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1 Efficacy and Safety of the Coadministration of Tadalafil Once Daily with Finasteride for 6 Months in Men with Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia Adolfo Casabe,* Claus G. Roehrborn,* Luigi F. Da Pozzo,* Sebastian Zepeda, R. Jonathan Henderson,* Sebastian Sorsaburu,* Carsten Henneges,* David G. Wong* and Lars Viktrup*, From the Instituto Medico Especializado, Buenos Aires, Argentina (AC); University of Texas Southwestern Medical Center, Dallas, Texas (CGR); Department of Urology, Ospedale Papa Giovanni XXIII-Bergamo, Bergamo, Italy (LFDP); Saltillo University Hospital, Saltillo, Mexico (SZ); Regional Urology LLC, Shreveport, Louisiana (RJH); Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana (SS, DGW, LV); and Global Statistical Sciences, Lilly Deutschland GmbH, Bad Homburg, Germany (CH) Purpose: Medical treatment for men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia is 5a-reductase inhibitor monotherapy or coadministration with an a-blocker. We assessed the effects of tadalafil 5 mg coadministered with finasteride 5 mg during 26 weeks on lower urinary tract symptoms and sexual symptoms. Materials and Methods: In an international, randomized, double-blind, parallel study of men 45 years old or older who were 5a-reductase inhibitor naïve and had an I-PSS (International Prostate Symptom Score) of 13 or greater and prostate volume 30 ml or greater, 350 were treated with placebo/finasteride and 345 received tadalafil/finasteride for 26 weeks. Changes in lower urinary tract symptoms secondary to benign prostatic hyperplasia were assessed with the I-PSS, erectile dysfunction improvements were assessed with the IIEF-EF (International Index of Erectile Function-Erectile Function) in sexually active men and safety was assessed by evaluating adverse events. Results: Least squares mean changes from baseline in I-PSS after 4, 12 and 26 weeks of tadalafil/finasteride coadministration were 4.0, 5.2 and 5.5, respectively. Corresponding values for placebo/finasteride coadministration were 2.3, 3.8 and 4.5 (p at all visits favoring tadalafil/finasteride coadministration). I-PSS subscores (storage and voiding) and quality of life index were also numerically improved with tadalafil/finasteride coadministration. Least squares mean changes from baseline in IIEF-EF with tadalafil/finasteride coadministration were 3.7 after 4 weeks, and 4.7 after 12 and 26 weeks. Corresponding values for placebo/finasteride coadministration were 1.1, 0.6 and 0.0 (p <0.001 at all visits favoring tadalafil/finasteride coadministration). Tadalafil/ finasteride coadministration was well tolerated and most adverse events were mild/moderate. Accepted for publication September 4, Study received institutional review board approval. * Financial interest and/or other relationship with Eli Lilly. Nothing to disclose. Correspondence: Eli Lilly and Company, Indianapolis, Indiana (telephone: ; FAX: ; viktrup_lars@lilly.com). Abbreviations and Acronyms 5-ARI ¼ 5a-reductase inhibitor AE ¼ adverse event BPH ¼ benign prostatic hyperplasia BPH-LUTS ¼ lower urinary tract symptoms secondary to benign prostatic hyperplasia ED ¼ erectile dysfunction LS ¼ least squares LSTD ¼ least squares treatment difference LUTS ¼ lower urinary tract symptoms PBO/FIN ¼ placebo/finasteride coadministration PDE5I ¼ phosphodiesterase type 5 inhibitor PE ¼ prostate enlargement Q max ¼ peak urinary flow rate QoL ¼ quality of life SAE ¼ serious adverse event TAD/FIN ¼ tadalafil/finasteride coadministration TEAE ¼ treatment emergent adverse event Editor s Note: This article is the fourth of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 878 and /14/ /0 THE JOURNAL OF UROLOGY 2014 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH,INC. Vol. 191, , March 2014 Printed in U.S.A. j 727

