Efficacy and safety of combined oral therapy with tadalafil and alfuzosin: an integrated approach to the management of patients with lower urinary tract symptoms and erectile dysfunction. Preliminary report.
BACKGROUND
Alpha1-blockers (AB) are the first-line monotherapy for lower urinary tract symptoms (LUTS). Phosphodiesterase type 5 (PDE5) inhibitors are the first-line treatment for erectile dysfunction (ED). Numerous studies have supposed a significant association between ED and LUTS, but a causal relationship cannot be established.


OBJECTIVE
The aim was to evaluate the efficacy of a combined therapy with an AB (alfuzosin) and PDE5 inhibitors (tadalafil) in patients with LUTS and ED.


METHODS
This was a randomized, open-label, three-arm study. A total of 66 men complaining of ED and LUTS were included in the study. Patients were assessed at baseline and after 12 weeks of study treatment, and then underwent randomized allocation to either alfuzosin 10 mg once a day (22 patients) or tadalafil 20 mg on alternative days (21 patients), or a combination of both (23 patients).


METHODS
All participants completed the erectile function domain of the International Index of Erectile Function (IIEF-EF) and the International Prostatic Symptom Score (IPSS). Other efficacy variables included maximum urinary flow rate (Qmax) and medium urinary flow rate (Qave).


RESULTS
IIEF-EF tended to improve with alfuzosin alone (+15%), while it was clearly improved with tadalafil alone (+36.3%). The greatest improvement was experienced with the combination therapy (+37.6%). Improvement in Qmax was observed in all groups, but patients receiving combination therapy had greater improvement (29.6%) than patients receiving either only alfuzosin (21.7%) or only tadalafil (9.5%). IPSS was significantly improved in alfuzosin group (27.2%), was more marked with the combination therapy (41.6%), and a small increase, although not significant, was also observed with tadalafil (8.4%).


CONCLUSIONS
Combined therapy improved ED and LUTS as demonstrated by the significant improvement in uroflowmetry measures and in IPSS and IIEF-EF scores. A significant improvement was also observed in quality of life assessments. The beneficial effects of tadalafil on LUTS similar to the benefits of alfuzosin on ED, although present, were smaller.
Liguori
Giovanni
G
Department of Urology, University of Trieste, Trieste, Italy. gioliguori@libero.it
Trombetta
Carlo
C
De Giorgi
Gioacchino
G
Pomara
Giorgio
G
Maio
Giuseppe
G
Vecchio
Daniele
D
Ocello
Giuseppe
G
Ollandini
Giangiacomo
G
Bucci
Stefano
S
Belgrano
Emanuele
E
D000284:Administration, Oral; D000317:Adrenergic alpha-Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D002243:Carbolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000453:epidemiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000068581:Tadalafil; D016896:Treatment Outcome; D014570:Urologic Diseases / Q000188:drug therapy* / Q000453:epidemiology*
D000317:Adrenergic alpha-Antagonists; D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D011799:Quinazolines; D000068581:Tadalafil; C047638:alfuzosin