STEPS

New Drug Reviews

Empagliflozin (Jardiance) for Type 2 Diabetes Mellitus

 

Am Fam Physician. 2016 Dec 15;94(12):1014-1015.

Empagliflozin (Jardiance) is one of three approved sodium-glucose cotransporter 2 (SGLT2) inhibitors for type 2 diabetes mellitus. It lowers blood glucose by reducing reabsorption of glucose in the kidney, which leads to increased urinary excretion of glucose.

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DrugDosageDose formCost*

Empagliflozin (Jardiance)

10 mg or 25 mg once daily

10- or 25-mg tablets

$410


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed October 20, 2016).

DrugDosageDose formCost*

Empagliflozin (Jardiance)

10 mg or 25 mg once daily

10- or 25-mg tablets

$410


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed October 20, 2016).

SAFETY

For all SGLT2 inhibitors, there have been rare postmarket case reports (less than 1%) of pyelonephritis, sepsis of urinary origin,1 and diabetic ketoacidosis without high blood glucose levels.2 Other rare serious adverse effects include hypovolemia and hypotension (number needed to harm [NNH] = 335). Although infrequent, severe hypoglycemia may occur in patients taking multiple-dose injection insulin. Mild or moderate hypoglycemia occurs most often when combining empagliflozin with any insulin and less often with sulfonylureas.3 No human studies have included pregnant or breastfeeding mothers.3 Empagliflozin is U.S. Food and Drug Administration pregnancy risk category C and should be avoided in the late second and third trimesters, during fetal renal development.

TOLERABILITY

Empagliflozin is generally well tolerated, with no greater discontinuation rate than placebo. There is no difference in the risk of urinary tract infection between the treatment and placebo groups.4 However, women and men are both more prone to genital fungal infections while taking empagliflozin. Over three years of treatment, 10% of women (NNH = 14) and 5% of men (NNH = 29) report a genital mycotic infection.5 Empagliflozin can cause minor increases in low-density lipoprotein cholesterol levels, a small decrease (less than 5 mm Hg) in systolic blood pressure, and a slight increase in hematocrit levels, which typically do not

Address correspondence to Jay Zimmermann, MD, at jzimmermann@hmc.psu.edu. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

REFERENCES

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1. U.S. Food and Drug Administration. SGLT2 inhibitors: drug safety communication—labels to include warnings about too much acid in the blood and serious urinary tract infections. December 4, 2015. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm475553.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed July 6, 2016....

2. Health Canada. Summary safety review—SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin)—assessing the risk of the body producing high levels of acids in the blood (diabetic ketoacidosis). May 16, 2016. http://www.hc-sc.gc.ca/dhp-mps/medeff/reviews-examens/sglt2-2-eng.php. Accessed July 6, 2016.

3. DailyMed. Label: Jardiance—empagliflozin tablet, film coated. Updated July 11, 2016. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=faf3dd6a-9cd0-39c2-0d2e-232cb3f67565. Accessed July 6, 2016.

4. Zinman B, Wanner C, Lachin JM, et al.; EMPA-REG Outcome Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373(22):2117–2128.

5. U.S. Food and Drug Administration. Endocrinologic and metabolic drugs advisory committee briefing document. EMPA-REG outcome trial. May 19, 2016. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM508423.pdf. Accessed July 8, 2016.

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, Contributing Editor.

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

 

 

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