Download presentation
Presentation is loading. Please wait.
Published bySuzanna Chase Modified over 9 years ago
1
Slide 1 Effect of Combination Therapy with PROSCAR ™† (finasteride, MSD) and Doxazosin on the Risk of Clinical Progression of BPH by Total Baseline Prostate Volume New Analysis from the Medical Therapy Of Prostatic Symptoms Trial (MTOPS) † Trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA
2
Slide 2 Ref 3, p 18, C1, ¶4, L1-5 Ref 3, p 17, C2, ¶3, L12-18 Ref 3, p 18, C1, ¶2, L1-3, 13-16 Ref 4, p 2, Figure BPH=benign prostatic hyperplasia Adapted from Roehrborn CG Curr Opin Urol 2001;11:17–25; National Cancer Institute. NIH Publication No. 99-4303, 1999. Alpha-blockers5-Alpha-reductase inhibitors Improve symptoms and increase urinary flow rate by relaxing prostatic and bladder-neck smooth muscle through sympathetic activity blockade Improve symptoms, increase urinary flow rate, and prevent BPH outcomes by reducing prostate enlargement through hormonal mechanisms Complementary Mechanism of Action to Provide Both Fast Symptom Relief and Sustained BPH Control
3
Slide 3 Study Design: Overview Double-blind, placebo-controlled, multicenter, randomized clinical trial Average follow-up: 4.5 years AUA=American Urological Association; Q max =maximum urinary flow Adapted from Bautista OM et al Control Clin Trials 2003;24:224–243. Randomized N=3047 Entry Criteria Men 50 years of age AUA symptom score 8–30 Q max 4–15 ml/sec Voided volume 125 ml Doxazosin (n=756) PROSCAR ™† (finasteride) (n=768) PROSCAR + doxazosin (n=786) Placebo (n=737) MTOPS (Medical Therapy Of Prostatic Symptoms) † Trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA Ref 1, p 226, ¶2, L1-5, ¶3, L5-6; p 229, ¶1, L1-4, ¶2, L1-2; p 230, L1-4, ¶1, L1-3; p 231, Table 3; p 233, Table 4
4
Slide 4 Combination Therapy with PROSCAR ™ plus Doxazosin Is Significantly More Effective than Either Drug Alone Combination therapy with finasteride plus doxazosin is the most effective form of medical therapy for BPH –66% reduction in risk of BPH progression (p<0.001) –64% reduction in worsening symptoms (p<0.001) –81% reduction in risk of AUR (p<0.001) –67% reduction in need for invasive BPH therapy (p<0.001) Long-term monotherapy and combination therapy were well tolerated and effective AUR=acute urinary retention Adapted from McConnell JD et al N Engl J Med 2003;349(25):2385–2396. Ref 7, p 2394, C2, ¶2, L12-17; p 2388, C1, ¶1, L10-11, C2, L1-2; p 2390, C1, ¶1, L4-9, C2, ¶1, L5-7; p 2391, C1, ¶3, L10-14 Ref 7, p 2394, C2, ¶2, L12-15 MTOPS: Results PROSCAR™ (finasteride) is a trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA.
5
Slide 5 Ref 2, C1, Intro, Bullets 2,3 Can Baseline Total Prostate Volume Be Used to Identify Whom to Treat with Combination Therapy? MTOPS: A New Analysis
6
Slide 6 Statistical Methods in New Analysis Intention-to-treat population Evaluation of effects of baseline TPV on study measures Results compared –Across three clinically relevant baseline TPV subgroups <25 ml (small glands) 25–<40 ml (moderately sized glands) ≥40 ml (enlarged glands) Ref 2, C1, Intro, Bullet 3, C2, Materials and Methods, Bullet 2 TPV=total prostate volume Adapted from Kaplan SA et al. Presented at the annual meeting of the European Association of Urology, Istanbul, Turkey, March 16–19, 2005. MTOPS: A New Analysis
7
Slide 7 TRUS=transrectal ultrasonography Adapted from Kaplan SA et al. Presented at the annual meeting of the European Association of Urology, Istanbul, Turkey, March 16–19, 2005. Demographics and Baseline Characteristics Number of men3047 Mean age62.6 years Mean AUA symptom score16.9 Mean Q max 10.5 ml/sec Median prostate volume (TRUS) 31 ml <25 ml31% 25–<40 ml38% ≥40 ml31% Ref 2, C1, ¶2, L7-9, C2, Materials & Methods, Bullet 1, L1 MTOPS: A New Analysis No differences among groups
8
Slide 8 Relative Risk of BPH Progression by Baseline TPV Category Ref 2, C3, Fig 1A MTOPS: A New Analysis CI=confidence interval Adapted from Kaplan SA et al. Presented at the annual meeting of the European Association of Urology, Istanbul, Turkey, March 16–19, 2005. 00.20.40.60.81.01.200.20.40.60.81.01.21.41.6 Relative risk (95% CI) of BPH progression ≥40 25–<40 <25 Baseline TPV (ml) Favors combination therapy Favors doxazosin Favors combination therapy Favors PROSCAR ™ PROSCAR™ (finasteride) is a trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA.
