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首页> 外文期刊>Controlled clinical trials >The UCSD Statin Study: a randomized controlled trial assessing the impact of statins on selected noncardiac outcomes.
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The UCSD Statin Study: a randomized controlled trial assessing the impact of statins on selected noncardiac outcomes.

机译：UCSD Statin研究：一项评估他汀类药物对某些非心脏预后影响的随机对照试验。

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There has been persistent controversy regarding possible favorable or adverse effects of statins or of cholesterol reduction on cognition, mood and behavior (including aggressive or violent behavior), muscle function, and quality of life. The UCSD Statin Study seeks to ascertain the beneficial or adverse effects of statin cholesterol-lowering drugs on a set of noncardiac endpoints, including cognition, behavior, and serotonin biochemistry. The study will enroll 1000 subjects (minimum 20% female) of mixed ethnicity from San Diego. Subjects must be age 20 and older, postmenopausal if female, without known cardiovascular disease or diabetes, and with LDL-cholesterol between 115 and 190 mg/dl. Subjects will be randomized to a double-blind, placebo-controlled trial with assignment 1/3, 1/3, 1/3 to placebo, simvastatin 20 mg, or pravastatin 40 mg (equipotent LDL-cholesterol-lowering doses for drug arms with simvastatin and pravastatin chosen to represent the extremes of the lipophilicity spectrum) for 6 months of treatment followed by 2 months postcessation follow-up. Primary outcomes are cognition (cognitive battery), irritability/aggression (behavior measure), and serotonin (gauged by whole blood serotonin), assessed as the difference between baseline and 6 months, judging combined statin groups vs. placebo. Secondary outcomes include mood (CES-D and Wakefield depression inventory), quality of life (SF-12V), sleep (Leeds sleep scale, modified), and secondary aggression measures (Conflict Tactics Scale; Overt Aggression Scale, Modified). Cardiovascular reactivity will be examined in a 10% subset. As additional secondary endpoints, primary and selected secondary outcomes will be assessed by statin assignment (lipophilic simvastatin vs. hydrophilic pravastatin). "Reversibility" of changes, if any, at 2 months postcessation will be determined. If effects (favorable or unfavorable) are identified, we will seek to ascertain whether there are baseline variables that predict who will be most susceptible to these favorable or adverse noncardiac effects (i.e., effect modification).
机译：关于他汀类药物或降低胆固醇对认知，情绪和行为（包括攻击性或暴力行为），肌肉功能和生活质量的可能有利或不利影响，一直存在争议。 UCSD Statin研究旨在确定降低他汀类药物胆固醇的药物对一系列非心脏终点（包括认知，行为和血清素生物化学）的有利或不利影响。该研究将招募来自圣地亚哥的1000名混合种族的受试者（至少20％的女性）。受试者必须年满20岁，女性绝经后，没有已知的心血管疾病或糖尿病，LDL-胆固醇在115至190 mg / dl之间。受试者将被随机分为一项双盲，安慰剂对照试验，分别分配给安慰剂1 / 3、1 / 3、1 / 3，辛伐他汀20毫克或普伐他汀40毫克（等剂量的LDL-胆固醇降低剂量用于选择辛伐他汀和普伐他汀代表亲脂性谱图的极端值）治疗6个月，然后进行2个月的进动后随访。主要结局为认知（认知能力），易怒/攻击（行为测度）和血清素（以全血血清素衡量），评估为他汀类药物组与安慰剂组的基线和6个月之间的差异。次要结果包括情绪（CES-D和韦克菲尔德抑郁量表），生活质量（SF-12V），睡眠（利兹睡眠量表，已修改）和次要攻击性度量（冲突策略量表;公开攻击量表，已修改）。将以10％的子集检查心血管反应性。作为其他次要终点，主要和选择的次要结局将通过他汀类药物分配评估（亲脂性辛伐他汀与亲水性普伐他汀）。如有变更，将在进退后2个月内确定变更的“可逆性”。如果确定了影响（有利或不利），我们将寻求确定是否存在基线变量，这些变量预测谁最容易受到这些有利或不利的非心脏影响（即影响改变）。

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