Cardiovascular Events in Parkinson's Disease Patients

Completed

• Conditions: Cardiovascular Event; Parkinson Disease
• Interventions: Drug: levodopa

• Registration Number: NCT01545856
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Cardiovascular (CV) disease is a common comorbidity of Parkinson's disease (PD). The background incidence rate of CV events in a levodopa-treated PD population was assessed to better understand these comorbidities in the PD population. One objective of the study is to identify a population of prevalent PD patients with incident levodopa use within the years 2004-2010 on the Integrated Health Care Information Services (IHCIS) database. The second objective is to report the incidence of CV events overall and during intervals 0-6, 6-12 and 12-18 months after first prescription of levodopa among all new levodopa users.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Individuals with one or more prescriptions of levodopa between 1st July 2004 and 30th June 2010
• Individuals on the database with medical and pharmacy benefit for at least 6 months prior to date of first prescription of levodopa
• Individuals with one or more diagnosis codes for Parkinson's disease within the 6 months prior or 6 months post first prescription of levodopa

Exclusion Criteria

• Individuals less than 20 years of age on date of first prescription of levodopa
• Individuals previously prescribed levodopa prior to study period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
New levodopa users	levodopa	Individuals with one or more prescriptions of levodopa between 1st July 2004 and 30th June 2010 but no previous levodopa prescriptions prior to study period

Primary Outcome Measures

Name	Time	Method
Occurrence of CV events during first 6 months	0-6 months after first prescription of levodopa
Occurrence of CV events during third 6 months	12-18 months after first prescription of levodopa
Overall occurrence of CV events	0-18 months overall after first prescription of levodopa
Occurrence of CV events during second 6 months	6-12 months after first prescription of levodopa