Evidence map›Paper›PMID 32034997›Full record

Observational studyJournal of diabetes investigation2020

Safety and effectiveness of tofogliflozin in Japanese patients with type 2 diabetes mellitus: Results of 24-month interim analysis of a long-term post-marketing study (J-STEP/LT).

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

Open access · goldAbstract 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 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 21% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Observational
  8. 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 UtsunomiyaCenter for Preventive Medicine, The Jikei University School of Medicine, Tokyo, Japan.
Seigo KakiuchiPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.ORCID https://orcid.org/0000-0002-2293-1100
Masayuki SendaPost Marketing Clinical Research, Sanofi K.K., Tokyo, Japan.ORCID https://orcid.org/0000-0001-6673-1429
Shoko FujiiPost Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.ORCID https://orcid.org/0000-0002-6029-5643
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.ORCID https://orcid.org/0000-0002-4241-9657
Ryusuke KoshidaMedical Affairs, Sanofi K.K., Tokyo, Japan.ORCID https://orcid.org/0000-0003-4726-7282
Hiroyuki KamedaPost Marketing Clinical Research, Sanofi K.K., Tokyo, Japan.
Masahiro TamuraPost Marketing Clinical Research, Sanofi K.K., Tokyo, Japan.
Kohei KakuKawasaki Medical School, Kurashiki, Japan.ORCID https://orcid.org/0000-0003-1574-0565
Kowa (Japan) · JPSanofi (Japan) · JPJikei University School of Medicine · JPKawasaki Medical School · JP

Funding

Kowa Company, LtdSanofi K.K
6 · The paper itself

Abstract

AIMS/

introductionTofogliflozin is a potent and highly selective sodium-glucose cotransporter 2 inhibitor, and is currently used to treat patients with type 2 diabetes mellitus. We designed a 3-year study of tofogliflozin in patients with type 2 diabetes mellitus to evaluate the safety and effectiveness in routine clinical practice. The 3- and 12-month interim analysis showed tofogliflozin was well-tolerated, safe and clinically effective. Here, we report the results of the 24-month interim analysis. MATERIALS AND

methodsThis is a 3-year prospective, observational and multicenter post-marketing study (Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients/Long Term).

resultsOf the 6,897 patients enrolled, 6,712 and 6,461 patients were analyzed for the safety and effectiveness of tofogliflozin, respectively. During the 24-month observation period, the incidence rates of adverse drug reactions (ADRs) and serious adverse drug reactions were 11.25 and 1.21%, respectively. As to adverse drug reactions of special interest, the incidence rates of hypoglycemia, polyuria/pollakiuria, volume depletion-related events, urinary tract infections and genital infection were 0.83, 1.28, 1.46, 1.18 and 1.62%, respectively. Renal disorders, and cardiovascular and cerebrovascular disorders occurred in 0.63 and 0.76% of the patients, respectively. Glycated hemoglobin A1c and bodyweight decreased significantly by -0.70% (P < 0.0001) and -2.95 kg (P < 0.0001), respectively, from baseline to week 104 (last observation carried forward).

conclusionsSignificant safety concerns have not been observed, and clinical benefit including a long-term reduction in glycated hemoglobin A1c over a 104-week (24 months) observation period with weight loss was suggested in this 24-month interim analysis of the 3-year Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients/Long Term in routine clinical practice.

Indexed as

AgedBenzhydryl CompoundsDiabetes Mellitus, Type 2FemaleGlucosidesGlycated HemoglobinHumansJapanMaleMiddle AgedProduct Surveillance, PostmarketingProspective StudiesSodium-Glucose Transporter 2 InhibitorsTreatment OutcomeWeight Loss6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triolBenzhydryl CompoundsGlucosidesGlycated Hemoglobinhemoglobin A1c protein, humanSodium-Glucose Transporter 2 InhibitorsPost-marketing studySodium-glucose transporter 2Tofogliflozin

Identifiers

PMID32034997
PMCPMC7378444
OpenAlexW3005098433

What OpenQuestion holds

Textmetadata
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.