Академический Документы
Профессиональный Документы
Культура Документы
DYSFUNCTIONS
PRESENTOR
DR. ANANT KUMAR RATHI
2nd YEAR RESIDENT
GUIDE
DR. D. K. SHARMA
PROF. & HEAD, DEPTT. OF PSYCHIATRY
GOVT. MEDICAL COLLEGE & N.M.C. HOSPITAL, KOTA
NORMAL PHYSIOLOGY (Ganong Physiology)
ERECTION EJACULATION
Penile Penile
Penetration
tumescence Detumesence
Plateau Resolution
High arousal/
Erection
Excitement
Time
Spectrum of Ejaculatory Dysfunctions
Cultural
Etiology of Premature Ejaculation
Treatment encompasses:-
Behavioral aspect
Pharmacological aspect
Psychological aspect
TREATMENT OF PREMATURE
EJACUALTION
Dapoxetine 30 mg Dapoxetine 60 mg
Cmax (ng/ml) 297 349
Tmax (h) 1.01 1.27
Initial T half 1.31 1.42
Terminal T half 18.7 21.0
Effect of high fat meal
Cmax (fasted) - 443
Cmax (high fat meal) - 398
Tmax (h) (fasted) - 1.30
Tmax (h) (high fat meal) - 1.83
Mechanism of action
Dapoxetine
↑ 5HT Activation of
neurotransmission 5HT2C
Delays Ejaculation
Discontinuation due to 0 9 1
adverse effect
Analysis
Magnitude of effect of 20 mg dapoxetine on IELT
was small
Adverse events were dose dependant
Most common AE were nausea, diarrhea
headache, dizziness
Overall 60 mg dose was better tolerated
Most common reason of study withdrawal at dose
100 mg was nausea
Based on these results 30, 60 mg dose were
chosen for phase 3 study
Phase 3 studies :- To present safety & efficacy data five
randomized, double blinded, placebo controlled studies
conducted in over 25 countries
All studies enrolled heterosexual men & their partners who were more than
18 yrs age, in monogamous relationship and met DSMIV TR criteria for PE
Internation Multicentre, D/B, 24 weeks 1162 IELT less than 2 mins during
randomized, placebo 4 week baseline period, met
al Study controlled DSM IV TR criteria
4
3.5
3
2.5
Placebo
Series 1
2
Series
Dapoxetine 2
30 mg
1.5 Series
Dapoxetine 3
60 mg
1
0.5
0
Baseline Week 4 Week 8 Week 12 Week 24
Percentage of subjects reporting that their
PE was better/much better at 12 weeks
(CGIC)
45 Placebo
40
Dapoxetine 30
35 mg
30
Dapoxetine 60
25 mg
20
15
10
5
0
Category 1
Effect of dapoxetine on female partner
Use cautiously in
Mild hepatic, mild to moderate renal impairment
concomitant therapy with potent CYP2D6 inhibitor or
moderate CYP3A4 inhibitors
Potential disadvantages
Lack of studies
Not U.S. FDA, UK approved
Several drug to drug interactions
Can not be used in hepatic and renal dysfunction
PE SYNDROME
Marcel Waldinger
F
Future trend