Objective To report the long-term impact on cardiovascular (CV) outcomes and mortality of a 2-year hospital-based multi-interventional care programme as compared with general practitioner (GP)-provided standard care. Methods Patients with type 2 diabetes with ≥ 1 additional CV risk factor were randomized to 2 years of specialist-based, multi-intervention comprising lifestyle modification and specific pharmacological treatment, or GP-based standard care. After the 2-year intervention period, all participants returned to pre-study care, but were followed up for CV outcomes and mortality. The primary outcome was time to any first severe CV event or death. Results A total of 120 patients (31 women) were enrolled in the study. During the mean ± SD observational period of 8.7 ± 2.0 years, 27 patients (16 and 11 in the multi-intervention and standard care groups, respectively) experienced at least one primary outcome event, with a hazard ratio (HR) if allocated to the multi-intervention group of 1.73 (95% confidence interval (CI) 0.80, 3.75). The HR for total mortality was 1.82 (95% CI 0.66, 5.01). Conclusions Hospital-based multi-intervention in patients with type 2 diabetes mellitus improved long-term glycaemic control, but failed to reduce CV outcomes and deaths. Clinical trials.gov id: NCT00133718.
Keywords: Type 2 diabetes mellitus; cardiovascular disease; cardiovascular events; glitazones; mortality; multifactorial treatment.