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Clinical Focus: Diabetes - Original Research

Dapagliflozin in the treatment of patients with type 2 diabetes presenting with high baseline A1C

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Pages 356-363 | Received 24 Feb 2016, Accepted 30 Mar 2016, Published online: 18 Apr 2016

References

  • Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405–412.
  • Fox CS, Coady S, Sorlie PD, et al. Increasing cardiovascular disease burden due to diabetes mellitus: the Framingham heart study. Circulation. 2007;115:1544–1550.
  • Gerstein HC, Swedberg K, Carlsson J, et al. The hemoglobin A1c level as a progressive risk factor for cardiovascular death, hospitalization for heart failure, or death in patients with chronic heart failure: an analysis of the Candesartan in Heart failure: assessment of reduction in mortality and morbidity (CHARM) program. Arch Intern Med. 2008;168:1699–1704.
  • Selvin E, Marinopoulos S, Berkenblit G, et al. Meta-analysis: glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Ann Intern Med. 2004;141:421–431.
  • UKPDS 33. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK prospective diabetes study (UKPDS) group. Lancet. 1998;352:837–853.
  • Laakso M. Cardiovascular disease in type 2 diabetes from population to man to mechanisms: the Kelly West Award Lecture 2008. Diabetes Care. 2010;33:442–449.
  • Ali MK, Bullard KM, Gregg EW. Achievement of goals in U.S. Diabetes Care, 1999-2010. N Engl J Med. 2013;369:287–288.
  • Centers for Disease Control and Prevention. A1c Distribution Among Adults with Diagnosed Diabetes, United States, 1988–1994 to 1999–2006. [cited 2015 Sep 9] Available from: http://www.cdc.gov/diabetes/statistics/a1c/a1c_dist.htm
  • National Quality Forum. Comprehensive diabetes care: hemoglobin A1c (HbA1c) Poor Control (>9.0%). [cited 2015 Oct 15]. Available from: http://www.qualityforum.org/QPS/QPSTool.aspx?Exact=False&Keyword=A1C
  • Samuels TA, Cohen D, Brancati FL, et al. Delayed diagnosis of incident type 2 diabetes mellitus in the ARIC study. Am J Manag Care. 2006;12:717–724.
  • Porta M, Curletto G, Cipullo D, et al. Estimating the delay between onset and diagnosis of type 2 diabetes from the time course of retinopathy prevalence. Diabetes Care. 2014;37:1668–1674.
  • Centers for Disease Control and Prevention. National diabetes statistics report: estimates of diabetes and its burden in the United States, 2014. [cited 2015 Oct 26]. Available from: http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf
  • Sherifali D, Nerenberg K, Pullenayegum E, et al. The effect of oral antidiabetic agents on A1C levels: a systematic review and meta-analysis. Diabetes Care. 2010;33:1859–1864.
  • 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.
  • 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.
  • Fonseca VA. Defining and characterizing the progression of type 2 diabetes. Diabetes Care. 2009;32(Suppl 2):S151–156.
  • Wallace TM, Matthews DR. Coefficient of failure: a methodology for examining longitudinal beta-cell function in Type 2 diabetes. Diabet Med. 2002;19:465–469.
  • Freeman JS. Review of insulin-dependent and insulin-independent agents for treating patients with type 2 diabetes mellitus and potential role for sodium-glucose co-transporter 2 inhibitors. Postgrad Med. 2013;125:214–226.
  • Kaku K, Kiyosue A, Inoue S, et al. Efficacy and safety of dapagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled by diet and exercise. Diabetes Obes Metab. 2014;16:1102–1110.
  • Ji L, Ma J, Li H, et al. Dapagliflozin as monotherapy in drug-naive Asian patients with type 2 diabetes mellitus: a randomized, blinded, prospective phase III study. Clin Ther. 2014;36(84–100):e9.
  • Bailey CJ, Iqbal N, T’Joen C, et al. Dapagliflozin monotherapy in drug-naive patients with diabetes: a randomized-controlled trial of low-dose range. Diabetes Obes Metab. 2012;14:951–959.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Henry RR, Murray AV, Marmolejo MH, et al. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract. 2012;66:446–456.