2 728 TADALAFIL/FINASTERIDE COADMINISTRATION FOR LOWER URINARY TRACT SYMPTOMS Conclusions: The coadministration of tadalafil/finasteride provides early improvement in lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement. Tadalafil/finasteride coadministration also improves erectile function in men who have comorbid erectile dysfunction. Key Words: prostatic hyperplasia, erectile dysfunction, finasteride, lower urinary tract symptoms, tadalafil PROSTATE gland enlargement secondary to benign prostatic hyperplasia may result in LUTS, including storage symptoms (increased frequency/urgency, incontinence) and voiding symptoms (slow/intermittent urine stream, straining). 1 3 Moderate to severe LUTS secondary to BPH is estimated to affect 10% to 25% of the current worldwide male population (approximately 900 million men) 4 6 and it is estimated that approximately 1.1 billion men will have BPH-LUTS by the year Currently several drug modalities are recommended to treat BPH-LUTS, including a 1 -adrenoceptor antagonists (a-blockers), 5-ARIs and the PDE5I tadalafil. 2,3 In men with moderate to severe LUTS and confirmed PE, 5-ARI therapy is indicated to prevent BPH progression, reduce prostate size, and reduce the risk of urinary retention and future surgery. 2 Finasteride, a 5-ARI originally approved in 1992, is effective in treating men with BPH-LUTS and PE, but significant improvement in LUTS is typically not observed before 6 to 12 months of therapy, and sexual AEs are frequently reported The American Urological Association and the European Association of Urology recommend coadministering an a-blocker with a 5-ARI to achieve earlier LUTS improvement. 2,3 In recent clinical studies 5-ARI/a-blocker coadministration frequently resulted in significantly greater LUTS improvement compared to monotherapy or placebo. 9,12e15 However, most of these studies evaluated BPH and PE during several years, and only 2 (the CombAT [Combination of AvodartÒ and Tamsulosin] and VA-COOP [Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia] studies) examined LUTS changes during the first 6 months of coadministration. 9,14 In addition, AEs related to sexual/ejaculatory dysfunction appear to increase with 5-ARI/a-blocker coadministration. 11,15 Alternatively, a long-acting PDE5I could be coadministered with a 5-ARI to treat BPH-LUTS and PE. Tadalafil, with its half-life of 17.5 hours, is currently the only PDE5I for daily use that is indicated to treat men with ED, the signs and symptoms of BPH, and men with both disorders. 16 Clinical studies of men with BPH-LUTS have demonstrated that tadalafil 5 mg once daily leads to statistically significant improvements in I-PSS total scores as early as 1 to 2 weeks after beginning therapy However, until now, to our knowledge no placebo controlled studies have been performed on the coadministration of tadalafil with finasteride in men with BPH-LUTS and PE. Therefore, we evaluated the efficacy and safety of tadalafil 5 mg once daily coadministered with finasteride 5 mg for 26 weeks compared to placebo coadministered with finasteride 5 mg in men with BPH-LUTS and PE. MATERIALS AND METHODS This study was an international, randomized, double-blind, parallel design trial of men with BPH-LUTS and PE that was conducted from November 2010 to September 2012 (fig. 1). The study was performed in accordance with the Declaration of Helsinki and all applicable regulations. Institutional review boards at each site approved the study and all participants provided written informed consent before undergoing any study procedure. Eligible patients included men 45 years old or older with BPH-LUTS for more than 6 months. Patients also had a prostate volume of 30 ml or greater (confirmed via transrectal ultrasound), I-PSS total score 13 or greater and Q max 4 to 15 ml per second, and were naïve to 5-ARI therapy. An interactive voice response system was used to allocate patients to treatment groups. Randomization was stratified by baseline LUTS severity (I-PSS less than 20 vs 20 or greater), ED history and region (United States/ Canada vs Latin America/Europe). Patients were randomized in a 1:1 ratio to receive TAD/FIN or PBO/FIN for 26 weeks. Post-baseline study visits/assessments were conducted at weeks 4, 12 and 26 (or end point). In this study the primary objective was to assess whether TAD/FIN once daily for 12 weeks was superior Figure 1. Study design

