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08-06-2017 | SGLT2 inhibitors | Article

Quality measure and weight loss assessment in patients with type 2 diabetes mellitus treated with canagliflozin or dipeptidyl peptidase-4 inhibitors

Journal: BMC Endocrine Disorders

Authors: Carol H. Wysham, Patrick Lefebvre, Dominic Pilon, Mike Ingham, Marie-Hélène Lafeuille, Bruno Emond, Rhiannon Kamstra, Wing Chow, Michael Pfeifer, Mei Sheng Duh

Publisher: BioMed Central

Abstract

Background

Achieving control of glycated hemoglobin (HbA1c), blood pressure (BP), and body weight (BW) remains a challenge for most patients with type 2 diabetes mellitus (T2DM). In clinical trials, canagliflozin (CANA), an inhibitor of sodium-glucose co-transporter 2, has shown significant improvement compared to some dipeptidyl peptidase-4 (DPP-4) inhibitors in the achievement of such quality measures. This study used recent electronic medical records (EMR) data to assess quality measure achievement of HbA1C, BP, and BW loss in patients treated with CANA versus DPP-4 inhibitors.

Methods

Adult patients with ≥1 T2DM diagnosis and ≥12 months of clinical activity (baseline) before first CANA or DPP-4 prescription (index) were identified in the QuintilesIMS Health Real-World Data EMRs–US database (03/29/2012–10/30/2015). Patients were observed from the index to last encounter. Inverse probability of treatment weighting (IPTW) was used to adjust for observed baseline confounders between groups. Kaplan-Meier (KM) rates and Cox proportional hazard models were used to compare achievement of HbA1c < 7% (among patients <65 years old), HbA1c < 8%, systolic BP < 140 mmHg, diastolic BP < 90 mmHg, and BW loss ≥ 5% among patients not meeting these respective targets at baseline.

Results

A total of 10,702 CANA and 17,679 DPP-4 patients were selected. IPTW resulted in balanced baseline demographic, comorbidity, and disease characteristics (CANA: N = 13,793, mean age: 59.0 years; DPP-4: N = 14,588, mean age: 58.9 years). Up until 24 months post-index, CANA patients were more likely to reach an HbA1c < 7% (hazard ratio [HR] = 1.10, P = 0.007, KM rates: 42.8% vs. 40.3%), an HbA1c < 8% (HR = 1.16, P < 0.001, KM rates: 63.7% vs. 60.0%), and a BW loss ≥ 5% (HR = 1.46, P < 0.001, KM rates: 55.2% vs. 46.2%), compared to DPP-4 patients. Up until 12 months post-index, CANA patients were more likely to reach a systolic BP < 140 mmHg (HR = 1.07, P = 0.04, KM rates: 87.8% vs. 83.9%). but not a diastolic BP < 90 mmHg (HR = 0.95, P = 0.361), compared to DPP-4 patients.

