Evidence map›Paper›PMID 23114081›Full record

Trial reportTrials2012

Lovastatin for adult patients with dengue: protocol for a randomised controlled trial.

James Whitehorn, Nguyen Van Vinh Chau, Nguyen Thanh Truong, Luong Thi Hue Tai, Nguyen Van Hao, Tran Tinh Hien, Marcel Wolbers, Laura Merson, Nguyen Thi Phuong Dung, Rosanna Peeling and 3 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
8.8field-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

24 citing papers in PubMed, 53 citations in OpenAlex.

  1. Lovastatin for the Treatment of Adult Patients With Dengue: A Randomized, Double-Blind, Placebo-Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
    Trial
  2. Article
  3. Review
  4. Article
  5. Review
  6. Dengue: A Minireview.Viruses · 2020
    Review
  7. A cocrystal structure of dengue capsid protein in complex of inhibitor.Proceedings of the National Academy of Sciences of the United States of America · 2020
    Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Small Molecules and Antibodies for Zika Therapy.The Journal of infectious diseases · 2017
    Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Dengue human infection models supporting drug development.The Journal of infectious diseases · 2014
    Article
  19. Review
  20. 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

13 authors at 4 institutions in 2 countries.

James WhitehornDepartment of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK. james.whitehorn@lshtm.ac.uk
Nguyen Van Vinh Chau
Nguyen Thanh Truong
Luong Thi Hue Tai
Nguyen Van Hao
Tran Tinh Hien
Marcel Wolbers
Laura Merson
Nguyen Thi Phuong Dung
Rosanna Peeling
Cameron Simmons
Bridget Wills
Jeremy Farrar
Hospital for Tropical Diseases · VNUniversity of Oxford · GBLondon School of Hygiene & Tropical Medicine · GBOxford University Clinical Research Unit · VN

Funding

Wellcome Trust 089276Wellcome Trust 097430/Z/11/Z
6 · The paper itself

Abstract

backgroundDengue is the most important vector-borne viral infection of man, with approximately 2 billion people living in areas at risk. Infection results in a range of manifestations from asymptomatic infection through to life-threatening shock and haemorrhage. One of the hallmarks of severe dengue is vascular endothelial disruption. There is currently no specific therapy and clinical management is limited to supportive care. Statins are a class of drug initially developed for lipid lowering. There has been considerable recent interest in their effects beyond lipid lowering. These include anti-inflammatory effects at the endothelium. In addition, it is possible that lovastatin may have an anti-viral effect against dengue. Observational data suggest that the use of statins may improve outcomes for such conditions as sepsis and pneumonia. This paper describes the protocol for a randomised controlled trial investigating a short course of lovastatin therapy in adult patients with dengue. METHODS/

designA randomised, double-blind, placebo-controlled trial will investigate the effects of lovastatin therapy in the treatment of dengue. The trial will be conducted in two phases with an escalation of dose between phases if an interim safety review is satisfactory. This is an exploratory study focusing on safety and there are no data on which to base a sample size calculation. A target sample size of 300 patients in the second phase, enrolled over two dengue seasons, was chosen based on clinical judgement and feasibility considerations. In a previous randomised trial in dengue, about 10% and 30% of patients experienced at least one serious adverse event or adverse event, respectively. With 300 patients, we will have 80% power to detect an increase of 12% (from 10% to 22%) or 16% (from 30% to 46%) in the frequency of adverse events. Furthermore, this sample size ensures some power to explore the efficacy of statins. DISCUSSION: The development of a dengue therapeutic that can attenuate disease would be an enormous advance in global health. The favourable effects of statins on the endothelium, their good safety profile and their low cost make lovastatin an attractive therapeutic candidate.

trial registrationInternational Standard Randomised Controlled Trial Number ISRCTN03147572.

Indexed as

Research DesignDengueDouble-Blind MethodEnglandHumansHydroxymethylglutaryl-CoA Reductase InhibitorsLovastatinSample SizeTime FactorsTreatment OutcomeVietnamHydroxymethylglutaryl-CoA Reductase InhibitorsLovastatin

Identifiers

PMID23114081
PMCPMC3495012
OpenAlexW2164515737

What OpenQuestion holds

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LicenceCC BY
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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.