PDE-5 inhibitors found safe, efficacious in male LUTS

Phosphodiesterase type-5 inhibitors are safe and effective, alone or in combination with alpha-blockers, against lower urinary tract symptoms (LUTS) secondary to BPH, according to a systematic review and meta-analysis.

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, 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. The other five examined the effects of PDE-5 inhibitors with an alpha-blocker.

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).

A 2.8-point reduction in International Prostate Symptom Score was noted in patients treated with PDE-5 inhibitor therapy alone and a reduction of 1.8 in patients who had received combination therapy, Dr. Gacci reported. International Index of Erectile Function score improved 5.5 points in PDE-5 inhibitor patients and 3.6 points in PDE-5 inhibitor/alpha-blocker patients. Dr. Gacci noted no change in Qmax in patients receiving PDE-5 inhibitor therapy alone and an improvement of 1.5 in patients treated with PDE-5 inhibitors/alpha blockers.

The meta-analysis demonstrated that age, BMI, and baseline IPSS score were the main determinants for PDE-5 inhibitor outcomes.

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