Evidence map›Paper›PMID 28378068›Full record

Trial reportClinical and experimental nephrology2017

A minimal impact of long-term S-flurbiprofen plaster application on kidney function in osteoarthritis patients.

Noboru Otsuka, Ikuko Yataba, Isao Matsushita, Hideo Matsumoto, Yuichi Hoshino, Yoshio Terada

Abstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Clinical and experimental nephrology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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

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

  1. Pooled it
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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.

Noboru OtsukaDevelopment Headquarters, Taisho Pharmaceutical Co., Ltd., 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan. n-otsuka@so.taisho.co.jp.ORCID http://orcid.org/0000-0002-9834-8384
Ikuko YatabaDevelopment Headquarters, Taisho Pharmaceutical Co., Ltd., 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.
Isao MatsushitaDevelopment Headquarters, Taisho Pharmaceutical Co., Ltd., 3-24-1 Takada, Toshima-ku, Tokyo, 170-8633, Japan.
Hideo MatsumotoInstitute for Integrated Sports Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Yuichi HoshinoOrthopedics Surgery, School of Medicine, Jichi Medical University, 3111-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.
Yoshio TeradaDepartment of Endocrinology, Metabolism and Nephrology, Kochi Medical School, Kochi University, Kohasu, Oko-cho, Nankoku, Kochi, 783-8505, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe number of kidney injury due to nonsteroidal anti-inflammatory drugs (NSAIDs) is the largest among drug-induced kidney diseases. Newly developed NSAID plaster containing S-flurbiprofen (SFP) shows innovative percutaneous absorption. However, systemic exposure to SFP following the repeated application of 80 mg/day was estimated as comparable to that of oral 120 mg/day flurbiprofen and prolonged use of topical NSAIDs is common in clinical practice. Thus, we report the safety focusing on the kidney function after long-term application of SFP plaster (SFPP).

methodsA total of 201 osteoarthritis patients (mean age; 66.3, 151 females, mean estimated glomerular filtration rate; 74.6 mL/min/1.73 mm

results161 (80.1%) patients completed 52-week application. In both groups of 40 and 80 mg, small but statistically significant increases were observed in BUN (mean 1.91 and 1.89 mg/dL, p < 0.05) and SCr (mean 0.019 and 0.022 mg/dL, p < 0.05). Although abnormal changes in laboratory test for renal function were observed in seven patients, all the changes were small and subclinical. Acute kidney injury was observed in two patients. Meanwhile, the investigators denied the relevance of SFPP according to the clinical course.

conclusionToward the end of 52-week application, a statistically significant increase in SCr was observed in both 40 and 80 mg, but increment was small and subclinical. Attention should be paid to kidney function when applying SFPP to patients with multiple risk factors.

Indexed as

Administration, CutaneousAgedAnti-Inflammatory Agents, Non-SteroidalFemaleFlurbiprofenHumansKidneyMaleMiddle AgedOsteoarthritisProspective StudiesRenal InsufficiencyAnti-Inflammatory Agents, Non-SteroidalFlurbiprofenAcute kidney injuryDrug-induced kidney diseaseKidney functionLong-term safetyNonsteroidal anti-inflammatory drugsS-flurbiprofen

Identifiers

PMID28378068
PMCPMC5698367

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Registered trials

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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.