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Targeting intensive glycaemic control versus targeting conventional glycaemic control for type 2 diabetes mellitus.

Abstract

BACKGROUND

Patients with type 2 diabetes mellitus (T2D) exhibit an increased risk of cardiovascular disease and mortality compared to the background population. Observational studies report a relationship between reduced blood glucose and reduced risk of both micro- and macrovascular complications in patients with T2D.

OBJECTIVES

To assess the effects of targeting intensive versus conventional glycaemic control in T2D patients.

SEARCH STRATEGY

Trials were obtained from searches of CENTRAL (The Cochrane Library), MEDLINE, EMBASE, Science Citation Index Expanded, LILACS, and CINAHL (until December 2010).

SELECTION CRITERIA

We included randomised clinical trials that prespecified different targets of glycaemic control in adults with T2D.

DATA COLLECTION AND ANALYSIS

Two authors independently assessed the risk of bias and extracted data. Dichotomous outcomes were assessed by risk ratios (RR) and 95% confidence intervals (CI).

MAIN RESULTS

Twenty trials randomised 16,106 T2D participants to intensive control and 13,880 T2D participants to conventional glycaemic control. The mean age of the participants was 62.1 years. The duration of the intervention ranged from three days to 12.5 years. The number of participants in the included trials ranged from 20 to 11,140. There was no significant difference between targeting intensive and conventional glycaemic control for all-cause mortality (RR 1.01, 95% CI 0.90 to 1.13; 29,731 participants, 18 trials) or cardiovascular mortality (RR 1.06, 95% CI 0.90 to 1.26; 29,731 participants, 18 trials). Trial sequential analysis (TSA) showed that a 10% RR reduction could be refuted for all-cause mortality. Targeting intensive glycaemic control did not show a significant effect on the risk of non-fatal myocardial infarction in the random-effects model but decreased the risk in the fixed-effect model (RR 0.86, 95% CI 0.78 to 0.96; P = 0.006; 29,174 participants, 12 trials). Targeting intensive glycaemic control reduced the risk of amputation (RR 0.64, 95% CI 0.43 to 0.95; P = 0.03; 6960 participants, 8 trials), the composite risk of microvascular disease (RR 0.89, 95% CI 0.83 to 0.95; P = 0.0006; 25,760 participants, 4 trials), retinopathy (RR 0.79, 95% CI 0.68 to 0.92; P = 0.002; 10,986 participants, 8 trials), retinal photocoagulation (RR 0.77, 95% CI 0.61 to 0.97; P = 0.03; 11,142 participants, 7 trials), and nephropathy (RR 0.78, 95% CI 0.61 to 0.99; P = 0.04; 27,929 participants, 9 trials). The risks of both mild and severe hypoglycaemia were increased with targeting intensive glycaemic control but substantial heterogeneity was present. The definition of severe hypoglycaemia varied among the included trials; severe hypoglycaemia was reported in 12 trials that included 28,127 participants. TSA showed that firm evidence was reached for a 30% RR increase in severe hypoglycaemic when targeting intensive glycaemic control. Subgroup analysis of trials exclusively dealing with glycaemic control in usual care settings showed a significant effect in favour of targeting intensive glycaemic control for non-fatal myocardial infarction. However, TSA showed more trials are needed before firm evidence is established.

AUTHORS' CONCLUSIONS

The included trials did not show significant differences for all-cause mortality and cardiovascular mortality when targeting intensive glycaemic control compared with conventional glycaemic control. Targeting intensive glycaemic control reduced the risk of microvascular complications while increasing the risk of hypoglycaemia. Furthermore, intensive glycaemic control might reduce the risk of non-fatal myocardial infarction in trials exclusively dealing with glycaemic control in usual care settings.

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  • Authors+Show Affiliations

    ,

    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark, DK-2100.

    , , , , ,

    Source

    MeSH

    Adult
    Blood Glucose
    Cardiovascular Diseases
    Cause of Death
    Diabetes Mellitus, Type 2
    Humans
    Hyperglycemia
    Hypoglycemia
    Hypoglycemic Agents
    Middle Aged
    Randomized Controlled Trials as Topic

    Pub Type(s)

