Dapagliflozin use in type 1 diabetes: industry, business and ethics
DOI:
https://doi.org/10.15277/bjd.2022.344Keywords:
type 1 diabetes, sodium glucose co-transporter-2 (SGLT-2) inhibitors, dapagliflozinAbstract
We provide a summary on the unprecedented withdrawal of dapagliflozin’s license in Type 1 diabetes by AstraZeneca. We also provide a summary from a national survey of 52 sites in the United Kingdom, with 70% respondents reporting clinically significant benefits following dapagliflozin use in type 1 diabetes. We describe some of the challenges faced by clinicians supporting people with type 1 diabetes using dapagliflozin. This withdrawal, which was solely for commercial reasons and not due to adverse safety events, raises important considerations about ethics and transparency required from the pharmaceutical industry. It also strongly highlights the need for consultation from key stakeholders including clinicians and patient groups prior to such decisions.
References
Type 1 diabetes drug was withdrawn because of a “commercial conflict of interest,” charity argues. BMJ 2022;376:o373. https://doi.org/10.1136/ bmj.o373
Dandona P, Mathieu C, Phillip M et al. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes: The DEPICT-1 52-Week Study. Diabetes Care 2018;41(12):2552–9. https://doi.org/ 10.2337/dc18-1087
Mathieu C, Dandona P, Gillard P et al. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (the DEPICT-2 Study): 24-week results from a randomized controlled trial. Diabetes Care 2018;41(9):1938–46. https://doi.org/10.2337/dc18-0623
Rosenstock J, Marquard J, Laffel LM et al. Empagliflozin as adjunctive to insulin therapy in type 1 diabetes: the EASE trials. Diabetes Care 2018; 41(12):2560–69. https://doi.org/10.2337/dc18-1749
Deeks ED. Sotagliflozin: A review in type 1 diabetes. Drugs 2019; 79(18):1977–87. https://doi.org/10.1007/s40265-019-01230-w
Wiviott SD, Raz I, Bonaca MP et al. Dapagliflozin and cardiovascular Outcomes in type 2 diabetes. N Engl J Med 2019;380(4):347–57. https://doi.org/10.1056/NEJMoa1812389
McMurray JJV, Solomon SD, Inzucchi SE et al. Dapagliflozin in patients with heart failure and reduced ejection fraction. N Engl J Med 2019; 381(21):1995–2008. https://doi.org/10.1056/NEJMoa1911303
Zelniker TA, Wiviott SD, Raz I et al. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet 2019;393(10166):31–39. https://doi.org/10.1016/S0140-6736(18)32590-X
Petrie JR. SGLT2 inhibitors and renal complications in type 1 diabetes. Lancet Diabetes Endocrinol 2020;8(10):803-05. https://doi.org/10.1016/S2213-8587(20)30311-9
EMA Press release 01/02/2019 [Internet] [cited 2022 May 01] Available from:https://www.ema.europa.eu/en/news/first-oral-add-treatment-insulin-treatment-certain-patients-type-1-diabetes
National Institute for Health and Care Excellence (NICE).Dapagliflozin with insulin for treating type 1 diabetes, 2019. Available from: https://www.nice.org.uk/guidance/ta597
Huang Y, Jiang Z, Wei Y. Efficacy and safety of the SGLT2 inhibitor dapagliflozin in type 1 diabetes: A meta-analysis of randomized controlled trials. Exp Ther Med 2021;21(4):382. https://doi.org/10.3892/etm.2021.9813
ABCD announcement regarding SGLT-2 inhibitors in people with type 1 and type 2 diabetes. 07/05/2020.[Internet] [cited 2022 May 01] Available from:https://abcd.care/announcement/abcd-announcement-regarding-sglt-2-inhibitors-people-type-i-and-type-2-diabetes
MHRA. Dapagliflozin (Forxiga): no longer authorised for treatment of type 1 diabetes mellitus. 10/12/2021.[cited 2022 May 01] Available from: https://www.gov.uk/drug-safety-update/dapagliflozin-forxiga-no-longer-authorised-for-treatment-of-type-1-diabetes-mellitus
ABCD announcement: Dapagliflozin (Forxiga): no longer authorised for treatment of type 1 diabetesmellitus. 13/12/2021. [cited 2022 May 01] Available from: https://abcd.care/announcement/dapagliflozin-forxiga-no-longer-authorised-treatment-type-1-diabetes-mellitus
Published
Issue
Section
License
Publish & Transfer of Copyright Agreement
For the mutual benefit and protection of the Author and the Journal Owner/Publisher it is necessary that the Author provides formal written Consent to Publish and Transfer of Copyright before publication of the Work.
