Etoricoxib Prescribing Patterns and Adverse Events of Interest in Primary Care in the United Kingdom (MK-0663-162 AM1)

Study Overview
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Brief Summary
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This postmarketing study was conducted to describe prescribing patterns for etoricoxib (ARCOXIA®) in General Practice and describe the incidence of selected adverse events recorded in the United Kingdom (UK) Medicines and Health Care Products Regulatory Agency (MHRA) General Practice Research Database (GPRD).

Official Title
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Etoricoxib Prescribing Patterns and Adverse Events of Interest During Etoricoxib Treatment in UK Primary Care; an Updated Analysis

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, Gout, Arthritis

Intervention / Treatment
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* Drug: Etoricoxib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients in the MHRA's Full Feature GPRD (FF-GPRD) who have at least one electronic outpatient prescription record for etoricoxib issued by a General Practitioner during the period (April 1, 2002 to December 31, 2015) at the date of query execution against the FF-GPRD data warehouse. Exclusion Criteria: Not registered in a GPRD-contributing practice that had continuously collected data deemed to be 'up-to-standard' for research purposes from 1 April 2002 through to 31 December 2015. Never registered as a permanent patient of a General Practitioner in the practice Registration details were not acceptable (i.e. incomplete data or logically implausible dates) Not registered with a General Practitioner for at least 365 days before the date that the patient's first etoricoxib prescription was recorded in the GPRD
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Etoricoxib Prescription (Period 1)<br>First Etoricoxib Prescription, Apr. 1, 2002 to Feb. 17, 2005 | Drug: Etoricoxib<br>* As per routine clinical practice in the United Kingdom<br>* Other names: ARCOXIA®);|
| Etoricoxib Prescription (Period 2)<br>First Etoricoxib Prescription, Feb. 18, 2005 to Dec. 31, 2015 | Drug: Etoricoxib<br>* As per routine clinical practice in the United Kingdom<br>* Other names: ARCOXIA®);|
| Repeat Etoricoxib Prescription<br>One prescription during the Period 1 and, at least, one etoricoxib prescription during Period 2. | Drug: Etoricoxib<br>* As per routine clinical practice in the United Kingdom<br>* Other names: ARCOXIA®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of Initial Etoricoxib Prescription |  | At first prescription (during a time period up to 13.75 years) | 
| Duration of Initial Etoricoxib Prescription |  | At first prescription (during a time period up to 13.75 years) | 
| Participant's Baseline Characteristics (Demographics and Medical) |  | At first prescription (during a time period up to 13.75 years) | 
| Incidence of Adverse Events of Special Interest Among Etoricoxib Users |  | During a time period up to 13.75 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Off-label use of Etoricoxib |  | At first prescription (during a time period up to 13.75 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Etoricoxib, ARCOXIA, Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, Gout, Arthritis