  • Nauck M, Del Prato S, Rohwedder K, et al. Long-term efficacy and safety of add-on dapagliflozin vs add-on glipizide in patients with T2DM inadequately controlled with metformin:2-year results [abstract]. Diabetes. 2011;60:0040–LB.
  • 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.
  • Bailey CJ, Gross JL, Hennicken D, et al. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial. BMC Med. 2013;11:43.
  • 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.
  • Cefalu WT, Leiter LA, De Bruin TW, et al. Dapagliflozin’s effects on glycemia and cardiovascular risk factors in high-risk patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled study with a 28-week extension. Diabetes Care. 2015;38:1218–1227.
  • 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.
  • Leiter LA, Cefalu WT, De Bruin TW, et al. Dapagliflozin added to usual care in individuals with type 2 diabetes mellitus with preexisting cardiovascular disease: a 24-week, multicenter, randomized, double-blind, placebo-controlled study with a 28-week extension. J Am Geriatr Soc. 2014;62:1252–1262.
  • Zhang M, Tsiatis AA, Davidian M. Improving efficiency of inferences in randomized clinical trials using auxiliary covariates. Biometrics. 2008;64:707–715.
  • Tsiatis AA, Davidian M, Zhang M, et al. Covariate adjustment for two-sample treatment comparisons in randomized clinical trials: a principled yet flexible approach. Stat Med. 2008;27:4658–4677.
  • Spann SJ, Nutting PA, Galliher JM, et al. Management of type 2 diabetes in the primary care setting: a practice-based research network study. Ann Fam Med. 2006;4:23–31.
  • Bays H. Sodium glucose co-transporter type 2 (SGLT2) inhibitors: targeting the kidney to improve glycemic control in diabetes mellitus. Diabetes Ther. 2013;4:195–220.
  • 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.
  • 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.
  • American Diabetes Association. 5. Glycemic targets. Diabetes Care. 2016;39(Suppl 1):S39–46.
  • Parati G, Bilo G, Ochoa JE. Benefits of tight blood pressure control in diabetic patients with hypertension: importance of early and sustained implementation of effective treatment strategies. Diabetes Care. 2011;34(Suppl 2):S297–303.
  • Adler AI, Stratton IM, Neil HA, et al. Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): prospective observational study. BMJ. 2000;321:412–419.
  • Wilding JP. The importance of weight management in type 2 diabetes mellitus. Int J Clin Pract. 2014;68:682–691.
  • Holman RR, Paul SK, Bethel MA, et al. Long-term follow-up after tight control of blood pressure in type 2 diabetes. N Engl J Med. 2008;359:1565–1576.
  • Lambers Heerspink HJ, De Zeeuw D, Wie L, et al. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab. 2013;15:853–862.
  • Nyirjesy P, Sobel JD. Genital mycotic infections in patients with diabetes. Postgrad Med. 2013;125:33–46.
  • Achkar JM, Fries BC. Candida infections of the genitourinary tract. Clin Microbiol Rev. 2010;23:253–273.
  • Whaley JM, Tirmenstein M, Reilly TP, et al. Targeting the kidney and glucose excretion with dapagliflozin: preclinical and clinical evidence for SGLT2 inhibition as a new option for treatment of type 2 diabetes mellitus. Diabetes Metab Syndr Obes. 2012;5:135–148.
  • 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
  • FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood. [cited 2016 Jan 6]. Available from: http://www.fda.gov/Drugs/DrugSafety/ucm446845.htm
  • AACE/ACE scientific and clinical review: association of SGLT2 inhibitors and DKA. October 24–25, 2015; Grand Hyatt Dallas Fort Worth Airport.
  • American Diabetes Association. 7. Approaches to glycemic treatment. Diabetes Care. 2016;39(Suppl 1):S52–9.

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