Evidence map›Paper›PMID 34853985›Full record

ArticleAdvances in therapy2022

Real-World Safety and Effectiveness of Canagliflozin Treatment for Type 2 Diabetes Mellitus in Japan: SAPPHIRE, a Long-Term, Large-Scale Post-Marketing Surveillance.

Nobuya Inagaki, Masaomi Nangaku, Yasushi Sakata, Kazuyo Sasaki, Kazumi Mori-Anai, Tomohisa Iwasaki, Koume Hamada

Open access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 13% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Observational
  3. Article
  4. Article
  5. Article
  6. Observational
  7. Article
  8. Article
  9. Review
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

7 authors at 4 institutions in 1 country.

Nobuya InagakiDepartment of Diabetes, Endocrinology and Nutrition, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Masaomi NangakuDivision of Nephrology and Endocrinology, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.
Yasushi SakataDepartment of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.
Kazuyo SasakiIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, 3-2-10, Dosho-machi, Chuo-ku, Osaka, 541-8505, Japan. sasaki.kazuyo@mh.mt-pharma.co.jp.ORCID http://orcid.org/0000-0001-5267-8284
Kazumi Mori-AnaiIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.ORCID http://orcid.org/0000-0002-7353-4201
Tomohisa IwasakiIkuyaku. Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Koume HamadaQuality and Vigilance Division, Mitsubishi Tanabe Pharma Corporation, Osaka, Japan.
Mitsubishi Group (Japan) · JPKyoto University · JPThe University of Osaka · JPThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis long-term post-marketing surveillance (SAPPHIRE) collected information on the safety and effectiveness of canagliflozin (approved dose 100 mg) prescribed to patients with type 2 diabetes mellitus (T2DM) in real-world practice in Japan.

methodsPatients with T2DM who were prescribed canagliflozin between December 2014 and September 2016 were registered and observed for up to 3 years. Safety was evaluated in terms of adverse drug reactions (ADRs). Effectiveness was assessed in terms of glycaemic control. Data were also analysed across age subgroups (< 65, ≥ 65 to < 75, and ≥ 75 years old) and the estimated glomerular filtration rate (eGFR) categories for chronic kidney disease (G1-G5 based on eGFR) at baseline.

resultsA total of 12,227 patients were included in the safety analyses and 11,675 in effectiveness analyses. Overall, 7104 patients were treated with canagliflozin for ≥ 3 years. The mean age, haemoglobin A1c (HbA1c), and eGFR at baseline were 58.4 ± 12.5 years, 8.01 ± 1.49%, and 80.04 ± 21.85 mL/min/1.73 m

conclusionThis surveillance in real-world clinical practice showed that canagliflozin provides sustained glucose-lowering effects in patients with T2DM, including elderly patients and patients with moderate renal impairment, without new safety concerns beyond those already described in the Japanese package insert.

trial registrationJapicCTI-153048.

Indexed as

CanagliflozinDiabetes Mellitus, Type 2AgedAluminum OxideBlood GlucoseGlycated HemoglobinHumansHypoglycemic AgentsJapanProduct Surveillance, PostmarketingTreatment OutcomeAluminum OxideBlood GlucoseCanagliflozinGlycated HemoglobinHypoglycemic AgentsCanagliflozinJapanPost-marketing surveillanceReal-worldSafetySodium–glucose cotransporter 2 inhibitorType 2 diabetes mellitus

Identifiers

PMID34853985
PMCPMC8799573
OpenAlexW3216012020

What OpenQuestion holds

Texttitle and abstract
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.