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首页> 外文期刊>Trials >Efficacy of n-3 polyunsaturated fatty acids and feasibility of optimizing preventive strategies in patients at high cardiovascular risk: rationale, design and baseline characteristics of the Rischio and Prevenzione study, a large randomised trial in general practice
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Efficacy of n-3 polyunsaturated fatty acids and feasibility of optimizing preventive strategies in patients at high cardiovascular risk: rationale, design and baseline characteristics of the Rischio and Prevenzione study, a large randomised trial in general practice

机译：n-3多不饱和脂肪酸在高心血管风险患者中的功效和优化预防策略的可行性：Rischio和Prevenzione研究的基本原理，设计和基线特征

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Background The optimization of preventive strategies in patients at high risk of cardiovascular events and the evaluation of bottlenecks and limitations of transferring current guidelines to the real world of clinical practice are important limiting steps to cardiovascular prevention. Treatment with n-3 polyunsaturated fatty acids improves prognosis after myocardial infarction, but evidence of this benefit is lacking in patients at high cardiovascular risk, but without a history of myocardial infarction. Methods/design Patients were eligible if their general practitioner (GP) considered them at high cardiovascular risk because of a cardiovascular disease other than myocardial infarction, or multiple risk factors (at least four major risk factors in non-diabetic patients and one in diabetics). Patients were randomly allocated to treatment with n-3 polyunsaturated fatty acids (1 g daily) or placebo in a double-blind study and followed up for five years by their GPs to assess the efficacy of the treatment in preventing cardiovascular mortality (including sudden death) and hospitalization for cardiovascular reasons. The secondary, epidemiological, aim of the study is to assess whether it is feasible to adopt current guidelines in everyday clinical practice, with a view to optimizing all the available preventive strategies in people at high cardiovascular risk. A nation-wide network of 860 GPs admitted 12,513 patients to the study between February 2004 and March 2007. The mean age was 64 years and 62% were males. Diabetes mellitus plus one or more cardiovascular risk factors was the main inclusion criterion (47%). About 30% of patients were included because of a history of atherosclerotic cardiovascular disease, 21% for four or more risk factors, and less than 1% for other reasons. Discussion The Rischio and Prevenzione (R&P) project provides a feasible model to test the efficacy of n-3 polyunsaturated fatty acid therapy in patients at high cardiovascular risk with no history of myocardial infarction, and to assess how to implement recommended preventive strategies in general practice. Trial registration ClinicalTrials.gov NCT00317707
机译：背景技术对心血管事件高风险患者的预防策略的优化以及瓶颈的评估和将当前指南应用于临床实践的局限性是限制心血管预防的重要步骤。用n-3多不饱和脂肪酸治疗可改善心肌梗塞后的预后，但对于具有高心血管风险但无心肌梗塞病史的患者，尚缺乏这种益处的证据。方法/设计如果患者的全科医生（GP）认为他们因心血管疾病而不是心肌梗塞或多种危险因素（至少在非糖尿病患者中有四种主要危险因素，而在糖尿病患者中有一种）而处于高心血管风险中，则该患者符合条件。在一项双盲研究中，患者被随机分配接受n-3多不饱和脂肪酸（每天1 g）或安慰剂治疗，并由其GP随访5年，以评估该治疗在预防心血管疾病死亡率（包括猝死）方面的功效），并因心血管原因住院。该研究的第二个流行病学目标是评估在日常临床实践中采用当前指南是否可行，以优化高心血管风险人群的所有可用预防策略。在2004年2月至2007年3月之间，由860名全科医生组成的全国性网络接纳了12,513名患者参加该研究。平均年龄为64岁，其中62％为男性。糖尿病加上一种或多种心血管危险因素是主要纳入标准（47％）。由于有动脉粥样硬化性心血管疾病的病史，因此纳入了约30％的患者;对于四个或更多危险因素，有21％的患者被纳入研究;由于其他原因，少于1％的患者被纳入研究。讨论Rischio and Prevenzione（R＆P）项目提供了一个可行的模型，以测试n-3多不饱和脂肪酸疗法在没有心血管梗塞病史的高心血管风险患者中的疗效，并评估如何在一般实践中实施推荐的预防策略。试用注册ClinicalTrials.gov NCT00317707

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