Renal Insufficiency as a Predictor of Cardiovascular Outcomes and the Impact of Ramipril: The HOPE Randomized Trial - HOPE Substudy of Renal Insufficiency

Description:

Renal Insufficiency as a Predictor of Cardiovascular Outcomes and the Impact of Ramipril: The HOPE Randomized Trial.

Hypothesis:

To determine whether mild chronic renal insufficiency (mild CRF) increases cardiovascular risk and whether ramipril decreases that risk.

Study Design

Study Design:

Patients Enrolled: 9287

Drug/Procedures Used:

A post hoc analysis of HOPE (Heart Outcomes and Prevention Evaluation), which assessed ramipril vs. placebo in patients with established vascular disease or diabetes with other risk factors. The 5-year frequency of cardiovascular death, MI or stroke was compared in the 980 patients with a serum creatinine >1.4 mg/dL (mild CRF) but less than 2.3 mg/dL to the 8307 with normal renal function.

Principal Findings:

The mild CRF group was older (68.5 vs. 65.5 years) and had more PVOD and hypertension, but less were diabetic (34% vs. 39%). Primary outcomes occurred in 22.2% with mild CRF vs. 15.1% with normal renal function and increased proportionately to the creatinine. Total and cardiovascular mortality increased by approximately 70% in mild CRF. The effect of renal insufficiency on outcome (risk ratio 1.4) was independent of other cardiovascular risk factors and treatment. Ramipril reduced the primary outcome by about 20% in those with and without mild CRF.

In patients with pre-existing vascular disease or diabetes with additional risk factors, mild renal insufficiency increased the risk for cardiovascular events. Ramipril reduced the cardiovascular risk without increasing adverse effects.

Interpretation:

Based on HOPE, many physicians have added ACE II to beta-blockers, ASA and statins for secondary prevention. This post hoc analysis suggests the value remains considerable in mild CRF. The statement that ramipril did not increase adverse events should have been supported by a table demonstrating subsequent renal function.

References:

1. Mann JFE, Gerstein HC, Pogue J, Bosch J, Yusuf S. Ann Intern Med 2001;134:629-36.

Keywords: Odds Ratio, Stroke, Secondary Prevention, Risk Factors, Creatinine, Ramipril, Diabetic Angiopathies, Hypertension, Renal Insufficiency, Chronic


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