Bexagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, for improvement of glycemia in type 2 diabetes mellitus: a systematic review and meta-analysis

ABSTRACT

Objectives

This study assessed the clinical safety and efficacy of bexagliflozin, a sodium-glucose cotransporter 2(SGLT2) inhibitor, in managing glycemia among patients with type 2 diabetes mellitus (T2DM).

Areas covered

We examined RCTs with T2DM comparing the clinical effectiveness and safety of 20 mg once daily oral dose of bexagliflozin with placebo for managing glycemia till 28 May 2023, published on databases like ClinicalTrials.gov, PubMed, Embase, and Cochrane Library. Furthermore, reduction of body weight, fasting plasma sugarr(FPG), systolic blood pressure (SBP) and the percentage of individuals who achieved glycated hemoglobin (HbA1c) of < 7% from baseline were also evaluated. The Review Manager 5 was utilized to investigate the retrieved data.

Expert opinion

We involved eight RCTs. Bexagliflozin was significantly superior in reducing HbA1c[least squares mean difference(LSMD) = -0.45,95% confidence interval (CI =-0.55 to −0.34,p < 0.00001], FPG [LSMD= −1.37, 95%CI =-1.73 to −1.00, p < 0.00001], body weight (LSMD= −1.77, 95%CI =-2.44 to-1.10, p < 0.00001), and SBP(LSMD= −4.11,95%CI = -6.18 to −2.03,p = 0.0001) in comparison to placebo. The safety outcomes of bexagliflozin were consistent with the placebo arm. This study concluded that bexagliflozin seems to be a promising oral anti-diabetic drug for enhancing glycemic management in adult patients with T2DM.

Plain Language Summary

Bexagliflozin, a novel hypoglycemic agent, is an extremely effective SGLT2 inhibitor developed by TheracosBio to manage glycemia in T2DM. The United States Food and Drug Administration (USFDA) granted first approval of bexagliflozin on 20 January 2023, for usage as an adjunctive therapy agent alongside lifestyle changes and exercise in T2DM. All included RCTs have investigated the therapeutic efficacy and safety of bexagliflozin 20 mg concerning glycemic and extra-glycemic effects in T2DM. Bexagliflozin 20 mg significantly reduces HbA1c, FPG (glycemic effect), body weight, and SBP (extra-glycemic effect) compared to the placebo arm in T2DM. Safety data show that bexagliflozin was comparable to placebo arm and polyuria, urinary tract infection (UTI), nasopharyngitis or upper respiratory tract infection (URTI), hypoglycemia, nausea, and diarrhea were the most common non-serious adverse effects. Bexagliflozin 20 mg seems to be an effective SGLT2 inhibitor compared to the placebo arm to manage glycemia in patients with T2DM along with favorable extra-glycemic effects.

KEYWORDS:

• Bexagliflozin
• SGLT2 inhibitor
• type 2 diabetes mellitus
• glycemia
• systolic blood pressure
• body mass index

Declarations of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

S Dholariya, S Dutta, and R Singh were engaged in the study’s conceptualization and design, collecting and interpreting data, preparation of the initial draft manuscript, and statistical analysis of the findings. D Parchwani, A Sonagra, and M Kaliya were involved in the manuscript’s critical editing for important intellectual content. All authors have provided final approval and agreed to be held accountable for all parts of the work to ensure accuracy and authenticity.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14656566.2023.2269854

Additional information

Funding

This paper was not funded.