Conclusions

This retrospective study of EMR data covering up to 30 months after CANA approval (March 2013) suggests that patients initiated on CANA were more likely to reach HbA1c, systolic BP, and weight loss objectives specified by general diabetes care guidelines than patients initiated on DPP-4 inhibitors.
Literature
1.
Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: U.S. Department of Health and Human Services; 2014.
2.
Stolar M. Glycemic control and complications in type 2 diabetes mellitus. Am J Med. 2010;123(3):S3–S11.CrossRefPubMed
3.
Palmer AJ, Roze S, Valentine WJ, Minshall ME, et al. Impact of changes in HbA1c, lipids and blood pressure on long-term outcomes in type 2 diabetes patients: an analysis using the CORE diabetes model. Curr Med Res Opin. 2004;20 Suppl 1:S53–8.CrossRefPubMed
4.
Lafeuille M-H, Grittner AM, Gravel J, Bailey RA, et al. Quality measure attainment in patients with type 2 diabetes mellitus. Am J Manag Care. 2014;20(1 Suppl):s5–15.PubMed
5.
Lafeuille M-H, Grittner AM, Gravel J, Bailey RA, et al. Economic simulation of canagliflozin and sitagliptin treatment outcomes in patients with type 2 diabetes mellitus with inadequate glycemic control. J Med Econ. 2015;18(2):113–25.CrossRefPubMed
6.
American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2017;40(Supplement 1):S25–32.CrossRef
7.
National Committee for Quality Assurance (NCQA). HEDIS 2016 - Volume 1: Narrative.; 2016. http://​www.​ncqa.​org/​hedis-quality-measurement/​hedis-measures/​hedis-2016.
8.
Bailey RA, Vijapurkar U, Meininger G, Rupnow MFT, et al. Diabetes-related composite quality End point attainment: canagliflozin versus sitagliptin based on a pooled analysis of 2 clinical trials. Clin Ther. 2015;5:1–10.
9.
Handelsman Y, Bloomgarden ZT, Grunberger G, Umpierrez G, et al. American association of clinical endocrinologists (AACE) and American college of endocrinology (ACE) – clinical practice guidelines for developing a diabetes mellitus comprehensive care plan – 2015. Endocr Pract. 2015;21 Suppl 1:1–87.CrossRefPubMedPubMedCentral
10.
Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, 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(1):140–9.CrossRefPubMed
11.
Battise DM. Efficacy and safety of canagliflozin as Add-on therapy to metformin in type 2 diabetes. Clin Diabetes. 2014;32(2):81–6.CrossRefPubMedPubMedCentral
12.
Seufert J. SGLT2 inhibitors - an insulin-independent therapeutic approach for treatment of type 2 diabetes: focus on canagliflozin. Diabetes, metab syndr obes: targets ther. 2015;8:543–54.CrossRef
13.
Buysman EK, Chow W, Henk HJ, Rupnow MFT. Characteristics and short-term outcomes of patients with type 2 diabetes mellitus treated with canagliflozin in a real-world setting. Curr Med Res Opin. 2015;31(1):137–43.CrossRefPubMed
14.
Forst T, Guthrie R, Goldenberg R, Yee J, 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;16:467–77.CrossRefPubMedPubMedCentral
15.
Lavalle-González FJ, Januszewicz A, Davidson J, Tong C, 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;56:2582–92.CrossRefPubMedPubMedCentral
16.
Nardolillo A, Kane M, Busch R, Watsky J, et al. A clinical perspective of canagliflozin in the management of type 2 diabetes mellitus. Clin Med Insights: Endocrinol Diabetes. 2014;7:25–30.
17.
Stenlöf K, Cefalu WT, Kim K, Alba M, 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;15:372–82.CrossRefPubMedPubMedCentral
18.
Cefalu WT, Leiter LA, Yoon KH, Arias P, et al. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013;382(9896):941–50.CrossRefPubMed
19.
Meckley L, Miyasato G, Kokkotos F, Bumbaugh J, et al. An observational study of glycemic control in canagliflozin treated patients. Curr Med Res Opin. 2015;Online:1–23.
20.
Schernthaner G, Gross JL, Rosenstock J, Guarisco M, et al. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea: a 52-week randomized trial. Diabetes Care. 2013;36(9):2508–15.CrossRefPubMedPubMedCentral
21.
Fulcher G, Matthews DR, Perkovic V, de Zeeuw D, et al. Efficacy and safety of canagliflozin when used in conjunction with incretin-mimetic therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2015;d:82–91.
22.
Thornberry NA, Gallwitz B. Mechanism of action of inhibitors of dipeptidyl-peptidase-4 (DPP-4). best practice & research. Clin endocrinol metab. 2009;23(4):479–86.
23.
