Sodium-glucose cotransporter-2 inhibitors and genital and urinary tract infections in type 2 diabetes

References

• Menke A, Rust KF, Fradkin J, et al. Associations between trends in race/ethnicity, aging, and body mass index with diabetes prevalence in the United States: a series of cross-sectional studies. Ann Intern Med. 2014;161:328–335.
   PubMed Web of Science ®Google Scholar
• Kahn SE, Hull RL, Utzschneider KM. Mechanisms linking obesity to insulin resistance and type 2 diabetes. Nature. 2006;444:840–846.
   PubMed Web of Science ®Google Scholar
• DeFronzo R. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58:773–795.
   PubMed Web of Science ®Google Scholar
• Kahn SE, Cooper ME, Del Prato S. Pathophysiology and treatment of type 2 diabetes: perspectives on the past, present, and future. Lancet. 2014;383:1068–1083.
   PubMed Web of Science ®Google Scholar
• Mann DM, Ponieman D, Leventhal H, et al. Predictors of adherence to diabetes medications: the role of disease and medication beliefs. J Behav Med. 2009;32:278–284.
   PubMed Web of Science ®Google Scholar
• American Diabetes Association. 7. Approaches to glycemic treatment. Diabetes Care. 2016;39(Suppl 1):S52–S59.
   Google Scholar
• Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015;38:140–149.
   PubMed Web of Science ®Google Scholar
• Kahn SE, Haffner SM, Heise MA, et al. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006;355:2427–2443.
   PubMed Web of Science ®Google Scholar
• Singh S, Loke YK, Furberg CD. Thiazolidinediones and heart failure: a teleo-analysis. Diabetes Care. 2007;30:2148–2153.
   PubMed Web of Science ®Google Scholar
• Freeman JS. A physiologic and pharmacological basis for implementation of incretin hormones in the treatment of type 2 diabetes mellitus. Mayo Clin Proc. 2010;85:S5–S14.
   PubMedGoogle Scholar
• Drucker DJ, Nauck MA. The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet. 2006;368:1696–1705.
   PubMed Web of Science ®Google Scholar
• Ferrannini E, Solini A. SGLT2 inhibition in diabetes mellitus: rationale and clinical prospects. Nat Rev Endocrinol. 2012;8:495–502.
   PubMed Web of Science ®Google Scholar
• Wilding JP, Charpentier G, Hollander P, et al. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea: a randomised trial. Int J Clin Pract. 2013;67:1267–1282.
   PubMed Web of Science ®Google Scholar
• Wilding JP, Woo V, Soler NG, et al. Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann Intern Med. 2012;156:405–415.
   PubMed Web of Science ®Google Scholar
• Neal B, Perkovic V, de Zeeuw D, et al. Efficacy and safety of canagliflozin, an inhibitor of sodium-glucose cotransporter 2, when used in conjunction with insulin therapy in patients with type 2 diabetes. Diabetes Care. 2015;38:403–411.
   PubMed Web of Science ®Google Scholar
• Strojek K, Yoon KH, Hruba V, et al. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011;13:928–938.
   PubMed Web of Science ®Google Scholar
• Haring HU, Merker L, Seewaldt-Becker E, et al. Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2013;36:3396–3404.
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Jelaska A, Frappin G, et al. Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care. 2014;37:1815–1823.
   PubMed Web of Science ®Google Scholar
• Farxiga® (dapagliflozin). Full prescribing information [package insert]. Princeton, NJ: Bristol-Myers Squibb and AstraZeneca; 2014.
   Google Scholar
• Nyirjesy P, Sobel JD. Genital mycotic infections in patients with diabetes. Postgrad Med. 2013;125:33–46.
   PubMed Web of Science ®Google Scholar
• Nyirjesy P, Zhao Y, Ways K, et al. Evaluation of vulvovaginal symptoms and Candida colonization in women with type 2 diabetes mellitus treated with canagliflozin, a sodium glucose co-transporter 2 inhibitor. Curr Med Res Opin. 2012;28:1173–1178.
   PubMed Web of Science ®Google Scholar
• Johnsson KM, Ptaszynska A, Schmitz B, et al. Vulvovaginitis and balanitis in patients with diabetes treated with dapagliflozin. J Diabetes Complicat. 2013;27:479–484.
