预测降压治疗对 2 型糖尿病患者主要心血管事件的影响：来自糖尿病和血管疾病行动（ADVANCE）研究的培哚普利贝那普利片和米格列醇二甲双胍复方制剂的控制评估。
Predicting the effects of blood pressure-lowering treatment on major cardiovascular events for individual patients with type 2 diabetes mellitus: results from Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation.
机构信息
From the Department of Vascular Medicine (J.v.d.L., F.L.J.V.), Julius Centre for Health Sciences and Primary Care (Y.v.d.G., D.E.G.), University Medical Centre Utrecht, Utrecht, The Netherlands; The George Institute for Global Health, University of Sydney, Sydney, Australia (M.W., S.Z., A.P.K., S.M., J.C.); NCRP for Cardiovascular and Metabolic Diseases, South African Medical Research Council and University of Cape Town, Cape Town, South Africa (A.P.K.); Centre for Research on Evidence Based Practice, Bond University, Robina, Queensland, Australia (P.G.); Centre Hospitalier de L'Université de Montréal, Montréal, Canada (P.H.); University of Oxford, Oxford, United Kingdom (S.M.); and Imperial College London, London, United Kingdom (N.P.).
出版信息
Hypertension. 2015 Jan;65(1):115-21. doi: 10.1161/HYPERTENSIONAHA.114.04421. Epub 2014 Oct 13.
UNLABELLED
Blood pressure-lowering treatment reduces cardiovascular risk in patients with diabetes mellitus, but the effect varies between individuals. We sought to identify which patients benefit most from such treatment in a large clinical trial in type 2 diabetes mellitus. In Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) participants (n=11 140), we estimated the individual patient 5-year absolute risk of major adverse cardiovascular events with and without treatment by perindopril-indapamide (4/1.25 mg). The difference between treated and untreated risk is the estimated individual patient's absolute risk reduction (ARR). Predictions were based on a Cox proportional hazards model inclusive of demographic and clinical characteristics together with the observed relative treatment effect. The group-level effect of selectively treating patients with an estimated ARR above a range of decision thresholds was compared with treating everyone or those with a blood pressure >140/90 mm Hg using net benefit analysis. In ADVANCE, there was wide variation in treatment effects across individual patients. According to the algorithm, 43% of patients had a large predicted 5-year ARR of ≥1% (number-needed-to-treat [NNT5] ≤100) and 40% had an intermediate predicted ARR of 0.5% to 1% (NNT5=100-`200). The proportion of patients with a small ARR of ≤0.5% (NNT5≥200) was 17%. Provided that one is prepared to treat at most 200 patients for 5 years to prevent 1 adverse outcome, prediction-based treatment yielded the highest net benefit. In conclusion, a multivariable treatment algorithm can identify those individuals who benefit most from blood pressure-lowering therapy in terms of ARR of major adverse cardiovascular events and may be used to guide treatment decisions in individual patients with diabetes.
CLINICAL TRIAL REGISTRATION URL
http://www.clinicaltrials.gov. Unique identifier: NCT00145925.
目的
降压治疗可降低糖尿病患者的心血管风险，但个体间疗效存在差异。我们旨在通过大型 2 型糖尿病临床试验确定哪些患者能从降压治疗中最大获益。在糖尿病和血管疾病的行动：培哚普利吲达帕胺与氨氯地平控释片对照评估（ADVANCE）中，我们根据培哚普利吲达帕胺（4/1.25mg）估算了 11140 例患者的主要不良心血管事件的个体患者 5 年绝对风险，包括治疗和不治疗时的情况。治疗和未治疗风险的差异即为个体患者的绝对风险降低（ARR）。预测基于包括人口统计学和临床特征的 Cox 比例风险模型，以及观察到的治疗相对效果。通过净效益分析，比较了针对 ARR 预测值大于一系列决策阈值的患者选择性治疗与对所有患者或血压>140/90mmHg 的患者进行治疗的效果。在 ADVANCE 中，个体间的治疗效果存在广泛差异。根据该算法，43%的患者有≥1%的大预测 5 年 ARR（需要治疗数[NNT5]≤100），40%的患者有 0.5%至 1%的中等预测 ARR（NNT5=100-200）。ARR≤0.5%（NNT5≥200）的患者比例为 17%。假设最多愿意治疗 200 例患者 5 年以预防 1 例不良结局，则基于预测的治疗可产生最高的净效益。综上，多变量治疗算法可识别出从主要不良心血管事件的 ARR 获益最大的个体，并可用于指导个体糖尿病患者的治疗决策。
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