Effectiveness and safety of sodium–glucose co-transporter-2 inhibitors in Thai adults with type 2 diabetes mellitus: a real-world study

Abstract

Background

Sodium–glucose co-transporter-2 inhibitors (SGLT2is) are widely used to improve both glycemic control and cardio-renal outcomes. We aim to evaluate the real-life clinical effectiveness, safety and outcomes of SGLT2is in Thai adults with type 2 diabetes mellitus (T2DM).

Methods

This was a retrospective study involving adults with T2DM who were treated with SGLT2is for ≥3 months.

Results

Among 1159 participants (women 52.6%; age: 61.1 ± 10.9 years; body mass index: 28.7 ± 5.2 kg/m²), 65.1%, 34.3% and 0.6% received dapagliflozin, empagliflozin and canagliflozin, respectively. Median SGLT2i treatment duration was 15 (IQR, 8–23) months. Of the patients, 16.5%, 6.4%, 4.9% and 1.6% had pre-existing coronary artery disease, stroke, heart failure and peripheral arterial disease, respectively. Mean HbA1c decreased by 0.7% (95% CI, −1.0 to −0.4) from a baseline of 8.3 ± 1.5%. At 24 months, body weight, and systolic and diastolic blood pressure decreased significantly from the baseline average of 2.5 kg, 3.5 mmHg and 2.4 mmHg, respectively. The median decline in eGFR was −1.3 ml/min/1.73 m²/year. The incidences of pollakiuria, genital tract infection, urinary tract infection and hypoglycemia were 7.2%, 2.8%, 2.2% and 0.9%, respectively. No participants developed diabetic ketoacidosis during the observation period.

Conclusions

SGLT2is improved cardiometabolic parameters in Thai adults, clinically confirming findings in controlled trials.

Keywords:

• Asian
• cardiovascular
• diabetic ketoacidosis
• kidney
• sodium–glucose co-transporter-2 inhibitors
• type 2 diabetes mellitus

Data availability statement

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Transparency

Declaration of funding

Sponsorship for this study was provided by AstraZeneca (KS). The funder had no role in the study design, data collection and analysis. All authors had access to all of the results in this study and take complete responsibility for the integrity of the data and the accuracy of the data analysis.

Declaration of financial/other relationships

No potential conflict of interest was reported by C.S., Y.T., S.B., N.Y., W.U., L.L. or T.H. K.S. has disclosed that he has received a research grant from AstraZeneca. A peer reviewer on this manuscript discloses consulting for AstraZeneca. The remaining peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole and have given their approval for this version to be published. Author contributions were as follows: design: C.S., Y.T. and S.B.; data collection: C.S., Y.T., S.B., N.Y., W.U., L.L. and T.H.; analysis and manuscript writing: C.S., Y.T., S.B. and K.S. All authors reviewed and approved the final manuscript.

Acknowledgements

We thank Jane Charbonneau DVM from Edanz Group (www.edanzediting.com/ac) for editing a draft of this manuscript.

Previous presentation

Part of this manuscript was presented as a poster presentation (abstract) at the International Diabetes Federation Congress 2019; 2019 Dec 2–6; Busan, South Korea.

Compliance with ethics guidelines

The study was approved by the Ethical Committee from each participating medical center. The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. As the study only used existing data in the databases, written informed consent was not required. Clinical trial registration was not required for this study because it was not a prospective study and did not involve any intervention.