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Effects of the Selective α 1A ‐Adrenoceptor Antagonist Silodosin on ECGs of Healthy Men in a Randomized, Double‐Blind, Placebo‐ and Moxifloxacin‐Controlled Study
Author(s) -
Morganroth J,
Lepor H,
Hill L A,
Volinn W,
Hoel G
Publication year - 2010
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2009.265
Subject(s) - silodosin , placebo , moxifloxacin , qt interval , medicine , heart rate , dosing , assay sensitivity , confidence interval , anesthesia , randomized controlled trial , urology , cardiology , pharmacology , blood pressure , prostate , lower urinary tract symptoms , alternative medicine , pathology , cancer , microbiology and biotechnology , biology , antibiotics
In order to determine the effects of therapeutic and supratherapeutic doses of silodosin on QT interval, healthy men ( N = 186; aged 18–45 years) were randomized to receive silodosin (8 or 24 mg) or placebo for 5 days or moxifloxacin 400 mg (positive control, known to prolong QT) once on day 5. At baseline and on day 5, five ECGs were recorded 0.25 h before dosing and 1, 1.5, 2, 3, 4, 6, 8, 10, and 23.5 h after dosing. Adjusted mean differences (analysis of covariance) between silodosin and placebo in the change in individual heart rate–corrected QTc (QTcI) from baseline to day 5 were <5 ms at all times (all 90% confidence interval (CI) upper limits <10 ms). The QTcI difference for moxifloxacin compared with placebo often exceeded 5 ms, establishing assay sensitivity. For silodosin, no statistically or clinically significant correlation was seen between plasma concentration and QTcI, and no clinically important effects on heart rate, PR segment, QRS complex, or morphologic ECG data were observed. Clinical Pharmacology & Therapeutics (2010) 87 5, 609–613. doi: 10.1038/clpt.2009.265