3 TADALAFIL/FINASTERIDE COADMINISTRATION FOR LOWER URINARY TRACT SYMPTOMS 729 to PBO/FIN in improving BPH-LUTS as measured by changes in I-PSS total scores. 19 Secondary objectives included other I-PSS measures (storage and voiding subscores, I-PSS-nocturia and quality of life index [I-PSS-QoL] 19 ) after 4, 12 and 26 weeks of therapy; the erectile function domain of the IIEF-EF 20 after 4, 12 and 26 weeks of therapy in men who were sexually active and had ED at baseline; and the PGI-I (Patient Global Impression of Improvement) and CGI-I (Clinician Global Impression of Improvement) 21 after 26 weeks (or end point) of therapy. Safety assessments included patient reported TEAEs, SAEs, vital signs and clinical laboratory values. Analyses of BPH-LUTS efficacy variables and safety analyses were performed using results from patients who were randomized to study treatment and received 1 or more doses of double-blind study drug. Analyses of IIEF- EF scores were performed using results from these patients who were also sexually active with a female partner and had ED at baseline. Sample size calculations, which included the assumption that approximately 10% of I-PSS total score measurements would be missing at 12 weeks, were used to determine that 289 patients per group would provide 85% power to confirm the superiority of tadalafil over placebo and detect an I-PSS total score difference of 1.5 (using the 2-group t-test of equal means, assuming a SD of 6.0 and a 2-sided alpha level of 0.05). The primary analysis model was a mixed effects model for repeated measures analysis using the intent to treat population with I-PSS total score changes from baseline to weeks 4, 12 and 26 as dependent variables. The mixed effects model for repeated measures included baseline, treatment, region, visit and treatment by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance structure was assumed. The superiority of TAD/FIN compared to PBO/FIN was concluded if the upper limit of the 95% CI of the LS mean estimate of the treatment difference (TAD/FIN vs PBO/FIN) was less than 0.0 (p <0.05). A fixed sequence testing procedure was implemented to control the family-wise Type I error in the primary and key secondary end points. 22 The order of key secondary analyses was prespecified for treatment group comparison as 1) I-PSS total score change at 4 weeks, 2) IIEF-EF score change at 4 weeks, 3) IIEF-EF score change at 12 weeks, 4) IIEF-EF score change at 26 weeks and 5) I-PSS total score change at 26 weeks. The results from PGI-I and CGI-I scales were analyzed using a Cochran-Mantel-Haenszel test adjusted by baseline LUTS severity. All tests for treatment effects were conducted at a 2-sided alpha level of 0.05 unless otherwise stated and 2-sided 95% CIs were produced for continuous variables. Data were analyzed using SASÒ 9.2 software. of double-blind therapy and 592 (TAD/FIN 306 [88.4%] and PBO/FIN 286 [81.7%]) completed the entire 26-week period (fig. 2). Demographics were well-balanced across treatment groups (table 1). Overall mean age (SD) was 63.7 (7.7) years, and of the patients 85.5% were Caucasian, 31.7% had severe BPH-LUTS (I-PSS total score 20 or greater), 46.5% had a Q max less than 10 ml per second and mean prostate volume was 49.4 (20.4) ml. A total of 404 patients had ED at baseline and reported that they were sexually active with a female partner. Tadalafil 5 mg once daily coadministered with finasteride 5 mg for 12 weeks resulted in an I-PSS total score improvement that was significantly better than PBO/FIN. The LS mean change from baseline with TAD/FIN at 12 weeks was 5.2 vs 3.8 for PBO/FIN (resulting in a LSTD of 1.4 [95% CI 2.3, 0.6; p ¼ 0.001]; table 2). Thus, the primary objective of the study was achieved. Moreover significant LUTS improvements were observed with TAD/FIN at 4 and 26 weeks after baseline. After 4 weeks the LS mean change in I-PSS total score with TAD/FIN was 4.0 vs 2.3 with PBO/FIN (LSTD 1.7 [95% CI 2.4, 0.9; p <0.001]) while the LS mean change for TAD/FIN at 26 weeks was 5.5 vs 4.5 for placebo (LSTD 1.0; [95% CI 1.9, 0.2; p ¼ 0.022], fig. 3). Among sexually active patients who had ED at baseline (201 PBO/FIN, 203 TAD/FIN), TAD/FIN led to significant improvements (compared to PBO/ FIN) in IIEF-EF scores at all 3 points after baseline. LS mean changes in IIEF-EF scores were 3.7, 4.7 and 4.7 after 4, 12 and 26 weeks of TAD/FIN, respectively. Meanwhile, LS mean changes in IIEF-EF scores with PBO/FIN were 1.1, 0.6 and 0.0 at 4, 12 and 26 weeks, respectively, resulting in LSTDs of 4.9, 4.1 and 4.7 favoring TAD/FIN RESULTS A total of 695 patients were randomized to therapy and received 1 or more doses of study drug during double-blind treatment (TAD/FIN 345, PBO/FIN 350). Of these patients 659 completed 12 weeks Figure 2. Study disposition. Patient CONSORT (Consolidated Standards of Reporting Trials) diagram.

