Pooled Analysis Demonstrates Safety, Tolerability of Empagliflozin
A pooled safety analysis included over 8,000 adult patients with type 2 diabetes.
Jardiance® (empagliflozin; Boehringer Ingelheim and Lilly) was shown to be well tolerated with no higher rate of limb amputations or bone fractures vs placebo, according to the findings of a pooled safety analysis published in Advances in Therapy.1,2
The pooled data for this safety analysis included 15 randomized trials (Phase 1-3) as well as 4 extension studies of adult patients with type 2 diabetes treated with Jardiance 10 mg (n=4221), Jardiance 25 mg (n=4196), and placebo (n=4203). The analysis showed the incidence of any adverse events, severe adverse events, serious adverse events, and adverse events leading to discontinuation were no greater in adults taking Jardiance vs placebo.
Specifically, the rate of lower limb amputations were similar for treatment groups at 1.1%. The proportion of study patients with lower limb amputations were similar for Jardiance (1.9%) and placebo groups (1.8%) in the EMPA-REG OUTCOME (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients; ClinicalTrials.gov identifier: NCT01131676) study. The incidences of other events potentially related to amputations were shown to be similar in the placebo and Jardiance groups.
The rate of bone fractures was also similar with 2.9% for placebo, 2.8% for Jardiance 10 mg, and 2.5% for Jardiance 25 mg groups. Genital infection was more common in patients taking Jardiance 10 mg (6.1%) and Jardiance 25 mg (6.0%) compared to placebo (1.6%) but urinary tract infection incidence was similar across treatment groups at 14.5% to 15.1%.
Regarding hypoglycemia, Jardiance was not associated with an increased risk when compared to placebo except for patients who were already taking sulfonylurea therapy: Jardiance 10 mg (21.9%) and Jardiance 25 mg (24.5%) vs placebo (23.4%).
Jardiance, a sodium-glucose co-transporter 2 (SGLT2) inhibitor is currently indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, and to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.
Jardiance is available as 10mg and 25mg strength tablets.
For more information call (800) 243-0127 or visit Jardiance.com.
- Johler S, Illiev H, Kaspers S. Safety and tolerability of empagliflozin in patients with type 2 diabetes: pooled analysis of phase I-III clinical trials. Adv Ther. 2017;64(7):1-12.
- Jardiance® (emphagliflozin) analysis reinforces established safety profile [news release]. Ridgefield, CT and Indianapolis, IN: Boehringer Ingelheim. https://www.boehringer-ingelheim.us/press-release/jardiance-empagliflozin-analysis-reinforces-established-safety-profile. Published June 13, 2017. Accessed June 16, 2017.