Abstract

BackgroundHypoglycaemia is a serious adverse effect of antidiabetic drug therapy. We aimed to determine incidence rates of hypoglycaemia in type-2 diabetic patients and identify predictors of hypoglycaemia when treatment is intensified.MethodsDiaRegis is a prospective German registry that follows 3810 patients with type-2 diabetes referred for treatment intensification because of insufficient glycaemic control on one or two oral antidiabetic drugs.ResultsOut of a total of 3347 patients with data available for the present analysis 473 (14.1%) presented any severity hypoglycaemia over a follow-up of 12 months. 0.4% were hospitalized (mean of 1.3±0.6 episodes), 0.1% needed medical assistance (1.0±0.0), 0.8% needed any help (1.1±0.5) and 10.1% no help (3.4±3.7), and 8.0% had no specific symptoms (3.6±3.5). Patients with incident hypoglycaemia had longer diabetes duration, higher HbA1c and a more frequent smoking history; more had co-morbid disease conditions such as coronary artery disease, peripheral arterial disease, amputation, heart failure, peripheral neuropathy, diabetic retinopathy and clinically relevant depression at baseline. Multivariable adjusted positive predictors of incident hypoglycaemia over the follow-up were prior anamnestic hypoglycaemia, retinopathy, depression, insulin use and blood glucose self-measurement, but not sulfonylurea use as previously reported for anamnestic or recalled hypogylcaemia. On the contrary, glitazones, DPP-4 inhibitors and GLP-1 analogues were associated with a reduced risk of hypoglycaemia.ConclusionsHypoglycaemia is a frequent adverse effect in ambulatory patients when antidiabetic treatment is intensified. Particular attention is warranted in patients with prior episodes of hypoglycaemia, microvascular disease such as retinopathy and in patients receiving insulin. On the other hand glitazones, DPP-4 inhibitors and GLP-1 analogues are associated with a reduced risk.

Highlights

  • Hypoglycaemia is a serious adverse effect of antidiabetic drug therapy

  • With many antidiabetic drugs such as sulfonylureas or insulin, intensified blood glucose lowering has been associated with an increase in the rate of hypoglycaemia [2,3,4]

  • We conclude that hypoglycaemia is a frequent adverse effect in ambulatory patients when antidiabetic treatment is intensified from oral mono- or dual oral combination therapy

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Summary

Introduction

Hypoglycaemia is a serious adverse effect of antidiabetic drug therapy. We aimed to determine incidence rates of hypoglycaemia in type-2 diabetic patients and identify predictors of hypoglycaemia when treatment is intensified. Hypoglycaemia is a serious adverse effect while using antidiabetic pharmacotherapy, irrespective of its severity. With many antidiabetic drugs such as sulfonylureas or insulin, intensified blood glucose lowering has been associated with an increase in the rate of hypoglycaemia [2,3,4] To assess the incidence of hypoglycaemia in a cohort of type-2 diabetic patients in whom treatment was intensified because of insufficient glycaemic control on one or two oral antidiabetic drugs the prospective registry DiaRegis was conducted. The primary objective was to determine the proportion of patients with at least 1 episode of severe hypoglycaemia (requiring medical help or hospitalization) within one year. Hypoglycaemia related secondary objectives were to evaluate the number of patients with at least 1 episode of severe, moderate or mild hypoglycaemia, and to evaluate the number of hypoglycaemic events per patient, respectively

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