Safety profile of 3 months' therapy with alfuzosin in 13,389 patients suffering from benign prostatic hypertrophy.

The safety profile of alfuzosin, a selective alpha 1-adrenergic antagonist, was assessed in a total of 13,389 patients (mean age 66.9 +/- 8.5 years) with symptomatic benign prostatic hypertrophy in two open, noncontrolled, multicentre, post-marketing surveillance studies, both conducted in France. Alfuzosin was prescribed at the recommended dose of 2.5 mg t.i.d., according to the current labelling recommendations, for a 3-month period. Clinical safety was assessed using spontaneous reporting of adverse events leading to discontinuation of treatment. Overall, 89.7% of the patients completed the treatment period. Drop outs were recorded in 10.3% of patients: 3.7% for intolerance; 1.5% for resolution of urinary symptoms; 2.1% for lack of efficacy, and 3.0% for loss to follow-up, noncompliance, and miscellaneous reasons. Two thirds of the adverse events leading to discontinuation were vasodilatory and occurred in 2.7% of the patients: vertigo/dizziness (1.4%); malaise (0.6%); hypotension (0.4%), and headache (0.4%). Other adverse events (predominantly gastrointestinal disorders) were recorded in < 1.2% of the patients. Three quarters of the adverse events occurred during the first week of therapy. As expected, adverse events were more frequent in the elderly (aged over 75 years) and in patients taking cardiovascular drugs or with concomitant cardiovascular disease. Overall, alfuzosin was very well tolerated and the adverse event profile was consistent with the cumulative experience of the drug. No unexpected or serious adverse events considered to be related to alfuzosin were recorded. Particular care must be taken when prescribing for very elderly patients and/or those with concomitant cardiovascular disease for which they are receiving therapy.