4 730 TADALAFIL/FINASTERIDE COADMINISTRATION FOR LOWER URINARY TRACT SYMPTOMS Table 1. Demographics and baseline characteristics PBO/FIN TAD/FIN Overall Mean pt age (SD) 63.6 (7.9) 63.8 (7.5) 63.7 (7.7) Pt age range No. pt age older than 65 yrs (%) 142 (40.6) 147 (42.6) 289 (41.6) No. pt age 75 yrs or older (%) 28 (8.0) 27 (7.8) 55 (7.9) No. ethnicity (%): Caucasian 296 (84.6) 298 (86.4) 594 (85.5) Native American 37 (10.6) 33 (9.6) 70 (10.1) Black/African-American 15 (4.3) 6 (1.7) 21 (3.0) Other 2 (0.6) 8 (2.3) 10 (1.5) Mean body mass index (SD) 28.3 (3.8) 28.3 (4.0) 28.3 (3.9) No. current alcohol consumption (%) 185 (52.9) 163 (47.2) 348 (50.1) No. history of tobacco use (%) 143 (40.9) 151 (43.8) 294 (42.3) No. current tobacco use (%)* 53 (37.1) 43 (28.5) 96 (32.7) Mean I-PSS total score (SD) 17.4 (5.9) 17.1 (5.6) 17.3 (5.7) No. LUTS severity (%): Mild-moderate (I-PSS total less than 20) 235 (67.3) 238 (69.2) 473 (68.3) Severe (I-PSS total 20 or greater) 114 (32.7) 106 (30.8) 220 (31.7) No. ml/sec Q max (%): Less than (48.3) 154 (44.6) 323 (46.5) (51.4) 190 (55.1) 370 (53.2) Greater than 15 1 (0.3) 1 (0.3) 2 (0.3) Mean ml post-void residual urine vol (SD) 62.6 (59.6) 65.5 (60.7) 64.1 (60.1) Mean ml prostate vol (SD) 50.6 (21.2) 48.2 (19.4) 49.4 (20.4) Mean serum prostate specific antigen (SD) 2.5 (2.1) 2.3 (2.0) 2.4 (2.0) No. previous a-blocker therapy (%) 137 (39.1) 118 (34.1) 255 (36.6) No. ED (%): Yes 223 (63.7) 227 (65.8) 450 (64.7) No 127 (36.3) 118 (34.2) 245 (35.3) No. sexually active with ED (%) 201 (57.4) 203 (58.5) 404 (58.1) * The patients sampled for this characteristic indicated a history of tobacco use (143 PBO/FIN, 151 TAD/FIN, 294 overall). over PBO/FIN (p <0.001 for LSTDs at all 3 points) (table 2, fig. 4). Examination of the primary and 5 key secondary efficacy outcomes under the prespecified fixed testing procedure revealed that all key secondary efficacy analyses were statistically significant (p for all). Compared to PBO/FIN, TAD/FIN significantly improved I-PSS storage and voiding subscores at week 4 and week 12 as well as I-PSS voiding subscores at week 26 (table 2). The I-PSS-QoL index was numerically improved with TAD/FIN (compared to PBO/FIN) at all 3 post-baseline assessments but only reached statistical significance at week 4. No differences were observed between TAD/FIN and PBO/FIN treatment for I-PSS-nocturia at any post-baseline assessments. In addition, after 26 weeks of therapy no significant differences were observed between the treatment groups in the distribution of responses to the CGI-I (p ¼ 0.328). However, the corresponding response distribution for the PGI-I significantly favored TAD/ FIN (p ¼ 0.034). This observation was likely due to the larger percentage of patients on TAD/FIN who reported that LUTS were much better after 26 weeks of therapy (40.1% of patients on TAD/FIN vs 28.5% on PBO/FIN) (table 2). Table 3 summarizes safety outcomes. During double-blind treatment an 80-year-old male patient died of metastatic pancreatic carcinoma 35 days after randomization to TAD/FIN and a 65-year-old male died 148 days after randomization to the PBO/ FIN group after experiencing a cerebrovascular accident. Investigators determined that neither death was related to study drug or procedures. In addition, 1 patient died of an undetermined cause during the 4-week placebo lead-in period, during which neither tadalafil nor finasteride