Tolerability and Efficacy of Ipragliflozin in The Management of Inadequately Controlled Type 2 Diabetes mellitus: A Systematic Review and Meta-analysis

Elgebaly, Ahmed; Abdelazeim, Nesrine; Abdelazeim, Bassant; Ashal, Gehad El; Mattar, Omar Mohamed; Namous, Lubaba O; Nasreldin, Noha

doi:10.1055/a-0579-7860

Cited by 8 publications

(15 citation statements)

References 39 publications

(62 reference statements)

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“…The addition of sitagliptin to ipragliflozin was generally well tolerated, with an AE profile consistent with the safety profiles of sitagliptin 7 and ipragliflozin 35 . No additional safety concerns were apparent in this study.…”

Section: Discussionsupporting

confidence: 66%

A randomized, placebo‐controlled trial to assess the efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes and inadequate glycaemic control on ipragliflozin

Seino

Kaku

Kadowaki

et al. 2021

Diabetes Obesity Metabolism

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Aims To investigate the efficacy, safety and tolerability of sitagliptin 50 mg once daily added to ipragliflozin 50 mg once daily monotherapy in Japanese patients with type 2 diabetes (T2D). Materials and Methods Japanese patients with T2D and glycated haemoglobin (HbA1c) 7.0% to 10.0% while treated with ipragliflozin 50 mg once daily were randomized 1:1 to additional treatment with sitagliptin 50 mg once daily (N = 70) or matching placebo (N = 71) for 24 weeks. The primary efficacy endpoint was change in HbA1c at Week 24. Secondary efficacy endpoints were changes in 2‐hour post‐meal glucose (PMG), total PMG 0‐ to 2‐hour area under the curve (AUC0‐2h), and fasting plasma glucose (FPG). Results Baseline characteristics were similar in the two groups (mean age 55.5 years, mean baseline HbA1c 8.0%). After 24 weeks, the addition of sitagliptin provided significantly greater reduction in HbA1c compared to placebo (least squares [LS] mean difference −0.83% [95% confidence interval −1.05, −0.62]; P <0.001). Significant reductions were also observed in all secondary endpoints: LS mean differences from placebo in changes in 2‐hour PMG, total PMG AUC0‐2h, and FPG were −42.5 mg/dL, −67.0 mg·h/dL and −11.2 mg/dL, respectively (all P <0.001). The incidence of adverse events (AEs) overall and incidence of predefined AEs of clinical interest (symptomatic hypoglycaemia, urinary tract infection, genital infection, hypovolaemia and polyuria/pollakiuria) were similar in the two groups. Conclusions In Japanese patients with T2D, sitagliptin 50 mg once daily added to ipragliflozin 50 mg once daily monotherapy provided significant improvement in glycaemic control and was generally well tolerated. ClinicalTrials.gov: NCT02577016.

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Section: Discussionsupporting

confidence: 66%

A randomized, placebo‐controlled trial to assess the efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes and inadequate glycaemic control on ipragliflozin

Seino

Kaku

Kadowaki

et al. 2021

Diabetes Obesity Metabolism

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“…[30][31][32][33][34][35][36][37][38][39][40] In addition, we considered results from published quantitative systematic reviews reporting on various efficacy and safety end points. 7,[41][42][43][44]…”

Section: Clinical Efficacy Of Ipragliflozinmentioning

confidence: 99%

“…34 These results are consistent with previous quantitative systematic reviews which used different eligibility criteria for study inclusion in their meta-analysis. 41,43 For example, Elgebaly et al meta-analysed 13 RCTs (n=2535 patients) and found that ipragliflozin 50mg as monotherapy, compared to placebo, reduced HbA1c by 1.20% (95% CI -1.47, −0.93) and FPG by 1.30 mg/dL (95% CI -1.93, −0.67). Ipragliflozin 50mg as add-on therapy to metformin, sulfonylurea, pioglitazone, and insulin also reduced plasma glucose as measured by HbA1c and FPG.…”

Section: Glycemic Controlmentioning

confidence: 99%

“…Although a 2017 meta-analysis of six trials reported a significant reduction in both systolic and diastolic blood pressures for ipragliflozin 50mg vs placebo, 42 a larger 2018 meta-analysis did not find any differences in blood pressure and was consistent with our findings. 41…”

Section: Blood Pressure Reductionmentioning

confidence: 99%

“…[67][68][69][70] In respect to UTIs, individual RCTs do not suggest an increased risk among ipragliflozin users (Figure S4) which is corroborated by evidence from systematic reviews and meta-analyses. 41,44 Ketone-Related Adverse Events…”

Section: Genital and Urinary Tract Infectionsmentioning

confidence: 99%

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Profile of Ipragliflozin, an Oral SGLT-2 Inhibitor for the Treatment of Type 2 Diabetes: The Evidence to Date

Alkabbani¹,

Gamble²

2021

DDDT

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Background: Sodium-glucose cotransporter-2 (SGLT-2) inhibitors are a novel class of pharmacotherapeutics for type 2 diabetes management that work by reducing renal reabsorption of glucose. Ipragliflozin is a potent, selective SGLT-2 inhibitor used for the management of type 2 diabetes. Objective: The primary aim of this review is to summarize the available evidence on the efficacy and safety of ipragliflozin for the management of type 2 diabetes. We also review the discovery, pharmacokinetic, and pharmacodynamic profile of ipragliflozin. Methods: To inform our review, we searched MEDLINE, International Pharmaceutical Abstracts, and Embase to identify relevant papers to ipragliflozin use in type 2 diabetes. Clinical trial registries were also searched. Results: Findings from randomized clinical trials demonstrate that compared to placebo, ipragliflozin significantly reduces glucose as measured via Hemoglobin A1c and fasting plasma glucose levels. Ipragliflozin is also associated with weight reduction and an improvement in some, but not all, cardiovascular risk markers. Ipragliflozin has a favourable safety profile with a low risk of hypoglycemia and the rates of common adverse events are not significantly different than placebo. Limited data are available to assess rare and long-term adverse effects. Conclusion:Current evidence shows that ipragliflozin is an effective therapeutic option for the management of glucose control in type 2 diabetes. However, no cardiovascular outcome trials have been conducted to date. Real-world observational studies are still needed to accurately capture any possible rare or long-term adverse events.

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Reply to: “Ipragliflozin improves the hepatic outcomes of patients with diabetes with NAFLD”

Kleef

Knegt

2022

Hepatol Commun

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Tolerability and Efficacy of Ipragliflozin in The Management of Inadequately Controlled Type 2 Diabetes mellitus: A Systematic Review and Meta-analysis

Abstract: The presented meta-analysis provides class one evidence that ipragliflozin is safe and effective in the management of T2DM either as monotherapy or an add-on.

Cited by 8 publications

References 39 publications

A randomized, placebo‐controlled trial to assess the efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes and inadequate glycaemic control on ipragliflozin

A randomized, placebo‐controlled trial to assess the efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes and inadequate glycaemic control on ipragliflozin

Profile of Ipragliflozin, an Oral SGLT-2 Inhibitor for the Treatment of Type 2 Diabetes: The Evidence to Date

Reply to: “Ipragliflozin improves the hepatic outcomes of patients with diabetes with NAFLD”

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