Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care - ADDITION-Europe

Description:

The goal of this trial was to compare a strategy of intensive treatment of cardiovascular risk factors compared with routine care among patients with diabetes detected by screening.

Hypothesis:

Intensive treatment of cardiovascular risk factors will reduce adverse cardiovascular events.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patient Populations:

Number of enrollees: 3,057
Duration of follow-up: Mean 5.3 years
Mean patient age: 60.3 years
Percentage female: 42%

Exclusions:

  • Limited life expectancy (<1 year)
  • Psychological or psychiatric disorder
  • Housebound
  • Pregnant or lactating


Primary Endpoints:

  • First cardiovascular event, including cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, revascularization, and nontraumatic amputation within 5 years

Drug/Procedures Used:

Patients in Denmark, the Netherlands, and the United Kingdom with diabetes detected by screening were randomized at the clinic level to intensive treatment of cardiovascular risk factors (n = 167 clinics, n = 1,678 patients) versus routine diabetes care (n = 176 clinics, n = 1,379 patients).

Concomitant Medications:

At follow-up for intensive versus routine care groups, the use of statins was 80% versus 72%, and aspirin was 71% versus 42%, respectively.

Principal Findings:

Overall, 3,057 patients were randomized. In the intensive treatment group, the mean age was 60 years and 42% were women. At follow-up for intensive versus routine care groups, the frequency of current smokers was 20% versus 18%, mean glycated hemoglobin was 6.6% versus 6.7%, mean systolic blood pressure was 135 mm Hg versus 138 mm Hg, and mean low-density lipoprotein (LDL) cholesterol was 81 mg/dl versus 89 mg/dl, respectively.

At a mean follow-up of 5.3 years, the primary composite endpoint had occurred in 7.2% of the intensive treatment group versus 8.5% of the routine care group (p = 0.12). The results were similar among younger patients and those with a history of a cardiovascular event.

All-cause mortality was 6.2% versus 6.7%, cardiovascular mortality was 1.5% versus 1.6%, myocardial infarction was 1.7% versus 2.3%, stroke was 1.3% versus 1.4%, revascularization was 2.6% versus 3.2%, and amputation was 0% versus 0%, respectively.

Interpretation:

Among patients with diabetes detected by screening, a strategy of intensive treatment of cardiovascular risk factors led to small reductions in mean glycated hemoglobin, systolic blood pressure, and LDL cholesterol levels. Despite these benefits, there was no reduction in the primary composite outcome.

Possible explanations to the lack of benefit from this approach include excellent baseline care in the routine care group, which led to low adverse events. Also, a longer follow-up period might have been necessary to detect a difference between these two treatment strategies.

References:

Griffin SJ, Borch-Johnsen K, Davies MJ, et al. Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial. Lancet 2011;Jun 25:[Epub ahead of print].

Clinical Topics: Dyslipidemia, Lipid Metabolism, Nonstatins

Keywords: Hemoglobin A, Glycosylated, Cholesterol, Great Britain, Myocardial Infarction, Stroke, Denmark, Netherlands, Risk Factors, Blood Pressure, Diabetes Mellitus


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