Data show no evidence of increased risk of adverse events in patients aged ≥80 years, compared to patients aged 70 - 79 years.
Patients who suffer from type 2 diabetes (T2D) and chronic kidney disease (CKD) may experience a reduction in incidence of kidney and cardiovascular (CV) events with an SGLT-2 inhibitor, such as canagliflozin.
Investigators, led by Tae Won Yi, MD, The George Institute for Global Health, found a reduction in risk of kidney and CV events in these patient population treated with canagliflozin.
The data was presented at the American Diabetes Association 2021 Virtual Meeting.
Investigators used data from the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) study. Patients with type 2 diabetes and CKD were randomized in CREDENCE.
The CREDENCE study randomized 4401 patients with T2Dm eGFR 30 - 90 mL/min/1.72 m
They noted the effects of canagliflozin on the primary outcome included kidney failure, doubling of serum creatinine level, or death from kidney or CV causes.
Further, secondary outcomes were then evaluated by age at the baseline, including <60, 60 - 69, and ≥70 years, as well as sex, with investigators using Cox regression models that were stratified by eGFR.
Secondary analysis was performed in participants ≥70 years, where patients aged ≥80 years were compared to patients aged 70 - 79 years.
Safety outcomes included any adverse event, adverse events leading to discontinuation of study medication, fracture, amputation, hypoglycemia, kidney related adverse event, urinary tract infection, and hospitalization.
Of total patients (n = 4401), 33.5% were <60 years, 42.1% were 60 - 69 years, and 24.4% were ≥70 years at baseline. Investigators noted that 33.9% of patients were female.
There were 2202 patients assigned to the canagliflozin group and 2199 patients assigned to the placebo group.
The team found canagliflozin reduced the risk of the primary outcome by age and for both males and females (HR 0.70, 95% confidence interval 0.59 to 0.82; P <0.001).
According to the data, 53.7 events per 1000 patient-years occurred in patients treated with canagliflozin and 78.1 events per 1000 patient-years treated with placebo in age group <60 years.
Further, investigators noted 38.3 events per 1000 patient-years with canagliflozin and 59.4 events per 1000 patient-years with placebo in age 60 - 69 years.
Also, they found 38.1 events per 1000 patient-years with canagliflozin and 42.6 events per 1000 patient-years with placebo in age ≥70 years.
In addition, primary events in females occurred in 43.1 events per 1000 patient-years with canagliflozin and 59.2 events per placebo (P = .02).
In male patients, primary events occured in 43.3 events per 1000 patient-years with canagliflozin and 62.3 events per 1000 patient-years with placebo.
In the data, investigators noted safety outcomes of canaglifozin were consistent among age groups and sex.
Further mention was made of no evidence showing patients aged ≥80 years were more at risk of adverse events from canagliflozin, compared to patients aged 70 - 79 years.
In fact, there were similar rates observed in volume depletion, kidney related adverse events, hospitalization and serious adverse events.
Only 2 serious adverse events were observed in patients aged ≥80 years, with 1 patient in each group.
The team concluded that the results showed consistent safety and reduction of adverse events in patients with type 2 diabetes and CKD, regardless of age or sex.
“Given the small number of participants aged over 80 years, the generalizability of these findings to this population requires further study,” investigators wrote.
The study, “Kidney and Cardiovascular Effects of Canagliflozin According to Age and Sex in the CREDENCE Trial,” was presented online at ADA 2021.