TY - JOUR
T1 - Efficacy and safety of oral pleconaril for treatment of colds due to picornaviruses in adults
T2 - Results of 2 double-blind, randomized, placebo-controlled trials
AU - Hayden, Frederick G.
AU - Herrington, Darrell T.
AU - Coats, Teresa L.
AU - Kim, Kenneth
AU - Cooper, Ellen C.
AU - Villano, Stephen A.
AU - Liu, Siyu
AU - Hudson, Spencer
AU - Pevear, Daniel C.
AU - Collett, Marc
AU - McKinlay, Mark
AU - Pleconaril Respiratory Infection Study Group, Respiratory Infection Study Group
PY - 2003/6/15
Y1 - 2003/6/15
N2 - The novel capsid-binding antiviral pleconaril inhibits in vitro replication of most rhinoviruses and entero-viruses. 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.
AB - The novel capsid-binding antiviral pleconaril inhibits in vitro replication of most rhinoviruses and entero-viruses. 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.
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U2 - 10.1086/375069
DO - 10.1086/375069
M3 - Article
C2 - 12802751
AN - SCOPUS:0038548251
SN - 1058-4838
VL - 36
SP - 1523
EP - 1532
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 12
ER -