Evidence map›Paper›PMID 27921320›Full record

Trial reportBritish journal of clinical pharmacology2017

Cardiac effects of amiselimod compared with fingolimod and placebo: results of a randomised, parallel-group, phase I study in healthy subjects.

Tomohiko Harada, Darren Wilbraham, Guillemette de La Borderie, Shinsuke Inoue, Jim Bush, A John Camm

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

Trial report in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 12% 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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
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  3. Single-dose of LC51-0255, a selective S1PClinical and translational science · 2022
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  18. First use of cenerimod, a selective S1PLupus science & medicine · 2019
    Article
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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 at 4 institutions in 2 countries.

Tomohiko HaradaMitsubishi Tanabe Pharma Europe Ltd., Dashwood House, 69 Old Broad Street, London, EC2M 1QS, UK.
Darren WilbrahamMitsubishi Tanabe Pharma Europe Ltd., Dashwood House, 69 Old Broad Street, London, EC2M 1QS, UK.
Guillemette de La BorderieMitsubishi Tanabe Pharma Europe Ltd., Dashwood House, 69 Old Broad Street, London, EC2M 1QS, UK.
Shinsuke InoueMitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, 103-8405, Japan.
Jim BushPrincipal Investigator, Covance CRU Ltd., Springfield House, Hyde Street, Leeds, LS2 9LH, UK.
A John CammCardiovascular and Cell Sciences Research Institute, St. George's University of London, London, SW17 0RE, UK.
Mitsubishi Corporation (United Kingdom) · GBCovance (United Kingdom) · GBMitsubishi Tanabe Pharma CorporationSt George's, University of London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimAmiselimod (MT-1303) is a selective sphingosine 1-phosphate 1 (S1P

methodsA total of 81 healthy subjects aged 18-55 years were equally randomized to receive amiselimod 0.4 mg, amiselimod 0.8 mg, placebo or fingolimod 0.5 mg once daily for 28 days. The chronotropic/dromotropic and inotropic effects were evaluated using intensive Holter electrocardiogram and echocardiography.

resultsUnlike fingolimod, neither amiselimod dose exerted acute (1-6 h) negative chronotropic effects on Days 1 and 2. The lowest nadir mean hourly heart rate was observed on Day 14 in the amiselimod 0.4 mg group (least squares mean difference: -4.40 bpm, 95% confidence interval -7.15, -1.66) and Day 7 in the 0.8 mg group [-3.85 bpm (-6.58, -1.11)] compared with placebo, but these changes were smaller than those with fingolimod on Day 1 [-6.49 bpm (-8.95, -4.02)]. No clinically significant bradyarrhythmia or cardiac functional abnormalities were observed in either amiselimod group. Both amiselimod doses were well tolerated and no serious adverse events were reported. Fingolimod was also generally well tolerated, although one subject was withdrawn owing to highly frequent 2:1 atrioventricular blocks on Day 1.

conclusionThe study demonstrated a more favourable cardiac safety profile for amiselimod than fingolimod when administered over 28 days in healthy subjects.

Indexed as

AdultAtrioventricular BlockDose-Response Relationship, DrugEchocardiographyElectrocardiography, AmbulatoryFingolimod HydrochlorideHeart RateHumansImmunosuppressive AgentsMaleMiddle AgedPropanolaminesReceptors, LysosphingolipidSingle-Blind MethodYoung AdultamiselimodFingolimod HydrochlorideImmunosuppressive AgentsPropanolaminesReceptors, Lysosphingolipidamiselimod (MT-1303)cardiac effectsfingolimodhealthy subjectsphingosine 1-phosphate

Identifiers

PMID27921320
PMCPMC5401982
OpenAlexW2559880118

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.