Dapagliflozin therapy for type 2 diabetes in primary care: Changes in HbA1c, weight and blood pressure over 2 years follow-up

Primary Care Diabetes

Volumn 11, Issue 5, 2017, Pages 437-444

  Wilding, J ^a   Bailey, C ^b   Rigney, U ^c   Blak, B ^c   Kok, M ^c   Emmas, C ^c  

^a UNIVERSITY HOSPITAL AINTREE   (United Kingdom)

^b ASTON UNIVERSITY   (United Kingdom)

^c ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

2,4 THIAZOLIDINEDIONE DERIVATIVE; DAPAGLIFLOZIN; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; GLUCOSE; HEMOGLOBIN A1C; INSULIN; METFORMIN; SULFONYLUREA; 2-(3-(4-ETHOXYBENZYL)-4-CHLOROPHENYL)-6-HYDROXYMETHYLTETRAHYDRO-2H-PYRAN-3,4,5-TRIOL; ANTIDIABETIC AGENT; BENZHYDRYL DERIVATIVE; BIOLOGICAL MARKER; GLUCOSIDE; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN;

ADULT; AGED; ARTICLE; BODY WEIGHT; CLINICAL PRACTICE; COHORT ANALYSIS; FEMALE; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; NON INSULIN DEPENDENT DIABETES MELLITUS; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; RESEARCH; SYSTOLIC BLOOD PRESSURE; UNITED KINGDOM; WEIGHT REDUCTION; BLOOD; BLOOD PRESSURE; BODY WEIGHT LOSS; DRUG EFFECT; FACTUAL DATABASE; GLUCOSE BLOOD LEVEL; METABOLISM; MULTIVARIATE ANALYSIS; ODDS RATIO; PATHOPHYSIOLOGY; PRESCRIPTION; PRIMARY HEALTH CARE; STATISTICAL MODEL; TIME FACTOR; TREATMENT OUTCOME; TRENDS;

AGED; BENZHYDRYL COMPOUNDS; BIOMARKERS; BLOOD GLUCOSE; BLOOD PRESSURE; DATABASES, FACTUAL; DIABETES MELLITUS, TYPE 2; DRUG PRESCRIPTIONS; FEMALE; FOLLOW-UP STUDIES; GLUCOSIDES; GLYCATED HEMOGLOBIN A; HUMANS; HYPOGLYCEMIC AGENTS; LOGISTIC MODELS; MALE; MIDDLE AGED; MULTIVARIATE ANALYSIS; ODDS RATIO; PRACTICE PATTERNS, PHYSICIANS'; PRIMARY HEALTH CARE; TIME FACTORS; TREATMENT OUTCOME; UNITED KINGDOM; WEIGHT LOSS;

EID: 85020106750     PISSN: 17519918     EISSN: 18780210     Source Type: Journal    
DOI: 10.1016/j.pcd.2017.04.004     Document Type: Article

References (40)

