Evidence-based guideline of the German Diabetes Association (DDG) Update from October 2008 Medical antihyperglycaemic treatment of diabetes mellitus type 2 Update of the evidence …
Diabetes mellitus type 2 is a chronically progressive disease that is characterised by inherited and acquired insulin resistance and an increasing insulin secretion disorder. In order to reduce the morbidity and mortality rates among type 2 diabetics, which are increased significantly by macro- and microangiopathic complications, besides the antihyperglycaemic therapy discussed here it is also essential to administer the optimum treatment for arterial hypertension (see also DDG guideline “Managing hypertension in patients with diabetes mellitus”), diabetic dyslipidaemia (see also DDG guideline on “Lipid metabolism disorders”, in preparation), and hypercoagulopathy that are often associated with type 2 diabetes. The effectiveness of a multifactorial intervention in reducing macro- and microvascular complications [Gaede et al, 2003, evidence class (EC) Ib] and also mortality (absolute risk lowered by 20% in 13.3 years) [Gaede et al, 2008, EC Ib] has been demonstrated convincingly by the results of the Steno-2 study. The favourable effect of an optimised antihyperglycaemic treatment in terms of reducing microvascular complications has been shown equally convincingly in the UKPDS (relative risk reduction ~40%) [UKPDS 33, 1998, EC Ib] and the ADVANCE study [The ADVANCE Collaborative Group, 2008, EC Ib]. Moreover, the 10-year follow-up data from the UKPDS which was published recently attests to the long-term benefits of intensified antihyperglycaemic therapy in reducing macrovascular end points such as myocardial infarction [Holman et al., 2008, EC Ib]. A recently published meta-analysis of the effects of antihyperglycaemic therapy on macrovascular results in patients with type 2 diabetes reported a relative risk reduction of 19% [Stettler et al., 2006, EC Ia]. Because of the chronically progressive nature of the disease, the antihyperglycaemic treatment must be selected according to the pathophysiological phase of the disease at the time the treatment is begun (see also flowchart of “Antihyperglycaemic treatment for type 2 diabetes” [2.0]). At the same time, non- pharmacological therapies (structured patient education, nutrition therapy (see also DDG guideline “Nutrition and diabetes mellitus”, as well as exercise therapy) are extremely important in all phases of the disease. In the context of the data from the UKPDS, the UKPDS 10-year follow-up, and ADVANCE, and in accordance with the European Diabetes Policy Group (Desktop Guide to Type 2 Diabetes mellitus) as well as the global IDF guidelines, the target range for HbA1c recommended in this guideline is < 6.5%. In the light of the recently published results of the ACCORD and ADVANCE studies, however, it is also imperative to avoid adverse side effects such as severe hypoglycaemia and significant weight gain [The Action to Control Cardiovascular Risk in Diabetes Study Group, 2008, EC Ib; The ADVANCE Collaborative Group, 2008, EC Ib]. The appendix to this guideline (starting on p.64) includes the position statement of the DDG with respect to both of these studies. This statement has also been posted on the DDG homepage: http://www.deutsche-diabetes- gesellschaft.de/redaktion news/ACCORD_ADVANCE_DDG_Stellungnahme_2008_07_09.pdf The conclusions to be drawn from the results of the two studies have been incorporated in the flowchart (see section 2.0) and in the associated legend (see section 2.1). Endpoint data are available for the following substances in the pharmacological antihyperglycaemic treatment of subjects with type 2 diabetes: metformin, glibenclamide, insulin, pioglitazone, and rosiglitazone. Cardiovascular endpoint data of this kind is not yet available for the other substances listed in this guideline, and there is as yet little long-term information for the newer compounds for obvious reasons...

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