Cardiovascular Events in Parkinson's Disease Patients

NCT01545856 | Completed

• 2 other identifiers: 116493WEUKBRE5922
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Event; Parkinson Disease

Keywords

Parkinson's Disease; cardiovascular events; Levodopa

Outcome Measures

Primary Outcomes (4)

• Occurrence of CV events during first 6 months

  0-6 months after first prescription of levodopa

• Occurrence of CV events during second 6 months

  6-12 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

Study Arms (1)

New levodopa users

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

Drug: levodopa

Interventions

levodopa DRUG

levodopa use

New levodopa users

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study cohorts of interest will be identified from the most recent datacut of the IHCIS database. Individuals with one or more prescriptions of levodopa between 1st July 2004 and 30th June 2010 will be included. The date of the first prescription of levodopa in the study time period is defined as the INDEX DATE. All individuals must be on the database with medical and pharmacy benefit for at least 6 months prior to the INDEX DATE. All individuals must have one or more diagnosis codes for Parkinson's disease within the 6 months prior or 6 months post INDEX DATE. Individuals will be excluded if age is \<20 years on the INDEX date. Individuals will also be excluded if they have a previous levodopa prescription prior to the INDEX date as only new users of levodopa are of interest.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: March 7, 2012
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 16, 2017

Record last verified: 2017-05