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10-year follow-up of intensive glucose control in type 2 diabetes.

Abstract

BACKGROUND

During the United Kingdom Prospective Diabetes Study (UKPDS), patients with type 2 diabetes mellitus who received intensive glucose therapy had a lower risk of microvascular complications than did those receiving conventional dietary therapy. We conducted post-trial monitoring to determine whether this improved glucose control persisted and whether such therapy had a long-term effect on macrovascular outcomes.

METHODS

Of 5102 patients with newly diagnosed type 2 diabetes, 4209 were randomly assigned to receive either conventional therapy (dietary restriction) or intensive therapy (either sulfonylurea or insulin or, in overweight patients, metformin) for glucose control. In post-trial monitoring, 3277 patients were asked to attend annual UKPDS clinics for 5 years, but no attempts were made to maintain their previously assigned therapies. Annual questionnaires were used to follow patients who were unable to attend the clinics, and all patients in years 6 to 10 were assessed through questionnaires. We examined seven prespecified aggregate clinical outcomes from the UKPDS on an intention-to-treat basis, according to previous randomization categories.

RESULTS

Between-group differences in glycated hemoglobin levels were lost after the first year. In the sulfonylurea-insulin group, relative reductions in risk persisted at 10 years for any diabetes-related end point (9%, P=0.04) and microvascular disease (24%, P=0.001), and risk reductions for myocardial infarction (15%, P=0.01) and death from any cause (13%, P=0.007) emerged over time, as more events occurred. In the metformin group, significant risk reductions persisted for any diabetes-related end point (21%, P=0.01), myocardial infarction (33%, P=0.005), and death from any cause (27%, P=0.002).

CONCLUSIONS

Despite an early loss of glycemic differences, a continued reduction in microvascular risk and emergent risk reductions for myocardial infarction and death from any cause were observed during 10 years of post-trial follow-up. A continued benefit after metformin therapy was evident among overweight patients. (UKPDS 80; Current Controlled Trials number, ISRCTN75451837.)

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  • Authors+Show Affiliations

    ,

    Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology, and Metabolism, Churchill Hospital, Headington, Oxford OX3 7LJ, United Kingdom. rury.holman@dtu.ox.ac.uk

    , , ,

    Source

    The New England journal of medicine 359:15 2008 Oct 09 pg 1577-89

    MeSH

    Aged
    Blood Glucose
    Diabetes Mellitus, Type 2
    Diabetic Angiopathies
    Female
    Follow-Up Studies
    Glycated Hemoglobin A
    Humans
    Hypoglycemic Agents
    Insulin
    Kaplan-Meier Estimate
    Male
    Metformin
    Middle Aged
    Myocardial Infarction
    Risk
    Sulfonylurea Compounds

    Pub Type(s)

    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    18784090

    Citation

    Holman, Rury R., et al. "10-year Follow-up of Intensive Glucose Control in Type 2 Diabetes." The New England Journal of Medicine, vol. 359, no. 15, 2008, pp. 1577-89.
    Holman RR, Paul SK, Bethel MA, et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008;359(15):1577-89.
    Holman, R. R., Paul, S. K., Bethel, M. A., Matthews, D. R., & Neil, H. A. (2008). 10-year follow-up of intensive glucose control in type 2 diabetes. The New England Journal of Medicine, 359(15), pp. 1577-89. doi:10.1056/NEJMoa0806470.
    Holman RR, et al. 10-year Follow-up of Intensive Glucose Control in Type 2 Diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. PubMed PMID: 18784090.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - 10-year follow-up of intensive glucose control in type 2 diabetes. AU - Holman,Rury R, AU - Paul,Sanjoy K, AU - Bethel,M Angelyn, AU - Matthews,David R, AU - Neil,H Andrew W, Y1 - 2008/09/10/ PY - 2008/9/12/pubmed PY - 2008/10/29/medline PY - 2008/9/12/entrez SP - 1577 EP - 89 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 359 IS - 15 N2 - BACKGROUND: During the United Kingdom Prospective Diabetes Study (UKPDS), patients with type 2 diabetes mellitus who received intensive glucose therapy had a lower risk of microvascular complications than did those receiving conventional dietary therapy. We conducted post-trial monitoring to determine whether this improved glucose control persisted and whether such therapy had a long-term effect on macrovascular outcomes. METHODS: Of 5102 patients with newly diagnosed type 2 diabetes, 4209 were randomly assigned to receive either conventional therapy (dietary restriction) or intensive therapy (either sulfonylurea or insulin or, in overweight patients, metformin) for glucose control. In post-trial monitoring, 3277 patients were asked to attend annual UKPDS clinics for 5 years, but no attempts were made to maintain their previously assigned therapies. Annual questionnaires were used to follow patients who were unable to attend the clinics, and all patients in years 6 to 10 were assessed through questionnaires. We examined seven prespecified aggregate clinical outcomes from the UKPDS on an intention-to-treat basis, according to previous randomization categories. RESULTS: Between-group differences in glycated hemoglobin levels were lost after the first year. In the sulfonylurea-insulin group, relative reductions in risk persisted at 10 years for any diabetes-related end point (9%, P=0.04) and microvascular disease (24%, P=0.001), and risk reductions for myocardial infarction (15%, P=0.01) and death from any cause (13%, P=0.007) emerged over time, as more events occurred. In the metformin group, significant risk reductions persisted for any diabetes-related end point (21%, P=0.01), myocardial infarction (33%, P=0.005), and death from any cause (27%, P=0.002). CONCLUSIONS: Despite an early loss of glycemic differences, a continued reduction in microvascular risk and emergent risk reductions for myocardial infarction and death from any cause were observed during 10 years of post-trial follow-up. A continued benefit after metformin therapy was evident among overweight patients. (UKPDS 80; Current Controlled Trials number, ISRCTN75451837.) SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/18784090/10_year_follow_up_of_intensive_glucose_control_in_type_2_diabetes_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa0806470?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -