PMID- 20584129
OWN - NLM
STAT- MEDLINE
DCOM- 20110225
LR  - 20220408
IS  - 1743-6109 (Electronic)
IS  - 1743-6095 (Linking)
VI  - 7
IP  - 10
DP  - 2010 Oct
TI  - Durability of response following cessation of tadalafil taken once daily as 
      treatment for erectile dysfunction.
PG  - 3487-94
LID - 10.1111/j.1743-6109.2010.01908.x [doi]
AB  - INTRODUCTION: Research has focused on improvement of erectile function during 
      treatment with phosphodiesterase type 5 (PDE5) inhibitors, but less is known 
      about what occurs after treatment cessation. AIM: The aim of this retrospective 
      analysis was to examine durability of response, defined as sustainability of 
      erectogenic benefits following treatment cessation, in men with erectile 
      dysfunction (ED) following long-term treatment with daily tadalafil. METHODS: The 
      subjects (N=160) had participated in a 12-week double-blind trial followed by a 
      one-year, open-label extension of tadalafil 5mg once daily. The extension was 
      followed by a 4-week, treatment-free follow-up period. A total of 158 subjects 
      completed International Index of Erectile Function-Erectile Function (IIEF-EF) 
      domain score and were included in this analysis. MAIN OUTCOME MEASURES: The 
      primary measures for this analysis were changes in ED severity category as 
      captured by the IIEF-EF domain score. RESULTS: At the end of the 1-year 
      open-label treatment period, a majority (86.1%, n=136) of subjects had either 
      improved by at least one ED severity category (e.g., Severe to Moderate) (n=128), 
      or maintained Normal erectile function (EF domain score >/=26) (n=8), compared to 
      baseline. Following the 4-week, treatment-free period, 63 of those subjects 
      (46.3% of the 136 subjects) had continued improvement of at least one ED severity 
      category (n=61) or maintained scores in the Normal category (n=2) compared with 
      baseline. Subjects who showed a sustained benefit of treatment were considered to 
      have demonstrated a "durable response." Seventy-three subjects (53.7%) did not 
      have a durable response following treatment cessation. A few patient 
      characteristics were associated with durability of response. CONCLUSIONS: Of 
      those men who demonstrated improved erectile function while taking tadalafil 5mg 
      once daily for 1 year, 46.3% continued to show improvement compared with baseline 
      following a 4-week treatment free period. Durability of response should be a 
      focus of future research.
CI  - (c) 2010 International Society for Sexual Medicine.
FAU - Porst, Hartmut
AU  - Porst H
AD  - Private Urological Practice, Hamburg, Germany. porst20354@aol.com
FAU - Glina, Sidney
AU  - Glina S
FAU - Ralph, David
AU  - Ralph D
FAU - Zeigler, Haoyue
AU  - Zeigler H
FAU - Wong, David G
AU  - Wong DG
FAU - Woodward, Brad
AU  - Woodward B
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - J Sex Med
JT  - The journal of sexual medicine
JID - 101230693
RN  - 0 (Carbolines)
RN  - 0 (Phosphodiesterase 5 Inhibitors)
RN  - 742SXX0ICT (Tadalafil)
SB  - IM
MH  - Carbolines/administration & dosage/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Erectile Dysfunction/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Penile Erection/drug effects
MH  - Phosphodiesterase 5 Inhibitors/administration & dosage/*therapeutic use
MH  - Retrospective Studies
MH  - Tadalafil
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2010/06/30 06:00
MHDA- 2011/02/26 06:00
CRDT- 2010/06/30 06:00
PHST- 2010/06/30 06:00 [entrez]
PHST- 2010/06/30 06:00 [pubmed]
PHST- 2011/02/26 06:00 [medline]
AID - S1743-6095(15)32740-5 [pii]
AID - 10.1111/j.1743-6109.2010.01908.x [doi]
PST - ppublish
SO  - J Sex Med. 2010 Oct;7(10):3487-94. doi: 10.1111/j.1743-6109.2010.01908.x.