intention-to-treat and per-protocol analysis. Results Four hundred and forty-seven subjects were randomized to INT ( n = 224) or to usual care ( n = 223). After 36 months ESC-SCORE development favouring INT was observed (INT: 8.70% to 10.03% vs. usual care: 8.49% to 12.09%; p = 0.005; net difference: 18.50%). Moreover, a significant reduction in the composite cardiovascular events was observed: (INT: n = 11 vs. usual care: n = 27). Hazard ratio of intervention versus control was 0.51 (95% confidence interval 0.25-1.03; p = 0.062) in the intention-to-treat analysis and 0.41 (95% confidence interval 0.18-0.90; p = 0.026) in the per-protocol analysis, respectively. No intervention-related adverse events or side-effects were observed. Conclusions Our results demonstrate the efficiency of identifying cardiovascular high-risk subjects by the ESC-SCORE in order to enrol them to a risk adjusted primary prevention programme. This strategy resulted in a significant improvement of ESC-SCORE, as well as a reduction in predefined cardiovascular endpoints in the INT within 36 months. (ISRCTN 23536103.).
AimTo evaluate the effects of a multimodal intervention (including exercise training, psychosocial interventions, nutrition coaching, smoking cessation program, medical care) on the health and long-term cardiovascular disease (CVD) mortality risk of company employees with pre-diabetes or diabetes mellitus (DM) at high CVD risk.MethodsIn the PreFord study, German company employees (n=4196) participated in a free-of-charge CVD mortality risk screening at their workplace. Based on their European Society of Cardiology – Systematic Coronary Risk Evaluation score (ESC-SCORE), they were subdivided into three risk groups. High-risk patients (ESC-SCORE≥5%) were randomly assigned to a 15-week lifestyle intervention or usual care control group. Data from patients with pre-DM/DM were analyzed intention-to-treat (ITT: n=110 versus n=96) and per protocol (PP: n=60 versus n=52).ResultsBody mass index, glycated hemoglobin, total cholesterol, low-density lipoprotein, triglyceride levels as well as systolic and diastolic blood pressure improved through the intervention (ITT, PP: p<0.001). The ESC-SCORE markedly decreased from pre- to post-intervention (ITT, PP: p<0.001). ESC-SCORE changes from baseline differed significantly between the groups, with the intervention group achieving more favorable results in all follow-up visits 6, 12, 24 and 36 months later (at each time point: ITT: p<0.001; PP: p ≤ 0.010).ConclusionThe study demonstrates the feasibility of attracting employees with pre-DM/DM at high CVD mortality risk to participate in a multimodal lifestyle program following a free CVD mortality risk screening at their workplace. The lifestyle intervention used in the PreFord study shows high potential for improving health of company employees with pre-DM/DM in the long term. ISRCTN23536103.
Background: The optimization of primary preventive cardiovascular (CV) strategies is urgently needed. The objective of the present study was to evaluate the long-term effects of a standardized multimodal and lifestyle based therapeutic approach in high-risk-subjects according to the ESC-SCORE on predefined cardiovascular end-points. The ESC-SCORE allows a systematic estimation of the 10-year-risk for fatal CV events. Methods: The individual CV risk was assessed in a cohort of 4.196 employees of the Ford-Company, Germany, using the ESC-SCORE. Subjects were subsequently classified into three risk-groups. Subjects at high-risk, (ESC-SCORE ≥ 5%; n=447), were randomized either into a multimodal 15-week lifestyle based outpatient intervention program (INT n=224) or into a usual care group (UC n=223) and followed up for 36 months. The primary endpoint was a reduction of the ESC-SCORE in the INT as compared to the UC at the end of the trial. Secondary endpoints were a composite of fatal and non-fatal CV events (coronary artery disease, cerebrovascular or peripheral arterial disease, CV death and total mortality) and the time to the first CV event. An intention to treat analysis was performed. Results: After 36 months a difference of the ESC-SCORE development favoring the INT was achieved (INT: 8.70 to 10.03% vs. UC: 8.49 to 12.09%; p<0.016). Moreover, a reduction in the composite secondary endpoint was observed (INT: n=11 vs. UC: n=27; p=0.032; HR 0.45 (CI 0.22 - 0.94). Conclusions: Our results demonstrate an intermediate-term improvement of the ESC-SCORE as well as a reduction of predefined CV endpoints by a primary CV prevention program within 36 months in a cohort of persons determined to be at high CV risk by assessment with the ESC-SCORE.
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