Long-term effects of intensive multifactorial therapy in individuals with screen-detected type 2 diabetes in primary care: 10-year follow-up of the ADDITION-Europe cluster-randomised trial.,The Lancet Diabetes & Endocrinology

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Long-term effects of intensive multifactorial therapy in individuals with screen-detected type 2 diabetes in primary care: 10-year follow-up of the ADDITION-Europe cluster-randomised trial.
The Lancet Diabetes & Endocrinology ( IF 44.0 ) Pub Date : 2019-12-01 , DOI: 10.1016/s2213-8587(19)30349-3
Simon J Griffin ₁ , Guy E H M Rutten ₂ , Kamlesh Khunti ₃ , Daniel R Witte ₄ , Torsten Lauritzen ₅ , Stephen J Sharp ₆ , Else-Marie Dalsgaard ₅ , Melanie J Davies ₃ , Greg J Irving ₇ , Rimke C Vos ₈ , David R Webb ₃ , Nicholas J Wareham ₆ , Annelli Sandbæk ₉

Affiliation

MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Primary Care Unit, Institute of Public Health, School of Clinical Medicine, University of Cambridge, Cambridge, UK.
Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, Netherlands.
Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.
Section of Epidemiology, Aarhus University, Aarhus, Denmark; Department of Public Health, Aarhus University, Aarhus, Denmark; Danish Diabetes Academy, Odense, Denmark.
Section for General Practice, Aarhus University, Aarhus, Denmark.
MRC Epidemiology Unit, Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Primary Care Unit, Institute of Public Health, School of Clinical Medicine, University of Cambridge, Cambridge, UK.
Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht University, Utrecht, Netherlands; Department of Public Health and Primary Care, Leiden University Medical Center, Campus The Hague, The Hague, Netherlands.
Section for General Practice, Aarhus University, Aarhus, Denmark; Steno Diabetes Center, Aarhus University Hospital, Aarhus, Denmark.

BACKGROUND The multicentre, international ADDITION-Europe study investigated the effect of promoting intensive treatment of multiple risk factors among people with screen-detected type 2 diabetes over 5 years. Here we report the results of a post-hoc 10-year follow-up analysis of ADDITION-Europe to establish whether differences in treatment and cardiovascular risk factors have been maintained and to assess effects on cardiovascular outcomes. METHODS As previously described, general practices from four centres (Denmark, Cambridge [UK], Leicester [UK], and the Netherlands) were randomly assigned by computer-generated list to provide screening followed by routine care of diabetes, or screening followed by intensive multifactorial treatment. Population-based stepwise screening programmes among people aged 40-69 years (50-69 years in the Netherlands), between April, 2001, and December, 2006, identified patients with type 2 diabetes. Allocation was concealed from patients. Following the 5-year follow-up, no attempts were made to maintain differences in treatment between study groups. In this report, we did a post-hoc analysis of cardiovascular and renal outcomes over 10 years following randomisation, including a 5 years post-intervention follow-up. As in the original trial, the primary endpoint was a composite of first cardiovascular event, including cardiovascular mortality, cardiovascular morbidity (non-fatal myocardial infarction and non-fatal stroke), revascularisation, and non-traumatic amputation, up to Dec 31, 2014. Analyses were based on the intention-to-treat principle. ADDITION-Europe is registered with ClinicalTrials.gov, NCT00237549. FINDINGS 343 general practices were randomly assigned to routine diabetes care (n=176) or intensive multifactorial treatment (n=167). 317 of these general practices (157 in the routine care group, 161 in the intensive treatment group) included eligible patients between April, 2001, and December, 2006. Of the 3233 individuals with screen-detected diabetes, 3057 agreed to participate (1379 in the routine care group, 1678 in the intensive treatment group), but at the 10-year follow-up 14 were lost to follow-up and 12 withdrew, leaving 3031 to enter 10-year follow-up analysis. Mean duration of follow-up was 9·61 years (SD 2·99). Sustained reductions over 10 years following diagnosis were apparent for bodyweight, HbA1c, blood pressure, and cholesterol in both study groups, but between-group differences identified at 1 and 5 years were attenuated at the 10-year follow-up. By 10 years, 443 participants had a first cardiovascular event and 465 died. There was no significant difference between groups in the incidence of the primary composite outcome (16·1 per 1000 person-years in the routine care group vs 14·3 per 1000 person-years in the intensive treatment group; hazard ratio [HR] 0·87, 95% CI 0·73-1·04; p=0·14) or all-cause mortality (15·6 vs 14·3 per 1000 person-years; HR 0·90, 0·76-1·07). INTERPRETATION Sustained reductions in glycaemia and related cardiovascular risk factors over 10 years among people with screen-detected diabetes managed in primary care are achievable. The differences in prescribed treatment and cardiovascular risk factors in the 5 years following diagnosis were not maintained at 10 years, and the difference in cardiovascular events and mortality remained non-significant. FUNDING National Health Service Denmark, Danish Council for Strategic Research, Danish Research Foundation for General Practice, Novo Nordisk, Novo Nordisk Foundation, Danish Centre for Evaluation and Health Technology Assessment, Danish National Board of Health, Danish Medical Research Council, Aarhus University Research Foundation, Astra, Pfizer, GlaxoSmithKline, Servier, HemoCue, Wellcome Trust, UK Medical Research Council, UK National Institute for Health Research, UK National Health Service, Merck, Julius Center for Health Sciences and Primary Care, UK Department of Health, and Nuts-OHRA.

