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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01332435

First Posted: April 11, 2011

Last Update Posted: June 27, 2017

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Information provided by (Responsible Party):

GlaxoSmithKline

Purpose

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).

Condition	Intervention
Prostatic Hyperplasia	Drug: 5ARI + AB


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Dutasteride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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).


Enrollment:	6896
Study Start Date:	November 2009
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Early 5ARI Initiation Patients with EP receiving combination therapy (AB + 5ARI) with early initiation of 5ARI (within 30 days of initiation of AB)	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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

This study aims to identify eligible patient data between July 1, 2000, and December 31, 2006, and allows for patient data to be followed for 6 months prior to and up to 1 year following index prescription date.

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01332435 History of Changes
Other Study ID Numbers:	113984
First Submitted:	April 7, 2011
First Posted:	April 11, 2011
Results First Submitted:	April 14, 2011
Results First Posted:	July 22, 2011
Last Update Posted:	June 27, 2017
Last Verified:	June 2017

Keywords provided by GlaxoSmithKline:


Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, early, costs

Additional relevant MeSH terms:


Hyperplasia Prostatic Hyperplasia Pathologic Processes Prostatic Diseases Genital Diseases, Male Dutasteride 5-alpha Reductase Inhibitors	Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

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