Phase III CREDENCE study of Invokana finds benefits for kidney function in diabetic nephropathy.- Janssen Pharma
The Janssen Pharmaceutical Companies of Johnson & Johnson announced results of an important new analysis from the landmark Phase III CREDENCE study, which found that Invokana (canagliflozin) consistently reduced the risk of renal and cardiovascular (CV) events in patients with various levels of kidney function, or estimated glomerular filtration rates (eGFR).
This analysis showed that Invokana provides a strong, consistent safety profile and efficacy at all tested eGFR levels. Specifically, greater renal absolute benefits were observed in those with the most advanced renal insufficiency (eGFR <60 ml min 1.73 m2). in this prespecified secondary analysis, credence researchers investigated whether the effects of invokana on clinically important outcomes were consistent across screening egfr levels. of the 4,401 patients enrolled, 1,313 (30 percent) had moderately to severely decreased kidney function (egfr 30 to><45 ml min 1.73 m2), 1,279 (29 percent) had mildly to moderately decreased kidney function (egfr 45 to><60 ml min 1.73 m2) and 1,809 (41 percent) had mildly decreased kidney function (egfr 60 to><90 ml min 1.73 m2).>90>60>45>60>
The results of the analysis were consistent with the primary study findings, with the following observations: Invokana consistently lowered the risk of CV and renal events in patients across all eGFR subgroups (all p-interaction >0.11). Canagliflozin led to fewer adverse events and serious adverse events overall, with consistent results across screening eGFR subgroups (p-interaction = 0.40 and 0.15, respectively). Invokana also reduced A1c, blood pressure, body weight, and albuminuria (protein in the urine) compared to placebo across all eGFR subgroups. Results from this secondary analysis were presented at the American Society of Nephrology (ASN) Kidney Week 2019 and build on the positive primary results from the Phase III CREDENCE study.
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