Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use
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ClinicalTrials.gov Identifier: NCT01332435 |
Recruitment Status :
Completed
First Posted : April 11, 2011
Results First Posted : July 22, 2011
Last Update Posted : June 27, 2017
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Condition or disease | Intervention/treatment |
---|---|
Prostatic Hyperplasia | Drug: 5ARI + AB |
Study Type : | Observational |
Actual Enrollment : | 6896 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | January 2010 |

Group/Cohort | Intervention/treatment |
---|---|
Early 5ARI Initiation
Patients with EP receiving combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)
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Drug: 5ARI + AB
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin |
Late 5ARI Initiation
Patients with EP receiving combination therapy (AB + 5ARI) with late initiation of 5ARI (more than 30 days but less than 6 months after initiation of AB)
|
Drug: 5ARI + AB
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin |
- Number of Participants With Clinical Progression [ Time Frame: Day 1 of a 1-day study ]Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes.
- Number of Participants With Acute Urinary Retention [ Time Frame: Day 1 of a 1-day study ]Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.
- Number of Participants Who Needed Prostate-Related Surgery [ Time Frame: Day 1 of a 1-day study ]Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.
- Total BPH-related Costs [ Time Frame: Day 1 of a 1-day study ]All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
- BPH-related Medical Costs [ Time Frame: Day 1 of a 1-day study ]Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
- BPH-related Pharmacy Costs [ Time Frame: Day 1 of a 1-day study ]Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Male patients aged 50 years or older
- a medical claim of EP
- a prescription claim for a 5ARI and AB (provided both are within 180 days of index date)
- continuously eligible for 6 months prior to and at least 12 months after index prescription date.
Exclusion Criteria:
- diagnosis of prostate or bladder cancer
- any prostate-related surgical procedure within 5 months of index date
- prescription claim for finasteride indicative of male pattern baldness
- 5ARI therapy initiated prior to initiating AB therapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332435
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01332435 |
Other Study ID Numbers: |
113984 |
First Posted: | April 11, 2011 Key Record Dates |
Results First Posted: | July 22, 2011 |
Last Update Posted: | June 27, 2017 |
Last Verified: | June 2017 |
Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, early, costs |
Prostatic Hyperplasia Hyperplasia Pathologic Processes Prostatic Diseases |