Introduction. The current armamentarium of drugs for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) is diverse and includes both monotherapy and combination therapy. Indirect and limited direct comparisons have demonstrated that all alpha-1-blockers (a1-ABs) have similar efficacy when used at appropriate doses. Differences in tropism to the prostate of modern α1-ABs are largely responsible for the severity of their side effects, mainly negative influence on sexual function and cardiovascular system.
Aim. To evaluate the influence of Alfuprost® MR 10 mg once daily on sexual function in patients with LUTS due to BPH during 3-months therapy in real clinical practice. The secondary endpoint was an effect on systolic, diastolic blood pressure (BP) and heart rate.
Materials and methods. A total of 537 men with LUTS/BPH were included in the study by urologists from 21 outpatient departments of the Russian Federation. The follow-up included 3 visits: visit of inclusion in the program of patients with a previously prescribed drug of Alfuprost® MR in a dosage of 10 mg once a day (visit "0"), visit 1 at 30 days (±5 days) later, and visit 2 at 90 days (±5 days) after inclusion in the study. At each visit, evaluation of complaints and physical examination was performed. In addition, patients completed questionnaires: International prostate symptom score (IPSS) and quality of life (QoL) index; the full version of the International Index of Erectile Function (IIEF) questionnaire; the Likert scale for the patient and for the physician. Also, laboratory and instrumental studies used in routine clinical practice were recorded: total prostate specific antigen (PSA) in serum; ultrasound examination (US) of the bladder; transrectal ultrasound examination (TRUS) of the prostate; uroflowmetry (maximum urine flow rate (Qmax)); measurement of systolic and diastolic BP; measurement of heart rate.
Results: after 3 months of therapy with Alfuprost® MR in a dosage of 10 mg once a day, significant (p<0.05) improvement of all urodynamic parameters was documented, including a decrease in the average IPSS score by 55% and improvement of quality of life by 2.46 points (on the QoL index); increase of Qmax by 53%; reduction of the average postvoid residual to normal values.
In addition to a significant improvement in the quality of urination, changes in sexual function were also positive. Thus, the average total IIEF score increased significantly (p<0,05) from 45.35 to 53.18 points. When considering specific domains of male sexual function, positive dynamics in all domains was noted: overall improvement of orgasm function, sexual desire, sexual satisfaction and overall sexual functioning was 11.98%, 15.14%, 19.7% and 18.46%, respectively.
Hemodynamic indices remained stable during the 3-month follow-up; only clinically insignificant decrease in systolic BP by no more than 2 mm Hg during the entire follow-up period was observed. At the same time there was no influence on diastolic BP. Changes in heart rate were also clinically insignificant, averaging no more than 1 beat per minute.
Conclusions: The results of observational study allow to recommend Alfuprost® MR as a first-line therapy for BPH, including for sexually active men and patients with various types of sexual dysfunction. Considering minimal and clinically insignificant vasodilatory effects observed during 3 months of therapy, it is possible to prescribe Alfuprost® MR in a dosage of 10 mg once daily, including comorbid patients.

Keywords: Alfuprost® MR, LUTS, BPH, alfuzosin, sexual function, blood pressure