Clinical trial NCT01270711: Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)
Official title: Study on Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Hyperprolactinemia
Keywords: compliance study
effectiveness study
hyperprolactinemia
Parkinson's disease
retrospective cohort study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-01-05
Enrollment: 22014
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of patients, who are treated with cabergoline during the study period. This cohort will be divided in new users and prevalent users based on when cabergoline was started. New (incident) users will be all persons who have a first prescription for cabergoline after the date that the change in SPC was made. Prevalent users will be all cohort members who received a cabergoline prescription during the study period but who had also been using cabergoline prior to the change in SPC.

Brief summary: The overall goal of this study will be to assess and monitor the adherence to and effectiveness of the new prescribing guidelines for cabergoline.

Specific objectives will be to assess: 1. The indication for use of cabergoline (Parkinson, hyperprolactinemia, other) 2. Prior treatment strategies in patients who start cabergoline treatment for Parkinson's Disease 3. The percentage of cabergoline users who are prescribed doses above 3 mg per day 4. Whether cabergoline users are monitored by echocardiography prior and during treatment. 5. The incidence and prevalence of valvular fibrosis

Detailed description: does not involve random selection

Eligibility criteria: Inclusion Criteria:

* Treated with cabergoline during the study period (January 1st, 2006 and will end on July 1st 2012) and identified in one of 6 databases: The Health Information Network, Health Search Database, Integrated Primary Care Information database, PHARMO, Aarhus hospital databases, and the Universitaet Bremen - Bremen Institute for Prevention

Exclusion Criteria:

* Patients with eligibility dates that start after July 1st 2007 (meaning that they would have less than one year of valid data before publication of the results of the EMEA review), will be excluded as well as patients whose eligibility ends before July 1st 2008 (date of SmPC changes).

Primary outcomes:
measure: Number of Cabergoline Prescriptions by Database and Indication: Year 1
timeFrame: Year 1 (Year 2006)
measure: Number of Cabergoline Prescriptions by Database and Indication: Year 2
timeFrame: Year 2 (Year 2007)
measure: Number of Cabergoline Prescriptions by Database and Indication: Year 3
timeFrame: Year 3 (Year 2008)
measure: Number of Cabergoline Prescriptions by Database and Indication: Year 4
timeFrame: Year 4 (Year 2009)
measure: Number of Cabergoline Prescriptions by Database and Indication: Year 5
timeFrame: Year 5 (Year 2010)
measure: Number of Cabergoline Prescriptions by Database and Indication: Year 6
timeFrame: Year 6 (Year 2011)
measure: Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1
timeFrame: Year 1 (Year 2006)
measure: Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2
timeFrame: Year 2 (Year 2007)
measure: Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3
timeFrame: Year 3 (Year 2008)
measure: Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4
timeFrame: Year 4 (Year 2009)
measure: Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5
timeFrame: Year 5 (Year 2010)
measure: Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6
timeFrame: Year 6 (Year 2011)
measure: Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1
timeFrame: Year 1 (Year 2006)
measure: Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2
timeFrame: Year 2 (Year 2007)
measure: Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3
timeFrame: Year 3 (Year 2008)
measure: Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4
timeFrame: Year 4 (Year 2009)
measure: Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5
timeFrame: Year 5 (Year 2010)
measure: Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6
timeFrame: Year 6 (Year 2011)
measure: Total Number of Echocardiography Examinations in Cabergoline Users
timeFrame: Baseline (Week 1) up to Week 339
measure: Incidence of Valvular Fibrosis
timeFrame: Baseline (Week 1) up to Week 339
measure: Prevalence of Valvular Fibrosis
timeFrame: Baseline (Week 1) up to Week 339
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: