|Widimsky J, Jerie P|
Czech and Slovak Spirapril Intervention Study (CASSIS)
Journal of Clinical and Basic Cardiology 2000; 3 (1): 7-10
Keywords: ACE-Hemmer, Herzinsuffizienz, Mortalitšt, spirapril, ACE inhibitors, cardiac failure, mortality, spirapril
CASSIS is a randomized, double blind, placebo- and active controlled 12-week multicentric study with spirapril in patients with congestive heart failure of NYHA class II-IV. The patients were randomized to one of five treatment arms: placebo (48 pts.), spirapril 1.5 mg (48 pts.), spirapril 3 mg (53 pts.), spirapril 6 mg (51 pts.) and enalapril 5/10 mg (48 pts.). Spirapril treatment (pooled spirapril groups) induced during these twelve weeks a significant reduction in total mortality when compared to placebo patients and a trend for reduction of serious cardiovascular adverse events as well as duration of hospitalization. These effects and improvement in lung congestion appeared to be dose-dependent. After the double blind period of twelve weeks the study was opened and patients were studied during a further 92 weeks (ie, for a total of 104 weeks equal two years). The second year of follow-up has been analysed. The improvement of NYHA functional classification at the end of the double-blind study with spirapril continued during the second year. The excellent tolerability of spirapril was surprising; hypotension, deterioration of renal function and cough were very rare. The incidence of cough was 0.6 %. Thus spirapril might be an effective alternative to enalapril in the treatment of patients with congestive heart failure. J Clin Basic Cardiol 2000; 3: 7-10.