Rechallenging nonresponders to tadalafil and vardenafil: a reallife study

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Rechallenging non-responders to tadalafil and
vardenafil a real-life study

• Hatzimouratidis K, Moysidis K, Bekos A,
• Tsimtsiou Z, Ioannidis E, Hatzichristou D
• 2nd Department of Urology, Papageorgiou General
  Hospital and
• Center for Sexual and Reproductive Health,
• Aristotle University of Thessaloniki, Greece

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Study design

• 100 consecutive patients non-responders to
  tadalafil or vardenafil
• treated in a single center, basic work-up
• drug expenses covered by patients

Treatment Phases
Study Phases
Screening
Phase I
Phase II
Phase III
Inappropriate use adequate instructions retrial 4
max doses on demand
New instructions Tadalafil gt2h before
sex Vardenafil fasted Retrial 4 max doses on
demand
Scheduled use Tadalafil 20mg / 48h Vardenafil
20mg OD
Demographics Sex-Med history IIEF
Q1 Were your erections rigid and last for
successful intercourse? YES NO Q2 Do you
want a new prescription? YES NO
Response definition
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Results baseline characteristics (I)
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Results baseline characteristics (II)
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Results - Tadalafil group
Non-responders to tadalafil (n86)
Salvage 38 pts (44.2)
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Results - Vardenafil group
Non-responders to vardenafil (n88)
Salvage 34 pts (38.7)
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Conclusions

• Timing of intercourse and food instructions may
  play a significant role in the response rate of
  ED patients under PDE5 inhibitors treatment
• Continuous administration scheme may maximize
  efficacy
• As much as 44 of so-called non-responders to
  tadalafil and vardenafil may be salvaged after
  new dosing instructions depending on
  pharmacokinetics of each drug despite current
  labeling information
• Further research is needed on the appropriate
  dose and adverse events profile of the continuous
  administration of these new drugs