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J Clin Endocrinol Metab. 2013 Feb;98(2):668-77. doi: 10.1210/jc.2012-3042. Epub 2013 Jan 31.

Mortality and other important diabetes-related outcomes with insulin vs other antihyperglycemic therapies in type 2 diabetes.

Author information

1
School of Medicine, Cardiff University, The Pharma Research Centre, Cardiff MediCentre, Cardiff CF14 4UJ, United Kingdom. currie@cardiff.ac.uk

Abstract

CONTEXT:

The safety of insulin in the treatment of type 2 diabetes mellitus (T2DM) has recently undergone scrutiny.

OBJECTIVE:

The objective of the study was to characterize the risk of adverse events associated with glucose-lowering therapies in people with T2DM.

DESIGN AND SETTING:

This was a retrospective cohort study using data from the UK General Practice Research Database, 2000-2010.

PATIENTS:

Patients comprised 84 622 primary care patients with T2DM treated with one of five glucose-lowering regimens: metformin monotherapy, sulfonylurea monotherapy, insulin monotherapy, metformin plus sulfonylurea combination therapy, and insulin plus metformin combination therapy. There were 105 123 exposure periods.

MAIN OUTCOME MEASURES:

The risk of the first major adverse cardiac event, first cancer, or mortality was measured. Secondary outcomes included these individual constituents and microvascular complications.

RESULTS:

In the same model, and using metformin monotherapy as the referent, the adjusted hazard ratio (aHR) for the primary end point was significantly increased for sulfonylurea monotherapy (1.436, 95% confidence interval [CI] 1.354-1.523), insulin monotherapy (1.808, 95% CI 1.630-2.005), and insulin plus metformin (1.309, 95% CI 1.150-1.491). In glycosylated hemoglobin/morbidity subgroups, patients treated with insulin monotherapy had aHRs for the primary outcome ranging from 1.469 (95% CI 0.978-2.206) to 2.644 (95% CI 1.896-3.687). For all secondary outcomes, insulin monotherapy had increased aHRs: myocardial infarction (1.954, 95% CI 1.479-2.583), major adverse cardiac events (1.736, 95% CI 1.441-2.092), stroke (1.432, 95% CI 1.159-1.771), renal complications (3.504, 95% CI 2.718-4.518), neuropathy (2.146, 95% CI 1.832-2.514), eye complications (1.171, 95% CI 1.057-1.298), cancer (1.437, 95% CI 1.234-1.674), or all-cause mortality (2.197, 95% CI 1.983-2.434). When compared directly, aHRs were higher for insulin monotherapy vs all other regimens for the primary end point and all-cause mortality.

CONCLUSIONS:

In people with T2DM, exogenous insulin therapy was associated with an increased risk of diabetes-related complications, cancer, and all-cause mortality. Differences in baseline characteristics between treatment groups should be considered when interpreting these results.

PMID:
23372169
PMCID:
PMC3612791
DOI:
10.1210/jc.2012-3042
[Indexed for MEDLINE]
Free PMC Article

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