Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment

This retrospective study aims to assess the clinical and economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI monotherapy or combination therapy with an alpha-blocker (AB) compared to late initiation of 5ARI therapy in patients receiving combination therapy. The Henry Ford Health System databases will be utilized for this study (2000-2008).

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males
aged 50 years or older
medical claim of EP
prescription claim(s) for either a 5ARI or both 5ARI and AB (provided both are within 180 days of index date)
continuously eligible for 3 months prior to and at least 5 months after their index prescription date.

Exclusion criteria

Patients with prostate or bladder cancer
any prostate-related surgical procedure within 5 months of index date
prescription claim for finasteride indicative of male pattern baldness; AB monotherapy only; initiation of 5ARI occurring more than 180 days after initiation of AB

Treatment and study plan

5ARI

Drug

Dutasteride or Finasteride

Other names: Avodart® is a registered trademark of GlaxoSmithKline, Proscar® is a registered trademark of Merck

5ARI + AB

Drug

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

Other names: Proscar® is a registered trademark of Merck, Hytrin® is a registered trademark of Abbott Laboratories, Flomax® is a registered trademark of Astellas Pharma, Avodart® is a registered trademark of GlaxoSmithKline, Cardura® is a registered trademark of Pfizer Inc, Uroxatral® is a registered trademark of Sanofi-Aventis

Primary outcomes

Number of Participants With Clinical Progression

Time frame: 3 months prior to and 12 months following index date

Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.

Secondary outcomes

Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month

Time frame: 3 months prior to and 12 months following index date

EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jul 1, 2011
Registry last updated: May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed