HEPATOTOXICITY RELATED TO INTRACAVERNOUS PHARMACOTHERAPY WITH PAPAVERINE

Objectives. To determine the incidence of hepatotoxicity related to se lf-administration of intracavernous papaverine or papaverine/phentolam ine (bimix). Methods. From October 1994 through June 1996, we retrospe ctively reviewed the medical records of 71 consecutive patients diagno sed with organic erectile dysfunction (ED) and receiving intracavernou s injection therapy. Inclusion criteria were documentation of normal b aseline liver function tests (LFTs), a minimum of 6 months of follow-u p that included LFTs, at least one self-injection every 2 weeks, and n o other prior or concurrent treatment for ED. Thirty evaluable patient s satisfied the inclusion criteria and formed group 1. Mean age was 63 years (range 40 to 77), mean follow-up was 18 months (range 6 to 32), and mean number of injections per month was 5.7 (range 3 to 12). An a ge-matched population of 20 patients (mean age 69 years, range 46 to 9 0) without ED but with similar comorbid risk factors formed the contro l group (group 2). All patients in group 2 had routine long-term follo w-up of LFTs (mean 52 months, range 10 to 114). Results. Two patients (6.67%) from group 1 had elevated LFTs during treatment: one experienc ed a mild elevation in alanine aminotransferase and the other develope d transient elevations of total bilirubin and aspartate aminotransfera se 6 months after beginning therapy. Both patients reported a history of alcohol abuse. Both patients remained asymptomatic. Neither patient required discontinuation of therapy. One patient (5%) from group 2 de veloped an elevation of total bilirubin at a follow-up of 12 months. C onclusions. Routine monitoring of LFTs is probably unnecessary during intracavernous pharmacotherapy. Patients with a history of alcohol abu se or liver disease, however, should be followed up more closely when papaverine is selected for intracavernous injection. in these patients , LFTs should be obtained before initiating treatment and at 6-month i ntervals.