中文翻译：

强化多因素治疗对初级保健中筛查检测出的 2 型糖尿病患者的长期影响：ADDITION-Europe 整群随机试验的 10 年随访。

背景多中心、国际 ADDITION-Europe 研究调查了在 5 年以上筛查检测出的 2 型糖尿病患者中促进强化治疗多种危险因素的效果。在这里，我们报告了 ADDITION-Europe 的事后 10 年随访分析的结果，以确定治疗和心血管危险因素的差异是否得到维持，并评估对心血管结局的影响。方多因素治疗。在 40-69 岁（荷兰为 50-69 岁）人群中进行基于人群的逐步筛查计划，2001 年 4 月至 2006 年 12 月期间，确定了 2 型糖尿病患者。分配对患者隐瞒。在 5 年随访之后，没有尝试保持研究组之间的治疗差异。在这份报告中，我们对随机化后 10 年的心血管和肾脏结局进行了事后分析，包括 5 年的干预后随访。与最初的试验一样，主要终点是截至 2014 年 12 月 31 日的首次心血管事件的复合终点，包括心血管死亡率、心血管发病率（非致命性心肌梗死和非致命性中风）、血运重建和非创伤性截肢. 分析基于意向治疗原则。ADDITION-Europe 已在 ClinicalTrials.gov 注册，NCT00237549。调查结果 343 名全科医生被随机分配到常规糖尿病护理 (n=176) 或强化多因素治疗 (n=167)。2001 年 4 月至 2006 年 12 月期间，这些常规治疗中有 317 例（常规治疗组 157 例，强化治疗组 161 例）纳入符合条件的患者。在筛查检测出糖尿病的 3233 例患者中，3057 例同意参与（1379 例在常规治疗组 1678 人，强化治疗组 1678 人），但 10 年随访时失访 14 人，退出 12 人，剩余 3031 人进入 10 年随访分析。平均随访时间为 9·61 年 (SD 2·99)。两个研究组的体重、HbA1c、血压和胆固醇在诊断后 10 年内持续下降，但在 1 年和 5 年时确定的组间差异在 10 年随访时减弱。到 10 年时，443 名参与者发生了第一次心血管事件，465 人死亡。主要复合结局的发生率在组间没有显着差异（常规治疗组每 1000 人年 16·1 vs 强化治疗组每 1000 人年 14·3；风险比 [HR] 0 ·87, 95% CI 0·73-1·04; p=0·14) 或全因死亡率（每 1000 人年 15·6 对比 14·3；HR 0·90, 0·76-1· 07). 解释在初级保健机构接受筛查检测出的糖尿病患者中，10 年来持续降低血糖和相关心血管危险因素是可以实现的。诊断后 5 年内处方治疗和心血管危险因素的差异未维持在 10 年，心血管事件和死亡率的差异仍然不显着。资助丹麦国家卫生服务局、丹麦战略研究委员会、丹麦全科医学研究基金会、诺和诺德公司、诺和诺德基金会、丹麦评估和卫生技术评估中心、丹麦国家卫生委员会、丹麦医学研究委员会、奥胡斯大学研究基金会, Astra, Pfizer, GlaxoSmithKline, Servier, HemoCue, Wellcome Trust, UK Medical Research Council, UK National Institute for Health Research, UK National Health Service, Merck, Julius Center for Health Sciences and Primary Care, UK Department of Health, 和 Nuts- OHRA。

更新日期：2019-11-20

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