Evidence map›Paper›PMID 28681394›Full record

Trial reportThe Journal of dermatology2017

Amenamevir, a novel helicase-primase inhibitor, for treatment of herpes zoster: A randomized, double-blind, valaciclovir-controlled phase 3 study.

Makoto Kawashima, Osamu Nemoto, Mariko Honda, Daisuke Watanabe, Juichiro Nakayama, Shinichi Imafuku, Toshiyuki Kato, Tsuneo Katsuramaki, study investigators

Abstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of dermatology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
–field-weighted citation impact
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

30 citing papers in PubMed.

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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

9 authors.

Makoto KawashimaDepartment of Dermatology, Tokyo Women's Medical University, Tokyo, Japan.
Osamu NemotoSapporo Skin Clinic, Sapporo, Japan.
Mariko HondaDr Mariko Skin and Dermatology Clinic, Yokohama, Japan.
Daisuke WatanabeDepartment of Dermatology, Aichi Medical University, Aichi, Japan.
Juichiro NakayamaGeneral Medical Research Center, Fukuoka University Faculty of Medicine, Fukuoka, Japan.
Shinichi ImafukuDepartment of Dermatology, Fukuoka University Faculty of Medicine, Fukuoka, Japan.ORCID http://orcid.org/0000-0001-8568-4349
Toshiyuki KatoMaruho Co., Ltd, Kyoto, Japan.
Tsuneo KatsuramakiMaruho Co., Ltd, Kyoto, Japan.ORCID http://orcid.org/0000-0002-9939-8391
study investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Amenamevir is a potent helicase-primase inhibitor and a novel class of antiviral agent other than nucleoside compounds, such as aciclovir, valaciclovir and famciclovir. This study is the first randomized, double-blind, valaciclovir-controlled phase 3 study to evaluate the efficacy and safety of amenamevir in Japanese patients with herpes zoster when treated within 72 h after onset of rash. A total of 751 patients were randomly assigned to receive either amenamevir 400 mg or 200 mg p.o. once daily or valaciclovir 1000 mg three times daily (daily dose, 3000 mg) for 7 days. The primary efficacy end-point was the proportion of cessation of new lesion formation by day 4 ("day 4 cessation proportion"). The day 4 cessation proportions for amenamevir 400 and 200 mg and valaciclovir were 81.1% (197/243), 69.6% (172/247) and 75.1% (184/245), respectively. Non-inferiority of amenamevir 400 mg to valaciclovir was confirmed by a closed testing procedure. Days to cessation of new lesion formation, complete crusting, healing, pain resolution and virus disappearance were evaluated as secondary end-points. No significant differences were observed in any of the treatment groups. Amenamevir 400 and 200 mg were well tolerated as well as valaciclovir. The proportions of patients who experienced drug-related adverse events were 10.0% (25/249), 10.7% (27/252) and 12.0% (30/249) with amenamevir 400 and 200 mg and valaciclovir, respectively. In conclusion, amenamevir 400 mg appears to be effective and well tolerated for treatment of herpes zoster in immunocompetent Japanese patients.

Indexed as

AcyclovirAgedAntiviral AgentsDouble-Blind MethodFemaleHerpes ZosterHumansMaleMiddle AgedOxadiazolesTreatment OutcomeValacyclovirValineAcyclovirAntiviral AgentsASP2151OxadiazolesValacyclovirValineamenamevirhelicase-primase inhibitorherpes zosterrandomized controlled trialvalaciclovir

Identifiers

PMID28681394
PMCPMC5697646

What OpenQuestion holds

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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.