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- Title
Proportion of tadalafil-treated patients with clinically meaningful improvement in lower urinary tract symptoms associated with benign prostatic hyperplasia - integrated data from 1 499 study participants.
- Authors
Nickel, John Curtis; Brock, Gerald B.; Herschorn, Sender; Dickson, Ruth; Henneges, Carsten; Viktrup, Lars
- Abstract
Objectives To evaluate the proportion of patients achieving clinically meaningful improvement of lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( BPH- LUTS) with tadalafil using two definitions of response. 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 [Qmax] 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.
- Subjects
URINARY tract infections; PROSTATE cancer treatment; BENIGN prostatic hyperplasia; ADRENERGIC alpha blockers; PLACEBOS
- Publication
BJU International, 2015, Vol 115, Issue 5, p815
- ISSN
1464-4096
- Publication type
Article
- DOI
10.1111/bju.12926