Evidence map›Paper›PMID 31197929›Full record

Observational studyJournal of diabetes investigation2020

Safety and effectiveness of tofogliflozin in Japanese patients with type 2 diabetes mellitus in real-world practice: Results of 12-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, Kohei Kaku

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

Observational study in Journal of diabetes investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Observational
  5. 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

9 authors.

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.ORCID https://orcid.org/0000-0002-3464-0669
Ryoji GunjiPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
Shoko FujiiPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
Kohei KakuDepartment of Medicine, Kawasaki Medical School, Kurashiki, Japan.ORCID https://orcid.org/0000-0003-1574-0565

Funding

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

Abstract

AIMS/

introductionDue to the paucity of tofogliflozin data, we assessed the safety and effectiveness of tofogliflozin among Japanese patients with type 2 diabetes mellitus in the clinical setting, stratifying the patients by age, sex, estimated glomerular filtration (eGFR) rate and body mass index. We report the results of a 12-month interim analysis. MATERIALS AND

methodsThis was a 3-year prospective, observational and multicenter post-marketing study (Japanese Study of tofogliflozin with type 2 diabetes mellitus Patients/Long Term).

resultsOut of 6,897 patients enrolled, the safety and effectiveness analysis populations consisted of 6,712 and 6,449 patients, respectively. During 12 months, adverse drug reactions and their incidence were 9.12 and 0.88%, respectively. The incidence of hypoglycemia was 0.67%. Polyuria/pollakiuria occurred more frequently in patients aged ≥65 years than in patients aged <65 years. Women experienced higher rates of urinary tract and genital infection than men. The lowest eGFR subgroup experienced maximum volume depletion-related events. Cardiovascular and cerebrovascular disorders occurred in 0.55% of the patients. Glycated hemoglobin (HbA1c) and bodyweight significantly decreased by -0.76% and -2.73 kg, respectively, from baseline to the last observation carried forward (P < 0.0001). Except for the lowest eGFR subgroup, other eGFR subgroups showed significantly decreased HbA1c values. All eGFR subgroups showed significantly decreased bodyweight, and all body mass index subgroups showed significantly decreased HbA1c and bodyweight.

conclusionsOur interim 12-month data suggest that tofogliflozin could be used safely and effectively in Japanese patients with type 2 diabetes mellitus, as tofogliflozin was well tolerated with low hypoglycemia risk, and significantly improved HbA1c and bodyweight.

Indexed as

Benzhydryl CompoundsBiomarkersBlood GlucoseDiabetes Mellitus, Type 2FemaleFollow-Up StudiesGlucosidesGlycated HemoglobinHumansMaleMiddle AgedPatient SafetyPractice Patterns, Physicians'Product Surveillance, PostmarketingPrognosisProspective Studies6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triolBenzhydryl CompoundsBiomarkersBlood GlucoseGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanSodium-Glucose Transporter 2 InhibitorsPost-marketing studyTofogliflozinType 2 diabetes mellitus

Identifiers

PMID31197929
PMCPMC6944822

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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.