title: Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors: 1st Department of Cardiology, Athens Medical School, Athens, Greece.
authors: C
authors: C
authors: Vlachopoulos
authors: Department of Urology, Hannover Medical School, Hannover, Germany.
authors: M
authors: M
authors: Oelke
authors: University of Florence, Florence, Italy.
authors: M
authors: M
authors: Maggi
authors: Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
authors: J P
authors: JP
authors: Mulhall
authors: Mid Michigan Physicians, Jackson, MI, USA.
authors: M T
authors: MT
authors: Rosenberg
authors: University of Western Ontario, London, ON, Canada.
authors: G B
authors: GB
authors: Brock
authors: Inventiv Health Clinical, Indianapolis, IN, USA.
authors: A
authors: A
authors: Esler
authors: Eli Lilly Biomedicines BU - Men's Health Therapeutic Area Europe, c/o Lilly Deutschland, GmbH, Bad Homburg, Germany.
authors: H
authors: H
authors: Büttner
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000150:complications*; D015897:Comorbidity; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage*; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D012307:Risk Factors; D000068581:Tadalafil / Q000008:administration & dosage*; D014665:Vasodilator Agents / Q000008:administration & dosage*
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D014665:Vasodilator Agents; D000068581:Tadalafil