Likelihood of tadalafil-associated adverse events in integrated multiclinical trial database: classification tree analysis in men with erectile dysfunction.
Level 3 - non-randomized controlled study
Exploratory classification and regression tree analysis of pooled cohort data from 21 randomized trials
PubMed 19193420 · doi:10.1016/j.urology.2008.10.058
What was done
Researchers conducted a classification and regression tree (CART) analysis on pooled safety data from 3,488 men with erectile dysfunction who received tadalafil (taken as needed or once daily) across 21 placebo-controlled clinical trials. The study evaluated patient demographic factors, comorbidities, and concomitant medications associated with three categories of adverse events (AEs): vasodilatory (headache, flushing, nasal congestion, nasopharyngitis, dizziness), musculoskeletal (back pain, myalgia), and gastrointestinal (dyspepsia).
What was found
Of the 3,488 tadalafil-treated patients, 973 (27.9%) experienced at least one vasodilatory, musculoskeletal, or gastrointestinal AE. Predictors associated with a change in the likelihood of any tadalafil-associated AE were diabetes, geographic region, and age. Vasodilatory AEs were specifically associated with antihypertensive medication use, geographic region, and height. No patient characteristics were identified for musculoskeletal or gastrointestinal AEs due to low incidence.
Why it matters
Identifying clinical and demographic factors linked to side effects helps clinicians anticipate tolerability issues and support treatment persistence in men treated with tadalafil.
Limits
The abstract does not report specific numerical risk estimates, subgroup event rates, or decision tree cutoff values. Musculoskeletal and gastrointestinal AEs could not be modeled due to low event frequency. Data pooled different dosing regimens (as needed vs. daily) and analyzed only treated patients rather than comparing risk against placebo arms.
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