Zhang X, Zhao Q. Effects of dipeptidyl peptidase-4 inhibitors on blood pressure in patients with type 2 diabetes: a systematic review and meta-analysis. J Hypertens. 2016;34(2):167–75.CrossRefPubMed
24.
Phung OJ, Scholle JM, Talwar M, Coleman CI. Effect of noninsulin antidiabetic drugs added to metformin therapy on glycemic control, weight gain, and hypoglycemia in type 2 diabetes. JAMA. 2010;303(14):1410–8.CrossRefPubMed
25.
Thayer S, Chow W, Korrer S, Aguilar R. Real-world evaluation of glycemic control among patients with type 2 diabetes mellitus treated with canagliflozin versus dipeptidyl peptidase-4 inhibitors. Current medical research and opinion. 32(6):1087–96.
26.
United States Food and Drug Administration. FDA approves Invokana to treat type 2 diabetes. https://​www.​jnj.​com/​media-center/​press-releases/​us-fda-approves-invokana-canagliflozin-for-the-treatment-of-adults-with-type-2-diabetes. Accessed 1 June 2017.
27.
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373–83.CrossRefPubMed
28.
Young BA, Lin E, Von Korff M, Simon G, et al. Diabetes complications severity index and risk of mortality, hospitalization, and healthcare utilization. Am J Manag Care. 2008;14(1):15–23.PubMedPubMedCentral
29.
Elixhauser A, Steiner C, Kruzikas D. Comorbidity Software Documentation. HCUP Methods Series Report # 2004-1. U.S. Agency for Healthcare Research and Quality. 2004. https://​www.​hcup-us.​ahrq.​gov/​reports/​methods/​2004_​1.​jsp. Accessed 1 June 2017.
30.
Cohen J. Statistical power analysis for the behavioral sciences. Toronto: Academic; 1977.
31.
Austin PC. Using the standardized difference to compare the prevalence of a binary variable between two groups in observational research. Commun Stat-Simul Comput. 2009;38(6):1228–34.CrossRef
32.
Austin PC, Stuart EA. The performance of inverse probability of treatment weighting and full matching on the propensity score in the presence of model misspecification when estimating the effect of treatment on survival outcomes. Statistical methods in medical research. 2015;1–21.
33.
Curtis LH, Hammill BG, Eisenstein EL, Kramer JM, et al. Using inverse probability-weighted estimators in comparative effectiveness analyses with observational databases. Med Care. 2007;45(10 Supl 2):S103–7.CrossRefPubMed
34.
Hernán MA, Hernández-Díaz S, Robins JM. A structural approach to selection bias. Epidemiology. 2004;15(5):615–25.CrossRefPubMed
35.
Weir MR, Januszewicz A, Gilbert RE, Vijapurkar U, et al. Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus. J clin hypertens (Greenwich, Conn. 2014;16(12):875–82.CrossRef
36.
Grabner M. Demographic and clinical profiles of type 2 diabetes mellitus patients initiating canagliflozin versus DPP-4 inhibitors in a large U.S. Managed care population. J manag care spec pharm. 2015;21(12):1204–12.CrossRefPubMed
37.
Bailey RA, Damaraju CV, Martin SC, Meininger GE, et al. Attainment of diabetes-related quality measures with canagliflozin versus sitagliptin. Am J Manag Care. 2014;20(1 Suppl):s16–24.PubMed
38.
Ektare VU, Lopez JMS, Martin SC, Patel DA, et al. Cost efficiency of canagliflozin versus sitagliptin for type 2 diabetes mellitus. Am J Manag Care. 2014;20(10 Suppl):S204–15.PubMed
39.
Bailey RA, Vijapurkar U, Meininger GE, Rupnow MFT, et al. Diabetes-related quality measure attainment: canagliflozin versus sitagliptin based on a pooled analysis of 2 clinical trials. Am J Manag Care. 2014;20(13 Suppl):s296–305.PubMed
40.
Solini A, Penno G, Bonora E, Fondelli C, et al. Age, renal dysfunction, cardiovascular disease, and antihyperglycemic treatment in type 2 diabetes mellitus: findings from the renal insufficiency and cardiovascular events Italian multicenter study. J Am Geriatr Soc. 2013;61(8):1253–61.CrossRefPubMed
41.
Heerspink HJL, Desai M, Jardine M, Balis D, et al. Canagliflozin slows progression of renal function decline independently of glycemic effects. J Am Soc Nephrol. 2017;28(1):368–75.CrossRefPubMed
42.
Wanner C, Inzucchi SE, Lachin JM, Fitchett D, et al. Empagliflozin and progression of kidney disease in type 2 diabetes. N Engl J Med. 2016;375(4):323–34.CrossRefPubMed
43.
American Diabetes Association. Standards of medical care in diabetes. Diabetes Care. 2015;38(Supplement 1):S1–S94.
44.
Janssen Pharmaceuticals Inc. Prescribing information for InvokanaTM (canagliflozin). 2015. https://​www.​invokana.​com/​prescribing-information.​pdf. Accessed 1 June 2017.

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