Efficacy and safety of ipragliflozin as an add-on to pioglitazone in Japanese patients with inadequately controlled type 2 diabetes: a randomized, double-blind, placebo-controlled study (the SPOTLIGHT study)

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

doi:10.1007/s13340-014-0182-y

Cited by 48 publications

(59 citation statements)

References 20 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%

“…These results support those observed in the pre-approval clinical trials of ipragliflozin in younger patients. [2][3][4][5][6][7] The findings of this study should be interpreted in light of its limitations. First, the criteria for renal/hepatic impairment may not have been strictly observed among physicians, because in each case, an individual physician judged the impairment based on laboratory data.…”

Section: Discussionmentioning

confidence: 87%

“…[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%

“…[5] These earlier trials enrolled Japanese patients aged 20-75 years. However, Japan is an aging society with more than 25% of its population aged ≥65 years; moreover, many patients with type 2 diabetes mellitus are of an advanced age.…”

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: Discussionmentioning

confidence: 87%

Section: Safetymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

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

Sodium‐glucose cotransporter 2 inhibitor plus pioglitazone vs pioglitazone alone in patients with diabetes mellitus: A systematic review and meta‐analysis of randomized controlled trials

Liao¹,

Sue

et al. 2018

Endocrino Diabet & Metabol

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Summary Aims To evaluate the efficacy and safety of combined therapy with sodium‐glucose cotransporter 2 (SGLT‐2) inhibitors plus pioglitazone versus pioglitazone alone in type 2 diabetic patients. Materials and Methods Systematic literature searches were performed across PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and clinicaltrials.gov from 1966 to September 2018 to identify randomized, controlled trials. Mean difference (MD) or odds ratio (OR) was used to evaluate efficacy and safety end‐points (active group vs control group), wherever appropriate. Heterogeneity was assessed by P value of χ 2 statistics and I 2 . Results Four randomized controlled trials with 1411 diabetic patients were included. Pooling data from included trials showed that HbA1c change was significantly larger in both low‐dose SGLT‐2 inhibitors (MD: −0.59%, 95% CI: −0.77 to −0.41%) and high‐dose SGLT‐2 inhibitors (MD: −0.65%, 95% CI: −0.78 to −0.53%) plus pioglitazone than pioglitazone alone in 24‐26 weeks. Favourable outcomes were also found in fasting blood glucose level reduction and more patients achieving HbA1c <7% in SGLT‐2 inhibitor plus pioglitazone (OR: 3.21, 95% CI: 1.99 to 5.16). Also, SGLT‐2 inhibitor plus pioglitazone vs pioglitazone, reduced weight and blood pressure. The risks of death, heart failure, hypoglycaemia and urinary tract infection were not different between active and control groups although genital tract infection was more frequently seen in SGLT‐2 inhibitor group. Conclusions Compared to pioglitazone alone, SGLT‐2 inhibitor plus pioglitazone improved glycaemic control, reduced body weight and lowered blood pressure, but increased genital tract infection.

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Effect of SGLT2 inhibitor on renal function in patients with type 2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials

Feng¹,

Minxiang²,

Zheng-yue³

et al. 2019

Int Urol Nephrol

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Efficacy and safety of ipragliflozin as an add-on to pioglitazone in Japanese patients with inadequately controlled type 2 diabetes: a randomized, double-blind, placebo-controlled study (the SPOTLIGHT study)

Cited by 48 publications

References 20 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

Sodium‐glucose cotransporter 2 inhibitor plus pioglitazone vs pioglitazone alone in patients with diabetes mellitus: A systematic review and meta‐analysis of randomized controlled trials

Effect of SGLT2 inhibitor on renal function in patients with type 2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials

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