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Is it worth CANVASing for CREDENCE? A Benefit-risk Analysis

Author(s):

Binayak Sinha and Samit Ghosal*   Pages 1 - 6 ( 6 )

Abstract:


Background and Aims: A number of significant positive and negative signals emerged from the CANVAS Program and CREDENCE trial with the use of canagliflozin. These signals are confusing. A Likelihood of being Helped of Harmed (LHH) analysis was conducted to determine the risk, benefit ratio associated with canagliflozin use and address the signals as a continuum.

Materials & Methods: LHH was calculated from the number needed to treat (NNT) and number needed to harm (NNH) available from the absolute risk reductions reported with the outcomes of interest, in these two trials.

Results: In the CANVAS Program, LHH for major adverse cardiovascular events (MACE) and renal outcome, points at significant benefit with canagliflozin use in comparison to amputation (1.65), fractures (1.65) and euglycaemic diabetic ketoacidosis (euDKA) (16.67) risks. Only genital fungal infections were significantly more in both sexes (0.21-M & 0.1-F) when LHH was matched against the positive outcomes. In contrast the hHF benefits were outweighed by amputation (0.95) & fracture risks (0.95).

In CREDENCE trial the LHH for Primary composite, Renal composite & MACE were all supporting the benefits in comparison to any adverse events encountered in the trial.

The LHH from pooled data (CANVAS Program & CREDENCE trial) was in favour of all the benefits (hHF& renal composites) except for MACE matched against amputation (0.66).

Conclusion: The outcome benefits were in favour of canagliflozin in comparison to all reported adverse events, when hHF& renal composite were under consideration, in both the individual & pooled LHH analysis. However, the MACE benefits were overwhelmed by amputation risk in the pooled analysis.

Keywords:

Type 2 diabetes, Canagliflozin, NNT, NNH, LHH, MACE, amputation.

Affiliation:

Consultant Endocrinologist: AMRI Hospitals. KB 24, KB Block, Sector III, Bidhannagar, Kolkata700098, Consultant Endocrinologist: Nightingale Hospital. 11 Shakespeare Sarani. Kolkata 700071.



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