Efficacy of Continuous Dosing of Tadalafil Once Daily vs Tadalafil On Demand in Clinical Subgroups of Men With Erectile Dysfunction: A Descriptive Comparison Using the Integrated Tadalafil Databases.
Various factors play a role in the development of erectile dysfunction (ED).



To provide a descriptive comparison of erectile function response for tadalafil on-demand (PRN) and once-daily (OAD) dosing regimens in patients with common comorbid conditions, treatments, or risk factors that can be considered when treating ED.



In total, 17 PRN and 4 OAD placebo-controlled studies were included in the integrated database in these pooled analyses. Data were analyzed from patients treated with placebo, tadalafil 10 mg (low dose), and 20 mg (high dose) for the PRN studies and placebo, tadalafil 2.5 mg (low dose), and 5 mg (high dose) for the OAD studies.



The effects of tadalafil were measured using the International Index of Erectile Function administered from baseline to week 12. A descriptive comparison of the efficacy of tadalafil PRN vs OAD was examined in the clinical populations.



Baseline characteristics of 4,354 men were comparable between the PRN and OAD groups, with differences seen only in the variables of race, body mass index (BMI) of at least 30 kg/m(2), and alcohol use. Tadalafil was efficacious at improving erectile function for all clinical populations, except for the low-dose OAD group, which demonstrated a weaker effect vs placebo than the high-dose OAD group, and the low- and high-dose PRN groups vs placebo for patients with BMI of at least 30 kg/m(2) for patients without a cardiovascular disorder, smokers, patients with ED duration shorter than 1 year, and patients without previous phosphodiesterase type 5 inhibitor use. Tadalafil was efficacious for patients with or without diabetes mellitus, arterial hypertension, hyperlipidemia, and alcohol use at baseline.



Tadalafil OAD and PRN regimens showed efficacy in patients with ED. No clinical populations of patients with ED seemed to benefit overwhelmingly from one dose regimen over the other.
Western University, Canadian Urological Association, London, ON, Canada.
Gerald
G
Brock
Eli Lilly and Company, Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.
Xiao
X
Ni
Department of Urology, Hannover Medical School, Hannover, Germany.
Matthias
M
Oelke
Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
John
J
Mulhall
Mid Michigan Health Centers, Jackson, MI, USA.
Matt
M
Rosenberg
Cooper Medical School of Rowan University, Camden, NJ, USA.
Allen
A
Seftel
inVentiv Health Company, LLC, Indianapolis, IN, USA.
Deborah
D
D'Souza
Eli Lilly and Company, Basingstoke, Hampshire, UK. Electronic address: jbarry@lilly.com.
Jane
J
Barry
D000328:Adult; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000523:psychology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D057240:Patient Preference; D010410:Penile Erection / Q000187:drug effects; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use*; D000068581:Tadalafil / Q000627:therapeutic use*; D016896:Treatment Outcome
D058986:Phosphodiesterase 5 Inhibitors; D000068581:Tadalafil
Data Pooling; Erectile Dysfunction; Phosphodiesterase Type 5 Inhibitors; Tadalafil; Treatment Efficacy