were administered. A total of 108 patients on TAD/FIN (31.3%) and 95 on PBO/FIN (27.1%) reported 1 or more TEAEs. Most TEAEs were mild to moderate in severity. In addition, the incidences of SAEs and discontinuations due to AEs were low, and were not significantly different between treatment groups. Overall 5 patients on PBO/FIN reported ED as an adverse event compared to 1 patient on TAD/FIN. Five patients on PBO/FIN also reported decreased or lost libido while no patients on TAD/FIN reported this event. Two patients on TAD/FIN experienced ejaculation delay/failure while no patients on PBO/FIN reported adverse ejaculation issues. No clinically meaningful AEs were observed in vital signs or clinical laboratory measures.

5 TADALAFIL/FINASTERIDE COADMINISTRATION FOR LOWER URINARY TRACT SYMPTOMS 731 Table 2. Summary of efficacy outcomes PBO/FIN TAD/FIN LSTD (95% CI) p Value LS mean change I-PSS total scores (SE):* After 4 wks 2.3 (0.3) 4.0 (0.3) 1.7 ( 2.4, 0.9) <0.001 After 12 wks 3.8 (0.3) 5.2 (0.3) 1.4 ( 2.3, 0.6) After 26 wks (or end point) 4.5 (0.3) 5.5 (0.3) 1.0 ( 1.9, 0.2) LS mean change IIEF-EF domain scores (SE):*, After 4 wks 1.1 (0.5) 3.7 (0.5) 4.9 (3.5, 6.2) <0.001 After 12 wks 0.6 (0.6) 4.7 (0.6) 4.1 (2.6, 5.6) <0.001 After 26 wks (or end point) 0.0 (0.6) 4.7 (0.6) 4.7 (3.2, 6.3) <0.001 LS mean change other secondary outcomes (SE): I-PSS storage (irritative) subscore: 4 wks 0.8 (0.1) 1.3 (0.1) 0.5 ( 0.9, 0.1) wks 1.3 (0.1) 1.7 (0.1) 0.4 ( 0.8, 0.0) wks 1.7 (0.2) 2.0 (0.2) 0.3 ( 0.8, 0.1) I-PSS voiding (obstructive) subscore: 4 wks 1.5 (0.2) 2.7 (0.2) 1.2 ( 1.7, 0.7) < wks 2.4 (0.2) 3.4 (0.2) 1.0 ( 1.6, 0.5) < wks 2.8 (0.2) 3.5 (0.2) 0.7 ( 1.3, 0.1) I-PSS-nocturia: 4 wks 0.2 (0.1) 0.2 (0.1) 0.0 ( 0.2, 0.1) wks 0.3 (0.1) 0.3 (0.1) 0.0 ( 0.2, 0.2) wks 0.4 (0.1) 0.4 (0.1) 0.1 ( 0.1, 0.2) I-PSS-QoL: 4 wks 0.3 (0.1) 0.6 (0.1) 0.3 ( 0.5, 0.1) < wks 0.8 (0.1) 1.0 (0.1) 0.2 ( 0.4, 0.0) wks 0.9 (0.1) 1.1 (0.1) 0.2 ( 0.4, 0.0) No./total No. PGI-I at 26 wks (%): Very much better 29/288 (10.1) 21/309 (6.8) Much better 82/288 (28.5) 124/309 (40.1) A little better 112/288 (38.9) 102/309 (33.0) No change 52/288 (18.1) 49/309 (15.9) A little worse 5/288 (1.7) 10/309 (3.2) Much worse 7/288 (2.4) 2/309 (0.6) Very much worse 1/288 (0.3) 1/309 (0.3) No./total No. CGI-I at 26 wks (%): Very much better 22/290 (7.6) 23/307 (7.5) Much better 97/290 (33.4) 129/307 (42.0) A little better 106/290 (36.6) 98/307 (31.9) No change 48/290 (16.6) 47/307 (15.3) A little worse 10/290 (3.4) 5/307 (1.6) Much worse 6/290 (2.1) 5/307 (1.6) Very much worse 1/290 (0.3) 0/307 (0.0) * Primary efficacy outcome was I-PSS total score after 12 weeks. Key secondary efficacy outcomes were generated in prespecified order according to a fixed sequence testing procedure as 1) I-PSS after 4 weeks, 2) IIEF-EF after 4 weeks, 3) IIEF-EF after 12 weeks, 4) IIEF-EF after 26 weeks and 5) I-PSS after 26 weeks. Assessed in sexually active patients with ED at baseline (201 PBO/FIN and 203 TAD/FIN). DISCUSSION Tadalafil 5 mg once daily coadministered with finasteride 5 mg in men with LUTS and PE secondary to BPH resulted in significant and early LUTS improvement compared to finasteride coadministered with placebo. In addition, TAD/FIN significantly improved erectile function in men who were sexually active and had ED before initiating finasteride. The incidence of AEs was low, with most being mild to moderate