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DSECT/DSEN Monthly Seminar Series - Jun 24 2021 - Post-marketing observational studies to inform the safety profile of the sodium glucose transporter-2 inhibitors

“Evidence in motion: Post-marketing observational studies to inform the safety profile of the sodium glucose co-transporter-2 inhibitors”

 

Presented by

Dr. JM Gamble PhD RPh

Clinical Associate Professor, School of Pharmacy, University of Waterloo

Thursday, June 24, 2021 3- 4pm EST

 

Abstract: 

 

The sodium glucose co-transporter 2 (SGLT2) inhibitors are effective glucose lowering medications with cardiovascular and renal benefits that are used in the management of type 2 diabetes. Despite these established benefits, numerous safety concerns have emerged. This presentation will use case examples to review the accumulation of scientific evidence for drug safety concerns raised by regulatory agencies after the marketing of SGLT2 inhibitors.

 

Learning Objectives: 

 

  1. To review the complementary nature of evidence from randomized clinical trials and observational studies.
  2. To present the findings from studies on the safety of SGLT2 inhibitors in type 2 diabetes.
  3. To demonstrate the accumulation of evidence over time due in respect to SGLT2 drug safety.

 

Supporting Resources 

  • Alkabbani W, Pelletier RT, Gamble JM. Sodium glucose co-transporter-2 (SGLT2) inhibitors and the risk of diabetic ketoacidosis: comparing evidentiary sources. American Journal of Epidemiology 2021 (online ahead of print). https://doi.org/10.1093/aje/kwab052
  • Pelletier RT, Alkabbani W, NG K, Labib Y, Mourad N, Gamble JM. Adverse Events Associated With Sodium Glucose Co-transporter 2 (SGLT-2) Inhibitors: An Overview of Quantitative Systematic Reviews. Therapeutic Advances in Drug Safety 2021;12:2042098621989132.https://doi.org/10.1177/2F2042098621989134
  • Pelletier RT, Alkabbani W, NG K, Labib Y, Mourad N, Gamble JM. The Association of Sodium Glucose Co-transporter 2 (SGLT-2) Inhibitors and Cancer: An Overview of Quantitative Systematic Reviews. Endocrinology, Diabetes, and Metabolism 2020;3:e00145. https://doi.org/10.1002/edm2.145
  • Donnan JR, Grandy C, Chibrikov E, Marra C, Aubrey-Bassler K, Johnston K, Najafzadeh M, Swab M, Hache J, Curnew D, Nguyen H, Gamble JM. Comparative Safety of the Sodium Glucose Co-transporter (SGLT2) Inhibitors: A systematic review and meta-analysis. BMJ Open 2019;9:e022577. doi: 10.1136/bmjopen-2018-022577
  • Donnan JR, Grandy C, Chibrikov E, Marra C, Aubrey-Bassler K, Johnston K, Najafzadeh M, Swab M, Hache J, Curnew D, Nguyen H, Gamble JM. Dose response of sodium glucose cotransporter-2 inhibitors in relation to urinary tract infections: a systematic review and network meta-analysis of randomized controlled trials. CMAJ Open 2018;6:E594-E602. doi: 10.9778/cmajo.20180111

This session will not be recorded