Prostatic HyperplasiaNCT01376258
Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database
An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline.
Trial summary
Adherence and length of treatment with a 5-alpha reductase inhibitor (5ARI) therapy may be associated with improved clinical outcomes for patients with enlarged prostates (EP) and lower health care related costs. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- 5ARI
- How many people
- 28,903 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- No healthy volunteers
- Older adult
Study population: The study will include retrospective data from male patients aged 65 years and older with continuous health plan enrollment from July 1, 2003 and June 30, 2009. Patient records will be reviewed for data from the 6-months prior to and 1-year following the index date, which represents the first prescription fill for a 5ARI
Who may be able to join
- Male
- Age 65 or older
- A diagnostic claim of BPH (ICD-9-CM code 222.2x or 600.xx)
- A prescription claim for a 5ARI for at least 60 days during the observation period
- Continuous eligibility for 6 months prior to and at least 91 days after the index date
Who cannot join
- A prostate cancer diagnosis
- A procedure cost for any prostate-related surgical procedure prior to the index date
About this study
Adherence and length of treatment with a 5-alpha reductase inhibitor (5ARI) therapy may be associated with improved clinical outcomes for patients with enlarged prostates (EP) and lower health care related costs.
The objectives of this study are to quantify 1.) the relationship between 5ARI adherence and length of therapy and the likelihood of acute urinary retention (AUR), prostate-related surgery (emergency and non-emergency), and clinical progression (defined as AUR and/or prostate-related surgery); and 2.) the monthly EP-related, medical costs in a Medicaid and Medicare population. The null hypothesis is that no differences will be observed in the outcomes and costs of patients who adhere to long-term 5ARI therapy and those who do not. The test hypothesis is that patients with higher levels of adherence to 5ARI for a longer period of time will experience significantly fewer adverse outcomes and significantly lower treatment costs.
Read more
The data source for this analysis is the MarketScan database, which contains medical and pharmacy claims for commercial health plan members and Medicare recipients. Medical and pharmacy claims data are sourced directly from health plans and employers. The database represents approximately 18 to 20 million individuals annually and nearly 22 million Medicaid enrollees from multiple states. The database includes the Medicare-covered portion of payment, the employer-paid portion, and any out-of-pocket expenses paid by the beneficiary.
The study design is a retrospective cohort analysis. Each patient's index date was defined as the date of the first fill for a 5ARI prescription.
- Conditions
- Prostatic Hyperplasia
- Being tested
- 5ARI
- Keywords
- benign prostatic hyperplasia, acute urinary retention, adherence, 5-alpha reductase inhibitor, enlarged prostate, surgery
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5ARIDrug
Also called Proscar® (finasteride), Avodart® (dutasteride)
dutasteride or finasteride
| Study group | Role | What they receive |
|---|---|---|
| Patients adherent to 5-alpha reductase inhibitor (5ARI) | Patients with benign prostate hyperplasia (BPH) who are adherent (as measured by a medication possession ratio (MPR)) based on 3 MPR threshold values of 70%, 75% and 80% Receives: Drug: 5ARI | |
| Patients who are non-adherent to 5ARI therapy | Patients with BPH who are not adherent to 5ARI therapy as measured by 3 MPR threshold values of 70%, 75%, and 80% Receives: Drug: 5ARI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of patients with a diagnosis code for acute urinary retention (AUR) and/or a procedure code for prostate surgery
AUR and prostate surgery are indicative of clinical progression of enlarged prostate (EP)
Measured: 1 year following the first therapy date or until an event that signifies clinical progression is observed (whichever occurs first)
Secondary outcomes (2)
Adjusted benign prostatic hyperplasia (BPH)-related costs
Differences in cost will be compared across cohorts. BPH-related costs include those associated with ICD-9-CM codes 222.2x or 600.xx
Measured: 1 year following the first therapy date
Medication Possession Ratio (MPR)
A measure of medication adherence (compliance and discontinuation) in patients taking monotherapy versus early combination therapy. Discontinuation is defined as a 30-day gap in therapy
Measured: 1 year following the first therapy date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28,903 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376258
- Sponsor's protocol ID
- 113907
- Status last verified
- May 2017
- First submitted
- 16 Jun 2011
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database
- ClinicalTrials.gov ID
- NCT01376258
- Acronym / sponsor ID
- 113907
- Conditions
- Prostatic Hyperplasia
- Keywords
- benign prostatic hyperplasia, acute urinary retention, adherence, 5-alpha reductase inhibitor, enlarged prostate, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28,903 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adherence and length of treatment with a 5-alpha reductase inhibitor (5ARI) therapy may be associated with improved clinical outcomes for patients with enlarged prostates (EP) and lower health care related costs.
