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Dapagliflozin superior to placebo for patients with type 2 diabetes, CVD
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In type 2 diabetes patients with preexisting cardiovascular disease, the use of dapagliflozin is superior to placebo in decreasing HbA1c, body weight and systolic blood pressure without negatively affecting cardiovascular safety, according to recent study findings.
In the multicenter, randomized, double-blind placebo-controlled study, William T. Cefalu, MD, of the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge, and colleagues evaluated 922 patients with type 2 diabetes, known preexisting CVD and a history of treated hypertension to determine the safety and efficacy of dapagliflozin compared with placebo.
Participants were assigned to receive either once-daily 10-mg dapagliflozin (n = 455) or placebo (n = 459) for 24 weeks. A 28-week extension period followed. Participants who were being treated with insulin were placed on a 25% decreased dose at randomization. Age (< 65 years; ≥ 65 years), insulin use and time from most recent qualifying CV event were used to stratify patients. More than half of participants in both groups were older than 65 years.
Primary endpoints included absolute decrease from baseline HbA1c level and proportion of patients who achieved combined HbA1c reduction of 0.5% or more, body weight of 3% or more and systolic BP of 3 mm Hg or more.
Compared with placebo, which yielded a slight increase in HbA1c at 24 weeks (0.8%) from baseline, dapagliflozin significantly decreased HbA1c levels (-0.38%). More participants in the dapagliflozin group met the three-item endpoint (11.7%) compared with placebo (0.9%) and the changes persisted over 52 weeks.
Similar rates of serious adverse events, hypoglycemia, urinary tract infection and cardiac anomalies were found among both groups whereas hypotension/hypovolemia, genital infection and renal failure were more prevalent in the dapagliflozin group.
“Given the paucity of available data, the current study assists clinicians when determining appropriate regimens for patients with type 2 diabetes who are at high risk for CVD,” the researchers wrote. “As such, dapagliflozin, when added to usual care in a population with a high CVD risk, was superior to placebo in reducing HbA1c levels, as well as demonstrating combined efficacy for the lowering of HbA1c levels, [body weight] reduction and [systolic] BP reduction, in a year-long study. These data indicate that the safety profile of dapagliflozin makes it appropriate for use in a population of patients with advanced type 2 diabetes, CVD, and hypertension, and, as such, provides significantly new clinical information.” – by Jennifer Byrne
Disclosure: Cefalu reports various financial ties with AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Halozyme Therapeutics, Intarcia Therapeutics, Johnson & Johnson, Lexicon Pharmaceuticals, MannKind Corporation and Sanofi. The study was funded by AstraZeneca and Bristol-Myers Squibb. Please see the full study for a list of all other authors’ relevant financial disclosures.
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