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

14. April 2014 aktualisiert von: 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

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

does not involve random selection

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

22014

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Cabergoline Prescriptions by Database and Indication: Year 1
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2010

Primärer Abschluss (Tatsächlich)

1. Februar 2013

Studienabschluss (Tatsächlich)

1. Februar 2013

Studienanmeldedaten

Zuerst eingereicht

9. Dezember 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Januar 2011

Zuerst gepostet (Schätzen)

5. Januar 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

2. Mai 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. April 2014

Zuletzt verifiziert

1. Februar 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • A7231030

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