in severity, and few patients discontinued due to AEs. Results observed after 4 and 12 weeks of therapy with TAD/FIN (including I-PSS total score improvement) were consistent with previous 12-week studies of tadalafil monotherapy in men with BPH-LUTS. 17,23,24 Our results were also consistent with those from a recent study in which tadalafil 5 mg once daily was coadministered with dutasteride 0.5 mg for 12 weeks in Korean men with moderate to severe BPH-LUTS. In that study (which did not include a placebo control group) the patients administered tadalafil/dutasteride for 12 weeks demonstrated a mean (SD) baseline to end point change of 2.3 (0.5) in I-PSS total score. 25 Interestingly we observed steady increases in LUTS improvement at every visit with TAD/FIN and PBO/FIN (table 2 and fig. 3). These improvements may be attributable to a small, additive effect from finasteride. Typically LUTS improvement is not observed with finasteride monotherapy for 6 to 12 months However, the timing of finasteride improvement in those other studies was usually reported relative to a placebo group. Our study did not include a pure placebo group. Thus, with no pure placebo comparison, finasteride therapeutic efficacy appeared to occur earlier than in previous studies. Our study also included men with larger prostate volume, which may have influenced

6 732 TADALAFIL/FINASTERIDE COADMINISTRATION FOR LOWER URINARY TRACT SYMPTOMS Table 3. Summary of safety outcomes No. PBO/FIN (%) No. TAD/FIN (%) Figure 3. Time course of LS mean change (SE) from baseline in I-PSS total score. Double dagger indicates p and number sign indicates p <0.05. the early finasteride efficacy. Results from the MTOPS (Medical Therapy of Prostatic Symptoms) and CombAT studies suggest that men with larger prostate volume may experience earlier LUTS improvement with 5-ARI therapy. 10,14 Our study specifically selected men with larger prostates (mean baseline prostate volume 49.4 ml) (table 1). Thus, the effects of finasteride in reducing prostate volume may have translated to a small degree of LUTS improvement during the latter part of our study. The overall safety profile observed in this study did not deviate from what had previously been established for tadalafil and finasteride monotherapy. The prescribing information for finasteride indicates that impotence/ed, decreased libido and ejaculatory abnormalities are commonly reported AEs. 11 As noted, numerically more patients in the PBO/FIN group reported sexual function AEs than Figure 4. Time course of LS mean change (SE) from baseline in IIEF-EF score in men who were sexually active with ED at baseline (201 for PBO/FIN, 204 for TAD/FIN). Double dagger indicates p < At least 1 TEAE 95 (27.1) 108 (31.3) At least 1 SAE 5 (1.4)* 9 (2.6)* Discontinued due to AE 8 (2.3) 5 (1.4) At least 1 treatment related AE 19 (5.4) 30 (8.7) Frequently reported TEAEs (2% or more of pts treated with tadalafil): Back pain 6 (1.7) 16 (4.6) Headache 12 (3.4) 12 (3.5) Dyspepsia 2 (0.6) 8 (2.3) Influenza 8 (2.3) 8 (2.3) AEs related to sexual function: ED 5 (1.4) 1 (0.3) Ejaculation delayed 0 (0.0) 1 (0.3) Ejaculation failure 0 (0.0) 1 (0.3) Libido decreased/lost 5 (1.4) 0 (0.0) Peyronie disease 0 (0.0) 1 (0.3) Semen vol decreased 0 (0.0) 1 (0.3) *Includes 1 death in the treatment group. in the TAD/FIN group. Nevertheless, the incidence of sexual AEs reported with PBO/FIN in this study was lower than that typically reported for 5-ARI monotherapy. 