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Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: meta-analysis of randomised controlled trials.

Abstract

OBJECTIVE

To determine all cause mortality and deaths from cardiovascular events related to intensive glucose lowering treatment in people with type 2 diabetes.

DESIGN

Meta-analysis of randomised controlled trials.

DATA SOURCES

Medline, Embase, and the Cochrane database of systematic reviews.

STUDY SELECTION

Randomised controlled trials that assessed the effect of intensive glucose lowering treatment on cardiovascular events and microvascular complications in adults (≥ 18 years) with type 2 diabetes.

DATA EXTRACTION

Primary end points were all cause mortality and death from cardiovascular causes. Secondary end points were severe hypoglycaemia and macrovascular and microvascular events. Synthesis of results Results are reported as risk ratios with 99% confidence intervals. Statistical heterogeneity between trials was assessed with χ(2), τ(2), and I(2) statistics. A fixed effect model was used to assess the effect on the outcomes of intensive glucose lowering versus standard treatment. The quality of clinical trials was assessed by the Jadad score.

RESULTS

13 studies were included. Of 34,533 patients, 18,315 received intensive glucose lowering treatment and 16,218 standard treatment. Intensive treatment did not significantly affect all cause mortality (risk ratio 1.04, 99% confidence interval 0.91 to 1.19) or cardiovascular death (1.11, 0.86 to 1.43). Intensive therapy was, however, associated with reductions in the risk of non-fatal myocardial infarction (0.85, 0.74 to 0.96, P<0.001), and microalbuminuria (0.90, 0.85 to 0.96, P<0.001) but a more than twofold increase in the risk of severe hypoglycaemia (2.33, 21.62 to 3.36, P<0.001). Over a treatment period of five years, 117 to 150 patients would need to be treated to avoid one myocardial infarction and 32 to 142 patients to avoid one episode of microalbuminuria, whereas one severe episode of hypoglycaemia would occur for every 15 to 52 patients. In analysis restricted to high quality studies (Jadad score >3), intensive treatment was not associated with any significant risk of reductions but resulted in a 47% increase in risk of congestive heart failure (P<0.001).

CONCLUSIONS

The overall results of this meta-analysis show limited benefits of intensive glucose lowering treatment on all cause mortality and deaths from cardiovascular causes. We cannot exclude a 9% reduction or a 19% increase in all cause mortality and a 14% reduction or a 43% increase in cardiovascular death. The benefit:risk ratio of intensive glucose lowering treatment in the prevention of macrovascular and microvascular events remains uncertain. The harm associated with severe hypoglycaemia might counterbalance the potential benefit of intensive glucose lowering treatment. More double blind randomised controlled trials are needed to establish the best therapeutic approach in people with type 2 diabetes.

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  • Authors+Show Affiliations

    ,

    Department of General Medicine, Université Claude Bernard Lyon 1, Lyon, France.

    , , , , , , , ,

    Source

    BMJ (Clinical research ed.) 343: 2011 Jul 26 pg d4169

    MeSH

    Adult
    Aged
    Albuminuria
    Blood Glucose
    Cause of Death
    Diabetes Mellitus, Type 2
    Diabetic Angiopathies
    Female
    Humans
    Hypoglycemia
    Hypoglycemic Agents
    Male
    Microcirculation
    Middle Aged
    Myocardial Infarction
    Randomized Controlled Trials as Topic
    Risk Reduction Behavior
    Treatment Outcome
    Young Adult

    Pub Type(s)

    Journal Article
    Meta-Analysis
    Research Support, Non-U.S. Gov't
    Review

