Abstract | OBJECTIVES: PATIENTS AND METHODS: Post hoc integrated analysis of four placebo-controlled studies in men (aged ≥45 years; International Prostate Symptom Score [IPSS] of ≥13; maximum urinary flow rate [Q(max)] of ≥4 to ≤15 mL/s) with BPH-LUTS randomised to tadalafil 5 mg (752 patients) or placebo (747) for 12 weeks after a 4-week placebo run-in. Responders were defined as having a total IPSS improvement of ≥3 points or ≥25% from randomisation to endpoint (Week 12). Response status was calculated per patient, and relative benefit and odds ratio (OR) with 95% confidence interval (CI) of tadalafil vs placebo was calculated using a logistic Generalised Mixed Model for Repeated Measures. RESULTS:
Tadalafil 5 mg once daily resulted in a significantly greater proportion of patients achieving a ≥3-point IPSS improvement (71.1% and 56.0% for tadalafil and placebo patients, respectively [OR 1.9, 95% CI 1.5, 2.4; P < 0.001]) and achieving a ≥25% improvement in total IPSS randomisation to endpoint (61.7% and 45.5% for tadalafil and placebo patients, respectively [OR 2.0, 95% CI 1.6, 2.5; P < 0.001]). CONCLUSION: About two-thirds of tadalafil-treated patients achieve a clinically meaningful improvement in BPH-LUTS symptoms, based on two different definitions of responder status.
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Authors | John Curtis Nickel, Gerald B Brock, Sender Herschorn, Ruth Dickson, Carsten Henneges, Lars Viktrup |
Journal | BJU international
(BJU Int)
Vol. 115
Issue 5
Pg. 815-21
(May 2015)
ISSN: 1464-410X [Electronic] England |
PMID | 25195970
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | © 2014 The Authors. BJU International © 2014 BJU International. |
Chemical References |
- Carbolines
- Phosphodiesterase 5 Inhibitors
- Tadalafil
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Topics |
- Carbolines
(therapeutic use)
- Double-Blind Method
- Humans
- Lower Urinary Tract Symptoms
(drug therapy, etiology)
- Male
- Middle Aged
- Phosphodiesterase 5 Inhibitors
(therapeutic use)
- Prostatic Hyperplasia
(complications)
- Remission Induction
- Tadalafil
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