ENTADFI EFFICACY
ENTADFI provides better relief of BPH symptoms, including LUTS, faster than finasteride alone1,2
Results from an international, randomized, double-blind, parallel-design trial that measured the efficacy and safety of tadalafil 5 mg once daily combined with finasteride 5 mg for 26 weeks compared to placebo combined with finasteride 5 mg in men with BPH-LUTS and prostatic enlargement. Results were derived from least squares mean changes from baseline in the International Prostate Symptom Score after 4, 12, and 26 weeks between tadalafil/finasteride and placebo/finasteride.
Rapid and statistically significant symptom improvement seen as early as 4 weeks
Sustained improvement demonstrated throughout the 26-week study period
Statistical significance achieved across all primary and secondary endpoints by end of study
IPSS
What is the International Prostate Symptom Score (IPSS)?
The International Prostate Symptom Score (IPSS) is an eight-question, self-administered survey used to screen for, diagnose, track, and manage the symptoms of BPH.3
LS: least squares; SE: standard endpoint
* Secondary endpoint
† LS mean: a statistical methodology that computed the mean from a model such as SAS or ANOVA. The methodology allows for adjustment across multiple variables (age, sex, race, previous/existing urologic conditions, etc).2
‡ Primary endpoint
The dual components of ENTADFI significantly improved voiding scores through the full duration of the study2
DUAL MOA
Target the symptoms and the progression of BPH in a single, dual MOA, once-daily pill1,2
Some men with BPH experience frustrating sexual side effects with finasteride alone1,2
With a dual MOA, ENTADFI1,2:
Tadalafil helps provide quick relief from BPH2
Finasteride reduces the size of the prostate1
SAFETY INFORMATION
Drug-related adverse reactions with tadalafil and finasteride1
§N=581 and 576, tadalafil vs placebo, respectively.
‖ N=1524 and 1516, finasteride vs placebo, respectively.
ENTADFI contains tadalifil which is an ED medication and therefore it should not be prescribed with other ED medications
The dual components of ENTADFI significantly improved voiding scores through the full duration of the study2
ENTADFI DOSING
Dosing and administration with ENTADFI1
One capsule. Once daily.
At approximately the same time every day.
Efficacy was maintained through 26 weeks
To be taken orally without food