and *** for the relevant articles to be included in this systematic *** studies done in type 2 diabetes patients with NAFLD treated with SGLT-2 inhibitors for at least 12 wk were *** from eight studies(four randomised controlled trials and four observational studies)were extracted and a narrative synthesis was done.A total of 214 patients were treated with SGLT-2 inhibitors in these studies(94 in randomised controlled trials and 120 in observational studies).RESULTS The primary outcome measure was change in serum alanine aminotransferase *** of eight studies,seven studies showed a significant decrease in serum alanine aminotransferase *** of the studies revealed reduction in serum level of other liver enzymes like aspartate aminotransferase and gamma glutamyl *** studies that reported a change in hepatic fat exhibited a significant reduction in hepatic fat content in those treated with SGLT-2 ***,among the three studies that evaluated a change in indices of hepatic fibrosis,two studies revealed a significant improvement in liver ***,there was an improvement in obesity,insulin resistance,glycaemia,and lipid parameters in those subjects taking SGLT-2 *** st

关键词： Alanine aminotransferase Hepatic fat Hepatic fibrosis Non-alcoholic fatty liver disease sodium-glucose cotransporter-2 inhibitor Type 2 diabetes mellitus

Berberine enhances antidiabetic effects and attenuates untoward effects of canagliflozin in streptozotocin-induced diabetic mice

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Chinese Journal of Natural Medicines 2016年第7期14卷 518-526页

作者： TIAN Cai-Ming JIANG Xin OUYANG Xiao-Xi ZHANG Ya-Ou XIE Wei-Dong Department of chemistry Tsinghua University Shenzhen Key Lab of Health Science and Technology Division of Life Science & Health Graduate School at ShenzhenTsinghua University School of Life Sciences Tsinghua University

The present study aimed at determining whether berberine can enhance the antidiabetic effects and alleviate the adverse effects of canagliflozin in diabetes mellitus. Streptozotocin-induced diabetic mice were introduced, and the combined effects of berberine and canagliflozin on glucose metabolism and kidney functions were investigated. Our results showed that berberine combined with canagliflozin(BC) increased reduction of fasting and postprandial blood glucose, diet, and water intake compared with berberine or canagliflozin alone. Interestingly, BC showed greater decrease in blood urea nitrogen and creatinine levels and lower total urine glucose excretion than canagliflozin alone. In addition, BC showed increased phosphorylated 5' AMP-activated protein kinase(p AMPK) expression and decreased tumor necrosis factor alpha(TNFα) levels in kidneys, compared with berberine or canagliflozin alone. These results indicated that BC was a stronger antidiabetic than berberine or canagliflozin alone with less negative side effects on the kidneys in the diabetic mice. The antidiabetic effect was likely to be mediated by synergically promoting the expression of p AMPK and reducing the expression of TNFα in kidneys. The present study represented the first report that canagliflozin combined with berberine was a promising treatment for diabetes mellitus. The exact underlying mechanisms of action should be investigated in future studies.

关键词： Canagliflozin Berberine Diabetes mellitus AMP-activated protein kinase sodium-glucose cotransporter-2