| Title |
Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials
|
|---|---|
| Published in |
Diabetes Therapy, October 2019
|
| DOI | 10.1007/s13300-019-00699-8 |
| Pubmed ID | |
| Authors |
Atsunori Kashiwagi, Marina V. Shestakova, Yuichiro Ito, Masahiro Noguchi, Wim Wilpshaar, Satoshi Yoshida, John P. H. Wilding |
| Abstract |
Ipragliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor approved for the treatment of type 2 diabetes mellitus (T2DM). The objective of this pooled analysis was to characterise the safety profile of ipragliflozin based on safety data from published randomised controlled trials. Safety data from 12 randomised, phase II/III/IV placebo-controlled, parallel group, comparative studies of ipragliflozin in patients with T2DM were pooled. Treatment-emergent adverse events (TEAEs) were analysed for patients who had received at least one dose of ipragliflozin 50 mg (n = 1209) or placebo (n = 796) in studies lasting for up to 24 weeks. TEAEs of special interest and serious adverse events (SAEs) were assessed, as well as abnormal laboratory test and vital sign measurements. The overall incidences of TEAEs and SAEs between the ipragliflozin and placebo groups were similar, 63.8% vs 59.3% and 2.5% vs 3.3%, respectively. The incidence of TEAEs leading to permanent discontinuation was lower for ipragliflozin (3.6%) than placebo (6.5%). The incidences of TEAEs of special interest including those related to urinary tract infection, cardiovascular events, renal disorder, fracture, malignant tumours and hypoglycaemia were also similar between the groups. Genital infections were more frequent with ipragliflozin (2.4%) than placebo (0.6%), as were pollakiuria/polyuria (6.0% vs 2.0%), volume depletion (4.9% vs 1.8%) and skin/subcutaneous tissue disorders (7.7% vs 4.4%). There were no reported cases of diabetic ketoacidosis, fractures, lower-limb amputation or Fournier's gangrene in ipragliflozin-treated patients across the 12 studies. In randomised, placebo-controlled trials of patients with T2DM, ipragliflozin was well tolerated, with a similar overall incidence of TEAEs to placebo. No new safety signals were observed. NCT01071850, NCT00621868, NCT01057628, NCT01117584, NCT01135433, NCT01225081, NCT01242215, NCT02175784, NCT01505426, NCT02452632, NCT02794792, NCT01316094. Astellas Pharma Inc. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Japan | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 66 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 66 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Ph. D. Student | 8 | 12% |
| Student > Bachelor | 5 | 8% |
| Student > Master | 4 | 6% |
| Student > Postgraduate | 4 | 6% |
| Researcher | 4 | 6% |
| Other | 4 | 6% |
| Unknown | 37 | 56% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 17 | 26% |
| Pharmacology, Toxicology and Pharmaceutical Science | 2 | 3% |
| Chemistry | 2 | 3% |
| Nursing and Health Professions | 2 | 3% |
| Immunology and Microbiology | 1 | 2% |
| Other | 6 | 9% |
| Unknown | 36 | 55% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 15 October 2019.
All research outputs
#18,694,159
of 23,168,000 outputs
Outputs from Diabetes Therapy
#749
of 1,041 outputs
Outputs of similar age
#263,694
of 353,809 outputs
Outputs of similar age from Diabetes Therapy
#22
of 30 outputs
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