Summary

• The safety and efficacy of using INVOKANAin patients with prostate disorders have not been investigated in well-controlled clinical trials. However, patients with prostate disorders were not excluded from the CREDENCE study, the CANVAS Program, and INVOKANA phase 3 studies.^1-7

CLINICAL STUDIES

CREDENCE

CREDENCE (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) was a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven study designed to assess effects of INVOKANA (100 mg once daily) vs placebo on clinically important renal outcomes in patients with type 2 diabetes mellitus (T2DM) and established chronic kidney disease (estimated glomerular filtration rate 30 to <90 mL/min/1.73 m²) and albuminuria (urinary albumin to creatinine ratio >300 to 5000 mg/g), who were receiving a stable, maximum tolerated labeled dose (for ≥4 weeks prior to randomization) of an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker.^6,8-11

The CREDENCE study was not designed to specifically evaluate the safety and efficacy of INVOKANAin patients with prostate disorders (eg, benign prostatic hyperplasia, prostatitis); however, patients with prostatic disorders were not excluded from the study.⁹

CANVAS Program

The CANVAS Program (N=10,142) was comprised of 2 large INVOKANA cardiovascular (CV) outcome studies, including CANVAS and CANVAS-R.⁷ The CANVAS Program includes a prespecified integrated analysis of the 2 trials designed to meet the Food and Drug Administration postmarketing requirement to determine CV safety, as well as evaluate the potential for CV protection efficacy of INVOKANA in patients with T2DM.^12-15 The mean duration of diabetes at baseline was 13.5 years (13.5 years in INVOKANA treatment group; 13.7 years in the placebo group).⁷

The CANVAS Program studies were not designed to specifically evaluate the safety and efficacy of INVOKANAin patients with prostate disorders (eg, benign prostatic hyperplasia, prostatitis); however, patients with prostatic disorders were not excluded from these studies.¹⁶

Phase 3 Studies

Phase 3 studies were not designed to specifically evaluate the safety and efficacy of INVOKANAin patients with prostate disorders (eg, benign prostatic hyperplasia, prostatitis); however, patients with prostatic disorders were not excluded from phase 3 studies.

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 13 November 2024.