Aim There is limited information concerning the effects of canagliflozin (CANA), a sodium‐glucose co‐transporter 2 inhibitor (SGLT2i) in a real‐world clinical setting in Canada. CanCARE is a 12‐month, prospective, observational analysis to demonstrate the effectiveness and safety of CANA in usual clinical practice in Canada. Materials and methods SGLT2i‐naïve adult patients with type 2 diabetes mellitus (T2DM) (n = 527) on a stable antihyperglycemic agent (AHA) regimen with glycated hemoglobin (A1C) ≥ 7%, an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m 2 , were initiated on CANA as part of their usual treatment approach, and were followed for a period of 12 months. The primary effectiveness objective was the mean change in HbA1c from baseline to 6 and 12 months. Results Significant improvement from baseline in mean HbA1c levels were observed at 6 months (−0.90%; 95% CI, −1.02, −0.78) and at 12 months (−1.04%; 95% CI, −1.15, −0.92), regardless of duration of diabetes or background AHA treatment regimen. Similarly, significant decreases in systolic blood pressure (−4.65 mm Hg); body weight (−3.24 kg), waist circumference (−2.91 cm) and body mass index (−1.15 kg/m 2 ) were observed at 12 months. Additionally, 40.5% of patients achieved the double endpoint (≥0.5% HbA1c reduction and ≥ 3% weight loss), while 24.3% of patients achieved the triple composite endpoint (≥0.5% HbA1c reduction, ≥3% weight loss and ≥ 4 mm Hg systolic blood pressure reduction). No unexpected adverse events were reported. Conclusion CANA provided sustained clinically meaningful improvements in cardiometabolic parameters in this study in a real‐world setting, confirming findings from randomized controlled trials.
Aim To better understand the healthcare burden of people with type 2 diabetes (T2D) and estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m2 in Ontario, Canada. Materials and Methods We used administrative data to evaluate the prevalence of T2D, eGFR < 90 mL/min/1.73 m2 and adverse cardiovascular co‐morbidities in individuals aged ≥ 30 years living in Ontario, Canada. We also examined incremental healthcare costs and healthcare resource utilization (HCRU) for these patients with specific incident cardiovascular and renal outcomes, in comparison with controls without these outcomes. Results While the prevalence of T2D in the general population aged ≥ 30 years in Ontario increased by 1.8% over a 5‐year period (2011‐2012 to 2015‐2016), the prevalence of eGFR < 90 mL/min/1.73 m2 among people with T2D increased by 35%. In comparison with corresponding controls without these outcomes, the per patient average total costs (Canadian dollars) over a 2‐year analysis period were higher for patients with cardiovascular disease/chronic kidney disease related death ($69 827; n = 32 407), doubling of serum creatinine ($52 260; n = 22 825), those who started dialysis ($150 627; n = 3499) or received a kidney transplant ($50 664; n = 651). Similarly, HCRU was significantly greater for patients with these incident outcomes. Conclusions This real‐world retrospective study highlights an increasing prevalence of T2D, eGFR < 90 mL/min/1.73 m2, and the substantially higher healthcare costs and HCRU when these patients have adverse cardiovascular and renal outcomes. The existence of such a large economic burden underpins the importance of preventing these diabetes‐related complications.
Aim In the CANVAS Program and CREDENCE trials, the sodium glucose co‐transporter 2 inhibitor canagliflozin reduced the risk of cardiovascular and kidney events in patients with type 2 diabetes. The current study analysed a pooled population to ascertain the kidney protection provided by canagliflozin across the full spectrum of kidney parameters. Methods This post‐hoc pooled analysis of the CANVAS Program (N = 10 142) and CREDENCE trial (N = 4401), assessed the risk of the primary kidney composite (doubling of serum creatinine, end‐stage kidney disease, renal death), in all patients and subgroups defined by baseline estimated glomerular filtration rate (<30, 30 to <45, 45 to <60 and ≥60 ml/min/1.73 m2), albuminuria [<30, 30‐300, >300 mg/g (<3.39, 3.39‐33.9, >33.9 mg/mmol)] and 2012 Kidney Disease: Improving Global Outcomes (KDIGO) classification of chronic kidney disease (low/moderate, high and very high risk). Results In the overall population, the risk for the primary kidney composite outcome was 37% lower in the canagliflozin group versus placebo (HR: 0.63; 95% CI: 0.53, 0.77; p < .001). There was no evidence of heterogeneity in the kidney protective effects of canagliflozin across a range of kidney risks when stratified by baseline estimated glomerular filtration rate, albuminuria or KDIGO risk category (all pinteraction > .05). A statistically significant risk reduction of the primary kidney composite outcome was sustained by approximately 18 months after randomization. Conclusions These results emphasize a critical role of canagliflozin in kidney protection across a broad spectrum of participants with type 2 diabetes with varying levels of kidney function.
