Natalie Como, MD

Background: Dapagliflozin is a selective inhibitor of sodium-glucose transporter 2 (SGLT2) in the kidney; the drug blocks glucose reabsorption in the proximal tubule. It is taken once daily by mouth. An initial study sponsored by AstraZeneca was published January 2019 in the New England Journal of Medicine – “Dapagliflozin and cardiovascular outcomes in type 2 diabetes.” Until recently there was not an FDA-approved indication for the drug.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: 882 clinical sites in 33 countries.

Synopsis: The study randomized approximately 17,000 patients to receive either dapagliflozin or placebo in addition to any other diabetes treatments prescribed by their physician. This study demonstrated its primary safety outcome, which was that patients on dapagliflozin did not have any more major adverse cardiac events (MACE), compared with placebo. There were two primary efficacy outcomes. First, there was no change in MACE with dapagliflozin, compared with placebo. Second, and pertinent to this drug’s approval, was that dapagliflozin reduced risk of hospitalization for heart failure (HF) from 5.8% to 4.9%, compared to placebo; this includes both HF with both preserved and reduced ejection fractions.

Bottom line: Dapagliflozin now has an FDA-approved indication to reduce hospitalizations for HF in patients with type 2 diabetes. Based on this study, the number needed to treat with dapagliflozin is 111 patients to prevent one hospitalization for HF.

Citation: Farxiga approved in the US to reduce the risk of hospitalization for heart failure in patients with type-2 diabetes. AstraZeneca Press Release, 2019 Oct 21.

Dr. Como is a hospitalist and clinical instructor of medicine at the University of Utah, Salt Lake City.

Background: Dapagliflozin is a selective inhibitor of sodium-glucose transporter 2 (SGLT2) in the kidney; the drug blocks glucose reabsorption in the proximal tubule. It is taken once daily by mouth. An initial study sponsored by AstraZeneca was published January 2019 in the New England Journal of Medicine – “Dapagliflozin and cardiovascular outcomes in type 2 diabetes.” Until recently there was not an FDA-approved indication for the drug.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: 882 clinical sites in 33 countries.

Synopsis: The study randomized approximately 17,000 patients to receive either dapagliflozin or placebo in addition to any other diabetes treatments prescribed by their physician. This study demonstrated its primary safety outcome, which was that patients on dapagliflozin did not have any more major adverse cardiac events (MACE), compared with placebo. There were two primary efficacy outcomes. First, there was no change in MACE with dapagliflozin, compared with placebo. Second, and pertinent to this drug’s approval, was that dapagliflozin reduced risk of hospitalization for heart failure (HF) from 5.8% to 4.9%, compared to placebo; this includes both HF with both preserved and reduced ejection fractions.

Bottom line: Dapagliflozin now has an FDA-approved indication to reduce hospitalizations for HF in patients with type 2 diabetes. Based on this study, the number needed to treat with dapagliflozin is 111 patients to prevent one hospitalization for HF.

Citation: Farxiga approved in the US to reduce the risk of hospitalization for heart failure in patients with type-2 diabetes. AstraZeneca Press Release, 2019 Oct 21.

Dr. Como is a hospitalist and clinical instructor of medicine at the University of Utah, Salt Lake City.

Background: Dapagliflozin is a selective inhibitor of sodium-glucose transporter 2 (SGLT2) in the kidney; the drug blocks glucose reabsorption in the proximal tubule. It is taken once daily by mouth. An initial study sponsored by AstraZeneca was published January 2019 in the New England Journal of Medicine – “Dapagliflozin and cardiovascular outcomes in type 2 diabetes.” Until recently there was not an FDA-approved indication for the drug.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: 882 clinical sites in 33 countries.

Synopsis: The study randomized approximately 17,000 patients to receive either dapagliflozin or placebo in addition to any other diabetes treatments prescribed by their physician. This study demonstrated its primary safety outcome, which was that patients on dapagliflozin did not have any more major adverse cardiac events (MACE), compared with placebo. There were two primary efficacy outcomes. First, there was no change in MACE with dapagliflozin, compared with placebo. Second, and pertinent to this drug’s approval, was that dapagliflozin reduced risk of hospitalization for heart failure (HF) from 5.8% to 4.9%, compared to placebo; this includes both HF with both preserved and reduced ejection fractions.

Bottom line: Dapagliflozin now has an FDA-approved indication to reduce hospitalizations for HF in patients with type 2 diabetes. Based on this study, the number needed to treat with dapagliflozin is 111 patients to prevent one hospitalization for HF.

Citation: Farxiga approved in the US to reduce the risk of hospitalization for heart failure in patients with type-2 diabetes. AstraZeneca Press Release, 2019 Oct 21.

Dr. Como is a hospitalist and clinical instructor of medicine at the University of Utah, Salt Lake City.