Effect of aggressive versus moderate lipid-lowering therapy on myocardial ischemia: the rationale, design, and baseline characteristics of the Study Assessing Goals in the Elderly (SAGE).

BACKGROUND

Patients with stable CHD who experience episodes of ischemia during routine daily activities are at increased risk of coronary events. Older patients are at a particularly high risk. Few trials have specifically investigated the effects of lipid-lowering therapy with statins in older patients.

METHODS

The SAGE trial is a prospective, randomized, double-blind, parallel-arm study enrolling men and women with stable CHD at 192 centers worldwide. Qualifying participants (aged 65-85 years; low-density lipoprotein cholesterol 100-250 mg/dL) have had at least 1 episode of myocardial ischemia with total ischemia duration >or=3 minutes on 48-hour ambulatory electrocardiographic (AECG) monitoring performed during routine daily activities. Participants have been randomized to either atorvastatin 80 mg/day (aggressive lipid lowering) or pravastatin 40 mg/day (moderate lipid lowering). The primary efficacy measure is the absolute change in the total duration of myocardial ischemic events on 48-hour AECG monitoring from baseline to month 12.

RESULTS

SAGE is fully enrolled and 893 patients have been randomized. The majority of the study participants are white (97%) men (69%). The mean age of the participants is 72 years. Most participants (94%) have a history of angina. Other high-risk patient groups included in the study are patients with hypertension (65%), patients with diabetes (23%), and patients with peripheral vascular disease (12%).

CONCLUSIONS

SAGE will evaluate the effect of aggressive versus moderate lipid lowering on the total duration of myocardial ischemia in older ambulatory patients with CHD. It is likely to provide valuable data on the benefits of statins in this patient population.