Efficacy and safety of ipragliflozin as an add-on to a sulfonylurea in Japanese patients with inadequately controlled type 2 diabetes: results of the randomized, placebo-controlled, double-blind, phase III EMIT study

Kashiwagi, Atsunori; Akiyama, Nobuyuki; Shiga, Takanori; Kazuta, Kenichi; Utsuno, Atsushi; Yoshida, Satoshi; Ueyama, Eiji

doi:10.1007/s13340-014-0184-9

Cited by 52 publications

(78 citation statements)

References 22 publications

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“…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%

“…However, some TEAEs were more common with certain treatment combinations. For example, pollakiuria and constipation were more common with metformin in combination with ipragliflozin [3], and pollakiuria and thirst were more common with sulfonylurea in combination with ipragliflozin [2] than when metformin or sulfonylurea were administered in combination with placebo.…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Introductionmentioning

confidence: 99%

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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“…In these clinical trials, low-grade TEAEs, including pollakiuria and constipation, were more common in the metformin+ipragliflozin group [2] while pollakiuria and thirst were more common in the sulfonylurea+ipra-gliflozin group [7] than in the placebo groups, but the incidence of TEAEs was not increased in the pioglitazone+ipragliflozin group compared with the placebo group. [5] These earlier trials enrolled Japanese patients aged 20-75 years.…”

Section: Introductionmentioning

confidence: 89%

“…[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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Natural products with SGLT2 inhibitory activity: Possibilities of application for the treatment of diabetes

Moradi‐Marjaneh

Paseban

Sahebkar

2019

Phytotherapy Research

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Diabetes mellitus currently affects as many as 400 million people worldwide, creating a heavy economic burden and stretching health care resources. A dysfunction of glucose homeostasis underlies the disease. Despite advances in the treatment of diabetes, many patients still suffer from complications and side effects; hence, development of more effective treatments for diabetes is still desirable. SGLT2 is the principle cotransporter involved in glucose reabsorption in the kidney. SGLT2 inhibition reduces glucose reabsorption by the kidney and ameliorates plasma glucose concentration. The interest in natural products that can be used for the inhibition of SGLT2 is growing. The flavonoid phlorizin, which can be isolated from the bark of apple trees, has been used as lead structure due to its inhibitory activity of SGLT1 and SGLT2. Some phlorizin-derived synthetic compounds, including canagliflozin, dapagliflozin, empagliflozin, ipragliflozin, and ertugliflozin, are approved by the food and drug administration to treat type 2 diabetes mellitus (T2DM), whereas others are under clinical trials investigation. In addition, other natural product-derived compounds have been investigated for their ability to improve blood glucose control.The present review summarizes the natural products with SGLT2 inhibitory activity, and the synthetic compounds obtained from them, and discusses their application for the treatment of diabetes.

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Efficacy and safety of ipragliflozin as an add-on to a sulfonylurea in Japanese patients with inadequately controlled type 2 diabetes: results of the randomized, placebo-controlled, double-blind, phase III EMIT study

Cited by 52 publications

References 22 publications

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

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

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

Natural products with SGLT2 inhibitory activity: Possibilities of application for the treatment of diabetes

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