Clinical Trials Research Unit, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142, New Zealand.
Contemp Clin Trials. 2011 Nov;32(6):909-15. doi: 10.1016/j.cct.2011.07.006. Epub 2011 Jul 18.
Cardiovascular disease (CVD) is the leading cause of death, and principal reason for the large difference in life expectancy between indigenous Māori and the non-indigenous population in New Zealand. CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin, blood pressure lowering and lipid lowering therapies. However, prescribing and adherence rates are low and CVD events remain high.
To assess whether a medication strategy using a fixed dose combination pill ('polypill') could improve prescribing and adherence to recommended medications, lower blood pressure and improve lipids compared with current care over 12 months.
IMProving Adherence using Combination Therapy (IMPACT) is an open-label randomised controlled trial comparing a once-daily polypill containing four preventive medications with usual care. Six hundred participants who have had previous CVD events or are at high risk of CVD will be enrolled, including 300 Māori. Participants are identified, enrolled and prescribed either the polypill or current medications at their usual primary health care practice, with medications (including the polypill) dispensed through local community pharmacies. The polypill contains 75 mg aspirin, 40 mg simvastatin, 10mg lisinopril and either 12.5mg hydrochlorothiazide or 50mg atenolol. Primary outcomes are adherence to guidelines-recommended medications and changes in systolic blood pressure and low density lipoprotein at 12 months. Secondary outcomes include other lipids, medication dispensing, barriers to adherence, CVD and other serious adverse events, quality of life and prescriber acceptability. The trial is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12606000067572).
心血管疾病（CVD）是导致死亡的主要原因，也是新西兰土着毛利人和非土着人口预期寿命存在巨大差异的主要原因。CVD 指南建议，应向高危人群或曾患有 CVD 的人群提供阿司匹林、降压和降脂治疗。然而，处方率和遵医嘱率都很低，CVD 事件仍然居高不下。
评估固定剂量复方片剂（“复方丸”）药物治疗策略是否可以改善 12 个月内推荐药物的处方和遵医嘱情况，降低血压并改善血脂，与当前治疗相比。
IMProving Adherence using 组合 Therapy（IMPACT）是一项开放标签随机对照试验，比较了一种含有四种预防药物的每日一次复方丸与常规护理。将招募 600 名曾患有 CVD 事件或 CVD 高危人群的参与者，其中包括 300 名毛利人。参与者在其常规初级保健实践中被识别、招募并开出复方丸或当前药物，药物（包括复方丸）通过当地社区药房分发。复方丸含有 75 毫克阿司匹林、40 毫克辛伐他汀、10 毫克赖诺普利和 12.5 毫克氢氯噻嗪或 50 毫克阿替洛尔。主要结局是遵医嘱推荐药物的情况和 12 个月时收缩压和低密度脂蛋白的变化。次要结局包括其他血脂、药物配药、遵医嘱障碍、CVD 和其他严重不良事件、生活质量和处方者可接受性。该试验在澳大利亚新西兰临床试验注册中心（ACTRN12606000067572）注册。