CanCARE is a Canadian multicenter, prospective cohort study that enrolled SGLT2 inhibitor-naïve adult patients with T2DM, with A1c ≥7% on a stable anti-hyperglycemic agent (AHA) regimen at baseline and eGFR ≥ 60 mL/min/1.73m2, who were initiated on CANA as part of their usual treatment. This real-world (RW)study assessed the effectiveness and safety outcomes of the enrolled cohort of 527 subjects (mean age 60.7 years, mean baseline A1c 8.3%) over 12 months. Mean A1c reduction was -1.(1.12), with an observed dose response: -0.96 for CANA 100mg, -1.20 for CANA 300mg. 84.9%, 57.9% and 33% of subjects experienced >0%, ≥3%, ≥5% weight loss, respectively. Overall, 38.8% of subjects achieved A1c <7.0%, while 41% achieved the composite endpoint of A1c reduction ≥ 0.5%, body weight loss ≥ 3%. 17.9% subjects discontinued CANA. Safety data showed 37.4% subjects had ≥ 1 Adverse Event (AE), 3.5% had serious AEs, 14.5% had AEs special Interest: genital mycotic infections (9.5%), polyuria (3.7%), UTI (1.5%), severe hypoglycemia (0.9%) and volume-related AE (0.7%). No reports to date of diabetic ketoacidosis or amputation. CANA shows sustained, clinical meaningful improvement in cardiometabolic (CM) parameters in the RW, confirming findings from Phase 3 trials. Table 1: Baseline Values, Results of CM Parameters at 6 and 12 Months After CANA Initiation.Vital of Lab ValueBaseline6 Months12 MonthsChange 6 Months from Baseline mean (std)Change 12 Months from Baseline mean (std)Hemoglobin A1C (%)8.47.47.3-0.90 (1.16)-1.(1.12)Hemoglobin A1C (mmol/mol)68.857.756.2-33.34 (12.68)-35.(12.23)Weight (kg)90.188.589.4-2.87 (4.62)-3.24 (4.81)Body Mass Index (kg/m2)32.131.631.8-1.02 (1.61)-1.15 (1.68)Waist Circumference (cm)107.4104.7105.9-3.11 (9.39)-2.91 (11.12)Diastolic Blood Pressure (mmHg)78.375.375.3-2.90 (8.78)-3.50 (8.68)Systolic Blood Pressure (mmHg)130.8126.1126.3-4.52 (13.64)-4.65 (13.04)Glomerular Filtration Rate Corrected (mL/min/1.73ml2)85.881.381.4-3.96 (10.72)-5.55 (11.50)Potassium (mmol/L)4.44.54.50.04 (0.37)0.(0.40)HDLCholesterol (mmol/L)1.21.21.20.02 (0.43)0.(0.31)LDLCholesterol (mmol/L)1.91.92.00.01 (0.57)0.01 (0.65)Cholesterol (mmol/L)3.94.03.90.09 (0.76)0.(0.84)Triglycerides (mmol/L)1.91.81.7-0.(0.96)-0.24 (1.17)Triglycerides (mg/dL)172.5162.0151.8-7.53 (85.28)-21.27 (103.27)Albumin/Creatinine (mg/mmol)4.73.54.1-0.28 (5.66)-0.70 (7.96)Albumin/Creatinine (mg/g)41.631.336.3-2.47 (50.11)-6.16 (70.48) Disclosure V.C. Woo: Advisory Panel; Self; Janssen Pharmaceuticals, Inc., AstraZeneca, Novo Nordisk Inc., Sanofi, Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc. A.D. Bell: Advisory Panel; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Bayer AG, Eli Lilly and Company, Novo Nordisk Inc.. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Servier. M.A. Clement: Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc., AstraZeneca, Novo Nordisk Inc., Sanofi-Aventis, Eli Lilly and Company. F. Camacho: Consultant; Self; Janssen Inc. N. Georgijev: Employee; Self; Janssen Scientific Affairs, LLC. J.B. Rose: Employee; Self; Janssen Pharmaceuticals, Inc. W. Rapattoni: Employee; Self; Janssen Inc, Toronto Canada. H.S. Bajaj: Speaker's Bureau; Self; Abbott. Advisory Panel; Self; Amgen Inc.. Speaker's Bureau; Self; Amgen Inc.. Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca. Research Support; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca, Bayer AG. Advisory Panel; Self; Boehringer Ingelheim GmbH. Research Support; Self; Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Janssen Pharmaceuticals, Inc.. Research Support; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc., Medtronic. Advisory Panel; Self; Merck & Co., Inc.. Research Support; Self; Merck & Co., Inc.. Speaker's Bureau; Self; Merck & Co., Inc., Mylan. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Sanofi. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Advisory Panel; Self; Valeant Pharmaceuticals International, Inc.. Research Support; Self; Valeant Pharmaceuticals International, Inc.. Speaker's Bureau; Self; Valeant Pharmaceuticals International, Inc..
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