Clinical trial NCT01545856: Cardiovascular Events in Parkinson's Disease Patients
Official title: Background Incidence of Cardiovascular Ischaemic Events in Treated Parkinson's Disease Patients in the Impact Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Event
Parkinson Disease
Keywords: Parkinson's Disease
cardiovascular events
Levodopa
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-03-07
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of CV events during first 6 months
timeFrame: 0-6 months after first prescription of levodopa
measure: Occurrence of CV events during second 6 months
timeFrame: 6-12 months after first prescription of levodopa
measure: Occurrence of CV events during third 6 months
timeFrame: 12-18 months after first prescription of levodopa
measure: Overall occurrence of CV events
timeFrame: 0-18 months overall after first prescription of levodopa
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: