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| Predictive value of lipid profile for salutary coronary angiographic changes in patients on a low-fat diet and physical exercise program |
| Niebauer J, Hambrecht R, Velich T, Marburger C, Hauer K, Kreuzer J, Zimmermann R, von Hodenberg E, Schlierf G, Schuler G, Kubler W |
| The American Journal of Cardiology 1996 Jul 15;78(2):163-167 |
| clinical trial |
| 6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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In this study, 113 patients with modestly elevated levels of low-density lipoprotein cholesterol (< 210 mg/dl) and coronary artery disease were randomized to an intervention group (n = 56) or a control group (n = 57). The intervention program consisted of daily exercise and a low-fat diet according to the American Heart Association's recommendation phase III; patients in the control group received "usual care" rendered by their private physician. After 1 year, complete data were available for all 92 patients (intervention: n = 40; control: n = 52) who underwent repeat coronary angiography. During the study course, patients in the intervention group showed an increase in apolipoprotein A-I (123 +/- 18 versus 129 +/- 20 mg/dl; p < 0.02) and apolipoprotein A-I/B (1.3 +/- 0.4 versus 1.5 +/- 0.4; p < 0.01) and a decrease in apolipoprotein B (99 +/- 20 versus 89 +/- 18 mg/dl; p < 0.01), while apolipoprotein A-II remained unchanged (38 +/- 6 versus 38 +/- 6 mg/dl; p = NS). In the control group, there were no significant changes (apolipoprotein A-I, 124 +/- 17 versus 128 +/- 13 mg/dl; apolipoprotein A-II, 38 +/- 6 versus 39 +/- 6 mg/dl; apolipoprotein B, 100 +/- 21 versus 99 +/- 16 mg/dl; apolipoprotein A-I/B, 1.3 +/- 0.3 versus 1.4 +/- 0.5; all p = NS). As previously reported, there was a significant retardation of progression in patients in the intervention group (progression 23%, no change 45%, regression 32%) compared with the control group (progression 48%, no change 35%, regression 17%) (p < 0.05). Although retardation of progression was significantly associated with an increase in apolipoprotein A-I/B and a decrease in apolipoprotein B (p < 0.05), these gave way in multivariate analysis to changes in total cholesterol/high-density lipoprotein cholesterol, absolute levels of low-density lipoprotein cholesterol, and, in a subgroup of patients, to leisure-time physical activity (all p < 0.05). These data demonstrate that an intervention based on a low-fat diet and intensive physical exercise is capable of improving apolipoprotein levels, associated with retardation of progression of coronary artery disease. However, total cholesterol/high-density lipoprotein cholesterol and low-density lipoprotein cholesterol appear superior to apolipoproteins as metabolic markers for effective treatment in patients with coronary artery disease.
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