Evaluation of the risk of intracranial and gastrointestinal bleeding events in patients concurrently prescribed non-steroidal anti-inflammatory drugs and SSRI antidepressants.

Study type
Protocol
Date of Approval
Study reference ID
16_242
Lay Summary

Both non-steroidal anti-inflammatory drugs and antidepressants can cause the serious adverse effect of internal bleeding. However, these drugs are commonly prescribed in primary care both alone and together. There is evidence that prescribing these drugs together can increase the risk of internal bleeding compared with either drug alone. In this study we will compare the risk of internal bleeding in patients prescribed each drug individually and both drugs together to those taking neither drug. The degree of extra risk posed by the combination of these drugs is an important consideration for all prescribers.

Technical Summary

The objective of this study is to estimate the strength of the association between concurrent exposure to non-steroidal anti-inflammatory drugs and antidepressants and both gastrointestinal bleeding and intracranial haemorrhage. This association will be compared to exposure to each drug individually and to neither drug. The study will include a cohort of patients with no history of bleeding events and no prior exposure to either drug class. A Poisson regression model will be used to estimate the hazard ratio for each exposure compared to patients on neither drug.

Collaborators

Ian Douglas - Chief Investigator - London School of Hygiene & Tropical Medicine ( LSHTM )
Bruce Guthrie - Collaborator - University of Edinburgh
Liam Smeeth - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Rupert Payne - Collaborator - University of Bristol
Stewart Mercer - Collaborator - University of Edinburgh

Former Collaborators

Peter Fisher - Corresponding Applicant - UCL Hospital

Linkages

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