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Likelihood of tadalafil-associated adverse events in integrated multiclinical trial database: classification tree analysis in men with erectile dysfunction.

Abstract：

OBJECTIVES:To identify the patient demographic factors, comorbidities, and concomitant medications associated with a change in the likelihood of tadalafil-associated adverse events (AEs) in men with erectile dysfunction. METHODS:Pooled safety data were analyzed from 3488 tadalafil-treated men who participated in 21 placebo-controlled clinical trials of tadalafil taken as needed or once daily. Three categories of tadalafil-associated AEs were defined: vasodilatory (headache, flushing, nasal congestion, nasopharyngitis, and dizziness); musculoskeletal (back pain and myalgia); and gastrointestinal (dyspepsia). A classification and regression tree analysis was used to determine the patient characteristics most likely to be associated with a change in the likelihood of these types of AEs. RESULTS:Of the 3488 tadalafil-treated patients, 973 (27.9%) had any vasodilatory, musculoskeletal, and/or gastrointestinal tadalafil-associated AE. The patient characteristics associated with a change in the likelihood of any tadalafil-associated AE were diabetes, geographic region, and age. The patient characteristics associated with a change in the likelihood of a vasodilatory tadalafil-associated AE included antihypertensive medication use, geographic region, and height, with several additional splits occurring along these primary and secondary nodes. No patient characteristics associated with a change in the likelihood of musculoskeletal or gastrointestinal AEs were identified owing to the limitation of a relatively low incidence of these types of AEs. CONCLUSIONS:The findings from classification and regression tree analyses could help physicians to better understand some of the associations between patient characteristics and the tolerability of phosphodiesterase type 5 inhibitors and could contribute to improved patient outcomes, satisfaction, treatment seeking, and treatment persistence.

journal_name

Urology

journal_title

Urology

authors

Brock G,Glina S,Moncada I,Watts S,Xu L,Wolka A,Kopernicky V

doi

10.1016/j.urology.2008.10.058

subject

Has Abstract

pub_date

2009-04-01 00:00:00

pages

756-61

issue

eissn

0090-4295

issn

1527-9995

pii

S0090-4295(08)01834-7

journal_volume

pub_type

杂志文章,多中心研究

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Likelihood of tadalafil-associated adverse events in integrated multiclinical trial database: classification tree analysis in men with erectile dysfunction.