N/A
N=21,953
Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)
Parkinson's Disease · Hyperprolactinemia
Bottom Line
View on ClinicalTrials.gov: NCT01270711 ↗Enrolled (actual)
21,953
Serious AEs
—
Results posted
Mar 2014
Primary outcome: Primary: Number of Cabergoline Prescriptions by Database and Indication: Year 1 — 17; 1782; 6; 293 prescriptions
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Study Drug (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Cabergoline Prescriptions by Database and Indication: Year 1 |
17; 1782; 6; 293; 198; 87 | — |
| PRIMARY Number of Cabergoline Prescriptions by Database and Indication: Year 2 |
1925; 3616; 64; 2698; 3537; 741 | — |
| PRIMARY Number of Cabergoline Prescriptions by Database and Indication: Year 3 |
2098; 3493; 152; 2621; 3556; 507 | — |
| PRIMARY Number of Cabergoline Prescriptions by Database and Indication: Year 4 |
2260; 3629; 226; 2684; 3240; 306 | — |
| PRIMARY Number of Cabergoline Prescriptions by Database and Indication: Year 5 |
2395; 3793; 283; 2752; 3170; 201 | — |
| PRIMARY Number of Cabergoline Prescriptions by Database and Indication: Year 6 |
2286; 3686; 183; 2660; 3212; 141 | — |
| PRIMARY Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1 |
0; 0; 0 | — |
| PRIMARY Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2 |
4; 10; 10 | — |
| PRIMARY Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3 |
20; 39; 23 | — |
| PRIMARY Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4 |
7; 22; 12 | — |
| PRIMARY Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5 |
18; 43; 21 | — |
| PRIMARY Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6 |
11; 67; 0 | — |
| PRIMARY Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1 |
0; 5; 0; 0; 17 | — |
| PRIMARY Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2 |
0.2; 5; 2; 0; 13 | — |
| PRIMARY Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3 |
0; 3; 5; 0; 7 | — |
| PRIMARY Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4 |
0; 2; 1; 0; 5 | — |
| PRIMARY Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5 |
0; 3; 1; 0; 2 | — |
| PRIMARY Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6 |
0; 1; 0; 0; 2 | — |
| PRIMARY Total Number of Echocardiography Examinations in Cabergoline Users |
11; 3; 68 | — |
| PRIMARY Incidence of Valvular Fibrosis |
100; 0; 57.1 | — |
| PRIMARY Prevalence of Valvular Fibrosis |
57.2; 50.0; 55.9 | — |
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
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).
Data sourced from ClinicalTrials.gov (NCT01270711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.