Abstract 850: Long-Term Effects of Fosinopril on Cardiovascular Events in Subjects With Micro-albuminuria
BACKGROUND: The Prevention of Renal and Vascular End-stage Disease - Intervention Trial (PREVEND-IT) showed that treatment with fosinopril had a significant effect on urinary albumin excretion (UAE) and was associated with a trend in reducing cardiovascular events (p=0.098) in subjects with UAE >10mg/24h and a significant reduction in subjects with high UAE (>50mg/24h). The follow-up of PREVEND-IT was 4 years with an event rate of 5.2%. In the present study, we extended follow-up to approximately 9 years and hypothesize that fosinopril has a significant event on cardiovascular events in subjects with UAE >10mg/24h during long-term follow-up.
METHODS: PREVEND-IT is a single-center, double-blind, randomized, placebo-controlled clinical trial investigating the effect of fosinopril 20mg on cardiovascular events. The primary end point is cardiovascular mortality and hospitalization for cardiovascular morbidity.
RESULTS: Mean total follow-up was 9.5 years (range 9.4 to 10.7). In the post-trial period, the primary end-point occurred in 73 subjects (8.5%). During total follow-up, subjects assigned to fosinopril had an overall risk reduction of 16% (95% CI 0.58 –1.20 [p=0.33]). Subjects with an UAE>50mg/24hrs had a higher risk of developing cardiovascular disease (HR 2.05; 95%CI 1.39 –3.01 [P=<0.001]). In subjects with an UAE>50mg/24h and assigned to fosinopril in the original trial, a risk reduction of 51% (95%CI 6%–75% [P=0.033]) was observed vs. the low UAE group, where there was no effect.
CONCLUSIONS: Elevated UAE in normotensive subjects with no hypercholesterolemia is associated with a relative high mortality and morbidity risk. This risk more than doubles if the UAE is >50mg/24h. In this group, treatment with fosinopril significantly reduced mortality and morbidity. This benefit persisted and even increased in the 6 year after the blinded study period.