A recent study on horses using Velagliflozin entitled, “The sodium-glucose co-transporter 2 inhibitor velagliflozin reduces hyperinsulinemia and prevents laminitis in insulin-dysregulated ponies,” conducted by Queensland University of Technology, was paid for by the drug Velagliflozin’s maker – Boehringer Ingelheim Vetmedica of Germany.[i] It was not a fully independent study. Boehringer also makes another Sodium-glucose Cotransporter-2 (SGLT2) inhibitor drug called Empagliflozin which has the trade name Jardiance. Velagliflozin and Empagliflozin are both SGLT2 drugs.
The main action of these SGLT2 drugs is for type 2 diabetic people with high glucose – the drug helps in exporting glucose out in the urine. Horses with insulin resistance (IR) have normal glucose levels and high insulin levels. So giving this drug to a horse with normal glucose levels has unknown side effects.
The study on horses is not being forthcoming with the results. The horses had a mean of 149 uIV/ml insulin on Velagliflozin which is a major problem – this is 148% ABOVE the 60 uIV/ml maximum in glucose challenge testing in normal horses. Yes, the insulin was reduced from initial levels, but it went from sky high to very high – not to normal level -- not to a place where high insulin is not still creating damage. Many horses with insulin of 61 to 149 have foot pain and fat deposits. This disappointing result was after eight weeks on Velagliflozin.
FDA Warnings - Why Put Your Horse at Risk?
In humans on SGLT2 medications, urinary issues are a big problem seen in this class – which includes genital gangrene and fungal infections. In this horse study, the researchers did not do cultures and they did not do urinalysis of any horses.
The U.S. Food & Drug Administration (FDA) issued postmarket drug safety information for patients and providers on SGLT2 inhibitors in August 2018.[ii] In this report, the FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes.[iii] It also warns that SGLT2 drugs can create bone mineral density loss leading to increased bone fractures, and more foot and leg amputations. So, why put your horse at this risk? In regards to Empagliflozin SGLT-2 medication in the same class as Velagliflozin and made by the same company, there are warnings about acute kidney problems and dehydration due to more water loss from more frequent urination.[iv]
The cost associated with Empagliflozin is approximately $442 per year per person. A horse is five to six times larger than a person. Therefore, the cost per year to treat a horse is estimated at $2210 to $2652 -- to still be 148 percent above normal insulin levels on glucose challenge?
Meier A, Reiche D, de Laat M, Pollitt C, Walsh D, Sillence M (2018) The sodium-glucose cotransporter 2 inhibitor velagliflozin reduces hyperinsulinemia and prevents laminitis in insulin-dysregulated ponies. PLoS ONE 13(9): e0203655. https://doi.org/10.1371/journal.pone.0203655
[ii] https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/sodium-glucose-cotransporter-2-sglt2-inhibitors
[iii] FDA Warning: Fournier Gangrene and SGLT2 Inhibitors Daniel D. Dressler, MD, MSc, SFHM, FACP reviewing Bersoff-Matcha SJ et al. Ann Intern Med 2019 May 7