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.
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 gastrointestinaltadalafil-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.
Authors: Donald T Weed; Paolo Serafini; Jennifer L Vella; Isildinha M Reis; Adriana C De la Fuente; Carmen Gomez; Zoukaa Sargi; Ronen Nazarian; Joseph Califano; Ivan Borrello Journal: Clin Cancer Res Date: 2014-10-15 Impact factor: 12.531
Authors: Roberto F Machado; Robyn J Barst; Nancy A Yovetich; Kathryn L Hassell; Gregory J Kato; Victor R Gordeuk; J Simon R Gibbs; Jane A Little; Dean E Schraufnagel; Lakshmanan Krishnamurti; Reda E Girgis; Claudia R Morris; Erika B Rosenzweig; David B Badesch; Sophie Lanzkron; Onyinye Onyekwere; Oswaldo L Castro; Vandana Sachdev; Myron A Waclawiw; Rob Woolson; Jonathan C Goldsmith; Mark T Gladwin Journal: Blood Date: 2011-04-28 Impact factor: 22.113