Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use

Prostatic Hyperplasia Clinical Trial

Official title:

Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332435
• Other study ID #: 113984
• Status: Completed
• Phase: N/A
• First received: April 7, 2011
• Last updated: August 4, 2011
• Start date: November 2009
• Est. completion date: January 2010

Study information

• Verified date: August 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

Clinical Trial Summary

This retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information Solutions and PharMetrics databases will be utilized for this study (2000-2007).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6896
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• 5ARI + AB
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinical Progression	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.	Day 1 of a 1-day study	No
Primary	Number of Participants With Acute Urinary Retention	Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.	Day 1 of a 1-day study	No
Primary	Number of Participants Who Needed Prostate-Related Surgery	Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.	Day 1 of a 1-day study	No
Secondary	Total BPH-related Costs	All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).	Day 1 of a 1-day study	No
Secondary	BPH-related Medical Costs	Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).	Day 1 of a 1-day study	No
Secondary	BPH-related Pharmacy Costs	Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).	Day 1 of a 1-day study	No