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Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE) (SUCRE)

14 avril 2014 mis à jour par: 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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

does not involve random selection

Type d'étude

Observationnel

Inscription (Réel)

22014

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Cabergoline users
cohort of patients, who are treated with cabergoline during the study period ( from January 1st, 2006 to July 1st 2012)
Médicament: Study Drug
non interventional study - usage as per usual care

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Cabergoline Prescriptions by Database and Indication: Year 1
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Pfizer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 novembre 2010

Achèvement primaire (Réel)

1 février 2013

Achèvement de l'étude (Réel)

1 février 2013

Dates d'inscription aux études

Première soumission

9 décembre 2010

Première soumission répondant aux critères de contrôle qualité

4 janvier 2011

Première publication (Estimation)

5 janvier 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

2 mai 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 avril 2014

Dernière vérification

1 février 2014

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • A7231030

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