Janssen-Cilag International has reported positive results from the CANVAS programme of INVOKANA (canagliflozin) in combination with standard-of-care to address a combined risk of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke in type 2 diabetes patients.
Canagliflozin is a sodium glucose cotransporter-2 (SGLT2) inhibitor and under the trade name INVOKANA, the product is given to lower blood sugar in adults with type 2 diabetes.
The results showed that canagliflozin minimised the combined risk of CV, MI and stroke by 14% compared to placebo, as well as decreased the risk of hospitalisation due to heart failure by 33%.
The CANVAS programme evaluated the long-term efficacy and safety of 100mg and 300mg worth of canagliflozin in 10,142 patients at risk or with a history of CV disease.
The programme included two large outcomes trials, Canagliflozin cardiovascular assessment (CANVAS) with 4,330 patients, and a study of the effects of canagliflozin on renal endpoints in adult subjects with T2DM (CANVAS-R) included 5,812 subjects.
Both the randomised, placebo-controlled Phase III/IV trials’ primary endpoint was major adverse CV events (MACE), including non-fatal MI, non-fatal stroke and CV death, while the secondary endpoint was progression of albuminuria, beta-cell function, estimated glomerular filtration rate (eGFR) changes and urine albumin-to-creatinine ratio (UACR).
Janssen Europe, Middle-East and Africa Medical Affairs vice-president Jose Antonio Buron Vidal said: “Janssen has an ongoing commitment to address unmet needs in the treatment of type 2 diabetes, and the positive and broad benefit-risk profile demonstrated here with canagliflozin reinforces our commitment to exploring the potential of canagliflozin in additional patient populations.”
Canagliflozin also indicated renal protective effects with delayed progression of albuminuria, sustained positive effects on glycemic and blood pressure control, and demonstrated weight reduction.
Overall adverse events observed during the programme were found to be consistent with previous studies.
While an increased risk of amputation was found in both the CANVAS and the CANVAS-R trials, an increased risk of adjudicated low trauma fracture was only observed in the CANVAS trial.
Image: Janssen scientists at work. Photo: courtesy of © Janssen Global Services.