Evidence map›Paper›PMID 35648794›Full record

Trial reportPLoS neglected tropical diseases2022

Efficacy of rupatadine in reducing the incidence of dengue haemorrhagic fever in patients with acute dengue: A randomised, double blind, placebo-controlled trial.

Gathsaurie Neelika Malavige, Chandima Jeewandara, Ananda Wijewickrama, Dumni Gunasinghe, Sameera D Mahapatuna, Chathurika Gangani, Vimalahan Vimalachandran, Geethal Jayarathna, Yashoda Perera, Chandanie Wanigatunga and 8 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 3 pooled it
2.0field-weighted citation impact, top 14% 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

6 citing papers in PubMed, 3 syntheses or guidelines pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Per vaginal bleeding-an important but ignored feature of dengue.medRxiv : the preprint server for health sciences · 2024
    Article
  5. Proceedings of the 5th Asia Dengue Summit.Tropical medicine and infectious disease · 2023
    Article
  6. 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

18 authors at 1 institution in 2 countries.

Gathsaurie Neelika MalavigeFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.ORCID 0000-0001-9201-0449
Chandima JeewandaraFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Ananda WijewickramaNational Institute of Infectious Diseases, Angoda, Sri Lanka.
Dumni GunasingheFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Sameera D MahapatunaFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Chathurika GanganiFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Vimalahan VimalachandranFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Geethal JayarathnaFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Yashoda PereraFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Chandanie WanigatungaFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Harsha DissanayakeFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Shamini PrathapanFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Eranga NarangodaNational Institute of Infectious Diseases, Angoda, Sri Lanka.
Damayanthi IdampitiyaNational Institute of Infectious Diseases, Angoda, Sri Lanka.
Laksiri GomesFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Samurdhi WickramanayakeFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Pramodth SahabanduFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
Graham S OggFaculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
University of Sri Jayewardenepura · LK

Funding

Department of HealthMedical Research Council MC_UU_00008/5
6 · The paper itself

Abstract

backgroundRupatadine was previously shown to reduce endothelial dysfunction in vitro, reduced vascular leak in dengue mouse models and to reduce the extent of pleural effusions and thrombocytopenia in patients with acute dengue. Therefore, we sought to determine the efficacy of rupatadine in reducing the incidence of dengue haemorrhagic fever (DHF) in patients with acute dengue. METHODS AND

findingsA phase 2, randomised, double blind, placebo controlled clinical trial was carried out in patients with acute dengue in Sri Lanka in an outpatient setting. Patients with ≤3 days since the onset of illness were either recruited to the treatment arm of oral rupatadine 40mg for 5 days (n = 123) or the placebo arm (n = 126). Clinical and laboratory features were measured daily to assess development of DHF and other complications. 12 (9.7%) patients developed DHF in the treatment arm compared to 22 (17.5%) who were on the placebo although this was not significant (p = 0.09, relative risk 0.68, 95% CI 0.41 to 1.08). Rupatadine also significantly reduced (p = 0.01) the proportion of patients with platelet counts <50,000 cells/mm3 and significantly reduced (p = 0.04) persisting vomiting, headache and hepatic tenderness (p<0.0001) in patients. There was a significant difference in the duration of illness (p = 0.0002) although the proportion of individuals who required hospital admission in both treatment arms. Only 2 patients on rupatadine and 3 patients on the placebo developed shock, while bleeding manifestations were seen in 6 patients on rupatadine and 7 patients on the placebo.

conclusionsRupatadine appeared to be safe and well tolerated and showed a trend towards a reducing proportion of patients with acute dengue who developed DHF. Its usefulness when used in combination with other treatment modalities should be explored.

trial registrationInternational Clinical Trials Registration Platform: SLCTR/2017/024.

Indexed as

DengueSevere DengueAnimalsCyproheptadineDouble-Blind MethodHumansIncidenceMiceTreatment OutcomeCyproheptadinerupatadine

Identifiers

PMID35648794
PMCPMC9191706
OpenAlexW4281614874

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.