Summary and Comment
Intensified Early Treatment of Subclinical Diabetes: No Benefit at 5 Years
Longer follow-up might reveal benefit.
Clinicians often diagnose type 2 diabetes by screening asymptomatic patients, but how intensively patients should be managed at this early stage of disease is unclear.
Researchers in the U.K., Denmark, and the Netherlands randomized 343 primary care practices to provide either routine care or intensive multifactorial treatment to 3057 patients with early diabetes that was diagnosed through routine screening. Physicians and nurses in the intensive intervention received education on targets, algorithms, and lifestyle advice for managing hyperglycemia, blood pressure, and lipids; in some areas, patients also met periodically with diabetes nurses.
After a mean follow-up of 5.3 years, mean declines in levels of glycosylated hemoglobin (HbA1c), total and LDL cholesterol, and blood pressure were slightly but significantly greater in patients in the intensive treatment practices than in those receiving routine care. The incidence of the primary composite endpoint (cardiovascular death, nonfatal myocardial infarction or stroke, or revascularization), each of its components, and all-cause death was lower in the intensive treatment group. However, none of these differences in clinical outcomes reached significance (hazard ratio for composite endpoint, 0.83; P=0.12).
Comment: Although this trial had the virtue of a pragmatic setting, it took place against the background of improving evidence- and guideline-driven general diabetes care, which might have lessened the relative effect of the intensive intervention. The cumulative incidence curves for the primary endpoint began to diverge after 4 years; longer follow-up might reveal an important clinical benefit.
— Bruce Soloway, MD
Published in Journal Watch General Medicine July 12, 2011
Researchers in the U.K., Denmark, and the Netherlands randomized 343 primary care practices to provide either routine care or intensive multifactorial treatment to 3057 patients with early diabetes that was diagnosed through routine screening. Physicians and nurses in the intensive intervention received education on targets, algorithms, and lifestyle advice for managing hyperglycemia, blood pressure, and lipids; in some areas, patients also met periodically with diabetes nurses.
After a mean follow-up of 5.3 years, mean declines in levels of glycosylated hemoglobin (HbA1c), total and LDL cholesterol, and blood pressure were slightly but significantly greater in patients in the intensive treatment practices than in those receiving routine care. The incidence of the primary composite endpoint (cardiovascular death, nonfatal myocardial infarction or stroke, or revascularization), each of its components, and all-cause death was lower in the intensive treatment group. However, none of these differences in clinical outcomes reached significance (hazard ratio for composite endpoint, 0.83; P=0.12).
Comment: Although this trial had the virtue of a pragmatic setting, it took place against the background of improving evidence- and guideline-driven general diabetes care, which might have lessened the relative effect of the intensive intervention. The cumulative incidence curves for the primary endpoint began to diverge after 4 years; longer follow-up might reveal an important clinical benefit.
— Bruce Soloway, MD
Published in Journal Watch General Medicine July 12, 2011
Citation(s):
Griffin SJ 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 Jul 9; 378:156. (http://dx.doi.org/10.1016/
Medline abstract (Free)
Preiss D and Sattar N. The case for diabetes screening: ADDITION-Europe. Lancet 2011 Jul 9; 378:106. (http://dx.doi.org/10.1016/
Medline abstract (Free)
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