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The PREVENT IT Trial Prevention of Renal and Vascular End stage Disease Intervention Trial

The PREVENT IT Trial Prevention of Renal and Vascular End stage Disease Intervention Trial. Reference Asselbergs FW, Diercks GFH, Hillege HL, et al . Effects of fosinopril and pravastatin on cardiovascular events in subjects with microalbuminuria. Circulation . 2004;110:2809–2816. Background

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The PREVENT IT Trial Prevention of Renal and Vascular End stage Disease Intervention Trial

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  1. The PREVENT IT Trial Prevention of Renal and Vascular End stage Disease Intervention Trial Reference Asselbergs FW, Diercks GFH, Hillege HL, et al. Effects of fosinopril and pravastatin on cardiovascular events in subjects with microalbuminuria. Circulation. 2004;110:2809–2816.

  2. Background Microalbuminuria is associated with increased risk of cardiovascular events. It is important to note that microalbuminuria may reflect the renal manifestation of a global abnormality of vascular function even in subjects without diabetes or hypertension. Thus, microalbuminuria might be an easily detectable marker of generalized vascular dysfunction and might therefore identify subjects at risk for cardiovascular and renal events.

  3. Aim To assess whether therapeutic intervention aimed at lowering urinary albumin excretion would reduce cardiovascular events in microalbuminuric subjects (15–300 mg/24 h).

  4. Methods

  5. Compliance to the treatment regimen: • In the fosinopril vs placebo arm, 70.7% of subjects in the placebo group and 63.3% in the fosinopril group showed compliance above 75% after 4 years of follow-up. • In the pravastatin vs placebo arm, 66.4% of subjects in the placebo group and 74.1% in the pravastatin group showed compliance above 75% after 4 years of follow-up.

  6. Summary of Key Results • Fosinopril treatment resulted in a slight but significant fall in systolic and diastolic blood pressure on both short-term and long-term follow-up, while pravastatin lowered total cholesterol and LDL cholesterol significantly during follow-up. There was no significant effect on the level of HDL cholesterol, triglycerides, and lipid levels between the fosinopril and placebo groups. • Pravastatin did not lower systolic and diastolic blood pressure compared to placebo. • Fosinopril reduced urinary albumin excretion by 26% (P<0.001) and led to 40% lower incidence of the primary endpoint (hazard ratio: 0.60 [95% CI: 0.33–1.10], P<0.098, log-rank). • Pravastatin did not reduce urinary albumin excretion, and subjects treated with pravastatin showed a 13% lower incidence of the primary endpoint than subjects in the placebo group • During a mean follow-up, the primary endpoint occurred in 5.2%. Subjects treated with fosinopril had a 40% lower incidence of the primary endpoint than subjects in the placebo group (3.9% vs 6.5%, P<0.098; Fig. 2). • Subjects treated with pravastatin had a 13% lower incidence of the primary endpoint than subjects in the placebo group (4.8% vs 5.6%).

  7. Conclusion Though the PREVENT IT trial did not explain whether primary prevention is indicated in microalbuminuric subjects without any other indication for primary prevention; the results of the intervention with fosinopril, particularly in the high albuminuria (higher risk) group, support the hypothesis that treatment that has a significantly favorable effect on urinary albumin excretion rate is associated with a beneficial clinical outcome. In microalbuminuric subjects, treatment with fosinopril had a significant effect on urinary albumin excretion. In addition, fosinopril treatment was associated with a trend in reducing cardiovascular events. Treatment with pravastatin did not result in a significant reduction in urinary albumin excretion or cardiovascular events.

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