An analysis of pooled safety data from 19 studies, including the EMPA-REG OUTCOME® trial, involving more than 12,500 adults with type 2 diabetes demonstrated treatment with Jardiance® (empagliflozin) tablets (10 mg or 25 mg) was well tolerated, with no imbalance in lower limb amputations or bone fractures compared with placebo, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced today. The analysis was published this month in Advances in Therapy.
"This is an exciting time in the advancement of treatment options for people living with type 2 diabetes and cardiovascular disease," said Thomas Seck, M.D., vice president, Clinical Development and Medical Affairs, Primary Care, Boehringer Ingelheim Pharmaceuticals, Inc. "Boehringer Ingelheim and Lilly are committed to providing available data about the efficacy and safety of our treatment options. In this light, we are proud to share the most comprehensive analysis of the safety data for Jardiance."
Jardiance is the first and only type 2 diabetes medicine approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. The landmark EMPA-REG OUTCOME trial demonstrated that Jardiance reduced the risk of cardiovascular death by 38 percent versus placebo in people with type 2 diabetes and established cardiovascular disease when added to standard of care (including glucose-lowering agents and cardiovascular drugs). The overall safety profile of Jardiance in EMPA-REG OUTCOME was consistent with that of previous studies of Jardiance and current label information.
Pooled data for this analysis, which included 15 randomized Phase I-III trials and four extension studies, were analyzed from adults with type 2 diabetes treated with placebo (N=4203), Jardiance 10 mg (N=4221) or Jardiance 25 mg (N=4196). Adverse events were assessed in people who took at least one dose of Jardiance or placebo.
The analysis demonstrated that the incidences of any adverse events, severe adverse events, serious adverse events and adverse events leading to discontinuation were no higher in adults treated with Jardiance compared with those treated with placebo. The rate of lower limb amputations was similar across treatment groups (1.1 percent in all treatment groups). In EMPA-REG OUTCOME, the proportion of people with lower limb amputations was similar in those treated with placebo (1.8 percent) and Jardiance (1.9 percent). The incidences of other events potentially related to amputations (i.e., peripheral artery obstructive disease events, diabetes foot-related events, relevant infections and wounds) were similar in the placebo and Jardiance groups.
The incidence of bone fractures was also similar across treatment groups (2.9, 2.8 and 2.5 percent in the placebo, Jardiance 10 mg and Jardiance 25 mg groups, respectively). Events consistent with genital infection occurred more frequently in participants treated with Jardiance 10 mg and 25 mg (6.1 and 6.0 percent, respectively) than placebo (1.6 percent). The incidence of events consistent with urinary tract infection was similar across treatment groups (14.5-15.1 percent).
Jardiance was not associated with an increased risk of hypoglycemia compared with placebo, except in those who were on background sulfonylurea therapy (21.9, 24.5 and 23.4 percent in the placebo, Jardiance 10 mg and Jardiance 25 mg groups, respectively).
About the EMPA-REG OUTCOME Trial (NCT01131676)
EMPA-REG OUTCOME was a long-term, multicenter, randomized, double-blind, placebo-controlled trial of more than 7,000 patients from 42 countries with type 2 diabetes and established cardiovascular disease.
The study assessed the effect of Jardiance (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care. Standard of care was comprised of glucose-lowering agents and cardiovascular drugs (including for blood pressure and cholesterol). The primary endpoint was defined as time to first occurrence of cardiovascular death, non-fatal heart attack or non-fatal stroke.
The overall safety profile of Jardiance was consistent with that of previous trials.
What is JARDIANCE?
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults wi...
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