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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
does not involve random selection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabergoline users | cohort of patients, who are treated with cabergoline during the study period ( from January 1st, 2006 to July 1st 2012) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Drug | Drug | non interventional study - usage as per usual care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cabergoline Prescriptions by Database and Indication: Year 1 | 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 | 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 | 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 | 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Part 1 assessed adherence (compliance) with prescribing guidelines (PG) by using automated health care data which had information on strength, indication, referrals for echocardiography, recognized reputation in area of drug utilization, safety research. Part 2 assessed effectiveness of PG for cabergoline in participants with Parkinson's disease.
Part 1 recruited participants from North, Middle and South Europe and Part 2 from specialized clinical centers in Italy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aarhus [Part 1] | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. |
| FG001 | HSD [Part 1] | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. |
| FG002 | IPCI [Part 1] | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. |
| FG003 | PHARMO [Part 1] | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. |
| FG004 | THIN [Part 1] | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| FG005 | Cabergoline in Pre-SPC Change Period [Part 2] | Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC. |
| FG006 | Cabergoline in Post- SPC Change Period [Part 2] | Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130). |
| FG007 | Cabergoline in Cross-SPC Change Period [Part 2] | Participants who started cabergoline treatment for Parkinson's disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1: Compliance |
| |||||||||||||
| Part 2: Effectiveness |
|
Study population included all participants who were treated with cabergoline, registered in one of the databases and those recruited from specialized clinical centers in Italy for Parkinson’s disease during the study period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Aarhus [Part 1] | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age is stratified by Part 1 and Part 2, in Part 1 age is further stratified by indication, cabergoline use for prolactin reduction indication (ATC [Anatomical Therapeutic Code] G02CB03) and neurological indication (ATC N04BC06). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Cabergoline Prescriptions by Database and Indication: Year 1 | 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. | Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | prescriptions | Year 1 (Year 2006) |
|
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This retrospective study used participant-level electronic health related databases, in which adverse events (AEs) were not reportable as an individual AE report because an AE data for individual participant was not available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aarhus [Part 1] | Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. |
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Results not reported for Year 2012 (Year 7) since several databases did not contribute data for Year 7 and amount of person-time of follow-up dropped in all databases. Designation of primary and secondary endpoints was based on study team's input.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D006966 | Hyperprolactinemia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| Number of Cabergoline Prescriptions by Database and Indication: Year 6 |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| COMPLETED |
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| NOT COMPLETED |
|
| HSD [Part 1] |
Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. |
| BG002 | IPCI [Part 1] | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. |
| BG003 | PHARMO [Part 1] | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. |
| BG004 | THIN [Part 1] | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
| BG005 | Cabergoline in Pre-SPC Change Period [Part 2] | Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC. |
| BG006 | Cabergoline in Post- SPC Change Period [Part 2] | Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130). |
| BG007 | Cabergoline in Cross-SPC Change Period [Part 2] | Participants who started cabergoline treatment for Parkinson's disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC. |
| BG008 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | HSD [Part 1] | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. |
| OG002 | IPCI [Part 1] | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. |
| OG003 | PHARMO [Part 1] | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. |
| OG004 | THIN [Part 1] | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. |
|
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| Primary | Number of Cabergoline Prescriptions by Database and Indication: Year 2 | 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. | Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | prescriptions | Year 2 (Year 2007) |
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| Primary | Number of Cabergoline Prescriptions by Database and Indication: Year 3 | 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. | Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | prescriptions | Year 3 (Year 2008) |
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| Primary | Number of Cabergoline Prescriptions by Database and Indication: Year 4 | 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. | Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | prescriptions | Year 4 (Year 2009) |
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| Primary | Number of Cabergoline Prescriptions by Database and Indication: Year 5 | 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. | Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | prescriptions | Year 5 (Year 2010) |
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| Primary | Number of Cabergoline Prescriptions by Database and Indication: Year 6 | 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. | Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | prescriptions | Year 6 (Year 2011) |
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| Primary | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1 | 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. | Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Number | percentage of prescriptions | Year 1 (Year 2006) |
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| Primary | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2 | 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. | Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Number | percentage of prescriptions | Year 2 (Year 2007) |
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| Primary | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3 | 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. | Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Number | percentage of prescriptions | Year 3 (Year 2008) |
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| Primary | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4 | 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. | Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Number | percentage of prescriptions | Year 4 (Year 2009) |
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| Primary | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5 | 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. | Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Number | percentage of prescriptions | Year 5 (Year 2010) |
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| Primary | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6 | 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. | Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | Number | percentage of prescriptions | Year 6 (Year 2011) |
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| Primary | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1 | 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. | Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | percentage of prescriptions | Year 1 (Year 2006) |
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| Primary | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2 | 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. | Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | percentage of prescriptions | Year 2 (Year 2007) |
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| Primary | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3 | 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. | Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | percentage of prescriptions | Year 3 (Year 2008) |
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| Primary | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4 | 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. | Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | percentage of prescriptions | Year 4 (Year 2009) |
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| Primary | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5 | 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. | Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | percentage of prescriptions | Year 5 (Year 2010) |
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| Primary | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6 | 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. | Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | percentage of prescriptions | Year 6 (Year 2011) |
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| Primary | Total Number of Echocardiography Examinations in Cabergoline Users | 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. | Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson's disease during the study period. | Posted | Number | echocardiography examinations | Baseline (Week 1) up to Week 339 |
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| Primary | Incidence of Valvular Fibrosis | 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. | Study population:all participants recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson's disease during study period. | Posted | Number | percentage of participants | Baseline (Week 1) up to Week 339 |
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| Primary | Prevalence of Valvular Fibrosis | 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. | Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson's disease during the study period. | Posted | Number | percentage of participants | Baseline (Week 1) up to Week 339 |
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| EG001 | HSD [Part 1] | Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | 0 | 0 | 0 | 0 |
| EG002 | IPCI [Part 1] | Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | 0 | 0 | 0 | 0 |
| EG003 | PHARMO [Part 1] | Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | 0 | 0 | 0 | 0 |
| EG004 | THIN [Part 1] | Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. | 0 | 0 | 0 | 0 |
| EG005 | Cabergoline in Pre-SPC Change Period [Part 2] | Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC. | 0 | 0 | 0 | 0 |
| EG006 | Cabergoline in Post- SPC Change Period [Part 2] | Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130). | 0 | 0 | 0 | 0 |
| EG007 | Cabergoline in Cross-SPC Change Period [Part 2] | Participants who started cabergoline treatment for Parkinson's disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC. | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D004700 | Endocrine System Diseases |
| N04BC06 |
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| N04BC06 |
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| N04BC06 |
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| N04BC06 |
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| N04BC06 |
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