PubMed · 15853083
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Corinne Taéron. 2005. [Ezetimibe].. https://pubmed.ncbi.nlm.nih.gov/15853083/
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We consider the construction of efficient group sequential designs where the goal is a low expected sample size not only at the null hypothesis and the alternative (taken to be the minimal clinically meaningful effect size), but also at more optimistic anticipated effect sizes. Pre-specified Type I error rate and power requirements can be achieved both by standard group sequential tests and by more recently proposed adaptive procedures. We investigate four nested classes of designs: (A) group sequential tests with equal group sizes and stopping boundaries determined by a monomial error spending function (the 'rho-family'); (B) as A but the initial group size is allowed to be different from the others; (C) group sequential tests with arbitrary group sizes and arbitrary boundaries, fixed in advance; (D) adaptive tests-as C but at each analysis, future group sizes and critical values are updated depending on the current value of the test statistic. By examining the performance of optimal procedures within each class, we conclude that class B provides simple and efficient designs with efficiency close to that of the more complex designs of classes C and D. We provide tables and figures illustrating the performances of optimal designs within each class and defining the optimal procedures of classes A and B.
OBJECTIVE: To determine the impact of intake occasion (with or without a meal), and product fat level on the cholesterol-lowering efficacy of a plant sterol (PS)-enriched (3 g/day) single-dose yoghurt drink. DESIGN: Double-blind, randomized, placebo-controlled, parallel study with a 4 weeks run-in and 4 weeks intervention period. SETTING: Subjects recruited from the general community. SUBJECTS: A total of 184 moderate hypercholesterolaemic subjects (81 men and 103 women) (age 57+/-2 years) completed the study. INTERVENTIONS: The study product was a 100-g single-dose yoghurt drink with or without added PS in the form of PS esters. The subjects were randomly assigned to one of five 4-week treatments: (i) drink A (0.1% dairy fat, 2.2% total fat) with a meal, (ii) drink A without a meal, (iii) drink B (1.5% dairy fat, 3.3% total fat) with a meal, (iv) drink B without a meal and (v) placebo drink with a meal. RESULTS: LDL-cholesterol (LDL-C) was significantly lowered when the single-dose drink was taken with a meal independent of its fat content (drink A: -9.5% (P<0.001, 95% CI: -13.8 to -5.2); drink B: -9.3% (P<0.001, 95% CI: -13.7 to -4.9)) as compared to placebo. When consumed without a meal, LDL-C was also significantly decreased (drink A: -5.1% (P<0.05, 95% CI: -9.4 to -0.8); drink B: -6.9% (P<0.01, 95% CI: -11.3 to -2.5) as compared to placebo, however the effect was significantly smaller as compared to the intake with a meal. CONCLUSION: These results indicate that a PS-ester-enriched single-dose yoghurt drink effectively reduces LDL-C irrespective of the fat content of the product. A substantially larger decrease in serum cholesterol concentration was achieved when the single-dose drink was consumed with a meal emphasizing the importance of the intake occasion for optimal cholesterol-lowering efficacy. SPONSORSHIP: Unilever Research and Development, Vlaardingen, The Netherlands.
A number of reports have indicated that both lowering low density lipoprotein (LDL)-cholesterol and raising high density lipoprotein (HDL)-cholesterol can result in significant cardiovascular benefit, both in terms of reduction of events and also, to a variable extent, of atheromatous lesions. LDL and HDL have opposite roles in body cholesterol regulation and, in theory, both reduced deposition (LDL reduction) and increased removal (raised HDL) can improve vascular disease. A number of reports over the last 30 years have attempted to quantitate with cholesterol balance/turnover studies, the correlations between LDL and HDL levels and body cholesterol pool sizes. More recently, these studies have evaluated the effects of LDL or HDL changes on cholesterol elimination. Data have, at times, been fully consistent with theoretical expectations, whereas at others they have not. Evaluation of these, at times, historical data provides, however, an important clue to the understanding of current results with different medications for the management of lipoprotein disorders.