Evidence map›Paper›PMID 28107773›Full record

Observational studyJournal of diabetes investigation2017

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

Kazunori Utsunomiya, Naoki Shimmoto, Masayuki Senda, Yuji Kurihara, Ryoji Gunji, Shoko Fujii, Seigo Kakiuchi, Hisataka Fujiwara, Hiroyuki Kameda, Masahiro Tamura and 1 more

Abstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Journal of diabetes investigation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed.

  1. Trial
  2. Article
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Observational
  8. Review
  9. Observational
  10. Real-World Effectiveness of Sodium Glucose Co-Transporter-2 Inhibitors in Japanese Patients with Diabetes Mellitus.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019
    Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Kazunori UtsunomiyaDivision of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
Naoki ShimmotoPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
Masayuki SendaMedical Affairs, Sanofi K.K., Tokyo, Japan.
Yuji KuriharaPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
Ryoji GunjiPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
Shoko FujiiPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
Seigo KakiuchiPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
Hisataka FujiwaraPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
Hiroyuki KamedaMedical Affairs, Sanofi K.K., Tokyo, Japan.
Masahiro TamuraDiabetes & Cardiovascular Medical Operations, Sanofi K.K., Tokyo, Japan.
Kohei KakuDepartment of General Internal Medicine 1, Kawasaki Medical School, Kurashiki, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Product Surveillance, PostmarketingAgedBenzhydryl CompoundsDiabetes Mellitus, Type 2FemaleGlucosidesHumansHypoglycemic AgentsJapanMaleSodium-Glucose Transport Proteins6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triolBenzhydryl CompoundsGlucosidesHypoglycemic AgentsSodium-Glucose Transport ProteinsElderlySodium-glucose transporter 2Type 2 diabetes mellitus

Identifiers

PMID28107773
PMCPMC5668483

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.