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Siebenhofer, A; Plank, J; Berghold, A; Jeitler, K; Horvath, K; Narath, M; Gfrerer, R; Pieber, TR.
Short acting insulin analogues versus regular human insulin in patients with diabetes mellitus.
COCHRANE DATABASE SYST REV. 2006; 4(2): CD003287-CD003287.
Doi: 10.1002/14651858.CD003287.pub4
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- Führende Autor*innen der Med Uni Graz
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Siebenhofer-Kroitzsch Andrea
- Co-Autor*innen der Med Uni Graz
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Berghold Andrea
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Horvath Karl
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Jeitler Klaus
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Pieber Thomas
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- Abstract:
- BACKGROUND: Short acting insulin analogue use for diabetic patients is still controversial, as reflected in many scientific debates. OBJECTIVES: To assess the effects of short acting insulin analogues versus regular human insulin. SEARCH STRATEGY: The Cochrane Library (Issue 3, 2005), MEDLINE, EMBASE until September 2005. SELECTION CRITERIA: Randomised controlled trials with an intervention duration of at least 4 weeks. DATA COLLECTION AND ANALYSIS: Trial selection and evaluation of study quality was done independently by two reviewers. MAIN RESULTS: Altogether 8274 participants took part in 49 randomised controlled studies. Most studies were of poor methodological quality. In patients with type 1 diabetes, the weighted mean difference (WMD) of HbA1c was -0.1% (95% CI: -0.2 to -0.1) in favour of insulin analogue, whereas in patients with type 2 diabetes the WMD was 0.0% (95% CI: -0.1 to 0.0). In subgroup analyses of different types of interventions in type 1 diabetic patients, the WMD in HbA1c was -0.2% (95% CI: -0.3 to -0.1) in favour of insulin analogue in studies using continuous subcutaneous insulin injections (CSII), whereas for conventional intensified insulin therapy (IIT) studies the WMD in HbA1c was -0.1% (95% CI: -0.1 to 0.0). The WMD of the overall mean hypoglycaemic episodes per patient per month was -0.2 (95% CI: -1.1 to 0.7) and -0.2 (95% CI: -0.5 to 0.1) for analogues in comparison to regular insulin in patients with type 1 diabetes and type 2 diabetes, respectively. For studies in type 1 diabetes patients the incidence of severe hypoglycaemia ranged from 0 to 247.3 (median 21.8) episodes per 100 person-years for insulin analogues and from 0 to 544 (median 46.1) for regular insulin, in type 2 the incidence ranged from 0 to 30.3 (median 0.3) episodes per 100 person-years for insulin analogues and from 0 to 50.4 (median 1.4) for regular insulin. No study was designed to investigate possible long term effects (e.g. mortality, diabetic complications), in particular in patients with diabetes related complications. AUTHORS' CONCLUSIONS: Our analysis suggests only a minor benefit of short acting insulin analogues in the majority of diabetic patients treated with insulin. Until long term efficacy and safety data are available we suggest a cautious response to the vigorous promotion of insulin analogues. For safety purposes, we need a long-term follow-up of large numbers of patients and well designed studies in pregnant women to determine the safety profile for both the mother and the unborn child.
- Find related publications in this database (using NLM MeSH Indexing)
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Diabetes Mellitus, Type 1 - blood
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Diabetes Mellitus, Type 2 - blood
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Hemoglobin A, Glycosylated - metabolism
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Humans - metabolism
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Hypoglycemic Agents - therapeutic use
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Insulin - analogs and derivatives
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Randomized Controlled Trials as Topic - analogs and derivatives