Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE) (SUCRE)
14 de abril de 2014 actualizado por: Pfizer
Study on Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)
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
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
does not involve random selection
Tipo de estudio
De observación
Inscripción (Actual)
22014
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Cabergoline users
cohort of patients, who are treated with cabergoline during the study period ( from January 1st, 2006 to July 1st 2012)
|
non interventional study - usage as per usual care
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 1
Periodo de tiempo: Year 1 (Year 2006)
|
Cabergoline prescriptions were stratified by indications per year.
Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
|
Year 1 (Year 2006)
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 2
Periodo de tiempo: Year 2 (Year 2007)
|
Cabergoline prescriptions were stratified by indications per year.
Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
|
Year 2 (Year 2007)
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 3
Periodo de tiempo: Year 3 (Year 2008)
|
Cabergoline prescriptions were stratified by indications per year.
Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
|
Year 3 (Year 2008)
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 4
Periodo de tiempo: Year 4 (Year 2009)
|
Cabergoline prescriptions were stratified by indications per year.
Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
|
Year 4 (Year 2009)
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 5
Periodo de tiempo: Year 5 (Year 2010)
|
Cabergoline prescriptions were stratified by indications per year.
Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
|
Year 5 (Year 2010)
|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 6
Periodo de tiempo: Year 6 (Year 2011)
|
Cabergoline prescriptions were stratified by indications per year.
Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
|
Year 6 (Year 2011)
|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1
Periodo de tiempo: Year 1 (Year 2006)
|
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy.
Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy.
Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
|
Year 1 (Year 2006)
|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2
Periodo de tiempo: Year 2 (Year 2007)
|
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy.
Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy.
Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
|
Year 2 (Year 2007)
|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3
Periodo de tiempo: Year 3 (Year 2008)
|
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy.
Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy.
Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
|
Year 3 (Year 2008)
|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4
Periodo de tiempo: Year 4 (Year 2009)
|
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy.
Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy.
Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
|
Year 4 (Year 2009)
|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5
Periodo de tiempo: Year 5 (Year 2010)
|
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy.
Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy.
Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
|
Year 5 (Year 2010)
|
|
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6
Periodo de tiempo: Year 6 (Year 2011)
|
Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson's disease only in participants who have already taken or cannot take other treatments, that is as second line therapy.
Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy.
Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
|
Year 6 (Year 2011)
|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1
Periodo de tiempo: Year 1 (Year 2006)
|
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day.
To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
|
Year 1 (Year 2006)
|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2
Periodo de tiempo: Year 2 (Year 2007)
|
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day.
To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
|
Year 2 (Year 2007)
|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3
Periodo de tiempo: Year 3 (Year 2008)
|
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day.
To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
|
Year 3 (Year 2008)
|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4
Periodo de tiempo: Year 4 (Year 2009)
|
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day.
To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
|
Year 4 (Year 2009)
|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5
Periodo de tiempo: Year 5 (Year 2010)
|
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day.
To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
|
Year 5 (Year 2010)
|
|
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6
Periodo de tiempo: Year 6 (Year 2011)
|
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day.
To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
|
Year 6 (Year 2011)
|
|
Total Number of Echocardiography Examinations in Cabergoline Users
Periodo de tiempo: Baseline (Week 1) up to Week 339
|
The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment.
To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography.
|
Baseline (Week 1) up to Week 339
|
|
Incidence of Valvular Fibrosis
Periodo de tiempo: Baseline (Week 1) up to Week 339
|
Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment.
Percentage of participants with valvular fibrosis are reported.
|
Baseline (Week 1) up to Week 339
|
|
Prevalence of Valvular Fibrosis
Periodo de tiempo: Baseline (Week 1) up to Week 339
|
Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination.
Percentage of participants with valvular fibrosis are reported.
|
Baseline (Week 1) up to Week 339
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2010
Finalización primaria (Actual)
1 de febrero de 2013
Finalización del estudio (Actual)
1 de febrero de 2013
Fechas de registro del estudio
Enviado por primera vez
9 de diciembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
4 de enero de 2011
Publicado por primera vez (Estimar)
5 de enero de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
2 de mayo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
14 de abril de 2014
Última verificación
1 de febrero de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades del sistema endocrino
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Trastornos del movimiento
- Sinucleinopatías
- Enfermedades neurodegenerativas
- Enfermedades hipotalámicas
- Hiperpituitarismo
- Enfermedades de la pituitaria
- Enfermedad de Parkinson
- Hiperprolactinemia
Otros números de identificación del estudio
- A7231030
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