1. UKPDS, Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 352 (1998), 837–853.
2. US Department of Health and Human Services, Guidance for Industry: Diabetes Mellitus- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes. 2008 Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071627.pdf. [Accessed 20 September 2016].
3. European Medicines Agency, Guideline on Clinical Investigation of Medicinal Products in the Treatment or Prevention of Diabtes Mellitus. 2012 Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129256.pdf. Accessed 20 September 2016.
4. Zinman, B., Wanner, C., Lachin, J.M., Fitchett, D., Bluhmki, E., Hantel, S., Mattheus, M., Devins, T., Johansen, O.E., Woerle, H.J., Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N. Engl. J. Med. 373 (2015), 2117–2128.
5. Gilbert, R.E., Sodium–glucose linked transporter-2 inhibitors: potential for renoprotection beyond blood glucose lowering?. Kidney Int. 86 (2014), 693–700.
6. Bailey, C.J., Gross, J.L., Pieters, A., Bastien, A., List, J.F., Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: a randomised, double-blind, placebo-controlled trial. Lancet 375 (2010), 2223–2233.
7. Bailey, C.J., Gross, J.L., Hennicken, D., Iqbal, N., Mansfield, T.A., List, J.F., Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial. BMC Med., 11, 2013, 1.
8. Bolinder, J., Ljunggren, Ö., Johansson, L., Wilding, J., Langkilde, A., Sjöström, C., Sugg, J., Parikh, S., 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. 16 (2014), 159–169.
9. Jabbour, S.A., Hardy, E., Sugg, J., Parikh, S., 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 37 (2014), 740–750.
10. Strojek, K., Yoon, K., Hruba, V., Elze, M., Langkilde, A., Parikh, S., 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. 13 (2011), 928–938.
11. Matthaei, S., Bowering, K., Rohwedder, K., Grohl, A., Parikh, S., Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: a 24-week randomized double-blind clinical trial. Diabetes Care 38 (2015), 365–372.
12. Wilding, J.P., Woo, V., Soler, N.G., Pahor, A., Sugg, J., Rohwedder, K., Parikh, S., Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: a randomized trial. Ann. Intern. Med. 156 (2012), 405–415.
13. Ferrannini, E., Ramos, S.J., Salsali, A., Tang, W., List, J.F., 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 33 (2010), 2217–2224.
14. Nauck, M.A., Del Prato, S., Meier, J.J., Durán-García, S., Rohwedder, K., Elze, M., Parikh, S.J., Dapagliflozin versus glipizide as add-on therapy in patients with Type 2 diabetes who have inadequate glycemic control with metformin a randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care 34 (2011), 2015–2022.
15. Wilding, J., Bailey, C., Rigney, U., Blak, B., Beekman, W., Emmas, C., Glycated hemoglobin, body weight and blood pressure in Type 2 diabetes patients initiating dapagliflozin treatment in primary care: a retrospective study. Diabetes Ther., 2016, 10.1007/s13300-016-0193-8.
16. Walley, T., Mantgani, A., The UK general practice research database. Lancet 350 (1997), 1097–1099.
17. Inzucchi, S.E., Bergenstal, R.M., Buse, J.B., Diamant, M., Ferrannini, E., Nauck, M., Peters, A.L., Tsapas, A., Wender, R., Matthews, D.R., Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centred approach. Update to a position statement of the American Diabetes Association and the European Association for the study of diabetes. Diabetologia 58 (2015), 429–442.
18. National Institute for Health and Care Excellence, NICE Guideline 28. Type 2 Diabetes in Adults: Management. 2015 Available at: https://www.nice.org.uk/guidance/NG28. Accessed 20 September 2016.
19. Wing, R.R., Lang, W., Wadden, T.A., Safford, M., Knowler, W.C., Bertoni, A.G., Hill, J.O., Brancati, F.L., Peters, A., Wagenknecht, L., Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care 34 (2011), 1481–1486.
20. Bloomgarden, Z.T., Dodis, R., Viscoli, C.M., Holmboe, E.S., Inzucchi, S.E., Lower baseline glycemia reduces apparent oral agent glucose-lowering efficacy a meta-regression analysis. Diabetes Care 29 (2006), 2137–2139.
