The influence of cardiovascular risk factors/comorbidities on response to oral once-daily tadalafil 5 mg was explored in men with lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH).
This post hoc analysis pooled data from four double-blind studies in which 1498 men with > 6-mo history of LUTS/BPH were randomised and received either once-daily placebo (n = 746) or tadalafil 5 mg (n = 752) for 12 weeks. Descriptive statistics were reported for changes in total International Prostate Symptom Score (IPSS), IPSS voiding and storage subscores, and IPSS quality-of-life (QoL) index. Treatment group differences by baseline clinical and cardiovascular factors and medical therapies were examined using analysis of covariance.
Tadalafil was effective in men with LUTS/BPH and cardiovascular risk factors/comorbidities except for patients receiving > 1 antihypertensive medication. Placebo-adjusted least squares (LS) mean improvements in total IPSS were -1 2 (95% CI: -2 5 to -0 0) in men taking > 1 antihypertensive medication vs -3 3 (95% CI: -4 4 to -2 1) in men taking one medication (interaction p = 0 020). In addition, placebo-adjusted LS mean improvements in total IPSS were -0 2 (95% CI, -2 1 to 1 7) in men who reported use of diuretics vs -2 8 (95% CI, -3 7 to -1 9) in men who reported taking other antihypertensive medications vs -2 3 (95% CI, -3 2 to -1 5) in men who reported not using any antihypertensive drug (p-value for interaction = 0 053).
Once-daily tadalafil 5 mg improved LUTS/BPH, regardless of severity, in men with coexisting cardiovascular risk factors/comorbidities, except for patients with history of > 1 drug for arterial hypertension. Use of diuretics may contribute to patients' perception of a negated efficacy of tadalafil on LUTS/BPH. Comorbidities should be considered when choosing the optimal medicine to treat men with LUTS/BPH.
International journal of clinical practice 2015 Aug 24 [Epub ahead of print]
C Vlachopoulos, M Oelke, M Maggi, J P Mulhall, M T Rosenberg, G B Brock, A Esler, H Büttner
1st Department of Cardiology, Athens Medical School, Athens, Greece , Department of Urology, Hannover Medical School, Hannover, Germany , University of Florence, Florence, Italy , Memorial Sloan-Kettering Cancer Center, New York, NY, USA , Mid Michigan Physicians, Jackson, MI, USA , University of Western Ontario, London, ON, Canada , Inventiv Health Clinical, Indianapolis, IN, USA , Eli Lilly Biomedicines BU - Men's Health Therapeutic Area Europe, c/o Lilly Deutschland, GmbH, Bad Homburg, Germany