New “Zavvy” SGLT-2 Inhibitor Approved
There are now five SGLT-2 Inhibitors that are FDA approved for the treatment of diabetes. The latest one is bexagliflozin (Brenzavvy). We created the chart below to summarize the features and indications of the various SGLT-2i’s. We have also updated our eMedication PocketCard, with this 5th SGLT-2i.
According to TheracosBio, FDA approval of bexagliflozin was based on 23 studies in over 5,000 patients with type 2 diabetes. At a dose of 20mg a day, bexagliflozin decreases A1C by 0.6% to 1.0%, decreases body weight by about 3 kg and drops systolic blood pressure almost 3 mm Hg on average. This treatment can be utilized as a monotherapy or combined with metformin or as an add-on to standard-of-care treatment, including metformin, sulfonylureas, insulin, DPP-IV inhibitors or combinations of all these agents.
GFR cut off of 30: For those with chronic kidney disease, bexagliflozin was safe and well tolerated, however it is not recommended if the eGFR less than 30 mL/min/1.73 m2 and is contraindicated for those on dialysis.
No additional CV benefit data. Bexagliflozin was not found to be superior to placebo in reducing MACE (a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and hospitalization for unstable angina). In a trial that included patients with type 2 diabetes and either established CVD or multiple risk factors for CVD, 10.1% (57/567) of the placebo group experienced 1 MACE event vs 7.9% (89/1132) of the bexagliflozin group. However, while the phase 3 data do not indicate any apparent CVD risk, a robust CVD outcomes trial has not been done.
Lower extremity caution: An increased, although not statistically significant, incidence of lower limb amputations was observed among patients treated with bexagliflozin (8.3 vs. 5.1 events per 1,000 patient-years; HR = 1.64, 95% CI, 0.70, 3.82).
Other warnings in the Package Insert include genital mycotic infections, DKA, volume depletion, urinary tract infections and urosepsis, similar to other SGLT-2 inhibitors. Read more here.
Download eMedication PocketCard
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