As mentioned in my last blog, I learned about the management of type 2 diabetes mellitus in the fall of 2005 as a third-year professional pharmacy student. If you flash forward to 2018, I often wonder why I complained about having to learn about so many drugs for a disease state. I can only image how current student pharmacists feel about learning about the management of diabetes when I teach the information every Fall semester. As mentioned last month, I update my lecture and study guide to include more drugs that have been approved by the Food and Drug Administration or are very close to approval. One day in December, I was checking email and read that the FDA had approved ertugliflozin (STEGLATRO). I had immediate thoughts of “What? I did not even have this drug on my radar. How did I miss this?”
Prior to December 2017, there were three available SGLT-2 inhibitors – canagliflozin (INVOKANA), dapagliflozin (FARXIGA), and empagliflozin (JARDIANCE). Ertugliflozin or STEGLATRO is the fourth FDA-approved once-daily agent in this class of medications. A SGLT-2 inhibitor has one specific mechanism of action for controlling blood glucose; it inhibits the SGLT-2 transporter in the proximal convoluted tubule, resulting in glucose excretion. There are benefits to SGLT-2 inhibitors, such as reduction in blood pressure and weight loss, due to osmotic diuresis and loss of calories (200-300) through excretion of urine. However, there are disadvantages, such as dehydration in the elderly, urinary tract infections, or genital mycotic infections. In addition, there have been reports of ketoacidosis with SGLT-2 inhibitors among patients with type 1 and type 2 diabetes mellitus.
Here are the key points regarding ertugliflozin:
- Indication: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
- Formulation: Oral tablet
- Strengths: 5 and 15 mg
- Dosing: 5 mg by mouth once daily, allowing for 15 mg as a maximum dose if additional glycemic control is needed
- None for mild to moderate hepatic impairment but has not been studied in patients with severe hepatic impairment (therefore, not recommended)
- None for patients with estimated GFR is ≥ 60 mL/min/1.73m2
- Contraindications: Estimated GFR is < 30 mL/min/1.73m2 or patient is on dialysis and has end-stage renal disease
If ertugliflozin is used, then it could be considered a second- or third-line option in patients with type 2 diabetes mellitus and who have not achieved their glycemic goals.
Ertugliflozin has been studied in six clinical trials regarding its efficacy and safety among patients with type 2 diabetes mellitus. It has been compared to placebo, sitagliptin, and glimepiride. Hemoglobin A1c reduction has ranged from 0.68% to 1.5%; this range may be wide due to trials investigating its use as monotherapy or combination therapy. Weight loss has also ranged from 0.7 to 4.3 kg. It has not been compared to other SGLT-2 inhibitors.
To me, ertugliflozin seems like another “me-too” drug. It is hard to forget that cardiovascular evidence is available regarding empagliflozin (JARDIANCE) and canagliflozin (INVOKANA). If ertugliflozin is used, then it could be considered a second- or third-line option in patients with type 2 diabetes mellitus and who have not achieved their glycemic goals. However, it is important to assure adequate renal function prior to initiation; in addition, the patient should receive thorough education and preventative measures regarding precautions associated with SGLT-2 inhibitors. Cost will remain a big factor as always with any new medications. Overall, it is essential to remember that diabetes management is individualized considering efficacy, tolerability, patient preference and cost for our patients.
So, what do you think of ertugliflozin? What do you think are the advantages of this product? The disadvantages? Have you already recommended its use in clinical practice?
About the Author
Jennifer Clements received her Doctorate of Pharmacy from Campbell University in 2006 and completed a primary care residency at a Veterans Affairs Medical Center in 2007. She is also a certified diabetes educator and board certified in pharmacotherapy. Currently, she is an Associate Professor of Pharmacy Practice at Presbyterian College School of Pharmacy.