SAFETY UPDATE - FOCUS ON COUGH

Overall, angiotensin-converting enzyme (ACE) inhibitors have a very lo w side effect profile. However, several reports In the literature cite cough as a possible complication of ACE inhibitor therapy. These repo rts have prompted speculation that the risk of cough may differ among ACE inhibitors and that the risk may be greater in patients with renal impairment, perhaps because of excessive drug accumulation. However, these hypotheses have not been tested in prospective, controlled studi es. Fosinopril is a long-acting ACE inhibitor with a unique chemical s tructure and an elimination profile that is associated with stable cle arance, regardless of the degree of renal impairment. Favorable clinic al experience with fosinopril led to the evaluation of this agent's co ugh profile In a prospective, open-label study. This study focused on the frequency of cough in patients with mild-to moderate hypertension who had previously experienced cough while taking another ACE inhibito r. Whereas most prior controlled studies and postmarketing surveillanc e trials measured the frequency of cough through spontaneous adverse-e vent reporting in this study a methodology previously validated In ant itussive and mucolytic studies was adapted to provide an accurate and sensitive measure of fosinopril's cough profile. Twenty-four patients were switched from another AGE inhibitor to fosinopril, 10 mg once dai ly for 6 weeks. At study end, the mean occurrence of cough, frequency of cough, and cough severity significantly changed from baseline (p le ss than or equal to 0.0002). Thus, fosinopril use was associated with a less frequent, less severe cough in patients who experienced cough w hite taking other ACE inhibitors.