Evidence map›Paper›PMID 18548827›Full record

Trial reportSleep2008

Two randomized placebo-controlled trials to evaluate the efficacy and tolerability of mirtazapine for the treatment of obstructive sleep apnea.

Nathaniel S Marshall, Brendon J Yee, Anup V Desai, Peter R Buchanan, Keith K H Wong, Renee Crompton, Kerri L Melehan, Nadene Zack, Srinivas G Rao, R Michael Gendreau and 2 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Sleep, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
7.8field-weighted citation impact, top 2% 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

31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 216 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Drug therapy for obstructive sleep apnoea in adults.The Cochrane database of systematic reviews · 2013
    Pooled it
  4. Trial
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  8. Trial
  9. Review
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  11. Review
  12. Article
  13. Review
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  15. Obstructive sleep apnea.Handbook of clinical neurology · 2022
    Review
  16. Review
  17. Article
  18. Article
  19. Obstructive sleep apnea: current perspectives.Nature and science of sleep · 2018
    Review
  20. Impact of concomitant medications on obstructive sleep apnoea.British journal of clinical pharmacology · 2017
    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

12 authors at 2 institutions in 2 countries.

Nathaniel S MarshallNHMRC Centre for Sleep Medicine, Woolcock Institute of Medical Research, University of Sydney, NSW Australia.
Brendon J Yee
Anup V Desai
Peter R Buchanan
Keith K H Wong
Renee Crompton
Kerri L Melehan
Nadene Zack
Srinivas G Rao
R Michael Gendreau
Jay Kranzler
Ronald R Grunstein
Cypress College · USUniversity of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveMirtazapine is an a2A antagonist and mixed 5-HT2/5-HT3 antagonist that has been proposed as a potential treatment for obstructive sleep apnea (OSA). A small, randomized, controlled trial has previously found an approximate halving in the severity of OSA with daily doses of 4.5 and 15 mg. We aimed to confirm and extend these findings in 2 randomized placebo-controlled, proof-of-concept trials.

methodsTwo randomized, double-blind, placebo-controlled trials of mirtazapine for OSA (apnea-hypopnea index 10-40/h). Study 1: 3-way crossover, dose-finding study testing the self-administration of mirtazapine (7.5, 15, 30, and/or 45 mg) or placebo 30 minutes prior to bedtime for 2 weeks at each dose. Twenty patients were randomly assigned to 1 of 6 different dose-sequence groups, with each patient exposed to a maximum of 3 doses. Study 2: 3-arm, randomized, parallel-group trial of mirtazapine at 15 mg or mirtazapine 15 mg + Compound CD0012 or placebo for 4 weeks in 65 patients with OSA.

resultsTwo patients withdrew from Study 1 after complaints of unacceptable lethargy. Fifteen patients were withdrawn from study 2, 7 after complaints of unacceptable lethargy or other side-effects. No measurement of sleep apnea improved due to mirtazapine in either study. Weight gain was significantly greater on mirtazapine than on placebo in both trials.

conclusionsMirtazapine did not improve sleep apnea in either trial. Mirtazapine caused weight gain, which may further worsen OSA. Therefore, mirtazapine is not recommended for the treatment of OSA.

Indexed as

Drug ToleranceAdultCross-Over StudiesDouble-Blind MethodFemaleHistamine H1 AntagonistsHumansHypnotics and SedativesMaleMianserinMirtazapinePolysomnographySleep Apnea, ObstructiveSleep, REMTreatment OutcomeHistamine H1 AntagonistsHypnotics and SedativesMianserinMirtazapine

Identifiers

PMID18548827
PMCPMC2442407
OpenAlexW1513458054

What Socratic holds

Textmetadata
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 Socratic graph.