Moreover, the two-drug combination improves maximum flow rate compared to alpha-blockers alone. Younger men with lower body mass index and severe LUTS are the best candidates for PDE-5 inhibitor treatment, the review showed.
First author Mauro Gacci, MD, medical director of the University of Florence Careggi Hospital in Florence, Italy, and co-authors from Europe and the U.S. identified 508 studies in an electronic search, retrieving 106 for more detailed evaluation and finally including 12 for this review. In seven studies, patients with LUTS/BPH were treated with PDE-5 inhibitors alone: sildenafil citrate (Viagra, one study), tadalafil (Cialis, four studies), vardenafil (Levitra, Staxyn, one study), and UK-369003, an investigational agent (one study). The other five examined the effects of PDE-5 inhibitors with an alpha-blocker, using the PDE-5 inhibitors sildenafil (two studies), tadalafil (two studies), and vardenafil (one study).
The PDE-5 inhibitor monotherapy studies included 3,214 randomized patients, of whom 2,250 received PDE-5 inhibitors (83.5% completed the study) and 964 received placebo (90.2% completed the study). The combination therapy studies included 278 patients, of whom 107 received alpha-blockers only (92.5% completed the study) and 109 received PDE-5 inhibitors plus alpha-blockers (94.5% completed the study).