Evidence map›Paper›PMID 26770729›Full record

ArticleSAGE open medicine2014

Long-term post-marketing surveillance of mizoribine for the treatment of lupus nephritis: Safety and efficacy during a 3-year follow-up.

Nobuyuki Yagi, Kenya Okada, Yohei Sudo, Hiromichi Itoh, Hisao Yoshida, Tatsuhiko Kuroda

Open access · goldAbstract read
In one paragraph

Article in SAGE open medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 42% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
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

6 authors at 1 institution in 1 country.

Nobuyuki YagiScientific Affairs Department, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Kenya OkadaPost-Marketing Surveillance Department, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Yohei SudoScientific Affairs Department, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Hiromichi ItohScientific Affairs Department, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Hisao YoshidaPost-Marketing Surveillance Department, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Tatsuhiko KurodaPost-Marketing Surveillance Department, Asahi Kasei Pharma Corporation, Tokyo, Japan.
Asahi Kasei (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine the safety and efficacy of long-term use of mizoribine by undertaking a 3-year post-marketing surveillance study.

methodsSubjects were all lupus nephritis patients newly treated with mizoribine between 1 October 2003 and 30 September 2005 at contracted study sites.

resultsMizoribine was administered to 881 lupus nephritis patients in the safety analysis set consisting of 946 patients recruited from 281 contracted study sites after satisfying the eligibility criteria. There were 301 events of adverse drug reactions that were observed in 196 (20.7%) of the 946 subjects. There were 34 events of serious adverse drug reactions in 31 patients (3.2%). No deterioration in hematological and biochemical test values was observed, but immunological testing showed significant improvements in C3, CH50, and anti-DNA antibody titers. The negative rate of proteinuria also increased over time. The median steroid dosage was 15 mg/day at the commencement of treatment, but was reduced to 10 mg/day at 12 months and 8 mg/day at 36 months.

conclusionThe findings of the 3-year long-term drug use surveillance study indicated that mizoribine can be used over the long term with relatively few adverse drug reactions, suggesting its suitability for use in maintenance drug therapy.

Indexed as

long-term post-marketing surveillanceLupus nephritismizoribinesteroid sparing effect

Identifiers

PMID26770729
PMCPMC4607187
OpenAlexW1981619950

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.