ADA2020: Empagliflozin significantly, durably delays need for insulin and for large dose increases, in patients with type 2 diabetes and cardiovascular disease, finds study presented at ADA 80th Scientific Sessions.
Empagliflozin significantly and durably reduces the need for insulin initiation and the need for large dose increases in current insulin users with type 2 diabetes (T2D), according to research presented Friday, June 12, 2020 at the American Diabetes Association’s® Virtual 80th Scientific Sessions.
Delay to initiation of insulin was longer among those recently diagnosed.
Insulin use in treatment of T2D is associated with weight gain and hypoglycemia, requires training and education, can be costly, and increases daily disease management burden, state Muthiah Vaduganathan, MD, MPH, and colleagues in the study abstract. They note that "reducing insulin need is attractive to both patients and practitioners."
In EMPA-REG OUTCOME, 7020 patients with type 2 diabetes at high cardiovascular risk were treated with the sodium-glucose co-transporter-2 inhibitor empagliflozin 10, 25 mg, or placebo against a background of standard care. Median follow-up was 3.1 years.
After the first 12 weeks, changes in background glucose-lowering therapy were permitted.
Researchers assessed treatment effects of pooled empagliflozin vs placebo on time to new initiation of insulin among insulin-naïve patients and time to total daily insulin dose increase by >20% among insulin-treated patients.
In 3633 (52%) insulin-naïve patients, empagliflozin reduced the need for insulin use vs placebo by 54% (11.1% vs. 22.3%; HR 0.46 [0.39-0.54]), adjusted for key covariates (baseline A1c, time since T2D diagnosis, BMI, eGFR, geographic region and treatment status) .
In 3387 (48%) patients using insulin at baseline, empagliflozin reduced need for a >20% increase in insulin dose by 57% (19.1% vs. 36.8%; HR 0.43 [0.37-0.49]).
Reduction in incident insulin use was most pronounced in patients within 5 years of T2D diagnosis (HR 0.31 [0.21-0.45]) vs T2D duration of >5-10 yrs (0.42 [0.31-0.59]) or >10 yrs (0.56 [0.44-0.71); P interaction=0.03.
In patients with T2D and CVD, empagliflozin markedly and durably delays the need for insulin initiation, more so in those recently diagnosed, and reduces need for large dose increases in those already using insulin.
About EMPA-REG OUTCOME
EMPA-REG OUTCOME was an FDA-mandated trial to assess the cardiovascular safety of all new diabetes drugs. Results of the trial, first reported in November 2015, indicated that empagliflozin was superior to placebo in improving glycemic control and reducing CV events in patients with T2D and established CVD.