An Observational Study to Assess the Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Users of Proton Pump Inhibitors, and Users of Metoclopramide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this observational study is to assess the risk of out-of-hospital Sudden Cardiac (heart) Death (SCD) associated with current use of domperidone compared to current use of a Proton Pump Inhibitor (PPI), current use of metoclopramide, or non-use of any of these medications.

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Detailed Description

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This is a population-based, retrospective (a study in which the exposures and outcomes occurred before the study began), and nested case-control study (a study in which the patients with the study outcome \[cases\] and comparison patients without that outcome \[controls\] are observed to assess their exposure to the medication being studied \[domperidone, PPI's and metoclopramide\]). The data will come from the United Kingdom's Clinical Practice Research Datalink. The study will estimate the rate of SCD during periods of exposure to each of the study medications, and during periods of exposure to none of them; and the ratios of these rates. It will also use a "case-crossover" analysis (in which each case serves as his/her own control) to re-estimate these rate ratios in a manner that takes account of personal characteristics such as obesity or smoking that may affect the study findings and are incompletely recorded in the database.

Conditions

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Death, Sudden, Cardiac

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Domperidone/ a proton pump inhibitor/metoclopramide users

Study patients had at least one prescription for domperidone, a proton pump inhibitor, or metoclopramide. Proton pump inhibitors observed in this study are: omeprazole, lansoprazole, esomeprazole, rabeprazole, and pantoprazole.

No intervention

Intervention Type DRUG

This is an observational and a retrospective study of existing data, so there will be no interventions. The exposure groups will be domperidone, proton pump inhibitors (omeprazole, lansoprazole, esomeprazole, rabeprazole, and pantoprazole), and metoclopramide.

Interventions

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No intervention

This is an observational and a retrospective study of existing data, so there will be no interventions. The exposure groups will be domperidone, proton pump inhibitors (omeprazole, lansoprazole, esomeprazole, rabeprazole, and pantoprazole), and metoclopramide.

Intervention Type DRUG

Other Intervention Names

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Motilium

Eligibility Criteria

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Inclusion Criteria

\- Patients registered in English practices whose data are linkable to Hospital Episode Statistics (HES) and Office for National Statistics, UK (ONS). Patients are required to have at least 1 year in the Clinical Practice Research Datalink before they can enter the study

Exclusion Criteria

* Patients with a diagnosis of cancer other than non-melanoma skin cancer
* Patients from practices not linkable to HES and ONS data
* Patient time corresponding to the period between hospital admission date and 30 days after discharge date

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No