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 more than 6-months 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 more than 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 more than 1 antihypertensive medication versus -3.3 ( 95% CI: -4.4 to -2.1 ) in men taking one medication ( interaction p = 0.020 ).
In addition, placebo-adjusted least squares mean improvements in total IPSS were -0.2 ( 95% CI, -2.1 to 1.7 ) in men who reported use of diuretics versus -2.8 ( 95% CI, -3.7 to -1.9 ) in men who reported taking other antihypertensive medications versus -2.3 ( 95% CI, -3.2 to -1.5 ) in men who reported not using any antihypertensive drug ( p-value for interaction = 0.053 ).
In conclusion, once-daily Tadalafil 5 mg improves lower urinary tract symptoms associated with benign prostatic hyperplasia, regardless of severity, in men with coexisting cardiovascular risk factors / comorbidities, except for patients with history of more than 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. ( Xagena )
Vlachopoulos C et al, Int J Clin Pract 2015;69:1496-1507