21. Inzucchi, S.E., Bergenstal, R.M., Buse, J.B., Diamant, M., Ferrannini, E., Nauck, M., Peters, A.L., Tsapas, A., Wender, R., Matthews, D.R., Management of hyperglycemia in type 2 diabetes: a patient-centered approach position statement of the American Diabetes Association (ADA) and the European Association for the study of diabetes (EASD). Diabetes Care 35 (2012), 1364–1379.
22. Flory, J.H., Hennessy, S., Metformin use reduction in mild to moderate renal impairment: possible inappropriate curbing of use based on food and drug administration contraindications. JAMA Intern. Med. 175 (2015), 458–459.
23. Fioretto, P., Stefansson, B.V., Johnsson, E., Cain, V.A., Sjöström, C.D., Dapagliflozin reduces albuminuria over 2 years in patients with type 2 diabetes mellitus and renal impairment. Diabetologia 59 (2016), 2036–2039.
24. Heerspink, H., Johnsson, E., Gause-Nilsson, I., Cain, V., Sjöström, C., Dapagliflozin reduces albuminuria in patients with diabetes and hypertension receiving renin-angiotensin blockers. Diabetes Obes. Metab. 18 (2016), 590–597.
25. Turner, R.C., Cull, C.A., Frighi, V., Holman, R.R., U.P.D.S. Group, Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA 281 (1999), 2005–2012.
26. U.P.D.S. Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 352 (1998), 837–853.
27. Ong, K.L., Cheung, B.M., Wong, L.Y., Wat, N.M., Tan, K.C., Lam, K.S., Prevalence, treatment, and control of diagnosed diabetes in the US National Health and Nutrition Examination Survey 1999–2004. Ann. Epidemiol. 18 (2008), 222–229.
28. U.K.P.D.S. Group. Relative efficacy of randomly allocated diet, sulphonylurea, insulin, or metformin in patients with newly diagnosed non-insulin dependent diabetes followed for three years. BMJ 310 (1995), 83–88.
29. L.A.R. Group. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N. Engl. J. Med. 2013 (2013), 145–154.
30. Espeland, M., Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial. Diabetes Care, 2007.
31. Terranova, C., Brakenridge, C., Lawler, S., Eakin, E., Reeves, M., Effectiveness of lifestyle-based weight loss interventions for adults with type 2 diabetes: a systematic review and meta-analysis. Diabetes Obes. Metab. 17 (2015), 371–378.
32. Sjöström, C., Hashemi, M., Sugg, J., Ptaszynska, A., Johnsson, E., Dapagliflozin-induced weight loss affects 24-week glycated haemoglobin and blood pressure levels. Diabetes Obes. Metab. 17 (2015), 809–812.
33. Cefalu, W.T., Stenlöf, K., Leiter, L.A., Wilding, J.P., Blonde, L., Polidori, D., Xie, J., Sullivan, D., Usiskin, K., Canovatchel, W., Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes. Diabetologia 58 (2015), 1183–1187.
34. Zoppini, G., Targher, G., Chonchol, M., Ortalda, V., Negri, C., Stoico, V., Bonora, E., Predictors of estimated GFR decline in patients with type 2 diabetes and preserved kidney function. Clin. J. Am. Soc. Nephrol. 7 (2012), 401–408.
35. Ruggenenti, P., Porrini, E.L., Gaspari, F., Motterlini, N., Cannata, A., Carrara, F., Cella, C., Ferrari, S., Stucchi, N., Parvanova, A., Glomerular hyperfiltration and renal disease progression in type 2 diabetes. Diabetes Care 35 (2012), 2061–2068.
36. Premaratne, E., Macisaac, R.J., Tsalamandris, C., Panagiotopoulos, S., Smith, T., Jerums, G., Renal hyperfiltration in type 2 diabetes: effect of age-related decline in glomerular filtration rate. Diabetologia 48 (2005), 2486–2493.
37. Sattar, N., McLaren, J., Kristensen, S.L., Preiss, D., McMurray, J.J., SGLT2 inhibition and cardiovascular events: why did EMPA-REG outcomes surprise and what were the likely mechanisms. Diabetologia, 59, 2016, 1333.
38. Baker, W.L., Smyth, L.R., Riche, D.M., Bourret, E.M., Chamberlin, K.W., White, W.B., Effects of sodium-glucose co-transporter 2 inhibitors on blood pressure: a systematic review and meta-analysis. J. Am. Soc. Hypertens. 8 (2014), 262–275 e269.
39. ClinicalTrial.gov registration no. NCT01730534. www.timi.org/index.php?page=declare-timi-58.[Accessed 31 January 2017].
40. Geerlings, S., Fonseca, V., Castro-Diaz, D., List, J., Parikh, S., Genital and urinary tract infections in diabetes: impact of pharmacologically-induced glucosuria. Diabetes Res. Clin. Pract. 103 (2014), 373–381.