only INVOKANA® demonstrated A1C, body weight, and systolic BP reductions for up to 6.5 years1

  • As demonstrated in 10,142 patients in the longest cardiovascular outcomes program for an oral type 2 diabetes therapy1
  • The mean follow-up in the CANVAS Program was 188.2 weeks1

INVOKANA® is not indicated for weight loss or as an antihypertensive treatment.

A1C reductions for up to 6.5 years1

  • The INVOKANA® group received 9.3% fewer AHAs during follow-up than the placebo group (95% CI: –11.0, –7.6)1
  • The CANVAS Program was not designed to evaluate the effect of INVOKANA® vs placebo on A1C, body weight, or systolic BP over 338 weeks.1
  • Additional AHAs could be added to both treatment arms after week 181
  • Use of background therapy for glycemic management and other control of risk factors was guided by best practice according to local guidelines1

Adjusted mean change in A1C from baseline vs placebo + standard of care over 338 weeks1:

 

sustained effect on body weight reductions1

Adjusted mean change in body weight from baseline over 338 weeks (lb)1

  • INVOKANA® difference from placebo (on top of standard of care): –3.53 lb (–1.60 kg; 95% CI: –1.70, –1.51; P<0.001)1

The CANVAS Program was not designed to evaluate the effect of INVOKANA® vs placebo on A1C, body weight, or systolic BP over 338 weeks.1

BP=blood pressure; CV=cardiovascular.

sustained effect on systolic BP reductions1

Adjusted mean change in systolic BP from baseline over 338 weeks (mm Hg)1

  • INVOKANA® difference from placebo (on top of standard of care): –3.93 mm Hg (95% CI: –4.30, –3.56; P<0.001)1

The CANVAS Program was not designed to evaluate the effect of INVOKANA® vs placebo on A1C, body weight, or systolic BP over 338 weeks.1

BP=blood pressure; CV=cardiovascular.

The CANVAS Program was an integrated analysis of 2 trials (the CANVAS trial and the CANVAS-R trial) with a total of 10,142 patients with type 2 diabetes:

  • 65.6% of patients were 30 years of age with a history of symptomatic atherosclerotic cardiovascular disease*
  • 34.4% of patients were 50 years of age with 2 risk factors for cardiovascular disease

Select baseline characteristics1

Profile  
Age 63.3 years
Duration of diabetes 13.5 years
A1C 8.2%
eGFR 76.5 mL/min/1.73 m2
BMI 32.0 kg/m2
Current smoker 17.8%
LDL cholesterol 88.9 mg/dL
Additional patient history  
Cardiovascular disease 65.6%
Hypertension 90.0%
Heart failure 14.4%
Peripheral vascular disease 20.8%
Retinopathy 21.0%
Nephropathy 17.5%
Neuropathy 30.7%
Amputation 2.3%

*A history of cardiovascular disease was defined as a history of symptomatic atherosclerotic vascular disease (coronary, cerebrovascular, or peripheral).

Duration of diabetes ≥10 years, systolic BP >140 mm Hg while they were receiving ≥1 antihypertensive agents, currently smoking, microalbuminuria or macroalbuminuria, or HDL cholesterol level <1 mmol/L (38.7 mg/dL).

(standard of care for the overall patient population across both treatment arms)

Select baseline background therapies1*

Cardioprotective agents  
Statin 74.9%
Antithrombotic 73.6%
RAAS inhibitor (ACEi/ARB) 80.0%
Beta blocker 53.5%
Diuretic 44.3%
Antihyperglycemic agents  
Insulin 50.2%
Sulfonylurea 43.0%
Metformin 77.2%
GLP1 receptor agonist 4.0%
DPP4 inhibitor 12.4%

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; DPP4=dipeptidyl peptidase-4; GLP1=glucagon-like peptide-1; ITT=intent-to-treat; RAAS=renin-angiotensin-aldosterone system.

*One patient was randomized at 2 different sites and only the first randomization is included in the ITT analysis set.

Long-term cardiovascular outcomes trial at 338 weeks (Neal et al)

The CANVAS Program was an integrated analysis of 2 trials (the CANVAS trial and the CANVAS-R trial) with a total of 10,142 men and women with type 2 diabetes. Of the participants, 96.0% completed the trial and vital status was confirmed for 99.6%. The mean follow-up for the CANVAS Program was 188.2 weeks, while the length of follow-up was 295.9 weeks and 108.0 weeks in the CANVAS and CANVAS-R trials, respectively. Participants were either ≥30 years of age with a history of symptomatic atherosclerotic cardiovascular disease or ≥50 years of age with ≥2 risk factors* for cardiovascular disease. The primary efficacy outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.1

*≥2 of the following risk factors for CVD: duration of diabetes ≥10 years, systolic blood pressure >140 mm Hg while they were receiving ≥1 antihypertensive agents, currently smoking, microalbuminuria or macroalbuminuria, or HDL cholesterol level <1 mmol/L (38.7 mg/dL).

Reference: 1. Neal B, Perkovic V, Mahaffey KW, et al; CANVAS Program Collaborative Group. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017;377(7):644-657. Supplementary appendix available at: doi:10.1056/NEJMoal611925.