PMID- 19193420
OWN - NLM
STAT- MEDLINE
DCOM- 20090505
LR  - 20151119
IS  - 1527-9995 (Electronic)
IS  - 0090-4295 (Linking)
VI  - 73
IP  - 4
DP  - 2009 Apr
TI  - Likelihood of tadalafil-associated adverse events in integrated multiclinical 
      trial database: classification tree analysis in men with erectile dysfunction.
PG  - 756-61
LID - 10.1016/j.urology.2008.10.058 [doi]
AB  - 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.
FAU - Brock, Gerald
AU  - Brock G
AD  - Department of Surgery, Division of Urology, St. Joseph's Health Care London, 
      University of Western Ontario, London, Ontario, Canada. gebrock@sympatico.ca
FAU - Glina, Sidney
AU  - Glina S
FAU - Moncada, Ignacio
AU  - Moncada I
FAU - Watts, Steven
AU  - Watts S
FAU - Xu, Lei
AU  - Xu L
FAU - Wolka, Anne
AU  - Wolka A
FAU - Kopernicky, Vladimir
AU  - Kopernicky V
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20090204
PL  - United States
TA  - Urology
JT  - Urology
JID - 0366151
RN  - 0 (Carbolines)
RN  - 0 (Phosphodiesterase Inhibitors)
RN  - 742SXX0ICT (Tadalafil)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Carbolines/*adverse effects
MH  - Databases, Factual/*statistics & numerical data
MH  - Erectile Dysfunction/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Phosphodiesterase Inhibitors/*adverse effects
MH  - Tadalafil
MH  - Young Adult
EDAT- 2009/02/06 09:00
MHDA- 2009/05/06 09:00
CRDT- 2009/02/06 09:00
PHST- 2008/08/23 00:00 [received]
PHST- 2008/10/22 00:00 [revised]
PHST- 2008/10/31 00:00 [accepted]
PHST- 2009/02/06 09:00 [entrez]
PHST- 2009/02/06 09:00 [pubmed]
PHST- 2009/05/06 09:00 [medline]
AID - S0090-4295(08)01834-7 [pii]
AID - 10.1016/j.urology.2008.10.058 [doi]
PST - ppublish
SO  - Urology. 2009 Apr;73(4):756-61. doi: 10.1016/j.urology.2008.10.058. Epub 2009 Feb 
      4.