The objectives of this study are to quantify 1.) the relationship between 5ARI adherence and length of therapy and the likelihood of acute urinary retention (AUR), prostate-related surgery (emergency and non-emergency), and clinical progression (defined as AUR and/or prostate-related surgery); and 2.) the monthly EP-related, medical costs in a Medicaid and Medicare population. The null hypothesis is that no differences will be observed in the outcomes and costs of patients who adhere to long-term 5ARI therapy and those who do not. The test hypothesis is that patients with higher levels of adherence to 5ARI for a longer period of time will experience significantly fewer adverse outcomes and significantly lower treatment costs.
The data source for this analysis is the MarketScan database, which contains medical and pharmacy claims for commercial health plan members and Medicare recipients. Medical and pharmacy claims data are sourced directly from health plans and employers. The database represents approximately 18 to 20 million individuals annually and nearly 22 million Medicaid enrollees from multiple states. The database includes the Medicare-covered portion of payment, the employer-paid portion, and any out-of-pocket expenses paid by the beneficiary.
The study design is a retrospective cohort analysis. Each patient's index date was defined as the date of the first fill for a 5ARI prescription.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients adherent to 5-alpha reductase inhibitor (5ARI) | – | Drug: 5ARIPatients with benign prostate hyperplasia (BPH) who are adherent (as measured by a medication possession ratio (MPR)) based on 3 MPR threshold values of 70%, 75% and 80% |
| Patients who are non-adherent to 5ARI therapy | – | Drug: 5ARIPatients with BPH who are not adherent to 5ARI therapy as measured by 3 MPR threshold values of 70%, 75%, and 80% |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study will include retrospective data from male patients aged 65 years and older with continuous health plan enrollment from July 1, 2003 and June 30, 2009. Patient records will be reviewed for data from the 6-months prior to and 1-year following the index date, which represents the first prescription fill for a 5ARI
Key inclusion criteria (5 listed)
- Male
- Age 65 or older
- A diagnostic claim of BPH (ICD-9-CM code 222.2x or 600.xx)
- A prescription claim for a 5ARI for at least 60 days during the observation period
- Continuous eligibility for 6 months prior to and at least 91 days after the index date
Key exclusion criteria (2 listed)
- A prostate cancer diagnosis
- A procedure cost for any prostate-related surgical procedure prior to the index date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5ARIAlso: Proscar® (finasteride), Avodart® (dutasteride)dutasteride or finasteride | Drug | Patients adherent to 5-alpha reductase inhibitor (5ARI), Patients who are non-adherent to 5ARI therapy |
Primary outcome
Mean number of patients with a diagnosis code for acute urinary retention (AUR) and/or a procedure code for prostate surgery
Time frame: 1 year following the first therapy date or until an event that signifies clinical progression is observed (whichever occurs first)
AUR and prostate surgery are indicative of clinical progression of enlarged prostate (EP)
2 secondary outcomes
Adjusted benign prostatic hyperplasia (BPH)-related costs
Time frame: 1 year following the first therapy date
Medication Possession Ratio (MPR)
Time frame: 1 year following the first therapy date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of patients with a diagnosis code for acute urinary retention (AUR) and/or a procedure code for prostate surgery (time frame: 1 year following the first therapy date or until an event that signifies clinical progression is observed (whichever occurs first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.