11,15 A possible explanation for this finding could be patient bias. On entering the study the men knew that they had a 50% chance of receiving tadalafil, a drug which they were informed is used to treat ED and may improve sexual function. When preparing this study no drug-drug interactions were anticipated with TAD/FIN as the data available on the metabolism of both agents via cytochrome P450 3A4 isoenzymes (CYP3A4) demonstrate that neither inhibits or induces CYP3A4. 11,16 The study safety results affirmed this assumption as the incidence and severity of AEs were not increased or worsened with TAD/FIN. Previous studies of 5-ARI/a-blocker coadministration had treatment durations of 1 to 4 years while our study lasted weeks. Our selection of the shorter treatment period was intentional. While studies such as MTOPS and VA-COOP were designed to evaluate long-term BPH disease progression/ improvement, our study was designed to determine whether TAD/FIN would lead to early LUTS improvement. This study did not include placebo or tadalafil monotherapy arms as the efficacy and safety of tadalafil and finasteride are well established. 11,16 Thus, a direct, within-study comparison of the TAD/FIN results to those of tadalafil monotherapy was considered unnecessary. In addition, our primary objective was to determine whether the addition of tadalafil therapy to finasteride would result in earlier LUTS improvement than that typically observed with finasteride monotherapy. Therefore, the aims of the study were met with the TAD/FIN and PBO/FIN treatment groups, so the inclusion of a placebo monotherapy group was unnecessary. Finally, the 26-week study duration

7 TADALAFIL/FINASTERIDE COADMINISTRATION FOR LOWER URINARY TRACT SYMPTOMS 733 was not considered sufficient to include and assess changes in uroflowmetry parameters (such as Q max and post-void residual urine volume) with TAD/FIN. CONCLUSIONS TAD/FIN improved lower urinary tract symptoms in men with PE secondary to BPH as assessed by improvements (compared with PBO/FIN) in I-PSS total scores, I-PSS voiding and storage subscores and I-PSS-QoL. Significant LUTS improvements were observed with TAD/FIN at the first visit (week 4), and were maintained and numerically increased throughout the 26-week treatment period. In men who were sexually active and had ED, IIEF-EF scores significantly improved with TAD/FIN. Overall these results support the once daily coadministration of tadalafil 5 mg with finasteride 5 mg for early symptom improvement in men with LUTS and prostatic enlargement secondary to BPH. ACKNOWLEDGMENTS Scott Burke (inventiv Health Clinical), Robert Hauk (Lilly) and Cindi Wood (inventiv Health Clinical) contributed to this study. REFERENCES 1. Abrams P, Cardozo L, Fall M et al: The standardisation of terminology in lower urinary tract function: report from the standardization sub-committee of the International Continence Society. Urology 2003; 61: American Urological Association Guideline: Management of Benign Prostatic Hyperplasia (BPH). Updated Available at org/content/guidelines-and-quality-care/clinicalguidelines/main-reports/bph-management/chap_ 1_GuidelineManagementofBPH.pdf. Accessed March Oelke M, Bachmann A, Descazeaud A et al: EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. 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