Purpose: To compare the risk of liver injury in men treated with alpha1-blockers against that in a similar non-exposed population.
Methods: Using a study population registered on the UK General Practice Research Database (GPRD) we performed (a) a retrospective cohort analysis amongst men with lower urinary tract symptoms (LUTS) indicative of benign prostatic hypertrophy (BPH) comparing the incidence of liver injury in men exposed to alpha1-blockers with the incidence in those not exposed, and (b) two nested case-control studies looking at risk factors associated with the development of liver injury compared with age- or practice-matched controls.
Results: Amongst 45,851 men with LUTS/BPH, 9666 were exposed to an alpha1-blocker and 154 were identified with drug-induced/idiopathic liver injury. The crude incidence of liver injury in men with LUTS/BPH exposed to an alpha1-blocker was not statistically significantly different from that in the unexposed population (13.9 vs. 11.0 cases per 10,000 exposed years: incidence rate ratio (IRR) 1.28 [95% confidence interval (CI): 0.64, 2.31]). In the case-control analyses, the adjusted odds ratio (OR) of liver injury associated with exposure to alpha1-blockers compared with no use was not statistically significant (age-matched OR 0.92 [95%CI: 0.43, 1.97]; practice-matched OR 0.98 [95%CI: 0.45, 2.16]). Our analyses confirmed an association between liver injury and alcohol consumption as well as exposure to various classes of drugs known to be potentially hepatotoxic.
Conclusions: This study could not offer any evidence to support an association between exposure to alpha1-blockers and liver injury in men with LUTS/BPH.