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Long-term follow-up of a hospital-based, multi-intervention programme in type 2 diabetes mellitus: impact on cardiovascular events and death.

ABSTRACT: 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.

SUBMITTER: Ofstad AP

PROVIDER: S-EPMC5718720 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Long-term follow-up of a hospital-based, multi-intervention programme in type 2 diabetes mellitus: impact on cardiovascular events and death.

Ofstad Anne Pernille AP Ulimoen Geir Reinvik GR Orvik Elsa E Birkeland Kåre Inge KI Gullestad Lars L LL Fagerland Morten Wang MW Johansen Odd Erik OE

The Journal of international medical research 20170619 5

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 ...[more]

PMID: 28627980

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Project description:BackgroundIn this study, we tested the efficacy of a low-intensity lifestyle intervention aimed at reducing the risk of cardiovascular disease among mid-life individuals.MethodsWe conducted a randomized controlled trial in which participants were randomly assigned either to receive a health report card with counselling (from a Telehealth nurse) on smoking, exercise, nutrition and stress or to receive usual care. The patients were divided into 2 groups on the basis of risk: the primary prevention group, with a Framingham risk score of 10% or higher (intervention, n = 157; control, n = 158), and the secondary prevention group, who had a diagnosis of coronary artery disease (intervention, n = 153; control, n = 143). The primary outcome was a change in the Framingham global risk score between baseline and 1-year follow-up. Data were analyzed separately for the 2 prevention groups using an intention-to-treat analysis controlling for covariates.ResultsWithin the primary prevention group, there were statistically significant changes for the treatment group relative to the controls, from baseline to year 1, in Framingham score (intervention, -3.10 [95% confidence interval (CI) -3.98 to -2.22]; control, -1.30 [95% CI -2.18 to -0.42]; p < 0.01) and scores for total cholesterol (intervention, -0.41 [95% CI -0.59 to -0.23]; control, -0.14 [95% CI -0.32 to 0.04]; p < 0.05), systolic blood pressure (intervention, -7.49 [95% CI -9.97 to -5.01]; control, -3.58 [95% CI -6.08 to -1.08]; p < 0.05), nutrition level (intervention, 0.30 [95% CI 0.13 to 0.47]; control, -0.05 [95% CI -0.22 to 0.12]; p < 0.01), and health confidence (intervention, 0.20 [95% CI 0.09 to 0.31]; control, 0.04 [95% CI -0.07 to 0.15]; p < 0.05), with adjustment for covariates. No significant changes in outcome variables were found for the secondary prevention group.InterpretationWe found evidence for the efficacy of an intervention addressing multiple risk factors for primary prevention at 1 year using Framingham risk score report cards and telephone counselling. (Requirement for clinical trial registration waived [enrolment completed before requirement became applicable].).

Project description:BackgroundUnderstanding the relative risk of cardiovascular versus noncardiovascular death is important for designing clinical trials. These risks may differ depending on patient age, sex, and type of acute coronary syndrome (ACS).Methods and resultsIMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) was a randomized controlled trial of simvastatin plus either ezetimibe or placebo following stabilized ACS. Cause of death was adjudicated by an independent committee. We compared the cumulative incidence of cardiovascular and noncardiovascular death for patients with unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) and ST-segment elevation myocardial infarction (STEMI), in those <65 and ?65 years old, and males and females, over 7 years of follow-up. Of 18 131 patients, the presenting event was STEMI for 5190 (29%) and UA/NSTEMI for 12 941 (71%); 10 173 (56%) patients were <65 years old and 7971 (44%) were ?65 years old at presentation. UA/NSTEMI patients were older than STEMI patients, with more cardiovascular and noncardiovascular risk factors. In STEMI patients, the cumulative incidence of cardiovascular death was higher for ?4 years following the index event, after which noncardiovascular death predominated. In UA/NSTEMI patients, the cumulative incidence of cardiovascular death remained higher than noncardiovascular death over the full follow-up period. Patients ?65 years old and <65 years old had a higher incidence of cardiovascular death than noncardiovascular death over the entirety of follow-up. Female patients had a higher incidence of cardiovascular death than noncardiovascular death for ?6 years following the index event; male patients had a higher incidence of cardiovascular death than noncardiovascular death over the entirety of follow-up.ConclusionsAmong post-ACS patients enrolled in a long-term clinical trial, the relative incidence of cardiovascular and noncardiovascular death differed based on type of ACS presentation and sex, but not age. These findings further delineate long-term prognosis after ACS and should inform the design of future cardiovascular outcomes trials.

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Long-term follow-up of a hospital-based, multi-intervention programme in type 2 diabetes mellitus: impact on cardiovascular events and death.

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Long-term follow-up of a hospital-based, multi-intervention programme in type 2 diabetes mellitus: impact on cardiovascular events and death.

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