A Study of Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications

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

144337 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-09-30

Brief Summary

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The Purpose of this study is to examine whether evidence of channeling exists by analyzing within a cohort of participants with first prescriptions of single-ingredient paracetamol or ibuprofen (or both) whether participants with paracetamol were more likely to have an ibuprofen-related contraindication.

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Detailed Description

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Conditions

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Hemorrhage, Gastrointestinal Myocardial Infarction Stroke Kidney Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Any Paracetamol

Participants with age 18 and over who received a first prescription of single-ingredient paracetamol or ibuprofen in 2012 will be enrolled. Their status with respect to prior gastrointestinal bleeding, myocardial infarction, stroke, or kidney disease will be assessed based on the presence or absence of a diagnosis in the 2 years prior to the index date. This observational study will evaluate whether new users of paracetamol have a higher prevalence of certain conditions (gastrointestinal bleeding, myocardial infarction, stroke or kidney disease) in their history when compared to new users of ibuprofen, propensity scores and outcome models.

No interventions assigned to this group

Ibuprofen

Participants with age 18 and over who received a first prescription of single-ingredient ibuprofen in 2012 will be enrolled. Their status with respect to prior gastrointestinal bleeding, myocardial infarction, stroke, or kidney disease will be assessed based on the presence or absence of a diagnosis in the 2 years prior to the index date. This observational study will evaluate whether new users of paracetamol have a higher prevalence of certain conditions (gastrointestinal bleeding, myocardial infarction, stroke or kidney disease) in their history when compared to new users of ibuprofen, propensity scores and outcome models.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Enrolled in up-to-standard practices (practices that have been qualified for research purposes by the Clinical Practice Research Datalink \[CPRD\] administrators) in the CPRD
* Received a first prescription for paracetamol or a first prescription for ibuprofen in 2012
* Were age 18 or older in the date of their qualifying prescription in 2012

Exclusion Criteria

* Who received a prescription for paracetamol or ibuprofen in the 6 months prior to their qualifying prescription in 2012
* Who received a prescription for any acetaminophen- or ibuprofen-containing combination products in the 6 months prior to the qualifying prescription in 2012

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No