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
The National Heart, Lung and Blood Institute Type II Coronary Intervention Study, a double-blind, placebo-controlled trial, evaluated the efficacy of reduction in cholesterol levels induced by cholestyramine on progression of coronary artery disease (CAD). The rate of CAD progression in patients treated with cholestyramine plus diet was compared with that of patients treated with placebo plus diet. CAD progression was defined angiographically. Significant decrease in total cholesterol (TC) and low-density lipoprotein cholesterol (LDLC) and increases in high-density lipoprotein cholesterol (HDLL). as well as in HDLC/TC and HDLC/LDLC ratios, were observed with cholestyramine. HDLC change was due to increase in HDL2A and HDL2B. When the relationship between CAD progression and lipid changes was examined independent of specific treatment group, a significant inverse relationship was found between progression at 5 years and the combination of an increase in HDLC and a decrease in LDL,; changes in HDLC/TC and HDLC/LDLc were the best predictors of CAD change. While the testing of these relationships independent of treatment group was not part of the initial study design, the trends were observed in both the placebo-treated and cholestyramine-treated groups. Moreover, with multivariate analysis, the effect of cholestyramine treatment on CAD progression was eliminated by adding changes in HDLC/TC to the regression model. These findings support the hypothesis that increases in HDLC and decreases in TC (or LDLC) can prevent or delay CAD progression. Circulation 69, No. 2, 325-337, 1984 medication was prescribed, and patients were followed at monthly clinical visits over a period of 5 years. In previous articles the design and baseline findings,' the method of assessing angiographic progression of disease, and the primary end point results were reported.2 The major purpose of this report is to describe both the lipid response to treatment and the relationship between this lipid response and CAD progression. The relationship between baseline lipid levels and other characteristics, as well as the lipid response to treatment, is also explored.
MethodsThe specific criteria for this study stipulated that only those subjects with elevated levels of LDLC were eligible. Serial sampling before and after a low-cholesterol, low-fat diet effectively screened out those subjects with LDLC elevations secondary to diet.' Criteria for lipid screening used in the trial are presented in table 1. Compliance to taking medication was estimated at
The occurrence of nasotracheal intubation with feeding tubes of various types is well known but poorly documented. The small-diameter feeding tubes currently available for enteral hyperalimentation may be more prone to this complication because of their small size and the rigid guide wire which is required for placement. A high index of suspicion when placing these tubes in patients at risk, use of the wire guide to pass the nasopharynx only, and x-ray verification of tube location prior to usage should avert this potentially life-threatening mistake.
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