Risk of hypoglycaemia in users of sulphonylureas with renal impairment: a population-based cohort study

Date of ISAC Approval: 
23/02/2016
Lay Summary: 
Sulphonylureas are widely prescribed for use in patients with type 2 diabetes. A potential severe side effect of sulphonylureas is hypoglycaemia (low blood sugar). Accumulation of degradation products can occur in patients with renal (kidney) impairment, which is expected to give a higher risk of hypoglycaemia. However, there is sparse and conflicting data regarding the incidence of hypoglycaemia in patients with renal impairment. As diabetes is a leading cause of chronic kidney disease, it is important to have knowledge about hypoglycaemic effects of sulphonylureas in patients with renal impairment. Therefore, the aim of this study is to evaluate the relation between current use of SUs only and the risk of hypoglycaemia in relation to renal function.
Technical Summary: 
This study's objective is to evaluate the association between current use of sulphonylurea (SU) only and the risk of hypoglycaemia in relation to renal function, compared with current use of metformin-only. Within the CPRD, all adult patients with at least one prescription for non-insulin antidiabetic agents (NIAA) will be selected. The exposure of interest is use of SUs in patients with type 2 diabetes mellitus (T2DM) and renal impairment (RI). Current SU-only users will be stratified according to their most recent prescribed defined daily dose, most recent renal function and to type of SU (active vs. inactive metabolites). Exposure will be assessed in a time-dependent manner. Adjusted cox regression models will be used to derive hazard ratios for the association between SU use, renal function and the risk of hypoglycaemia.
Health Outcomes to be Measured: 
First ever event of hypoglycaemia
Collaborators: 

Frank de Vries - Chief Investigator - Utrecht University
Andre Krings - Collaborator - Atrium MC
Andrea Burden - Collaborator - Utrecht University
Hubert Leufkens - Collaborator - Utrecht University
Johanna Annemariek Driessen - Collaborator - Utrecht University
Judith van Dalem - Collaborator - Utrecht University
Martijn Brouwers - Collaborator - Maastricht University