Currently 15,000 people in the UK have the severe and chronic lung disease idiopathic pulmonary fibrosis (IPF) which is characterised by irreversible scarring of the lungs. Approximately 5,000 people are diagnosed with IPF each year and the number is rising. Medications for IPF are available since 2011but there is still no cure. Thus, the search for effective and widely available treatments for IPF is ongoing. As acid reflux is common in patients with IPF and can affect lung function, anti-acid therapies, including proton-pump inhibitors (PPIs), have been recommended as treatment for IPF in international treatment guidelines for IPF. However, the evidence supporting this recommendation is weak and it is unclear whether anti-acid therapy is indeed an effective treatment. Moreover, concerns have been raised regarding the overutilization of PPIs, highlighting the need for evidence regarding the effectiveness of PPIs in IPF.
This study will investigate whether the use of PPIs is associated with a reduction in mortality and an increased risk of hospitalisations in IPF patients using the Clinical Practice Research Datalink. This study will provide much needed information of these potential associations, which will provide support for treatment guidelines and be of value to regulatory committees, physicians, and patients.
Recent observational studies and post-hoc analyses of data from placebo arms of randomised controlled trials in patients with IPF have led to a conditional recommendation of anti-acid therapy as treatment for IPF. However, the evidence supporting the recommendation is weak and may even be biased leading to spurious associations. To date, no well-designed observational study with sufficiently large sample size and follow-up has investigated the effectiveness of PPIs in IPF. Thus, the objective of this study will be to assess the associations between PPIs and all-cause mortality and hospitalisations in a cohort of IPF patients who are at least 40 years of age and newly diagnosed with IPF on or after January 1, 2002 until December 31, 2015. Exposure to PPIs will be assessed in a time-dependent manner. All patients will be followed until death, end of registration with the practice, or end of the study period (December 31, 2016). Time-dependent Cox proportional hazard models will be used to estimate hazard ratios and 95% confidence intervals of death associated with the use of PPIs when compared to non-use. Additional analyses will assess the risk of hospitalisation associated with PPI use.
Death from any cause
- Respiratory-related deaths
- Hospitalisations
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Samy Suissa - Corresponding Applicant - Sir Mortimer B Davis Jewish General Hospital
Deborah Assayag - Collaborator - McGill University
Pierre Ernst - Collaborator - McGill University
Tanja Tran - Collaborator - McGill University
HES Admitted Patient Care;ONS Death Registration Data