Evidence map›Paper›PMID 28474460›Full record

Trial reportEuropean journal of pain (London, England)2017

Long-term efficacy and safety of oxycodone-naloxone prolonged-release formulation (up to 180/90 mg daily) - results of the open-label extension phase of a phase III multicenter, multiple-dose, randomized, controlled study.

D Dupoiron, A Stachowiak, O Loewenstein, A Ellery, W Kremers, B Bosse, M Hopp

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of pain (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
3.9field-weighted citation impact, top 7% 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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. SEOM clinical guideline for treatment of cancer pain (2017).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2018
    Guideline
  3. Trial
  4. Article
  5. Interpol review of controlled substances 2016-2019.Forensic science international. Synergy · 2020
    Review
  6. Article
  7. 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 5 institutions in 4 countries.

D DupoironDépartement d'Anesthésie - Douleur, Institut de Cancérologie de l'Ouest - Paul Papin, Angers, France.
A StachowiakPallmed sp. z o.o., NZOZ Dom Sue Ryder, Bydgoszcz, Poland.
O LoewensteinGemeinschaftspraxis Löwenstein - Dr. Hesselbarth, Schmerz- und Palliativzentrum DGS Mainz, Mainz, Germany.
A ElleryNHS Kernow Clinical Commissioning Group, Saint Austell, UK.
W KremersMundipharma Research GmbH & Co. KG, Limburg, Germany.
B BosseMundipharma Research GmbH & Co. KG, Limburg, Germany.
M HoppMundipharma Research GmbH & Co. KG, Limburg, Germany.
Mundipharma (Germany) · DEBristol Clinical Commissioning Group · GBInstitut de Cancérologie de l'Ouest · FRNZOZ Dom Sue Ryder · PLPraxis für Humangenetik · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe inclusion of naloxone with oxycodone in a fixed combination prolonged-release formulation (OXN PR) improves bowel function compared with oxycodone (Oxy) alone without compromising analgesic efficacy. In a recent 5-week, randomized, double-blind comparative trial of OXN PR and OxyPR, it could be shown that the beneficial properties of OXN PR extend to doses up to 160/80 mg.

methodsBowel function, pain, quality of life (QoL) and safety of OXN PR up to 180/90 mg daily were evaluated in a 24-week open-label extension phase of the 5-week randomized comparative study in patients with non-malignant or malignant pain requiring opioids and suffering from opioid-induced constipation.

resultsDuring treatment with a mean (SD) daily dose OXN PR of 130.7 (26.56) mg (median, maximum: 120 and 180 mg), the Bowel Function Index (BFI) decreased from 45.3 (26.37) to 26.7 (21.37) with the largest decrease seen in the first week. The average pain over the last 24 h remained stable (median Pain Intensity Scale score 4.0) and QoL was maintained throughout the study. Adverse events were consistent with the known effects of OXN PR and no new safety concerns emerged. Equivalent efficacy and safety benefits were observed in cancer patients.

conclusionsThe OXN PR in doses up to 180/90 mg provides effective analgesia with maintenance of bowel function during long-term treatment. The beneficial effects of such dose levels of OXN PR contribute to stable patient-reported QoL and health status despite serious underlying pain conditions, such as cancer. SIGNIFICANCE: In patients with pain requiring continuous opioid therapy at doses above 80 mg of oxycodone, stable and effective long-term analgesia can be achieved using OXN PR up to 180/90 mg daily without compromising bowel function and may be preferential to supplemental oxycodone.

Indexed as

AdultAgedAged, 80 and overAnalgesics, OpioidConstipationDelayed-Action PreparationsDouble-Blind MethodDrug CombinationsFemaleHumansMaleMiddle AgedNaloxoneOxycodonePainPain ManagementAnalgesics, OpioidDelayed-Action PreparationsDrug CombinationsNaloxoneOxycodone

Identifiers

PMID28474460
PMCPMC5655918
OpenAlexW2611878462

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.