BLOOD LIPID VARIATIONS AND ARTERIOSCLEROTIC PROGRESSION EVALUATED IN ASYMPTOMATIC HYPERLIPIDEMIC SUBJECTS TREATED WITH GEMFIBROZIL - A 12-MONTH STUDY

This open trial was designed to evaluate the effects of gemfibrozil on the 12-month progression of early subclinical atherosclerotic changes at the femoral and carotid bifurcations in asymptomatic hyperlipidemi c patients; assessments were made with high-resolution ultrasound. Cha nges in ultrasonic biopsy (UB) score and the intima-media thickness (I MT) were evaluated. Patients in class II (morphologic classification o f vessel walls: initial IMT changes, score 2) and class III (increased IMT, score 4) were included. After a 6-week pretrial diet phase, gemf ibrozil was administered orally, 600 mg twice daily for 3 months and 9 00 mg once daily for the following 9 months. Of the 40 patients includ ed in the trial, 36 (17 men, 19 women) completed the study (mean age 5 7.1 +/- 11.2 years). Dropouts were not related to treatment. Significa nt variations in blood lipid levels were associated with a significant decrease in progression of early arterial changes. No patients progre ssed to class IV (early plaque not causing stenosis, score 6) or class V (stenosing plaques, score 8). In a comparison of hyperlipidemic sub jects evaluated within a study of the prevalence of early atherosclero sis and in a progression study of diet therapy only, IMT increase was 5.1% (vs 14.7% in untreated control subjects) and UB score increase wa s 7.4% (vs 15.12% in untreated control subjects). In this study, IMT a nd UB score increases at 12 months were not significant, indicating a stabilization or a low level of progression of otherwise rapidly progr essing subclinical lesions, a phenomenon that cannot be realized by di et only. Results demonstrate that long-term gemfibrozil treatment may be useful in decreasing the rapid progression rate of subclinical athe ro sclerotic changes in hyperlipidemic subjects.