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

NCT01332435 | Completed Results

• 1 other identifier: 113984
• Study Type: observational
• Target: 6,896
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Prostatic Hyperplasia

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (3)

• Total BPH-related Costs

  Day 1 of a 1-day study

• BPH-related Medical Costs

  Day 1 of a 1-day study

• BPH-related Pharmacy Costs

  Day 1 of a 1-day study

Study Arms (2)

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

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

Interventions

5ARI + AB DRUG

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

Early 5ARI Initiation; Late 5ARI Initiation

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• ARI therapy initiated prior to initiating AB therapy

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: November 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: June 27, 2017
• Results First Posted: July 22, 2011

Record last verified: 2017-06