Tofogliflozin: A highly selective SGLT2 inhibitor for the treatment
of type 2 diabetes

Rosenwasser, Rebecca F; Rosenwasser, Joshua N; Sutton, David; Choksi, Rushab; Epstein, Benjamin J

doi:10.1358/dot.2014.50.11.2232267

Cited by 14 publications

(9 citation statements)

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“…Data from clinical studies have demonstrated that oral administration of SGLT2 inhibitors induces UGE, improves hyperglycemia, and reduces the body weight of patients with T2D [5][6][7]. These SGLT2 inhibitors were developed based on the structure of phlorizin [8].…”

Section: Safety and Tolerability Of The Sglt2 Inhibitor Empagliflozinmentioning

confidence: 99%

Emerging roles of SGLT2 inhibitors in obesity and insulin resistance: Focus on fat browning and macrophage polarization

Ota

2017

Adipocyte

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Obesity-associated low-grade inflammation underlies insulin resistance and associated metabolic comorbidities, such as type 2 diabetes (T2D) and nonalcoholic fatty liver disease. Excessive ectopic fat deposition in obesity causes disorders of energy homeostasis and low-grade chronic inflammation in metabolic tissues. In particular, obesity-induced recruitment and activation of adipose tissue macrophages play a key role in the pathogenesis of insulin resistance and T2D. Therefore, treatment options for energy metabolism and macrophage polarization in obese subjects are needed. Sodium-glucose cotransporter (SGLT) 2 inhibitors increase urinary glucose excretion by inhibiting renal glucose reabsorption, thereby having subsequent anti-hyperglycemic effects and reducing body weight. We recently reported that the SGLT2 inhibitor empagliflozin increases fat utilization and browning in white adipose tissue and attenuates obesity-induced inflammation and insulin resistance by activating M2 macrophages. Thus, this review focuses on the beneficial effects of empagliflozin in energy homeostasis and obesity-related inflammation and insulin resistance.

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Section: Safety and Tolerability Of The Sglt2 Inhibitor Empagliflozinmentioning

confidence: 99%

Emerging roles of SGLT2 inhibitors in obesity and insulin resistance: Focus on fat browning and macrophage polarization

Ota

2017

Adipocyte

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“…Tofogliflozin is a potent and highly selective sodium–glucose cotransporter 2 (SGLT2) inhibitor, and is currently used for the treatment of patients with type 2 diabetes mellitus in Japan. SGLT2 inhibitors exert their antidiabetic effects by inhibiting SGLT2, which is localized in the proximal renal tubule and is responsible for approximately 90% of glucose reabsorption in the kidney.…”

Section: Introductionmentioning

confidence: 99%

“…Tofogliflozin is a potent and highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor [1][2][3] , and is currently used for reabsorption and an increase in urinary glucose excretion results in decreased blood glucose levels 7 .…”

Section: Introductionmentioning

confidence: 99%

Long‐term safety and efficacy of the sodium–glucose cotransporter 2 inhibitor, tofogliflozin, added on glucagon‐like peptide‐1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52‐week open‐label, multicenter, post‐marketing clinical study

Terauchi

Fujiwara

Kurihara

et al. 2019

J of Diabetes Invest

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Aims/IntroductionTofogliflozin is a potent and highly selective sodium–glucose cotransporter 2 inhibitor that is currently used to treat patients with type 2 diabetes mellitus. The aim of the present study was to evaluate the safety and efficacy of tofogliflozin add‐on to glucagon‐like peptide‐1 (GLP‐1) receptor agonist monotherapy.Materials and MethodsIn this 52‐week, prospective, multicenter, single arm, post‐marketing clinical study, Japanese patients who had already been receiving GLP‐1 receptor agonist monotherapy for ≥8 weeks, glycated hemoglobin ≥7.0 and <10.5%, and body mass index ≥18.5 and <35.0 kg/m2 were enrolled. Tofogliflozin 20 mg was orally administered once daily for 52 weeks with GLP‐1 receptor agonist. Primary end‐points were safety and change in glycated hemoglobin from baseline to week 52. Safety was assessed on the basis of the adverse events. Changes from baseline in fasting plasma glucose, bodyweight, blood pressure, uric acid and lipid parameters were assessed as secondary efficacy end‐points.ResultsOf the 67 patients enrolled, 63 patients completed the study. Overall, 26 adverse drug reactions occurred in 17 patients (25.4%). Adverse drug reactions with a frequency of two or more patients (3.0%) were constipation, thirst, dehydration and pollakiuria. Hypoglycemia (n = 1) was limited. With the addition of tofogliflozin to GLP‐1 receptor agonist, the subsequent mean (standard deviation) reduction in glycated hemoglobin was −0.6% (1.0%; P < 0.0001). Fasting plasma glucose, bodyweight and blood pressure were significantly improved.ConclusionsTofogliflozin add‐on to GLP‐1 receptor agonist monotherapy is an effective treatment option with an acceptable safety profile.

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“…Suppression of renal glucose reabsorption and an increase in urinary glucose excretion results in decreased blood glucose levels in an insulin‐independent manner. Tofogliflozin is a potent and highly selective SGLT2 inhibitor with a 2,900‐fold selectivity for SGLT2 over SGLT1. Tofogliflozin was approved in Japan in 2014 for the treatment of type 2 diabetes mellitus as monotherapy or in combination with other antidiabetic agents.…”

Section: Introductionmentioning

confidence: 99%

Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post‐marketing study (J‐STEP/EL Study)

Utsunomiya

Shimmoto

Senda

et al. 2017

J of Diabetes Invest

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Aims/IntroductionAlthough sodium‐glucose cotransporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, they are associated with concerns about specific adverse drug reactions. We carried out a 1‐year post‐marketing study of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus.Materials and MethodsThis was a prospective, observational and multicenter post‐marketing study carried out in the context of routine clinical practice. The study included all type 2 diabetes patients aged ≥65 years who started treatment with tofogliflozin during the first 3 months after its launch on 23 May 2014.ResultsOf 1,535 patients registered, 1,507 patients whose electronic case report forms were collected and who had at least one follow‐up visit were included in the safety analysis. A total of 270 of 1,507 patients (17.92%) had at least one adverse drug reaction to tofogliflozin. The incidences of adverse drug reactions of special interest, namely, polyuria/pollakiuria, volume depletion‐related events, urinary tract infection, genital infection, hypoglycemia and skin disorders were 2.92, 3.85, 2.06, 1.33, 1.06 and 2.39%, respectively. Among those patients evaluable for clinical effectiveness, the mean change in glycated hemoglobin and bodyweight from baseline to last visit was −0.46% (P < 0.0001) and −2.71 kg (P < 0.0001), respectively.ConclusionsThe present study showed that the incidence of adverse drug reactions to tofogliflozin in this study of elderly patients aged ≥65 years differed little from the incidence in the preapproval clinical trials. It was shown that tofogliflozin significantly decreased glycated hemoglobin levels.

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Tofogliflozin: A highly selective SGLT2 inhibitor for the treatment of type 2 diabetes

Cited by 14 publications

References 0 publications

Emerging roles of SGLT2 inhibitors in obesity and insulin resistance: Focus on fat browning and macrophage polarization

Emerging roles of SGLT2 inhibitors in obesity and insulin resistance: Focus on fat browning and macrophage polarization

Long‐term safety and efficacy of the sodium–glucose cotransporter 2 inhibitor, tofogliflozin, added on glucagon‐like peptide‐1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52‐week open‐label, multicenter, post‐marketing clinical study

Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post‐marketing study (J‐STEP/EL Study)

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