   PubMed Web of Science ®Google Scholar
• Grandy S, Fox KM, Hardy E. Prevalence and recurrence of urinary tract and genital infections among adults with and without type 2 diabetes mellitus in the general population: a longitudinal cohort study. J Diabetes Res Clin Metab. 2013;2:5.
   Google Scholar
• Berhan A, Barker A. Sodium glucose co-transport 2 inhibitors in the treatment of type 2 diabetes mellitus: a meta-analysis of randomized double-blind controlled trials. BMC Endocr Disord. 2013;13:58.
   PubMed Web of Science ®Google Scholar
• Geerlings S, Fonseca V, Castro-Diaz D, et al. Genital and urinary tract infections in diabetes: impact of pharmacologically-induced glucosuria. Diabetes Res Clin Pract. 2014;103:373–381.
   PubMed Web of Science ®Google Scholar
• Johnsson KM, Ptaszynska A, Schmitz B, et al. Urinary tract infections in patients with diabetes treated with dapagliflozin. J Diabetes Complications. 2013;27:473–478.
   PubMed Web of Science ®Google Scholar
• Stenlof K, Cefalu WT, Kim KA, et al. Efficacy and safety of canagliflozin monotherapy in subjects with type 2 diabetes mellitus inadequately controlled with diet and exercise. Diabetes Obes Metab. 2013;15:372–382.
   PubMed Web of Science ®Google Scholar
• Lavalle-Gonzalez FJ, Januszewicz A, Davidson J, et al. Efficacy and safety of canagliflozin compared with placebo and sitagliptin in patients with type 2 diabetes on background metformin monotherapy: a randomised trial. Diabetologia. 2013;56:2582–2592.
   PubMed Web of Science ®Google Scholar
• Forst T, Guthrie R, Goldenberg R, et al. Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes on background metformin and pioglitazone. Diabetes Obes Metab. 2014;16:467–477.
   PubMed Web of Science ®Google Scholar
• Ferrannini E, Ramos SJ, Salsali A, et al. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 2010;33:2217–2224.
   PubMed Web of Science ®Google Scholar
• Bailey CJ, Gross JL, Pieters A, et al. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet. 2010;375:2223–2233.
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Vico M, Wei L, et al. Effects of dapagliflozin, an SGLT2 inhibitor, on HbA1c, body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 2012;35:1473–1478.
   PubMed Web of Science ®Google Scholar
• Jabbour SA, Hardy E, Sugg J, et al. Dapagliflozin is effective as add-on therapy to sitagliptin with or without metformin: a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Diabetes Care. 2014;37:740–750.
   PubMed Web of Science ®Google Scholar
• Roden M, Jianping Weng J, Eilbrach J, et al. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2013;1:208–219.
   PubMed Web of Science ®Google Scholar
• Haring HU, Merker L, Seewaldt-Becker E, et al. Empagliflozin as add-on to metformin in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2014;37:1650–1659.
   PubMed Web of Science ®Google Scholar
• Baron EJ, Miller JM, Weinstein MP, et al. A guide to utilization of the microbiology laboratory for diagnosis of infectious diseases: 2013 recommendations by the infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM)(a). Clin Infect Dis. 2013;57:e22–e121.
   PubMed Web of Science ®Google Scholar
• Schmiemann G, Kniehl E, Gebhardt K, et al. The diagnosis of urinary tract infection: a systematic review. Dtsch Arztebl Int. 2010;107:361–367.
   PubMed Web of Science ®Google Scholar
• Dason S, Dason JT, Kapoor A. Guidelines for the diagnosis and management of recurrent urinary tract infection in women. Can Urol Assoc J. 2011;5:316–322.
   PubMed Web of Science ®Google Scholar
• Colgan R, Williams M, Johnson JR. Diagnosis and treatment of acute pyelonephritis in women. Am Fam Physician. 2011;84:519–526.
   PubMed Web of Science ®Google Scholar
• Hirji I, Andersson SW, Guo Z, et al. Incidence of genital infection among patients with type 2 diabetes in the UK General Practice Research Database. J Diabetes Complications. 2012;26:501–505.
