Evidence map›Paper›PMID 30464579›Full record

ArticleJournal of pain research2018

Response to duloxetine in patients with knee pain due to osteoarthritis: an exploratory post hoc analysis of a Japanese Phase III randomized study.

Naohiro Itoh, Toshinaga Tsuji, Mitsuhiro Ishida, Toshimitsu Ochiai, Shinichi Konno, Yuji Uchio

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of pain research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02248480 (Effect of Duloxetine 60 mg Versus Placebo in Patients With Chronic Osteoarthritis and Knee Pain in Japan), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 35% 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.

NCT02248480 phase3completednot on this map

Effect of Duloxetine 60 mg Versus Placebo in Patients With Chronic Osteoarthritis and Knee Pain in Japan

TypeinterventionalSponsorEli Lilly and CompanyRan2014 to 2015Enrolled354ConditionsOsteoarthritis of the KneeArmsDuloxetine, Placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. 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 3 institutions in 1 country.

Naohiro ItohMedical Affairs Department, Shionogi & Co. Ltd, Osaka, Japan, toshinaga.tsuji@shionogi.co.jp.
Toshinaga TsujiMedical Affairs Department, Shionogi & Co. Ltd, Osaka, Japan, toshinaga.tsuji@shionogi.co.jp.
Mitsuhiro IshidaClinical Development Department, Shionogi & Co. Ltd, Osaka, Japan.
Toshimitsu OchiaiBiostatistics Center, Shionogi & Co. Ltd, Osaka, Japan.
Shinichi KonnoDepartment of Orthopaedic Surgery, Fukushima Medical University, Fukushima, Japan.
Yuji UchioDepartment of Orthopaedic Surgery, Shimane University School of Medicine, Shimane, Japan.
Shionogi (Japan) · JPFukushima Medical University · JPShimane University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess whether patients with knee osteoarthritis pain who have early pain reduction or treatment-related adverse events of special interest (TR-AESIs; constipation, decreased appetite, malaise, nausea, somnolence, thirst) with duloxetine treatment are more likely to have later improvements in pain and quality of life (QOL) relative to placebo than patients without these early indicators. PATIENTS AND

methodsThis was a post hoc analysis of 14-week randomized trial of Japanese patients with knee osteoarthritis pain (Brief Pain Inventory [BPI]-Severity average pain score ≥4) receiving duloxetine 60 mg/day (n=177 analyzed) or placebo (n=176). Primary trial outcome was change from baseline in BPI-Severity average pain at Week 14. Subgroups included early pain reduction (≥30%, 10%-30%, or <10% decrease in BPI-Severity average pain at Week 4) and early TR-AESIs (with/without TR-AESIs by Week 2). Measures included changes from baseline in BPI-Severity average pain, QOL (BPI-Interference, Western Ontario and McMaster Universities Osteoarthritis Index), Patient Global Impression of Improvement (PGI-I), and response rate (proportion achieving ≥30% or ≥50% pain reduction at Week 14).

resultsThe ≥30% early pain reduction subgroup (n=93) had significantly greater improvements in pain, QOL, and PGI-I and higher ≥30% and ≥50% response rates than placebo; the 10%-30% (n=45) and the <10% (n=33) pain reduction subgroups did not show the same (except 10%-30% group: PGI-I at Week 10 and some QOL at Weeks 10 and/or 14). Both TR-AESI subgroups (with, n=52; without, n=125) had significantly greater improvements in pain, PGI-I, and most QOL measures and higher response rates than placebo.

conclusionEarly efficacy responses to duloxetine treatment, but not early TR-AESIs, may predict later pain reduction and QOL improvements in Japanese patients with knee osteoarthritis pain. CLINICALTRIALSGOV: NCT02248480.

Indexed as

Brief Pain Inventoryresponder analysisWOMAC

Identifiers

PMID30464579
PMCPMC6209071
OpenAlexW2898386946

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

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.