Ipragliflozin improves glycemic control in Japanese patients with type 2 diabetes mellitus: the BRIGHTEN study

Kashiwagi, Atsunori; Kazuta, Kenichi; Takinami, Yuusuke; Yoshida, Satoshi; Utsuno, Atsushi; Nagase, Itsuro

doi:10.1007/s13340-014-0164-0

Cited by 78 publications

(107 citation statements)

References 25 publications

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“…previously reported by Yabe et al in an analysis of approved SGLT2 inhibitors (ipragliflozin, dapagliflozin, tofogliflozin and luseogliflozin) from the Japan Medical Data Center Claims Database. [11] Instead, our data on skin complications and the overall safety of ipragliflozin showed similar trends to those observed in the preapproval clinical trials [2][3][4][5][6][7] and there were no cases of Stevens-Johnson syndrome or toxic epidermal necrolysis in the present survey. Regarding AEs/ADRs reported in studies conducted outside of Japan, a pooled analysis of patients aged 18-92 years (mean 56.9 years) found that hypersensitivity-type reactions, which included skin events, occurred in 270/5936 (4.5%) patients, including in 21/1050 (2.0%) Asian patients treated with dapagliflozin for 12-208 weeks.…”

Section: Discussionsupporting

confidence: 86%

“…[2][3][4][5][6][7] The most common ADRs by system organ class in the preapproval trials were renal and urinary disorders (176 patients, 10.55%), investigations (133 patients, 7.97%), gastrointestinal disorders (102 patients, 6.11%), and general disorders and administration site conditions (101 patients, 6.05%). Of the 7170 patients enrolled in this survey, 721 patients (10.06%) experienced 898 ADRs.…”

Section: Safetymentioning

confidence: 99%

“…Several randomized placebo-controlled studies in Japanese patients with type 2 diabetes mellitus have demonstrated that ipragliflozin was effective in terms of improving glycemic control over 12-52 weeks. [2][3][4][5][6][7] In these studies, ipragliflozin was associated with a favorable safety profile, with low rates of mild-to-moderate treatment-emergent adverse events (TEAEs) including genital infection and hypoglycemia.…”

Section: Introductionmentioning

confidence: 99%

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Safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): Interim results of a post-marketing surveillance study

Terauchi

Yokote

Nakamura

et al. 2016

Expert Opinion on Pharmacotherapy

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Objective: To determine the incidence of adverse drug reactions (ADRs) associated with ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus. Research design and methods: We report interim results of a postmarketing surveillance survey. Japanese physicians recorded ADRs in elderly patients (≥65 years old) who were first prescribed with ipragliflozin within 3 months of its launch (April 2014). Main outcome measures: Incidence of ADRs within 1 year of starting treatment with ipragliflozin. Results: 898 ADRs occurred in 721/7,170 patients (10.06%). Skin complication-, volume depletion-, genital infection-, polyuria/pollakiuria-, urinary tract infection-, and hypoglycemia-related ADRs occurred in 2.23%, 1.90%, 1.45%, 1.32%, 0.77%, and 0.32%, respectively. ADRs were classified as serious in 44 (0.61%) patients. Half of the ADRs occurred within 30 days of starting treatment. There were no cases of Stevens-Johnson syndrome or toxic epidermal necrolysis. Most (92.1%) of the ADRs resolved or improved. Glycated hemoglobin, fasting blood glucose, body weight, and systolic blood pressure decreased by 0.6% (baseline 7.8%), 22.7 mg/dL (baseline 163.0 mg/dL), 2.3 kg (baseline 67.4 kg), and 3.1 mmHg (baseline 133.2 mmHg), respectively, from baseline to treatment discontinuation/last visit. Conclusions: Ipragliflozin is well tolerated and reduced surrogate endpoints in elderly Japanese patients with type 2 diabetes mellitus. Clinicaltrials.gov identifier: NCT02297620ARTICLE HISTORY

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Section: Discussionsupporting

confidence: 86%

Section: Safetymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): Interim results of a post-marketing surveillance study

Terauchi

Yokote

Nakamura

et al. 2016

Expert Opinion on Pharmacotherapy

View full text Add to dashboard Cite

show abstract

“…Ipragliflozin was the first SGLT2 inhibitor to be approved in Japan for the treatment of T2DM on the basis of several randomized placebo-controlled studies, which demonstrated that it improved glycemic control when administered as monotherapy or in combination with other oral antidiabetic drugs [2][3][4][5][6][7].…”

Section: Introductionmentioning

confidence: 99%

Real-world evidence for the safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): final results of a post-marketing surveillance study

Yokote

Terauchi

Nakamura

et al. 2016

Expert Opinion on Pharmacotherapy

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Objective: To investigate the real-world safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (T2DM). Research design and methods: Japanese patients (≥65 years old) who were first prescribed ipragliflozin within 3 months after its launch in April 2014 were registered in this post-marketing surveillance (PMS). Final data collection was in July 2015. Survey items included demographics, treatments, adverse drug reactions (ADRs), vital signs, and laboratory variables. Results: The PMS included 8505 patients (4181 males/4324 females). The mean age and diabetes duration were 72.3 years and 10.6 years, respectively. In 84.3% of patients, ipragliflozin was prescribed at 50 mg/day, which was continued unchanged. Overall, 16.91% of patients experienced 1880 ADRs, and 165 ADRs were classified as serious in 127 patients (1.49%). ADRs of special interest included skin complications, volume depletion, polyuria/pollakiuria, genital infection, urinary tract infection, renal disorders, hypoglycemia, cerebrovascular disease, cardiovascular disease, malignant tumor, fracture, and ketone body-related events. Conclusions: This 1-year PMS revealed probable ADRs in elderly Japanese patients with T2DM prescribed ipragliflozin in real-world settings, with no new safety concerns. The risk factors for ADRs varied but could be rationalized. The results should help physicians to identify possible treatment-emergent ADRs in ipragliflozin-treated patients.ARTICLE HISTORY

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“…The following indicates the strengths of this study. First, we showed that ipragliflozin ameliorated the index of hepatic steatosis in humans, although it has been reported that ipragliflozin improves the serum alanine aminotransferase levels in patients with type 2 diabetes [10][11][12]. Second, we investigated whether improvement of obesity or glucose intolerance could influence the FLI changes observed with ipragliflozin treatment.…”

Section: Discussionmentioning

confidence: 97%

Amelioration of fatty liver index in patients with type 2 diabetes on ipragliflozin: an association with glucose-lowering effects

et al. 2017

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Ipragliflozin improves glycemic control in Japanese patients with type 2 diabetes mellitus: the BRIGHTEN study

Cited by 78 publications

References 25 publications

Safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): Interim results of a post-marketing surveillance study

Safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): Interim results of a post-marketing surveillance study

Real-world evidence for the safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): final results of a post-marketing surveillance study

Amelioration of fatty liver index in patients with type 2 diabetes on ipragliflozin: an association with glucose-lowering effects

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