    Journal Article
    Meta-Analysis
    Review
    Systematic Review

    Language

    eng

    PubMed ID

    21678374

    Citation

    Hemmingsen, Bianca, et al. "Targeting Intensive Glycaemic Control Versus Targeting Conventional Glycaemic Control for Type 2 Diabetes Mellitus." The Cochrane Database of Systematic Reviews, 2011, p. CD008143.
    Hemmingsen B, Lund SS, Gluud C, et al. Targeting intensive glycaemic control versus targeting conventional glycaemic control for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2011.
    Hemmingsen, B., Lund, S. S., Gluud, C., Vaag, A., Almdal, T., Hemmingsen, C., & Wetterslev, J. (2011). Targeting intensive glycaemic control versus targeting conventional glycaemic control for type 2 diabetes mellitus. The Cochrane Database of Systematic Reviews, (6), p. CD008143. doi:10.1002/14651858.CD008143.pub2.
    Hemmingsen B, et al. Targeting Intensive Glycaemic Control Versus Targeting Conventional Glycaemic Control for Type 2 Diabetes Mellitus. Cochrane Database Syst Rev. 2011 Jun 15;(6)CD008143. PubMed PMID: 21678374.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Targeting intensive glycaemic control versus targeting conventional glycaemic control for type 2 diabetes mellitus. AU - Hemmingsen,Bianca, AU - Lund,Søren S, AU - Gluud,Christian, AU - Vaag,Allan, AU - Almdal,Thomas, AU - Hemmingsen,Christina, AU - Wetterslev,Jørn, Y1 - 2011/06/15/ PY - 2011/6/17/entrez PY - 2011/6/17/pubmed PY - 2011/8/25/medline SP - CD008143 EP - CD008143 JF - The Cochrane database of systematic reviews JO - Cochrane Database Syst Rev IS - 6 N2 - BACKGROUND: Patients with type 2 diabetes mellitus (T2D) exhibit an increased risk of cardiovascular disease and mortality compared to the background population. Observational studies report a relationship between reduced blood glucose and reduced risk of both micro- and macrovascular complications in patients with T2D. OBJECTIVES: To assess the effects of targeting intensive versus conventional glycaemic control in T2D patients. SEARCH STRATEGY: Trials were obtained from searches of CENTRAL (The Cochrane Library), MEDLINE, EMBASE, Science Citation Index Expanded, LILACS, and CINAHL (until December 2010). SELECTION CRITERIA: We included randomised clinical trials that prespecified different targets of glycaemic control in adults with T2D. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the risk of bias and extracted data. Dichotomous outcomes were assessed by risk ratios (RR) and 95% confidence intervals (CI). MAIN RESULTS: Twenty trials randomised 16,106 T2D participants to intensive control and 13,880 T2D participants to conventional glycaemic control. The mean age of the participants was 62.1 years. The duration of the intervention ranged from three days to 12.5 years. The number of participants in the included trials ranged from 20 to 11,140. There was no significant difference between targeting intensive and conventional glycaemic control for all-cause mortality (RR 1.01, 95% CI 0.90 to 1.13; 29,731 participants, 18 trials) or cardiovascular mortality (RR 1.06, 95% CI 0.90 to 1.26; 29,731 participants, 18 trials). Trial sequential analysis (TSA) showed that a 10% RR reduction could be refuted for all-cause mortality. Targeting intensive glycaemic control did not show a significant effect on the risk of non-fatal myocardial infarction in the random-effects model but decreased the risk in the fixed-effect model (RR 0.86, 95% CI 0.78 to 0.96; P = 0.006; 29,174 participants, 12 trials). Targeting intensive glycaemic control reduced the risk of amputation (RR 0.64, 95% CI 0.43 to 0.95; P = 0.03; 6960 participants, 8 trials), the composite risk of microvascular disease (RR 0.89, 95% CI 0.83 to 0.95; P = 0.0006; 25,760 participants, 4 trials), retinopathy (RR 0.79, 95% CI 0.68 to 0.92; P = 0.002; 10,986 participants, 8 trials), retinal photocoagulation (RR 0.77, 95% CI 0.61 to 0.97; P = 0.03; 11,142 participants, 7 trials), and nephropathy (RR 0.78, 95% CI 0.61 to 0.99; P = 0.04; 27,929 participants, 9 trials). The risks of both mild and severe hypoglycaemia were increased with targeting intensive glycaemic control but substantial heterogeneity was present. The definition of severe hypoglycaemia varied among the included trials; severe hypoglycaemia was reported in 12 trials that included 28,127 participants. TSA showed that firm evidence was reached for a 30% RR increase in severe hypoglycaemic when targeting intensive glycaemic control. Subgroup analysis of trials exclusively dealing with glycaemic control in usual care settings showed a significant effect in favour of targeting intensive glycaemic control for non-fatal myocardial infarction. However, TSA showed more trials are needed before firm evidence is established. AUTHORS' CONCLUSIONS: The included trials did not show significant differences for all-cause mortality and cardiovascular mortality when targeting intensive glycaemic control compared with conventional glycaemic control. Targeting intensive glycaemic control reduced the risk of microvascular complications while increasing the risk of hypoglycaemia. Furthermore, intensive glycaemic control might reduce the risk of non-fatal myocardial infarction in trials exclusively dealing with glycaemic control in usual care settings. SN - 1469-493X UR - https://www.unboundmedicine.com/medline/citation/21678374/full_citation L2 - https://doi.org/10.1002/14651858.CD008143.pub2 DB - PRIME DP - Unbound Medicine ER -