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Efficacy and Safety of SGLT2 Inhibitors in Pediatric Patients and Young Adults: A Systematic Review and Meta-Analysis
Rafael Dos Santos Borges1, Ana Flávia Conegundes1, Luiza Haikal de Paula1
1Faculty of Medicine, Universidade Federal de Minas Gerais, Avenue Prof. Alfredo Balena, 190-Santa Efigênia, Belo Horizonte-MG, Belo Horizonte 30130-100, Minas Gerais, Brazil.
Insights
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) significantly improve glycemic control in pediatric patients and young adults with type 2 diabetes mellitus (T2DM). This meta-analysis found SGLT2i to be effective and safe, with no significant increase in adverse events compared to placebo.
Area of Science:
- Endocrinology and Metabolism
- Pediatric Diabetes Research
- Pharmacological Interventions
Background:
- Rising incidence of type 2 diabetes mellitus (T2DM) in pediatric populations.
- Unique challenges in managing pediatric T2DM, including glycemic control durability and early complications.
- Limited approved treatment options and comprehensive studies for T2DM in youth.
Purpose of the Study:
- To conduct a meta-analysis evaluating the efficacy and safety of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in pediatric patients and young adults with T2DM.
- To compare SGLT2i treatment against placebo in this specific age group.
- To synthesize current evidence from randomized controlled trials on SGLT2i in youth-onset T2DM.
Main Methods:
- Systematic literature search of PubMed, Embase, Cochrane, and Web of Science for relevant randomized controlled trials.
- Inclusion criteria focused on patients aged 10–24 years with T2DM, comparing SGLT2i to placebo.
- Statistical analysis performed using RevMan 5.4 and R statistical software, with heterogeneity assessed using I statistics.
Main Results:
- Three studies with 334 patients demonstrated a significant reduction in HbA1c levels with SGLT2i compared to placebo (MD = -0.93; p < 0.0001).
- Fewer patients in the SGLT2i group required rescue medication or discontinued treatment due to lack of efficacy (RR = 0.64; p = 0.02).
- No statistically significant differences were observed in the incidence of any adverse events, serious side effects, or individual adverse effects between SGLT2i and placebo groups.
Conclusions:
- Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are effective in improving glycemic control in children, adolescents, and young adults with type 2 diabetes mellitus.
- SGLT2i demonstrated a favorable safety profile in this population, comparable to placebo regarding adverse events.
- These findings support the potential role of SGLT2i as a therapeutic option for managing T2DM in younger individuals.
Abstract:
Introduction: In recent decades, an increase in the incidence of type 2 diabetes mellitus (T2DM) in children and adolescents has been observed. Pediatric-onset T2DM differs from the adult-onset form, particularly regarding the durability of glycemic control and earlier appearance of complications. However, the scarcity of approved treatments and comprehensive studies on T2DM management in youth persists. Ongoing clinical trials seek to ascertain the efficacy and safety of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients aged between 10 and 24 years with T2DM. Therefore, we aimed to perform a meta-analysis exploring the efficacy and safety of SGLT2i in pediatric patients and young adults with T2DM. Methods: We searched PubMed, Embase, Cochrane, and Web of Science for randomized controlled clinical trials on the efficacy and safety of SGLT2i in children, adolescents, and young adults with T2DM compared with placebo. Statistical analysis was performed using RevMan 5.4 and R statistical software 4.2.1. Heterogeneity was assessed with I2 statistics. Results: We included three studies totaling 334 patients followed for 37.79 weeks. Reduction in HbA1C (MD = -0.93; 95% CI = -1.36 to -0.49; p < 0.0001; I2 = 0%) was significantly higher in SGLT2i group compared with placebo. The proportion of patients requiring rescue or discontinuation of study medication due to lack of efficacy was statistically lower in SGLT2i group compared with placebo (RR = 0.64; 95% CI = 0.43-0.94; p= 0.02; I2 = 0%). SGLT2i and placebo were similar in terms of any adverse event (RR = 1.10; 95% CI = 0.96-1.27; p= 0.17; I2 = 0%), serious side effects (RR = 1.06; 95% CI = 0.44-2.57; p=0.90; I2 = 0%), and individual adverse effects. Conclusion: In children, adolescents, and young adults with T2DM, SGLT2i appears to be effective and safe for glycemic control.
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