A double-blind placebo-controlled study of the efficacy and safety of pentoxifylline in early chronic Peyronie's disease.
OBJECTIVE
To analyse the safety and efficacy of pentoxifylline sustained-release (PTX-SR) treatment in patients with early chronic Peyronie's disease (PD).


METHODS
In all, 228 patients with a mean (sd) age of 51 (9) years who had early chronic PD were randomized to receive 400 mg PTX-SR (Apo-Pentoxifylline, Apotex Inc., Toronto, Canada) twice daily (group 1, 114) or similar regimen of placebo (group 2, 114) for 6 months. A medical history was taken and the men had a complete physical examination. The following variables were assessed before and after therapy: penile curvature and penile artery spectral traces (end-diastolic velocity, EDV, peak systolic velocity, PSV, and resistivity index, RI, of the right and left cavernous arteries assessed with dynamic penile duplex ultrasonography), plaque characteristics (assessed by penile X-ray and penile ultrasonography), pain (assessed by visual analogue scale), erectile function (assessed by the International Index of Erectile Function, IIEF questionnaire), treatment satisfaction (assessed by Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire), and side-effects. Patient perception of penile curvature and plaque size, and mean weekly intercourse attempts were also assessed.


RESULTS
Overall, 36.9% of patients who received PTX-SR reported a positive response, vs only 4.5% in the placebo group. Of patients in PTX-SR group, 12 (11%) had disease progression, vs 46 (42%) in placebo group (P = 0.01). Improvement in penile curvature (P = 0.01), and plaque volume (P = 0.001) was significantly greater in patients treated with PTX-SR than placebo. The increase in IIEF total score was significantly higher in the PTX-SR group (P = 0.02). Mean PSV changes after therapy compared to baseline were statistically significant between PTX-SR (right, +11.4%, left, +11.7%) and placebo-treated (+0.2% and -4.2%, respectively) patients (both P = 0.04).


CONCLUSIONS
PTX-R was moderately effective in reducing penile curvature and plaque volume in patients with early chronic PD. Further studies with different treatment regimens are needed to better elucidate the beneficial effects of PTX-SR in PD.
Department of Urology, Shaheed Modarress Hospital, Shahid Beheshti University, Tehran, Iran. safarinejad@unrc.ir
Mohammad Reza
MR
Safarinejad
Majid Ali
MA
Asgari
Seyyed Yousof
SY
Hosseini
Farid
F
Dadkhah
D000328:Adult; D002908:Chronic Disease; D003075:Coitus; D003692:Delayed-Action Preparations / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D010411:Penile Induration / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D010413:Penis / Q000098:blood supply / Q000000981:diagnostic imaging / Q000503:physiopathology*; D010431:Pentoxifylline / Q000009:adverse effects / Q000627:therapeutic use*; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014463:Ultrasonography
D003692:Delayed-Action Preparations; D010726:Phosphodiesterase Inhibitors; D010431:Pentoxifylline