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Proton Pump Inhibitors and Risk of Community-acquired Pneumonia

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ClinicalTrials.gov Identifier: NCT02555852
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : September 22, 2015
Sponsor:
Collaborators:
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Canadian Network for Observational Drug Effect Studies, CNODES

Brief 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.


Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease (GERD) Community-acquired Pneumonia Drug: esomeprazole Drug: omeprazole Drug: pantoprazole Drug: lansoprazole Drug: rabeprazole Drug: cimetidine Drug: ranitidine Drug: famotidine Drug: nizatidine Drug: niperotidine Drug: roxatidine Drug: ranitidine bismuth citrate Drug: lafutidine Drug: cimetidine combinations Drug: famotidine combinations

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 4238504 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Proton Pump Inhibitors and the Risk of Hospitalization for Community-acquired Pneumonia: Replicated Cohort Studies With Meta-analysis
Study Start Date : September 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
Users of PPIs
Exposure to proton pump inhibitors (PPIs) will be defined as a prescription for a PPI (esomeprazole, omeprazole, pantoprazole, lansoprazole, rabeprazole, and combinations) on the same day as the cohort entry defining prescription for an NSAID.
Drug: esomeprazole
Exposure to esomeprazole (ATC A02BC05, B01AC56, M01AE52, A02BD06) will be defined as a prescription for esomeprazole on the same day as a ≥ 30 day NSAID prescription.
Other Name: Proton pump inhibitor

Drug: omeprazole
Exposure to omeprazole (ATC A02BC01, A02BD01) will be defined as a prescription for omeprazole on the same day as a ≥ 30 day NSAID prescription.
Other Name: Proton pump inhibitor

Drug: pantoprazole
Exposure to pantoprazole (ATC A02BC02, A02BD04) will be defined as a prescription for pantoprazole on the same day as a ≥ 30 day NSAID prescription.
Other Name: Proton pump inhibitor

Drug: lansoprazole
Exposure to lansoprazole (ATC A02BC03, A02BD07, A02BD03, A02BD02) will be defined as a prescription for lansoprazole on the same day as a ≥ 30 day NSAID prescription.
Other Name: Proton pump inhibitor

Drug: rabeprazole
Exposure to rabeprazole (ATC A02BC04) will be defined as a prescription for rabeprazole on the same day as a ≥ 30 day NSAID prescription.
Other Name: Proton pump inhibitor

Users of H2RAs
Exposure to histamine-2 receptor antagonists (H2RAs) will be defined as a prescription for a H2RA (cimetidine, ranitidine, famotidine, nizatidine, niperotidine, roxatidine, ranitidine bismuth citrate, lafutidine, cimetidine combinations, and famotidine combinations) on the same day as the cohort entry defining prescription for an NSAID.
Drug: cimetidine
Exposure to cimetidine (ATC A02BA01) will be defined as a prescription for cimetidine on the same day as a ≥ 30 day NSAID prescription.
Other Name: histamine-2 receptor antagonist

Drug: ranitidine
Exposure to ranitidine (A02BA02) will be defined as a prescription for ranitidine on the same day as a ≥ 30 day NSAID prescription.
Other Name: histamine-2 receptor antagonist

Drug: famotidine
Exposure to famotidine (A02BA03) will be defined as a prescription for famotidine on the same day as a ≥30 day NSAID prescription.
Other Name: histamine-2 receptor antagonist

Drug: nizatidine
Exposure to nizatidine (A02BA04) will be defined as a prescription for nizatidine on the same day as a ≥ 30 day NSAID prescription.
Other Name: histamine-2 receptor antagonist

Drug: niperotidine
Exposure to niperotidine (A02BA05) will be defined as a prescription for niperotidine on the same day as a ≥ 30 day NSAID prescription.
Other Name: histamine-2 receptor antagonist

Drug: roxatidine
Exposure to roxatidine (A02BA06) will be defined as a prescription for roxatidine on the same day as a ≥ 30 day NSAID prescription.
Other Name: histamine-2 receptor antagonist

Drug: ranitidine bismuth citrate
Exposure to ranitidine bismuth citrate (A02BA07) will be defined as a prescription for ranitidine bismuth citrate on the same day as a ≥ 30 day NSAID prescription.
Other Name: histamine-2 receptor antagonist

Drug: lafutidine
Exposure to lafutidine (A02BA08) will be defined as a prescription for lafutidine on the same day as a ≥ 30 day NSAID prescription.
Other Name: histamine-2 receptor antagonist

Drug: cimetidine combinations
Exposure to cimetidine combinations (A02BA51) will be defined as a prescription for cimetidine combinations on the same day as a ≥ 30 day NSAID prescription.
Other Name: histamine-2 receptor antagonist

Drug: famotidine combinations
Exposure to famotidine combinations (A02BA53) will be defined as a prescription for famotidine combinations on the same day as a ≥ 30 day NSAID prescription.
Other Name: histamine-2 receptor antagonist

Unexposed group (Reference)
Patients that are considered to be unexposed will be defined as patients not prescribed a PPI or H2RA on the same day as the cohort entry defining prescription for an NSAID.



Primary Outcome Measures :
  1. Hospitalization for Community-Acquired Pneumonia (HCAP) [ Time Frame: Patients will be followed from the date of study cohort entry until HCAP, censoring, or for up to 6 months. ]

    HCAP during the 6 months following cohort entry

    Patients with HCAP with any of the following diagnostic codes: ICD-9: 487.0, 487.1, 487.0, 487.1, 487.0, 480.9, 481.x, 482.2, 482.0, 482.1, 482.30, 482.31, 482.32, 482.39, 482.40, 482.41, 482.42, 482.49, 482.81, 482.82, 482.83, 482.89, 482.9, 483.0, 484.7, 484.8, 485.X, 481.X, 486.X ; ICD-10: J10.0, J11.0, J11.1, J12.9, J13, J14, J15.X, J16.8, J17.0, J17.2, J17.3, J17.8, J18.0, J18.1, J18.8, J18.9.




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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In each jurisdiction, the investigators will assemble a study cohort that includes all patients with a new prescription for an oral NSAID between January 1, 1997 and March 31, 2010. The date of study cohort entry is defined by the prescription date of the newly-prescribed NSAID.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555852


Locations
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Canada, Quebec
Lady Davis Institute for Medical Research, Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Sponsors and Collaborators
Canadian Network for Observational Drug Effect Studies, CNODES
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Kristian Filion, PhD Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University

Additional Information:
Publications of Results:
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Responsible Party: Canadian Network for Observational Drug Effect Studies, CNODES
ClinicalTrials.gov Identifier: NCT02555852     History of Changes
Other Study ID Numbers: CNODES_DEMO-2
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

Keywords provided by Canadian Network for Observational Drug Effect Studies, CNODES:
Proton Pump Inhibitors
Pneumonia
NSAIDs
Histamine H2 Antagonists
Drug safety

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bismuth tripotassium dicitrate
Omeprazole
Esomeprazole
Rabeprazole
Pantoprazole
Lansoprazole
Dexlansoprazole
Famotidine
Ranitidine
Ranitidine bismuth citrate
Cimetidine
Nizatidine
Lafutidine
Roxatidine acetate
Bismuth
Citric Acid
Sodium Citrate
Proton Pump Inhibitors
Histamine
Histamine phosphate