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FDA Expands Labeling for Diabetes Drug Jardiance
The FDA has approved a new indication for empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) to reduce the risk of cardiovascular death in adults with type-2 diabetes (T2D) and established cardiovascular disease. Empagliflozin is the first T2D treatment with this additional indication and the only oral T2D medication shown in a clinical trial to provide a life-saving cardiovascular benefit, according to the manufacturers.
The approval was based on positive data from the landmark EMPA-REG OUTCOME trial, which involved more than 7,000 patients in 42 countries. The long-term, randomized, double-blind, placebo-controlled study assessed the effect of empagliflozin (10 mg or 25 mg once daily) added to standard of care (SoC) compared with that of placebo added to SoC. SoC consisted of glucose-lowering agents and cardiovascular drugs (including medications for blood pressure and cholesterol). The study’s combined primary endpoint was the time to the first occurrence of cardiovascular death, nonfatal heart attack, or nonfatal stroke.
Empagliflozin significantly reduced the primary endpoint by 14% compared with placebo (hazard ratio [HR], 0.86); the absolute risk reduction was 1.6% for empagliflozin compared with placebo. This primary finding was driven by a significant 38% reduction in the risk of cardiovascular death (HR, 0.62); the absolute risk reduction was 2.2% for patients treated with empagliflozin compared with those given placebo. There was no change in the risk of nonfatal heart attack (HR, 0.87) or nonfatal stroke (HR 1.24).
Empagliflozin is not indicated for patients with type-1 diabetes or diabetic ketoacidosis.
Adults with T2D should not take empagliflozin if they have severe kidney problems or are receiving dialysis, or if they are allergic to empagliflozin or to any ingredient in Jardiance. Empagliflozin can cause dehydration and hypotension. Empagliflozin can also cause ketoacidosis; serious urinary-tract infection; acute kidney injury; impaired renal function; low blood glucose when used with insulin or insulin secretagogues (e.g., sulfonylurea, a medication used to treat patients with T2D); vaginal yeast infections; yeast infections of the penis; and increased cholesterol.
Source: Boehringer Ingelheim; January 5, 2016.