Proton Pump Inhibitors and Risk of Community-acquired Pneumonia

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether proton pump inhibitors (PPIs), a medication used to treat gastric conditions, increase the risk of hospitalization for community-acquired pneumonia (HCAP).

The investigators will carry out separate population-based cohort studies using administrative health databases in eight jurisdictions in Canada, the US, and the UK. Cohort entry will be defined by the initiation of an oral non-steroidal anti-inflammatory drug, with follow-up until hospitalization for pneumonia or end of follow-up (6 months). The results from the separate sites will be combined using a statistical approach called meta-analysis to provide an overall assessment of the risk of HCAP with PPIs.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Canadian Network for Observational Drug Effect Studies, CNODES
• Collaborators: Canadian Institutes of Health Research (CIHR); Drug Safety and Effectiveness Network, Canada
• Treatments: Bismuth; Bismuth tripotassium dicitrate; Cimetidine; Citric Acid; Dexlansoprazole; Esomeprazole; Famotidine; Histamine; Histamine H2 Antagonists; Histamine phosphate; Lafutidine; Lansoprazole; Nizatidine; Omeprazole; Pantoprazole; Proton Pump Inhibitors; Rabeprazole; Ranitidine; Ranitidine bismuth citrate; Roxatidine acetate

Criteria

Inclusion Criteria:

• Patients with a first oral NSAID prescription

• Patients at least 40 years of age (except Alberta, Ontario, and Nova Scotia, where patients will be at least 66 years of age)

• Patients with at least 1 year of history in the database.

Exclusion Criteria:

• Patients aged < 40 years at cohort entry (or < 66 in Alberta, Ontario, and Nova Scotia)

• Received a prescription for a PPI, a H2RA, or a NSAID (any route of administration) in the 6 months prior to cohort entry

• Had an HCAP (ICD-9-CM code (in any field): 480.x-487.x; ICD-10-CA code: J10.0 - J18.9) or an extended emergency room visit for community-acquired pneumonia in the year prior to cohort entry (where available)

• Hospitalized at the time of cohort entry

• Received a prescription for medications used for the treatment of tuberculosis (ATC Code J04A) (where available)

• Had a history of cancer (other than non-melanoma skin cancer) in the year prior to cohort entry

• Hospitalized >3 days within the 30 days before cohort entry

• Had <1 year of continuous observation time in the database prior to cohort entry