β-blocker effects on the association of hypoglycaemia with cardiovascular and all-cause mortality

Study type
Protocol
Date of Approval
Study reference ID
16_104
Lay Summary

Episodes of low blood glucose (hypoglycaemia) significantly impair quality of life in people with diabetes mellitus. Recently, some studies have also suggested an increased risk of cardiovascular complications (for example, heart attack) in people experiencing severe hypoglycaemic episodes, possibly related to abnormal/irregular heartbeats during the episode (arrhythmia).
It is very common for people with diabetes to take other drugs on top of those to control diabetes, such as therapies to reduce blood pressure. These drugs can have an effect on the risk of arrhythmia. Therefore, it is relevant to clarify how such risk differs according to the use of these drugs. This information can be useful when prescribing other therapies in people with diabetes.

Technical Summary

The objective of this research is to assess the impact of cardioprotective drugs on the risk of cardiovascular disease in people with diabetes who experienced severe hypoglycaemic episodes. People experiencing hypoglycaemia are mainly at risk of arrhythmic disorders, and the effect of cardioprotective drugs on disarrhytmias is different (i.e., β-blockers vs ACE-inhibitors). Using HES- and ONS-linked data, we aim to assess whether the protective effects of β-blockers differ in subjects with and without previous hypoglycaemia. A nested case-control study design will be used for the analysis to estimate the risk of cardiovascular and all-cause death by exposure in people with and without a previous episode of severe hypoglycaemia (interaction analysis).

Health Outcomes to be Measured

CV events and all-cause mortality

Collaborators

Kamlesh Khunti - Chief Investigator - University of Leicester
Brian Thorsted - Collaborator - Novo Nordisk A/S
Francesco Zaccardi - Collaborator - University of Leicester
Lise Lotte Nystrup Husemoen - Collaborator - Novo Nordisk A/S

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation