Journal article
Efficacy and Safety of Oral Pleconaril for Treatment of Colds Due to Picornaviruses in Adults: Results of 2 Double-Blind, Randomized, Placebo-Controlled Trials
Clinical infectious diseases, Vol.36(12), pp.1523-1532
06/15/2003
DOI: 10.1086/375069
PMID: 12802751
Abstract
Abstract The novel capsid-binding antiviral pleconaril inhibits in vitro replication of most rhinoviruses and enteroviruses. Oral pleconaril treatment was studied in 2 parallel randomized, double-blind, placebo-controlled trials. Among 1363 picornavirus-infected participants (65%) in the studies combined, the median time to alleviation of illness was 1 day shorter for pleconaril recipients than for placebo recipients (P > .001). Cold symptom scores and frequency of picornavirus cultured from nasal mucus specimens were lower among pleconaril recipients by day 2 of treatment. No treatment effects were seen in those without picornavirus infection. Pleconaril was associated with a higher incidence of nausea (6% vs. 4%) and diarrhea (9% vs. 7%) and with small increases in mean serum cholesterol levels and platelet counts, compared with baseline measurements. A subsequent 6-week prophylaxis study found that pleconaril induces cytochrome P-450 3A enzymes, which metabolize a variety of drugs, including ethinyl estradiol. Early pleconaril treatment was well tolerated and significantly reduced the duration and severity of colds due to picornaviruses in adults.
Details
- Title: Subtitle
- Efficacy and Safety of Oral Pleconaril for Treatment of Colds Due to Picornaviruses in Adults: Results of 2 Double-Blind, Randomized, Placebo-Controlled Trials
- Creators
- Frederick G Hayden - University of Virginia, Charlottesville, VirginiaDarrell T Herrington - West Texas Medical Associates, San AngeloTeresa L Coats - Central Austin Internists, Austin, TexasKenneth Kim - West Coast Clinical Trials, Long Beach, CaliforniaEllen C Cooper - ViroPharma Incorporated, Exton, PennsylvaniaStephen A Villano - ViroPharma Incorporated, Exton, PennsylvaniaSiyu Liu - ViroPharma Incorporated, Exton, PennsylvaniaSpencer Hudson - ViroPharma Incorporated, Exton, PennsylvaniaDaniel C Pevear - ViroPharma Incorporated, Exton, PennsylvaniaMarc Collett - ViroPharma Incorporated, Exton, PennsylvaniaMark McKinlay - ViroPharma Incorporated, Exton, PennsylvaniaPleconaril Respiratory Infection Study Group
- Contributors
- Margo L Schilling (Contributor) - University of Iowa, Internal Medicine
- Resource Type
- Journal article
- Publication Details
- Clinical infectious diseases, Vol.36(12), pp.1523-1532
- DOI
- 10.1086/375069
- PMID
- 12802751
- ISSN
- 1058-4838
- eISSN
- 1537-6591
- Language
- English
- Date published
- 06/15/2003
- Academic Unit
- Family and Community Medicine; Internal Medicine
- Record Identifier
- 9984025264002771
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