    Language

    eng

    PubMed ID

    21791495

    Citation

    Boussageon, Rémy, et al. "Effect of Intensive Glucose Lowering Treatment On All Cause Mortality, Cardiovascular Death, and Microvascular Events in Type 2 Diabetes: Meta-analysis of Randomised Controlled Trials." BMJ (Clinical Research Ed.), vol. 343, 2011, pp. d4169.
    Boussageon R, Bejan-Angoulvant T, Saadatian-Elahi M, et al. Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: meta-analysis of randomised controlled trials. BMJ. 2011;343:d4169.
    Boussageon, R., Bejan-Angoulvant, T., Saadatian-Elahi, M., Lafont, S., Bergeonneau, C., Kassaï, B., ... Cornu, C. (2011). Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: meta-analysis of randomised controlled trials. BMJ (Clinical Research Ed.), 343, pp. d4169. doi:10.1136/bmj.d4169.
    Boussageon R, et al. Effect of Intensive Glucose Lowering Treatment On All Cause Mortality, Cardiovascular Death, and Microvascular Events in Type 2 Diabetes: Meta-analysis of Randomised Controlled Trials. BMJ. 2011 Jul 26;343:d4169. PubMed PMID: 21791495.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: meta-analysis of randomised controlled trials. AU - Boussageon,Rémy, AU - Bejan-Angoulvant,Theodora, AU - Saadatian-Elahi,Mitra, AU - Lafont,Sandrine, AU - Bergeonneau,Claire, AU - Kassaï,Behrouz, AU - Erpeldinger,Sylvie, AU - Wright,James M, AU - Gueyffier,François, AU - Cornu,Catherine, Y1 - 2011/07/26/ PY - 2011/7/28/entrez PY - 2011/7/28/pubmed PY - 2011/10/1/medline SP - d4169 EP - d4169 JF - BMJ (Clinical research ed.) JO - BMJ VL - 343 N2 - OBJECTIVE: To determine all cause mortality and deaths from cardiovascular events related to intensive glucose lowering treatment in people with type 2 diabetes. DESIGN: Meta-analysis of randomised controlled trials. DATA SOURCES: Medline, Embase, and the Cochrane database of systematic reviews. STUDY SELECTION: Randomised controlled trials that assessed the effect of intensive glucose lowering treatment on cardiovascular events and microvascular complications in adults (≥ 18 years) with type 2 diabetes. DATA EXTRACTION: Primary end points were all cause mortality and death from cardiovascular causes. Secondary end points were severe hypoglycaemia and macrovascular and microvascular events. Synthesis of results Results are reported as risk ratios with 99% confidence intervals. Statistical heterogeneity between trials was assessed with χ(2), τ(2), and I(2) statistics. A fixed effect model was used to assess the effect on the outcomes of intensive glucose lowering versus standard treatment. The quality of clinical trials was assessed by the Jadad score. RESULTS: 13 studies were included. Of 34,533 patients, 18,315 received intensive glucose lowering treatment and 16,218 standard treatment. Intensive treatment did not significantly affect all cause mortality (risk ratio 1.04, 99% confidence interval 0.91 to 1.19) or cardiovascular death (1.11, 0.86 to 1.43). Intensive therapy was, however, associated with reductions in the risk of non-fatal myocardial infarction (0.85, 0.74 to 0.96, P<0.001), and microalbuminuria (0.90, 0.85 to 0.96, P<0.001) but a more than twofold increase in the risk of severe hypoglycaemia (2.33, 21.62 to 3.36, P<0.001). Over a treatment period of five years, 117 to 150 patients would need to be treated to avoid one myocardial infarction and 32 to 142 patients to avoid one episode of microalbuminuria, whereas one severe episode of hypoglycaemia would occur for every 15 to 52 patients. In analysis restricted to high quality studies (Jadad score >3), intensive treatment was not associated with any significant risk of reductions but resulted in a 47% increase in risk of congestive heart failure (P<0.001). CONCLUSIONS: The overall results of this meta-analysis show limited benefits of intensive glucose lowering treatment on all cause mortality and deaths from cardiovascular causes. We cannot exclude a 9% reduction or a 19% increase in all cause mortality and a 14% reduction or a 43% increase in cardiovascular death. The benefit:risk ratio of intensive glucose lowering treatment in the prevention of macrovascular and microvascular events remains uncertain. The harm associated with severe hypoglycaemia might counterbalance the potential benefit of intensive glucose lowering treatment. More double blind randomised controlled trials are needed to establish the best therapeutic approach in people with type 2 diabetes. SN - 1756-1833 UR - https://www.unboundmedicine.com/medline/citation/21791495/full_citation L2 - http://www.bmj.com/cgi/pmidlookup?view=long&amp;pmid=21791495 DB - PRIME DP - Unbound Medicine ER -