No risk of drug-associated liver injury with alpha1-adrenoreceptor blocking agents in men with BPH: results from an observational study using the GPRD.
OBJECTIVE
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.
Clifford
Gary M
GM
Department of Pharmacoepidemiology, Postgraduate Medical School, University of Surrey, Guildford, UK.
Logie
John
J
Farmer
Richard D T
RD
D000317:Adrenergic alpha-Antagonists / Q000009:adverse effects* / Q000627:therapeutic use; D000368:Aged; D000369:Aged, 80 and over; D000428:Alcohol Drinking / Q000009:adverse effects; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology*; D015331:Cohort Studies; D016208:Databases, Factual; D006801:Humans; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D012189:Retrospective Studies; D012307:Risk Factors
D000317:Adrenergic alpha-Antagonists