用于服务不足人群心血管疾病预防的复方药。
Polypill for Cardiovascular Disease Prevention in an Underserved Population.
机构信息
From the Vanderbilt Translational and Clinical Cardiovascular Research Center (D.M., C.R., T.J.W.), the Division of Cardiovascular Medicine (D.M., C.R., H.G., W.S., T.J.W.), the Division of Epidemiology, Department of Medicine, and Vanderbilt Institute for Clinical and Translational Research (D.W., S.P., P.T., H.M., W.J.B.), Vanderbilt University Medical Center, Vanderbilt University, Nashville; and Franklin Primary Health Center, Mobile, AL (P.U., R.M., C.W.).
出版信息
N Engl J Med. 2019 Sep 19;381(12):1114-1123. doi: 10.1056/NEJMoa1815359.
BACKGROUND
Persons with low socioeconomic status and nonwhite persons in the United States have high rates of cardiovascular disease. The use of combination pills (also called "polypills") containing low doses of medications with proven benefits for the prevention of cardiovascular disease may be beneficial in such persons. However, few data are available regarding the use of polypill therapy in underserved communities in the United States, in which adherence to guideline-based care is generally low.
METHODS
We conducted a randomized, controlled trial involving adults without cardiovascular disease. Participants were assigned to the polypill group or the usual-care group at a federally qualified community health center in Alabama. Components of the polypill were atorvastatin (at a dose of 10 mg), amlodipine (2.5 mg), losartan (25 mg), and hydrochlorothiazide (12.5 mg). The two primary outcomes were the changes from baseline in systolic blood pressure and low-density lipoprotein (LDL) cholesterol level at 12 months.
RESULTS
The trial enrolled 303 adults, of whom 96% were black. Three quarters of the participants had an annual income below $15,000. The mean estimated 10-year cardiovascular risk was 12.7%, the baseline blood pressure was 140/83 mm Hg, and the baseline LDL cholesterol level was 113 mg per deciliter. The monthly cost of the polypill was $26. At 12 months, adherence to the polypill regimen, as assessed on the basis of pill counts, was 86%. The mean systolic blood pressure decreased by 9 mm Hg in the polypill group, as compared with 2 mm Hg in the usual-care group (difference, -7 mm Hg; 95% confidence interval [CI], -12 to -2; P = 0.003). The mean LDL cholesterol level decreased by 15 mg per deciliter in the polypill group, as compared with 4 mg per deciliter in the usual-care group (difference, -11 mg per deciliter; 95% CI, -18 to -5; P<0.001).
CONCLUSIONS
A polypill-based strategy led to greater reductions in systolic blood pressure and LDL cholesterol level than were observed with usual care in a socioeconomically vulnerable minority population. (Funded by the American Heart Association Strategically Focused Prevention Research Network and the National Institutes of Health; ClinicalTrials.gov number, NCT02278471.).
背景
在美国，社会经济地位较低和非裔美国人的心血管疾病发病率较高。使用含有已证实可预防心血管疾病益处的低剂量药物的联合药丸（也称为“复方药丸”）可能对这些人群有益。然而，在美国服务不足的社区中，关于使用复方药丸治疗的数据很少，在这些社区中，基于指南的护理的依从性通常较低。
方法
我们进行了一项随机对照试验，涉及无心血管疾病的成年人。参与者在阿拉巴马州的一家联邦合格社区卫生中心被分配到复方药丸组或常规护理组。复方药丸的成分包括阿托伐他汀（剂量为 10 毫克）、氨氯地平（2.5 毫克）、氯沙坦（25 毫克）和氢氯噻嗪（12.5 毫克）。两个主要结局是在 12 个月时收缩压和低密度脂蛋白（LDL）胆固醇水平从基线的变化。
结果
试验纳入了 303 名成年人，其中 96%为黑人。四分之三的参与者年收入低于 15000 美元。平均估计的 10 年心血管风险为 12.7%，基线血压为 140/83mmHg，基线 LDL 胆固醇水平为 113mg/dL。复方药丸每月的费用为 26 美元。在 12 个月时，根据药丸计数评估，复方药丸方案的依从性为 86%。与常规护理组相比，复方药丸组的收缩压下降了 9mmHg，而常规护理组仅下降了 2mmHg（差异，-7mmHg；95%置信区间[CI]，-12 至-2；P=0.003）。与常规护理组相比，复方药丸组的 LDL 胆固醇水平下降了 15mg/dL，而常规护理组仅下降了 4mg/dL（差异，-11mg/dL；95%CI，-18 至-5；P<0.001）。
结论
与常规护理相比，复方药丸策略可使收缩压和 LDL 胆固醇水平降低更为显著，这在社会经济脆弱的少数人群中更为明显。（由美国心脏协会战略性重点预防研究网络和美国国立卫生研究院资助；ClinicalTrials.gov 编号，NCT02278471。）
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