Effects of therapy with cholestyramine on progression of coronary arteriosclerosis: results of the NHLBI Type II Coronary Intervention Study.

Abstract

In the National Heart, Lung and Blood Institute Type Il Coronary Intervention Study, patients with Type lI hyperlipoproteinemia and coronary artery disease (CAD) were placed on a lowfat, low-cholesterol diet and then were randomly allocated to receive either 6 g cholestyramine four times daily or placebo. This double-blind study evaluated the effects of cholestyramine on the progression of CAD as assessed by angiography. Diet alone reduced the low-density lipoprotein cholesterol 6% in both groups. After randomization, low-density lipoprotein cholesterol decreased another 5% in the placebo group and 26% in the cholestyramine-treated group. Coronary angiography was performed in 1 16 patients before and after 5 years of treatment. CAD progressed in 49% (28 of 57) of the placebotreated patients vs 32% (19 of 59) of the cholestyramine-treated patients (p < .05). When only definite progression was considered, 35% (20 of 57) of the placebo-treated patients vs 25% (15 of 59) of the cholestyramine-treated patients exhibited definite progression; the difference was not statistically significant. However, when this analysis was performed with adjustment for baseline inequalities of risk factors, effect of treatment was more pronounced. Of lesions causing 50% or greater stenosis at baseline, 33% of placebo-treated and 12% of cholestyramine-treated patients manifested lesion progression (p < .05). Similar analyses with other end points (percent of baseline lesions that progressed, lesions that progressed to occlusion, lesions that regressed, size of lesion change, and all cardiovascular end points) all favored the cholestyramine-treated group, but were not statistically significant. Thus, although the sample size does not allow a definitive conclusion to be drawn, this study suggests MethodsStudy design. The study design has been described extensively elsewhere. 1 Briefly, patients were screened with two sets of eligibility criteria: elevated levels of low-density lipoprotein (LDL) cholesterol and angiographic evidence of CAD. Patients underwent coronary angiography if LDL cholesterol after 1 month of therapy with low-cholesterol, low-fat diet3 was in the

Normalization of plasma lipoprotein concentrations in patients with type II hyperlipoproteinemia by combined use of neomycin and niacin.

“…Treatment not only retards the development of coronary atherosclerosis, 19 20 it also prevents myocardial infarction and death. '1 2 Therefore, the questions involved in clinical practice shift from "whether to treat" to "how best to treat.…”

George Lyman Duff Memorial Lecture. Arterial imaging and atherosclerosis reversal.

“…In the NHLBI Type II study, 5% of subjects had mixed lesion responses, both progression and regression. 11 One explanation for this may be that atherosclerotic lesions of different ages respond differently to lipid lowering because of differing physiochemical and histological characteristics, as reported by Small et al 90 and others. 5455 Therefore, there are limitations to drawing conclusions about specific coronary artery lesions from changes in peripheral vessels.…”

“…11 Men and women with LDL-C levels exceeding the age-corrected 95th percentile were included. There were baseline and 5-year angiograms on 57 placebo-treated and 59 cholestyramine-treated subjects.…”

Terapia combinada de colestiramina e inibidores da HMG-CoA redutase na prevenção secundária da doença coronária

“…Essas modificações são semelhantes às obtidas em estudos realizados em tratamento com um único medicamento em dose mais elevada, como no National Heart Lung and Blood Institute Type II Coronary Intervention Study, em que o tratamento unimedicamentoso com colestiramina na dose de até 24g instituído a pacientes coronários hipercolesterolêmicos, levou a reduções de 17% e 26%, respectivamente para colesterol total e LDLcolesterol 10 . Também no estudo STARS (St Thomas Atherosclerosis Regression Study) em que pacientes com características semelhantes aos nossos foram avaliados, o grupo que recebeu rigoroso tratamento dietético hipogorduroso associado a colestiramina apresentou reduções de colesterol total de 25% e de LDL-colesterol de 36%, discretamente superiores aos verificados em nosso trabalho 11 .…”