Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

NCT01323998 | Completed Results

• 1 other identifier: 114462
• Study Type: observational
• Target: 35,032
• Locations: 0 countries
• Sites: N/A

Brief Summary

This retrospective study aims to assess treatment patterns within 1 year of initiating BPH treatment, including 5-alpha-reductase inhibitor (5ARI) monotherapy, alpha-blocker (AB) monotherapy, early combination therapy, and delayed combination therapy. The MarketScan database will be utilized for this study (2000-2008)

Conditions

Prostatic Hyperplasia

Keywords

enlarged prostate; Benign prostatic hyperplasia; alpha-blocker; 5-alpha-reductase inhibitor

Outcome Measures

Primary Outcomes (1)

• Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis

  The number of participants treated with alpha-blocker (AB) and 5a lpha reductase inhibitor (5ARI) as monotherapy or in combination reported by the presence or absence of a diagnosis code for BPH (International Classification of Disease, Ninth Revision, Clinical Modification codes: 222.2 and 600.xx). Early combination therapy was defined as the addition of 5ARI to existing AB therapy within 30 days of the initial AB pharmacy claim. Delayed combination therapy was defined as the addition of 5ARI to AB therapy after 30 day but within one year of the initial AB pharmacy claim.

  4 years

Study Arms (4)

5ARI monotherapy

Patients with BPH receiving 5ARI monotherapy

Drug: 5ARI

AB monotherapy

Patients with BPH receiving AB monotherapy

Drug: AB

Early combination (5ARI + AB) therapy

Patients receiving early initiation of combination therapy with a 5ARI plus AB. Early initiation defined as starting 5ARI therapy within 30 days of initiating AB therapy

Drug: 5ARI; Drug: AB

Delayed combination (5ARI + AB) therapy

Patients receiving delayed initiation of combination therapy with a 5ARI plus AB. Delayed initiation defined as starting 5ARI therapy more than 30 days but less than 6 months after initiating AB therapy

Drug: 5ARI; Drug: AB

Interventions

5ARI DRUG

Dutasteride or Finasteride

5ARI monotherapy; Delayed combination (5ARI + AB) therapy; Early combination (5ARI + AB) therapy

AB DRUG

Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin

AB monotherapy; Delayed combination (5ARI + AB) therapy; Early combination (5ARI + AB) therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients aged 50 years or older with a diagnostic claim for BPH and at least one prescription claim for a 5ARI or AB in the enrollment period

You may qualify if:

• Male
• aged 50 years or older
• a diagnostic claim for BPH
• at least one prescription claim for a 5ARI or AB in the enrollment period
• continuous eligibility for 6 months prior to and 12 months after index prescription date

You may not qualify if:

• diagnosis of prostate or bladder cancer during the study period
• any prostate-related surgical procedure within 1 month of the index prescription date
• prescription claim for finasteride 1 mg for male pattern baldness during the study period

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: March 24, 2011
• First Posted: March 28, 2011
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 6, 2017
• Results First Posted: February 29, 2012

Record last verified: 2017-06