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Canagliflozin Cardiovascular Safety

Canagliflozin's potential cardiovascular safety in diabetes vascular disease, impact on CV risk factors like blood pressure, weight, and albuminuria. Analyzing data from clinical studies to assess the protective effects on CV.

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Canagliflozin Cardiovascular Safety

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  1. Canagliflozin Cardiovascular Safety

  2. Potential CV protection pathways of SGLT2i Diab Vasc Dis Res. 2015 Mar;12(2):90-100.

  3. Effect of Canagliflozin on potential CV risk factors Disclaimer: Canagliflozin is not approved for treatment of Hypertension/Obesity/Dyslipidemia/ Albuminuria/Hyperuricemia Stenlöf K, et al. Diabetes Obes Metab. 2013 Apr;15(4):372-82. Cefalu et al. Lancet 2013; 382: 941–50 Yale JF, et al. Diabetes Obes Metab. 2013 May;15(5):463-73. Davies MJ, et al. Diabetes Obes Metab. 2015 Apr;17(4):426-9.

  4. Canagliflozin rapidly reduces BP in patients with T2DM and hypertension Hourly mean 24-hour ambulatory blood pressure (BP) monitoring (ABPM) systolic BP (SBP) and diastolic BP (DBP) for canagliflozin (CANA) 100 mg, and placebo at baseline, day 2, and week 6 (last observation carried forward). The x axis indicates the hourly time after the morning dose of the study medication. SE indicates standard error J Clin Hypertens (Greenwich). 2015 Dec 10. doi: 10.1111/jch.12747.

  5. Canagliflozin rapidly reduces BP in patients with T2DM and hypertension Canagliflozin rapidly reduced 24 hour ABPM-assessed SBP: both of which are important predictors of clinical CV risk and future events and was generally well tolerated Hourly mean 24-hour ambulatory blood pressure (BP) monitoring (ABPM) systolic BP (SBP) and diastolic BP (DBP) for canagliflozin (CANA) 100 mg, and placebo at baseline, day 2, and week 6 (last observation carried forward). The x axis indicates the hourly time after the morning dose of the study medication. SE indicates standard error J Clin Hypertens (Greenwich). 2015 Dec 10. doi: 10.1111/jch.12747.

  6. Canagliflozin CV safety data from interim meta-analysis of Phase 2/3 Studies Favors CANA Favors Non-CANA Hazard Ratio http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM336236.pdf

  7. Canagliflozin CV safety data from interim meta-analysis of Phase 2/3 Studies Favors CANA Favors Non-CANA Interim analysis of Phase 2 & 3 trials showed a HR of 0.91 for composite primary endpoint Hazard Ratio http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM336236.pdf

  8. CANVAS: Canagliflozin Cardiovascular Assessment StudyA close look at the study design Am Heart J. 2013 Aug;166(2):217-223.e11.

  9. The preliminary CV safety data from phase 2/3 studies including CANVAS trial suggest no increased CV risk • CANVAS results expected in 2017 Am Heart J. 2013 Aug;166(2):217-223.e11.

  10. Summary • SGLT2 inhibitors can potentially modulate CV risk factors like blood pressure, weight, albuminuria, uric acid • Canagliflozin have beneficial effects on these potential CV risk factors • CANVAS study is designed to provide broader insights about CV safety of Canagliflozin • The preliminary CV safety data from phase 2/3 studies including CANVAS trial suggest no increased CV risk

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