J & J's Invokana Reduces Risk of Kidney Failure in High-Risk Diabetic Patients

Janssen Pharmaceutical Unit of Johnson & Johnson Announces New Results Showing Invokana Diabetes Therapy First in Nearly 20 Years to Significantly Reduce Risk of Kidney Failure, Dialysis or Kidney Transplantation and death from renal or cardiovascular failure in patients with type 2 kidney disease.

Data from phase 3 of the CREDENCE study showed that Invokana (canagliflozin) significantly reduced the combined risk of cardiovascular death, myocardial infarction, and stroke.

The results also showed no imbalance in amputation or bone fracture – the results of a previous CANVAS trial testing its safety and cardiovascular benefits in one group. of patients with a high risk of cardiovascular problems, had shown that Invokana had doubled the risk of amputation of the finger lower leg. There were no new security issues either.

The latest data, announced at the International Society of Nephrology conference, showed that the drug resulted in a statistically significant 30% reduction in the risk badociated with the compound primary endpoint, including progression to the first trimester. end-stage renal disease, defined by the need for renal replacement therapy. such as chronic dialysis or renal transplantation, the doubling of serum creatine, a predictor of KST, and renal or cardiovascular death.

The study tested the efficacy and safety of Invokana versus placebo in patients with chronic renal failure (CKD) and type 2, in addition to standard treatment .

The results of the study also showed that Invokana reduced by 31% the risk of CV occurrence, CV death and hospitalization for heart failure, as well as serious adverse events related to CV (MACE); compound of nonfatal myocardial infarction [MI]nonfatal stroke and CV death) by 20% and hospitalization risk for heart failure alone by 39%.

The CREDENCE Phase 3 clinical trial was a multi-center, double-group, double-blind, event-controlled, event-controlled, multicenter trial. He evaluated 4,401 patients with type 2 diabetes, chronic stage 2 or 3 nephropathy and elevated blood albumin levels, who were receiving standard treatments, including a maximum tolerated daily intake of 1%. Angiotensin converting enzyme (ACE) or angiotensin II receptor antagonists (ARBs). ).

Last month, Janssen filed CREDENCE data with the FDA to expand the drug's label to reduce the risk of ESM, doubling serum creatine, and kidney or cardiovascular mortality in adults with kidney disease and stroke. Type 2 diabetes.

The independent trial data monitoring committee recommended that the trial be terminated as it would be unethical to allow the control arm to continue to receive standard care.

Several other manufacturers are also pursuing this indication – although AstraZeneca is advancing even further by testing its Forxiga (dapagliflozin), a competing clbad therapy of SLGT-2, in patients with chronic kidney disease without diabetes.