Likelihood of tadalafil-associated adverse events in integrated multiclinical trial database: classification tree analysis in men with erectile dysfunction.
OBJECTIVE
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.
Brock
Gerald
G
Department of Surgery, Division of Urology, St. Joseph's Health Care London, University of Western Ontario, London, Ontario, Canada. gebrock@sympatico.ca
Glina
Sidney
S
Moncada
Ignacio
I
Watts
Steven
S
Xu
Lei
L
Wolka
Anne
A
Kopernicky
Vladimir
V
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002243:Carbolines / Q000009:adverse effects*; D016208:Databases, Factual / Q000706:statistics & numerical data*; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects*; D000068581:Tadalafil; D055815:Young Adult
D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D000068581:Tadalafil