STEPS

New Drug Reviews

Dapagliflozin (Farxiga) for Preventing Hospitalization for Heart Failure

 

Am Fam Physician. 2020 Jul 15;102(2):115-116.

Dapagliflozin (Farxiga) is a selective sodium-glucose cotransporter 2 inhibitor that promotes glycosuria. It is labeled for the treatment of type 2 diabetes mellitus in adults as an adjunct to diet and exercise to improve glycemic control. Recently the labeling has been revised to include use in reducing the risk of hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease (CVD) or multiple cardiovascular risk factors, and to reduce the risk of cardiovascular death and hospitalization of adults with New York Heart Association (NYHA) class II to IV heart failure with reduced ejection fraction (HFrEF), with or without type 2 diabetes.

Safety

In postmarketing reports of dapagliflozin, adverse effects include hypotension, hypoglycemia, ketoacidosis, acute kidney injury, urosepsis, pyelonephritis, and necrotizing fasciitis of the perineum.1 Patients with diabetes who have or are at high risk of CVD are more likely to develop ketoacidosis (number needed to harm [NNH] = 500).2 Dapagliflozin is not recommended for use in patients with hypovolemia or those with an estimated glomerular filtration rate (eGFR) of less than 45 mL per minute per 1.73 m2. It should not be prescribed to patients with an eGFR of less than 30 mL per minute per 1.73 m2, those with end-stage renal disease, pregnant women in the second and third trimesters, or lactating women.1

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DrugDosageDose formCost*

Dapagliflozin (Farxiga)

10 mg once daily

Tablets: 5 mg, 10 mg

$500


*—Estimated lowest GoodRx price for one month of treatment. Actual cost will vary with insurance and by region. Information obtained at https://www.goodrx.com (accessed May 5, 2020; zip code: 66211).

DrugDosageDose formCost*

Dapagliflozin (Farxiga)

10 mg once daily

Tablets: 5 mg, 10 mg

$500


*—Estimated lowest GoodRx price for one month of treatment. Actual cost will vary with insurance and by region. Information obtained at https://www.goodrx.com (accessed May 5, 2020; zip code: 66211).

Tolerability

Dapagliflozin is well tolerated in patients who have HFrEF, with a drop-out rate similar to that of placebo (4.7%).3 About 8% of patients with diabetes who also have CVD or risk factors for CVD will stop treatment because of adverse effects (NNH = 83). These patients are more likely to develop genital yeast infections (NNH = 125) while taking dapagliflozin

Address correspondence to John D. Gazewood, MD, MSPH, FAAFP, at Jdg3k@hscmail.mcc.virginia.edu. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

References

1. DailyMed. Drug label information: Farxiga—dapagliflozin tablet, film coated. Updated May 5, 2020. Accessed May 28, 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=72ad22ae-efe6-4cd6-a302-98aaee423d69

2. Wiviott SD, Raz I, Bonaca MP, et al.; DECLARE–TIMI 58 Investigators. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2019;380(4):347–357.

3. McMurray JJV, Solomon SD, Inzucchi SE, et al.; DAPA-HF Trial Committees and Investigators. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med. 2019;381(21):1995–2008.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, assistant medical editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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