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Am J Cardiol. 1992 Oct 8;70(10):91C-97C.

Safety of long-term use of lisinopril for congestive heart failure.

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Medical Research Department, ICI Pharmaceuticals, Macclesfield, Cheshire, United Kingdom.


Early clinical experience with lisinopril suggested that it was well tolerated in congestive heart failure (CHF). An analysis of data from greater than 1,000 patients treated with lisinopril has been performed to examine the long-term safety of lisinopril in CHF. Of these, 620 have been studied for up to nearly 4 years, and a further 440 have been studied in comparative trials for 3 months. When patients who received lisinopril or placebo for the same period were compared, the proportion of lisinopril patients reporting an adverse event was 44.1% compared with 39.4% on placebo. Over a 4-year period, 205 patients (33.1%) discontinued treatment. About 33% of these died, 33% withdrew due to clinical adverse events, 21 (3.4%) were withdrawn because of adverse laboratory findings, and 56 (9.0%) withdrew for reasons unrelated to treatment. Sixteen patients (2.6%) withdrew because lisinopril was deemed ineffective. The most frequently reported drug-related adverse laboratory findings were increases in blood urea nitrogen, blood urea, serum creatinine, and plasma potassium. There appeared to be no differences in the pattern of adverse events with respect to the race of the patient. Elderly patients and those with the most severe forms of heart failure appeared to be at greater risk for an adverse event. Evaluation of the safety of lisinopril compared with enalapril, captopril, and digoxin in controlled clinical trials shows all the angiotensin-converting enzyme inhibitors to be equally well tolerated with a closely similar range of adverse events, suggesting that the satisfactory safety profile of lisinopril is shared by other drugs of this class.(ABSTRACT TRUNCATED AT 250 WORDS).

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