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01.09.2009 | Article | Ausgabe 9/2009 Open Access

Diabetologia 9/2009

Risk of malignancies in patients with diabetes treated with human insulin or insulin analogues: a cohort study

Zeitschrift:
Diabetologia > Ausgabe 9/2009
Autoren:
L. G. Hemkens, U. Grouven, R. Bender, C. Günster, S. Gutschmidt, G. W. Selke, P. T. Sawicki
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1007/​s00125-009-1418-4) contains supplementary material, which is available to authorised users.
L. G. Hemkens and U. Grouven contributed equally to this study.

Abstract

Aims/hypothesis

The aim of this cohort study was to investigate the risk of malignant neoplasms and mortality in patients with diabetes treated either with human insulin or with one of three insulin analogues.

Methods

Data were provided by the largest German statutory health insurance fund (time-frame: January 1998 to June 2005 inclusive), on patients without known malignant disease who had received first-time therapy for diabetes mellitus exclusively with human insulin, aspart, lispro or glargine. The primary outcome was the diagnosis of a malignant neoplasm. Data were analysed by multiple Cox regression models adjusting for potential confounders.

Results

A total of 127,031 patients were included, with a mean follow-up time of 1.63 (median 1.41, maximum 4.41) years. A positive association between cancer incidence and insulin dose was found for all insulin types. Because patients receiving combined therapy with insulin analogues and human insulin were excluded, the mean daily dose was much lower for glargine than for human insulin, and a slightly lower cancer incidence in the glargine group was found. After adjusting for dose, a dose-dependent increase in cancer risk was found for treatment with glargine compared with human insulin (p < 0.0001): the adjusted HR was 1.09 (95% CI 1.00 to 1.19) for a daily dose of 10 IU, 1.19 (95% CI 1.10 to 1.30) for a daily dose of 30 IU, and 1.31 (95% CI 1.20 to 1.42) for a daily dose of 50 IU. No increased risk was found for aspart (p = 0.30) or lispro (p = 0.96) compared with human insulin.

Conclusions/interpretation

Considering the overall relationship between insulin dose and cancer, and the lower dose with glargine, the cancer incidence with glargine was higher than expected compared with human insulin. Our results based on observational data support safety concerns surrounding the mitogenic properties of glargine in diabetic patients. Prospective long-term studies are needed to further evaluate the safety of insulin analogues, especially glargine.

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Zusatzmaterial
ESM Table 1 Baseline characteristics of patients who received human insulin or glargine, categorised according to daily dose received (PDF 73.1 kb)
125_2009_1418_MOESM1_ESM.pdf
ESM Table 2 Results of the final Cox regression model for malignant neoplasms (reference group: human insulin) based on data for 127,031 patients (PDF 34 kb)
125_2009_1418_MOESM2_ESM.pdf
ESM Table 3 Results of the final Cox regression model for all-cause mortality (reference group: human insulin) based on data for 127,031 patients (PDF 36 kb)
125_2009_1418_MOESM3_ESM.pdf
Literatur
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