   PubMed Web of Science ®Google Scholar
• Goswami R, Dadhwal V, Tejaswi S, et al. Species-specific prevalence of vaginal candidiasis among patients with diabetes mellitus and its relation to their glycaemic status. J Infect. 2000;41:162–166.
   PubMed Web of Science ®Google Scholar
• Schneeberger C, Kazemier BM, Geerlings SE. Asymptomatic bacteriuria and urinary tract infections in special patient groups: women with diabetes mellitus and pregnant women. Curr Opin Infect Dis. 2014;27:108–114.
   PubMed Web of Science ®Google Scholar
• Geerlings SE. Urinary tract infections in patients with diabetes mellitus: epidemiology, pathogenesis and treatment. Int J Antimicrob Agents. 2008;31(suppl 1):S54–S57.
   PubMed Web of Science ®Google Scholar
• Hirji I, Guo Z, Andersson SW, et al. Incidence of urinary tract infection among patients with type 2 diabetes in the UK General Practice Research Database (GPRD). J Diabetes Complicat. 2012;26:513–516.
   PubMed Web of Science ®Google Scholar
• Nicolle LE, Bradley S, Colgan R, et al. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults. Clin Infect Dis. 2005;40:643–654.
   PubMed Web of Science ®Google Scholar
• Gorter KJ, Hak E, Zuithoff NP, et al. Risk of recurrent acute lower urinary tract infections and prescription pattern of antibiotics in women with and without diabetes in primary care. Fam Pract. 2010;27:379–385.
   PubMed Web of Science ®Google Scholar
• Xiu F, Stanojcic M, Diao L, et al. Stress hyperglycemia, insulin treatment, and innate immune cells. Int J Endocrinol. 2014;2014:486403.
   PubMed Web of Science ®Google Scholar
• Renko M, Tapanainen P, Tossavainen P, et al. Meta-analysis of the significance of asymptomatic bacteriuria in diabetes. Diabetes Care. 2011;34:230–235.
   PubMed Web of Science ®Google Scholar
• Boyko EJ, Fihn SD, Scholes D, et al. Risk of urinary tract infection and asymptomatic bacteriuria among diabetic and nondiabetic postmenopausal women. Am J Epidemiol. 2005;161:557–564.
   PubMed Web of Science ®Google Scholar
• Nicolle LE, Friesen D, Harding GK, et al. Hospitalization for acute pyelonephritis in Manitoba, Canada, during the period from 1989 to 1992; impact of diabetes, pregnancy, and aboriginal origin. Clin Infect Dis. 1996;22:1051–1056.
   PubMed Web of Science ®Google Scholar
• Kalra OP, Raizada A. Approach to a patient with urosepsis. J Glob Infect Dis. 2009;1:57–63.
   PubMedGoogle Scholar
• U.S. Food and Drug Administration. SGLT2 Inhibitors: Drug Safety Communication – Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections; [cited 2016 Jan 6]. Available from: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm475553.htm
   Google Scholar
• Nyirjesy P, Sobel JD, Fung A, et al. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014;30:1109–1119.
   PubMed Web of Science ®Google Scholar
• Nicolle LE, Capuano G, Fung A, et al. Urinary tract infection in randomized phase III studies of canagliflozin, a sodium glucose co-transporter 2 inhibitor. Postgrad Med. 2014;126:7–17.
   PubMed Web of Science ®Google Scholar
• Bailey CJ, Morales Villegas EC, Woo V, et al. Efficacy and safety of dapagliflozin monotherapy in people with Type 2 diabetes: a randomized double-blind placebo-controlled 102-week trial. Diabet Med. 2015;32:531–541.
   PubMed Web of Science ®Google Scholar
• Wilding JP, Woo V, Rohwedder K, et al. Dapagliflozin in patients with type 2 diabetes receiving high doses of insulin: efficacy and safety over 2 years. Diabetes Obes Metab. 2014;16:124–136.
   PubMed Web of Science ®Google Scholar
• Bode B, Stenlof K, Harris S, et al. Long-term efficacy and safety of canagliflozin over 104 weeks in patients aged 55-80 years with type 2 diabetes. Diabetes Obes Metab. 2015;17:294–303.
