Evidence map›Paper›PMID 33258068›Full record

ArticleDrug safety2021

Evaluation of Opioid Overdose Reports in Patients Treated with Extended-Release Naltrexone: Postmarketing Data from 2006 to 2018.

Priya Jain, Kimberley McKinnell, Rose Marino, Prashanthi Vunnava, Marie A Liles-Burden, Avani Desai, Madé Wenten, James Fratantonio, Sarah C Akerman, Maria A Sullivan and 1 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.1field-weighted citation impact, top 19% 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, 7 citations in OpenAlex.

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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

11 authors at 1 institution in 1 country.

Priya JainAlkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA.
Kimberley McKinnellAlkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA.
Rose MarinoAlkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA.
Prashanthi VunnavaAlkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA.
Marie A Liles-BurdenAlkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA.
Avani DesaiAlkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA.
Madé WentenAlkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA.
James FratantonioAlkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA.
Sarah C AkermanAlkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA.
Maria A SullivanAlkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA.
Gary BloomgrenAlkermes, Inc., 852 Winter Street, Waltham, MA, 02451, USA. Gary.Bloomgren@alkermes.com.ORCID http://orcid.org/0000-0002-5519-7256
Alkermes (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAfter treatment with naltrexone extended-release injectable suspension (XR-NTX), a µ-opioid receptor antagonist, opioid tolerance is reduced from pretreatment baseline. Patients may be vulnerable to opioid overdose if they attempt to override the blockade during treatment, at the end of a dosing interval, after missing a dose, or after discontinuing treatment.

objectiveWe analyzed postmarketing data to characterize reporting rates of opioid overdose during treatment with and after discontinuation of XR-NTX.

methodsPostmarketing adverse event reports within the XR-NTX safety database, received 2006-2018, for patients treated with XR-NTX for any indication were reviewed for opioid overdose cases. Assessable cases were categorized by timing of the event from the last dose of XR-NTX (latency): ≤28 days (on treatment), 29-56 days, and >56 days from last dose of XR-NTX. Within each latency group, cases were further classified as serious and, of those, cases that had a fatal outcome.

resultsDuring the 12-year period, an estimated 495,602 patients received XR-NTX. Opioid overdose was reported in 161 cases; of these, 66 contained sufficient information to determine latency. Reporting rates of opioid overdose per 10,000 patients treated were similar among latency groups: 0.54 for ≤28 days (0.24 fatal), 0.34 for 29-56 days (0.16 fatal), and 0.44 for >56 days (0.40 fatal) from the last dose of XR-NTX.

conclusionsOver the 12-year period, the reporting rates of opioid overdose were similar during treatment with or after discontinuation of XR-NTX and <10/10,000 patients exposed. Our findings are limited by the nature of spontaneously reported safety data.

Indexed as

Opiate OverdoseOpioid-Related DisordersAnalgesics, OpioidDelayed-Action PreparationsDrug ToleranceHumansInjections, IntramuscularNaltrexoneNarcotic AntagonistsAnalgesics, OpioidDelayed-Action PreparationsNaltrexoneNarcotic Antagonists

Identifiers

PMID33258068
PMCPMC7892734
OpenAlexW3110435433

What OpenQuestion holds

Textmetadata
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.