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Invokana Cardiovascular Outcomes

Cardiovascular banner

Prescribing Information

Great Britain Northern Ireland

Cardiovascular Outcomes

Invokana reduces the risk of major CV events over the long term (6.5 years).1

CANVAS showed a 14% relative reduction in risk for MACE among a mix of both primary and secondary prevention patients compared to placebo. HR: 0.86 (95% CI, 0.75-0.97)1 ARR: 4.6 fewer events per 1000 patient-years.1

Death from Cardiovascular

All-cause mortality was the first secondary endpoint in the pre-specified hypothesis testing sequence.1

Because analysis of this endpoint failed to show superiority for Invokana, hypothesis testing could not be carried out for the other secondary endpoints.1

CANVAS also showed a 33% relative reduction in risk of hospitalisation for heart failure among a mix of both primary and secondary prevention patients compared to placebo. HR: 0.67 (95% CI, 0.52-0.87)1 ARR: 3.2 fewer events per 1000 patient-years.1

Hospitalization Chart

Abbreviations

ARR: Absolute Risk Reduction; CANVAS: Canagliflozin Cardiovascular Assessment Study; CI: Confidence Interval; CV: Cardiovascular; HHF: Hospitalisation for Heart Failure; HR: Hazard Ratio; MACE: Major Adverse Cardiovascular Events; SoC: Standard of Care; T2DM: Type 2 Diabetes Mellitus.

References

Reporting adverse events

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard.

Adverse events should also be reported to Napp Pharmaceuticals Limited on 01223 424444 or drugsafetyuk@napp.co.uk.