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Canagliflozin Cardiovascular Safety

Canagliflozin Cardiovascular Safety. Potential CV protection pathways of SGLT2i. Diab Vasc Dis Res. 2015 Mar;12(2):90-100. Effect of Canagliflozin on potential CV risk factors.

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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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