Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Steglatro for Adults with T2D

Pfizer news release; 2017 Dec 22

FDA has approved Steglatro (ertugliflozin) oral tablets for the treatment of adults with type 2 diabetes. The approval was granted to Merck and Pfizer Inc.

Indications: Steglatro is a sodium glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dosage and administration: Recommended starting dose is 5 mg once daily, taken in the morning, with or without food. Increase dose to 15 mg once daily in those tolerating Steglatro and needing additional glycemic control. Assess renal function before initiating Steglatro and periodically thereafter.

Adverse reactions: The most common adverse reactions associated with Steglatro (incidence ≤5%) were female genital mycotic infections.

Citation:

FDA approves SGLT2 inhibitor Steglatro (ertugliflozin) for adults with type 2 diabetes. [news release]. Merck, Pfizer: December 22, 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf. Accessed December 24, 2017.

This Week's Must Reads

Screening for Syphilis Infection in Pregnant Women, JAMA; 2018 Sep 4; US Preventive Services Task Force

Treatment Intensification Guidelines for T2D , Ann Intern Med; ePub 2018 Sep 4; Roglic, et al

Immediate vs Gradual Nicotine Reduction in Cigarettes, JAMA; ePub 2018 Sep 4; Hatsukami, et al

Prevalence of Diabetes Among US Adults, BMJ; ePub 2018 Aug 27; Xu, Liu, et al

Effect of Fish Oil Supplementation in Pregnancy, BMJ; ePub 2018 Sep 4; Vinding, Stokholm, et al

Must Reads in Diabetes

Treatment Intensification Guidelines for T2D , Ann Intern Med; ePub 2018 Sep 4; Roglic, et al

Prevalence of Diabetes Among US Adults, BMJ; ePub 2018 Aug 27; Xu, Liu, et al

Aspirin for Primary CV Prevention in Diabetes, N Engl J Med; ePub 2018 Aug 26; ASCEND Study Collaborative Group

Smoking Cessation & Body Weight in T2D, N Engl J Med; 2018 Aug 16; Hu, Zong, et al

CV Mortality Among Adults with Diabetes, Diabetes Care; ePub 2018 Aug 21; Cheng, et al