9
Slide 9 Relative Risk of Invasive Therapy by Baseline TPV Category Ref 2, C3, Fig 1B 0123456700.511.522.53 Favors combination therapy Favors doxazosin Favors combination therapy Favors PROSCAR ™ Relative risk (95% CI) of invasive therapy MTOPS: A New Analysis ≥40 25–<40 <25 Baseline TPV (ml) PROSCAR™ (finasteride) is a trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA. Adapted from Kaplan SA et al. Presented at the annual meeting of the European Association of Urology, Istanbul, Turkey, March 16–19, 2005.
10
Slide 10 Change in AUA Symptom Scores by Baseline TPV Category Ref 2, C3, Fig 1C –3–2–101 MTOPS: A New Analysis –3–2–101 Favors combination therapy Favors doxazosin Favors combination therapy Favors PROSCAR ™ Mean (95% CI) between-group difference in change from baseline at year 4 ≥40 25–<40 <25 Baseline TPV (ml) PROSCAR™ (finasteride) is a trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA. Adapted from Kaplan SA et al. Presented at the annual meeting of the European Association of Urology, Istanbul, Turkey, March 16–19, 2005.
11
Slide 11 Change in Maximum Urinary Flow Rate by Baseline TPV Category Mean (95% CI) between-group difference in change from baseline at year 4 (ml/sec) 42–101342 013 Favors Combination Therapy Favors doxazosin Favors Combination Therapy Favors PROSCAR ™ MTOPS: A New Analysis Ref 2, C3, Fig 1D ≥40 25–<40 <25 Baseline TPV (ml) PROSCAR™ (finasteride) is a trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA. Adapted from Kaplan SA et al. Presented at the annual meeting of the European Association of Urology, Istanbul, Turkey, March 16–19, 2005.
12
Slide 12 Conclusions In patients with LUTS and TPV ≥25 ml –Combination therapy with PROSCAR ™ plus doxazosin led to superior overall management of BPH compared to either doxazosin or PROSCAR alone In patients with LUTS and TPV < 25 ml –Combination therapy with PROSCAR plus doxazosin led to a similar level of overall improvement versus doxazosin alone and a superior level of overall improvement relative to PROSCAR alone MTOPS: A New Analysis PROSCAR™ (finasteride) is a trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA. LUTS=lower urinary tract symptoms Adapted from Kaplan SA et al. Presented at the annual meeting of the European Association of Urology, Istanbul, Turkey, March 16–19, 2005. Ref 2, C3, Conclusions
13
Slide 13 MTOPS Results—Medical Therapy Decision Tree MTOPS: A New Analysis Adapted from Kaplan SA et al. Presented at the annual meeting of the European Association of Urology, Istanbul, Turkey, March 16–19, 2005. LUTS patient with AUA symptom score ≥8 Determine TPV TPV <25 ml TPV 25–<40 ml TPV ≥40 ml DoxazosinDoxazosin + PROSCAR™ PROSCAR™ (finasteride) is a trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA. Ref 2, C3, Fig 2
14
Slide 14 References Please refer to notes page.
15
Slide 15 Copyright © 2005 Merck & Co., Inc., Whitehouse Station, NJ, USA. All rights reserved. 6-07 PSC 2004-W-14313-SS VISIT US ON THE WORLD WIDE WEB AT http://www.merck.com New Analysis from the Medical Therapy Of Prostatic Symptoms Trial (MTOPS) Before prescribing, please consult the manufacturers’ prescribing information. Merck does not recommend the use of any product in any different manner than as described in the prescribing information.
Similar presentations
© 2025 SlidePlayer.com. Inc.
All rights reserved.