Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE) (SUCRE)
14 de abril de 2014 atualizado 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
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
does not involve random selection
Tipo de estudo
Observacional
Inscrição (Real)
22014
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Cabergoline Prescriptions by Database and Indication: Year 1
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
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Patrocinador
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de novembro de 2010
Conclusão Primária (Real)
1 de fevereiro de 2013
Conclusão do estudo (Real)
1 de fevereiro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
9 de dezembro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de janeiro de 2011
Primeira postagem (Estimativa)
5 de janeiro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
2 de maio de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de abril de 2014
Última verificação
1 de fevereiro de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças do Sistema Endócrino
- Distúrbios parkinsonianos
- Doenças dos Gânglios da Base
- Distúrbios do Movimento
- Sinucleinopatias
- Doenças Neurodegenerativas
- Doenças hipotalâmicas
- Hiperpituitarismo
- Doenças da Hipófise
- Doença de Parkinson
- Hiperprolactinemia
Outros números de identificação do estudo
- A7231030
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