Evidence map›Paper›PMID 30702214›Full record

Observational studyJournal of diabetes investigation2019

Safety and efficacy of tofogliflozin in Japanese patients with type 2 diabetes mellitus in real-world clinical practice: Results of 3-month interim analysis of a long-term post-marketing surveillance study (J-STEP/LT).

Kazunori Utsunomiya, Masayuki Senda, Seigo Kakiuchi, Hiroyuki Kameda, Masahiro Tamura, Yuji Kurihara, Ryoji Gunji, Shoko Fujii, Hisataka Fujiwara, Kohei Kaku

Open access · goldAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Journal of diabetes investigation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.8field-weighted citation impact, top 15% of its field
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

7 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Observational
  3. Article
  4. Article
  5. Observational
  6. Observational
  7. 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

10 authors at 4 institutions in 1 country.

Kazunori UtsunomiyaDivision of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.
Masayuki SendaMedical Affairs, Sanofi K.K., Tokyo, Japan.ORCID https://orcid.org/0000-0001-6673-1429
Seigo KakiuchiPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
Hiroyuki KamedaMedical Affairs, Sanofi K.K., Tokyo, Japan.
Masahiro TamuraMedical 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.
Hisataka FujiwaraPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.ORCID https://orcid.org/0000-0001-9439-9283
Kohei KakuDepartment of Medicine, Kawasaki Medical School, Kurashiki, Japan.
Kowa (Japan) · JPSanofi (Japan) · JPJikei University School of Medicine · JPKawasaki Medical School · JP

Funding

Kowa Company, Ltd.Sanofi K.K.
6 · The paper itself

Abstract

AIMS/

introductionThe present study analysis was carried out to evaluate the safety and efficacy of tofogliflozin, a sodium-glucose cotransporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus in real-world clinical practice. MATERIALS AND

methodsThis was a 3-year non-interventional observational study of patients with type 2 diabetes mellitus newly administered tofogliflozin who were uncontrolled on current therapy. We carried out a 12-week interim analysis of tofogliflozin as part of 3-year post-marketing surveillance study. The incidence of adverse drug reactions was evaluated as a safety end-point. As efficacy end-points, glycated hemoglobin and bodyweight were evaluated.

resultsA total of 6,897 patients were enrolled. Tofogliflozin significantly reduced mean changes from baseline glycated hemoglobin (-0.63%, P < 0.0001) and bodyweight (-2.02 kg, P < 0.0001). The change in glycated hemoglobin and bodyweight reductions in response to tofogliflozin was consistently observed in all body mass index subgroups. Adverse drug reactions occurred in 345 of 6,712 patients (5.14%). There was a low incidence of adverse drug reactions known to be associated with sodium-glucose cotransporter 2 inhibitors, and they were reported as non-serious. The incidences of polyuria/pollakiuria were higher in patients aged ≥65 years than <65 years, and were significantly different among estimated glomerular filtration rate subgroups. Urinary tract and genital infections occurred more frequently in women than in men.

conclusionsTofogliflozin was well tolerated, and no emerging new safety concerns were observed. Tofogliflozin significantly improved glycemic control with no impact on bodyweight gain. The short-term administration of tofogliflozin is considered to have a favorable benefit-risk profile in Japanese patients with type 2 diabetes mellitus.

Indexed as

Product Surveillance, PostmarketingAdolescentAdultAgedBiomarkersBlood GlucoseBody Mass IndexBody WeightDiabetes Mellitus, Type 2FemaleFollow-Up StudiesGlucosidesGlycated HemoglobinHumansJapanMaleBiomarkersBlood GlucoseGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanipragliflozinSodium-Glucose Transporter 2 InhibitorsThiophenesPost-marketing studyTofogliflozinType 2 diabetes mellitus

Identifiers

PMID30702214
PMCPMC6717810
OpenAlexW2913267125

What OpenQuestion holds

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LicenceCC BY-NC
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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.