   PubMed Web of Science ®Google Scholar
• Sobel JD, Goldenberg R, Khunti K, et al. Incidence of genital mycotic infections decreases over time in patients with type 2 diabetes mellitus treated with canagliflozin over 2 years [poster 1178-P]. Presented at: American Diabetes Association; 2015 Jun 5–9; Boston, MA.
   Google Scholar
• Santer R, Kinner M, Lassen CL, et al. Molecular analysis of the SGLT2 gene in patients with renal glucosuria. J Am Soc Nephrol. 2003;14:2873–2882.
   PubMed Web of Science ®Google Scholar
• Santer R, Calado J. Familial renal glucosuria and SGLT2: from a mendelian trait to a therapeutic target. Clin J Am Soc Nephrol. 2010;5:133–141.
   PubMed Web of Science ®Google Scholar
• DeFronzo RA, Hompesch M, Kasichayanula S, et al. Characterization of renal glucose reabsorption in response to dapagliflozin in healthy subjects and subjects with type 2 diabetes. Diabetes Care. 2013;36:3169–3176.
   PubMed Web of Science ®Google Scholar
• Yu L, Lv JC, Zhou XJ, et al. Abnormal expression and dysfunction of novel SGLT2 mutations identified in familial renal glucosuria patients. Hum Genet. 2011;129:335–344.
   PubMed Web of Science ®Google Scholar
• Geerlings SE, Hoepelman AI. Immune dysfunction in patients with diabetes mellitus (DM). FEMS Immunol Med Microbiol. 1999;26:259–265.
   PubMed Web of Science ®Google Scholar
• Casqueiro J, Casqueiro J, Alves C. Infections in patients with diabetes mellitus: a review of pathogenesis. Indian J Endocrinol Metab. 2012;16(suppl 1):S27–36.
   PubMedGoogle Scholar
• Winston JA, Miller JL. Treatment of onychomycosis in diabetic patients. Clinical Diabetes. 2006;24:160–166.
   Google Scholar
• DeFronzo RA, Lewin A, Patel S, et al. Combination of empagliflozin and linagliptin as second-line therapy in subjects with type 2 diabetes inadequately controlled on metformin. Diabetes Care. 2015;38:384–393.
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Hansen L, Zee P, et al. Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin. Diabetes Care. 2015;38:376–383.
   PubMed Web of Science ®Google Scholar
• Achkar JM, Fries BC. Candida infections of the genitourinary tract. Clin Microbiol Rev. 2010;23:253–273.
   PubMed Web of Science ®Google Scholar
• Gupta K, Hooton TM, Naber KG, et al. International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women: A 2010 update by the Infectious Diseases Society of America and the European Society for Microbiology and Infectious Diseases. Clin Infect Dis. 2011;52:e103–e120.
   PubMed Web of Science ®Google Scholar
• Schneeberger C, Stolk RP, Devries JH, et al. Differences in the pattern of antibiotic prescription profile and recurrence rate for possible urinary tract infections in women with and without diabetes. Diabetes Care. 2008;31:1380–1385.
   PubMed Web of Science ®Google Scholar
• Hakeem LM, Bhattacharyya DN, Lafong C, et al. Diversity and complexity of urinary tract infection in diabetes mellitus. Br J Diabetes Vasc Dis. 2009;9:119–125.
   Google Scholar
• Invokana® (canagliflozin). Full prescribing information [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2014.
   Google Scholar
• Jardiance® (empagliflozin). Full prescribing information [package insert]. Ingelheim: Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company; 2014.
   Google Scholar
• Bolinder J, Ljunggren O, Johansson L, et al. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014;16:159–169.
   PubMed Web of Science ®Google Scholar
• Del Prato S, Nauck M, Duran-Garcia S, et al. Long-term glycaemic response and tolerability of dapagliflozin versus a sulphonylurea as add-on therapy to metformin in patients with type 2 diabetes: 4-year data. Diabetes Obes Metab. 2015;17:581–590.
   PubMed Web of Science ®Google Scholar
• Leiter LA, Yoon KH, Arias P, et al. Canagliflozin provides durable glycemic improvements and body weight reduction over 104 weeks versus glimepiride in patients with type 2 diabetes on metformin: a randomized, double-blind, phase 3 study. Diabetes Care. 2015;38:355–364.
   PubMed Web of Science ®Google Scholar