Rate of adverse effects for dapagliflozin similar to placebo

(HealthDay)—The overall incidence of adverse effects (AEs) and serious AEs (SAEs) is similar in patients with type 2 diabetes mellitus taking dapagliflozin or placebo, according to a study published online Sept. 26 in Diabetes, Obesity and Metabolism.

Serge Jabbour, M.D., from the Thomas Jefferson University in Philadelphia, and colleagues pooled data from 13 placebo-controlled trials of up to 24 weeks' duration (dapagliflozin: 2,360 patients; placebo: 2,295 patients).

The researchers found that over 24 weeks, the overall incidence of AEs and SAEs was similar between dapagliflozin and placebo (60.0 versus 55.7 percent and 5.1 versus 5.4 percent, respectively). The groups had similar rates of hypoglycemia, volume depletion AEs, urinary tract infections (UTIs), and fractures, while genital infections and renal function AEs were more frequent with dapagliflozin (5.5 versus 0.6 percent and 3.2 percent versus 1.8 percent, respectively). There were no cases of diabetic ketoacidosis (DKA) or ketonuria/metabolic acidosis, compared to one and three cases, respectively, with dapagliflozin.

"The overall incidence of AEs and SAEs was comparable in the dapagliflozin and placebo/control groups, including the incidence of hypoglycemia, volume depletion, fractures, UTIs, amputations, and DKA," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including AstraZeneca, which manufactures dapagliflozin and funded the study.