Dr Vivek Baliga short review on parts of the Canvas Study. You can view Dr Vivek's profile online here.
1. CANVAS Program was a pre-specified combined analysis of 2 trials, CANVAS and CANVAS-R, involving a total 10,142 patients with type 2 diabetes and high cardiovascular risk. The combined analysis was done as per the USFDA requirements.
The CANVAS patients were randomized 1:1:1 to canagliflozin 300 mg or 100 mg or placebo, and the CANVAS-R patients to 100 mg (with option to increase to 300 mg after week 13) or placebo. Mean follow-up was 188weeks (median, 126.1 weeks).
Globally the trial was conducted in 30 countries at 667 sites.
2. CANVAS Program included patients with type 2 diabetes and HbA1c >7.0% to <10.5% eGFR >30 mL/min/1.73 m2, age >30 years and history of prior CV event or established CVD patients (65%) or age >50 years with >2 CV risk factors (35%).
The Primary Outcome was Major adverse cardiovascular event (MACE) which included the composite of CV death, nonfatal myocardial infarction or nonfatal stroke.
The secondary outcomes included total mortality and cardiovascular mortality whereas the exploratory outcomes included nonfatal MI, nonfatal stroke, hospitalization for HF, hospitalization for HF or CV death, total hospitalizations, albuminuria progression, albuminuria regression and renal composite including 40% reduction in eGFR, end-stage renal disease, or renal death
3. Canagliflozin achieved a 14% reduction in the risk of MACE and demonstrated the CV safety and superiority compared to placebo. Canagliflozin was safe in terms of CV death and non fatal MI.
Moreover, Canagliflozin was not associated with an increased risk of stroke. Canagliflozin also resulted in 33% reduction in Hospitalization for Heart Failure and 22% reduction in CV Death or Hospitalization for Heart Failure.
4. In terms of renal outcomes, Canagliflozin induced sustained lowering of albuminuria, prevented progression in albuminuria, induced regression in albuminuria and reduced renal function loss events.
No increase in the risk of Hypoglycemia, Acute Kidney Injury, hyperkalaemia, cancer, pancreatitis was seen with Canaglilozin vs placebo. Adverse events leading to discontinuation was similar to placebo.
1. CANVAS Program was a pre-specified combined analysis of 2 trials, CANVAS and CANVAS-R, involving a total 10,142 patients with type 2 diabetes and high cardiovascular risk. The combined analysis was done as per the USFDA requirements.
The CANVAS patients were randomized 1:1:1 to canagliflozin 300 mg or 100 mg or placebo, and the CANVAS-R patients to 100 mg (with option to increase to 300 mg after week 13) or placebo. Mean follow-up was 188weeks (median, 126.1 weeks).
Globally the trial was conducted in 30 countries at 667 sites.
2. CANVAS Program included patients with type 2 diabetes and HbA1c >7.0% to <10.5% eGFR >30 mL/min/1.73 m2, age >30 years and history of prior CV event or established CVD patients (65%) or age >50 years with >2 CV risk factors (35%).
The Primary Outcome was Major adverse cardiovascular event (MACE) which included the composite of CV death, nonfatal myocardial infarction or nonfatal stroke.
The secondary outcomes included total mortality and cardiovascular mortality whereas the exploratory outcomes included nonfatal MI, nonfatal stroke, hospitalization for HF, hospitalization for HF or CV death, total hospitalizations, albuminuria progression, albuminuria regression and renal composite including 40% reduction in eGFR, end-stage renal disease, or renal death
3. Canagliflozin achieved a 14% reduction in the risk of MACE and demonstrated the CV safety and superiority compared to placebo. Canagliflozin was safe in terms of CV death and non fatal MI.
Moreover, Canagliflozin was not associated with an increased risk of stroke. Canagliflozin also resulted in 33% reduction in Hospitalization for Heart Failure and 22% reduction in CV Death or Hospitalization for Heart Failure.
4. In terms of renal outcomes, Canagliflozin induced sustained lowering of albuminuria, prevented progression in albuminuria, induced regression in albuminuria and reduced renal function loss events.
No increase in the risk of Hypoglycemia, Acute Kidney Injury, hyperkalaemia, cancer, pancreatitis was seen with Canaglilozin vs placebo. Adverse events leading to discontinuation was similar to placebo.
