The Combination Lipid Therapy and Blood

Pressure Control in ACCORD Study

—ACCORD 降脂和降压研究

吴永健

中国医学科学院 北京协和医学院心血管病研究所 阜外心血管医院

About ACCORD Trial

ACCORD was a randomized trial conducted at 77 clinical sites organized into seven networks in the United States and Canada

The trial enrolled 10,251 high-risk participants with type 2 diabetes mellitus. All participants were randomly assigned to either intensive or standard glycemic control (the ACCORD glycemia trial). In addition, 5518 of the ACCORD participants were also randomly assigned (in a 2-by-2 factorial design) to either simvastatin plus fenofibrate or simvastatin plus placebo (ACCORD lipid trial), and the remaining 4733 participants were also randomly assigned (in a 2-by-2 factorial design) to either intensive or standard blood-pressure control (ACCORD blood-pressure trial).

Supported by contracts from the National Heart, Lung, and Blood Institute. Other components of the National Institutes of Health, including the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Eye Institute, contributed funding

N Engl J Med 2010;362:1575-85

无论收缩压如何，糖尿病患者增加心血管发病率 2-3 倍

BMJ. 2000; 321(7258):412-9

"The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure"

provides a new guideline for hypertension prevention and management. The following are the key messages(1) In persons older than 50

years, systolic blood pressure (BP) of more than 140 mm Hg is a much more important cardiovascular disease (CVD) risk factor than

diastolic BP; (2) The risk of CVD, beginning at 115/75 mm Hg, doubles with each increment of 20/10 mm Hg; individuals who are

normotensive at 55 years of age have a 90% lifetime risk for developing hypertension; (3) Individuals with a systolic BP of 120 to 139 mm

Hg or a diastolic BP of 80 to 89 mm Hg should be considered as prehypertensive and require health-promoting lifestyle modifications to

prevent CVD; (4) Thiazide-type diuretics should be used in drug treatment for most patients with uncomplicated hypertension, either

alone or combined with drugs from other classes. Certain high-risk conditions are compelling indications for the initial use of other

antihypertensive drug classes (angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, beta-blockers, calcium channel

blockers); (5) Most patients with hypertension will require 2 or more antihypertensive medications to achieve goal BP (<140/90

mm Hg, or <130/80 mm Hg for patients with diabetes or chronic kidney disease); (6) If BP is more than 20/10 mm Hg above goal

BP, consideration should be given to initiating therapy with 2 agents, 1 of which usually should be a thiazide-type diuretic; and (7) The

most effective therapy prescribed by the most careful clinician will control hypertension only if patients are motivated. Motivation

improves when patients have positive experiences with and trust in the clinician. Empathy builds trust and is a potent motivator. Finally,

in presenting these guidelines, the committee recognizes that the responsible physician's judgment remains paramount

There is, however, a paucity of evidence from randomized

clinical trials to support these recommendations

研 究 方 法

The primary outcome for all three ACCORD trials was the first occurrence of a major cardiovascular event, which was defined as the composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Prespecified secondary outcomes included the combination of the primary outcome plus revascularization or hospitalization for congestive heart failure (termed the “expanded macrovascular outcome”); the combination of a fatal coronary event, nonfatal myocardial infarction, or unstable angina (termed “major coronary disease events”); nonfatal myocardial infarction; fatal or nonfatal stroke; nonfatal stroke; death from any cause; death from cardiovascular causes; and hospitalization or death due to heart failure

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Limitations

讨 论

N Engl J Med 2010;362:1563-74

他汀治疗是糖尿病合并高脂血症患者的基石，但是对于糖尿病高危的患者仅仅他汀治疗就足够吗？

Although statins are efficacious in patients with type 2 diabetes, rates

of cardiovascular events remain elevated in such patients even after

statin treatment— 上述 3 篇文献

Arch Intern Med. 2002;162:2597-2604

研 究 方 法

The primary outcome for all three ACCORD trials was the first occurrence of a major cardiovascular event, which was defined as the composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Prespecified secondary outcomes included the combination of the primary outcome plus revascularization or hospitalization for congestive heart failure (termed the “expanded macrovascular outcome”); the combination of a fatal coronary event, nonfatal myocardial infarction, or unstable angina (termed “major coronary disease events”); nonfatal myocardial infarction; fatal or nonfatal stroke; nonfatal stroke; death from any cause; death from cardiovascular causes; and hospitalization or death due to heart failure

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讨 论

One possibility is that the addition of fenofibrate to statin therapy benefited only

certain subgroups of patients and that other subgroups that did not benefit

diluted the overall effect

A second possibility is that the trial might have had fewer events than anticipated

Another possibility is poor adherence to the experimental protocol （ 80% ）

A fourth possibility is that fenofibrate is not as effective as gemfibrozil

敬请杨文英教授和郭静萱教授点评

ACCORD 研究： 一个把看似“简单问题”变成“复杂问题”的研究