PMID- 19845547
OWN - NLM
STAT- MEDLINE
DCOM- 20100830
LR  - 20131121
IS  - 1743-6109 (Electronic)
IS  - 1743-6095 (Linking)
VI  - 7
IP  - 4 Pt 1
DP  - 2010 Apr
TI  - Inhalation device allows novel administration of apomorphine in men with erectile 
      dysfunction-efficacy and safety findings.
PG  - 1508-17
LID - 10.1111/j.1743-6109.2009.01540.x [doi]
AB  - INTRODUCTION: Erectile dysfunction (ED) treatment is greatly influenced by 
      patient preference, and currently available oral therapies do not meet all 
      patients' needs. New therapies and formulations are therefore being investigated. 
      AIM: The aim of this article is to assess the clinical efficacy and safety of 
      inhaled apomorphine, VR004, in men with mild to severe ED. MAIN OUTCOME MEASURES: 
      Efficacy outcomes were the change in the proportion of positive responses to 
      sexual encounter profile questions, International Index of Erectile Function 
      (IIEF) scores and onset of therapeutic effect. Safety outcomes included a change 
      in vital signs at an orthostatic challenge and adverse events (AEs). METHODS: Two 
      consecutive, multicenter trials each comprised a 4-week no-treatment period and a 
      12-week "at home" treatment period with regular clinic visits. Patients (N = 211 
      and N = 389) were randomized to receive one of three set doses of VR004 (100-300 
      microg) or matching placebo in each trial. VR004 was administered by a dry-powder 
      inhaler at least once a week. RESULTS: Efficacy was generally dose dependent. The 
      proportion of per-protocol patients maintaining an erection long enough for 
      successful intercourse increased in all VR004 groups vs. placebo. IIEF scores 
      were higher in the VR004 groups compared with placebo, and the majority of 
      responders achieved an erection within 10 minutes of dosing. The safety profile 
      of VR004 was generally similar to that of placebo, and AEs were mild or moderate 
      in severity. The incidence of treatment-related AEs was dose dependent. Few 
      patients (4%) withdrew because of treatment-related AEs, and the majority of 
      these withdrawals occurred on the day of the stringent orthostatic challenge. 
      CONCLUSIONS: The VR004 system administers low apomorphine doses that are well 
      tolerated without compromising efficacy. This route of administration ensures a 
      rapid onset of action and reproducible efficacy and safety profiles. Inhaled 
      apomorphine is therefore a potential first-line treatment for ED.
FAU - Riley, Alan
AU  - Riley A
AD  - Kings Park Cwmann, Lampeter, Carmarthenshire, UK.
FAU - Main, Mark
AU  - Main M
FAU - Morgan, Frazer
AU  - Morgan F
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20091020
PL  - Netherlands
TA  - J Sex Med
JT  - The journal of sexual medicine
JID - 101230693
RN  - 0 (Dopamine Agonists)
RN  - 0 (Powders)
RN  - N21FAR7B4S (Apomorphine)
SB  - IM
MH  - Administration, Inhalation
MH  - Adult
MH  - Aged
MH  - Apomorphine/*administration & dosage/adverse effects
MH  - Dopamine Agonists/*administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Erectile Dysfunction/*drug therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Penile Erection/drug effects
MH  - Powders
MH  - Sexual Behavior/drug effects
MH  - Treatment Outcome
EDAT- 2009/10/23 06:00
MHDA- 2010/08/31 06:00
CRDT- 2009/10/23 06:00
PHST- 2009/10/23 06:00 [entrez]
PHST- 2009/10/23 06:00 [pubmed]
PHST- 2010/08/31 06:00 [medline]
AID - S1743-6095(15)32989-1 [pii]
AID - 10.1111/j.1743-6109.2009.01540.x [doi]
PST - ppublish
SO  - J Sex Med. 2010 Apr;7(4 Pt 1):1508-17. doi: 10.1111/j.1743-6109.2009.01540.x. 
      Epub 2009 Oct 20.