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Adverse Effect Profile and Effectiveness of Sodium Glucose Co-transporter 2 Inhibitors (SGLT2i) - A Prospective
Harmandeep Kaur Gill1, Parjeet Kaur1, Shama Mahendru1
1Division of Endocrinology and Diabetes, Medanta The Medicity, Gurugram, Haryana, India.
Background:
Clinical trials have shown promising results in terms of glycemic control and weight reduction with the use of sodium glucose co-transporter 2 inhibitors (SGLT2i) in type 2 diabetes mellitus (T2DM). However, real-world evidence from standard clinical practice especially from Asia is still limited. The aim of this study was to evaluate the safety and effectiveness of SGLT2i in patients with T2DM in real-world setting.
Methods:
This was a prospective observational longitudinal study involving consecutive patients with T2DM, initiated on SGLT2i from 1 April 2015 to 31 March 2016. The adverse effects and metabolic parameters were evaluated at 3 monthly intervals up to 1 year.
Results:
Total 486 patients were initiated on SGLT2i. At baseline, mean age, glycosylated haemoglobin (HbA1c), and weight was 51.03 ± 9.82 years, 8.76 ± 1.59%, and 89.32 ± 16.04 kg, respectively. Data of 388 patients were available at 6 months of follow-up for analysis of adverse effects profile. About 38.6% patients experienced adverse effects. Genitourinary tract infection was the most common adverse effect (20.6%) followed by generalized weakness (10.5%). Significant reduction in mean weight and HbA1c reduction seen at 6 months (n = 202): 3.2 kg and 1.26%, respectively, and at 12 months (n = 104): 3.9 kg and 1.27%, respectively.
Conclusion:
In this real-world study of patients with T2DM living in hot climate, use of SGLT2i was associated with adverse effects in higher proportion of patients than those reported in clinical trials, but effectiveness was comparable. Patient guidance regarding adequate hydration and hygiene can maximize the benefits of this promising class of drugs.
Insights
Sodium glucose co-transporter 2 inhibitors (SGLT2i) show comparable effectiveness for type 2 diabetes mellitus (T2DM) management in real-world Asian settings. However, adverse effects like genitourinary infections occurred more frequently than in clinical trials.
Area of Science:
- Endocrinology
- Pharmacology
Background:
- Sodium glucose co-transporter 2 inhibitors (SGLT2i) demonstrate efficacy in clinical trials for type 2 diabetes mellitus (T2DM).
- Limited real-world data exists for SGLT2i use in Asian populations.
Purpose of the Study:
- To assess the safety and effectiveness of SGLT2 inhibitors in a real-world setting for T2DM patients in Asia.
- To compare real-world outcomes with findings from clinical trials.
Main Methods:
- Prospective observational longitudinal study.
- Consecutive T2DM patients initiated on SGLT2i between April 2015 and March 2016.
- Adverse effects and metabolic parameters monitored at 3-month intervals for up to 1 year.
Main Results:
- 486 patients initiated on SGLT2i; 388 had data at 6 months.
- Adverse effects reported in 38.6% of patients, primarily genitourinary tract infections (20.6%) and generalized weakness (10.5%).
- Significant reductions in HbA1c (1.26% at 6 months, 1.27% at 12 months) and weight (3.2 kg at 6 months, 3.9 kg at 12 months) were observed.
Conclusions:
- SGLT2i use in T2DM patients in a hot climate was associated with a higher incidence of adverse effects compared to clinical trials.
- The effectiveness of SGLT2i in terms of glycemic control and weight reduction was comparable to clinical trial findings.
- Patient education on hydration and hygiene is crucial for maximizing SGLT2i benefits and mitigating risks.
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