Trial Outcomes & Findings for Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment (NCT NCT01386983)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

332 participants

Primary outcome timeframe

3 months prior to and 12 months following index date

Results posted on

2017-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	Early Cohort Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users \[dutasteride and finasteride\]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB \[doxazosin, tamsulosin, terazosin, and alfuzosin\]) (early combination users)	Delayed Cohort Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
Overall Study STARTED	264	68
Overall Study COMPLETED	264	68
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Early Cohort n=264 Participants Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users \[dutasteride and finasteride\]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB \[doxazosin, tamsulosin, terazosin, and alfuzosin\]) (early combination users)	Delayed Cohort n=68 Participants Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)	Total n=332 Participants Total of all reporting groups
Age, Customized >=50 years old	264 participants n=5 Participants	68 participants n=7 Participants	332 participants n=5 Participants
Age, Customized <50 years old	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	264 Participants n=5 Participants	68 Participants n=7 Participants	332 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months prior to and 12 months following index date

Population: Participants with enlarged prostate during the enrollment period (EP)/pre-index period; treated with AB and 5ARI within 180 days of index date (ID), or 5ARI only, in the EP; and with continuous Health Maintenance Organization enrollment (access to medical/pharmacy services) for at least 3 months prior to and 5 months of ID.

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

Outcome measures

Outcome measures
Measure	Early Cohort n=264 Participants Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users \[dutasteride and finasteride\]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB \[doxazosin, tamsulosin, terazosin, and alfuzosin\]) (early combination users)	Delayed Cohort n=68 Participants Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
Number of Participants With Clinical Progression	14 participants	5 participants

SECONDARY outcome

Timeframe: 3 months prior to and 12 months following index date

Population: Enrolled Population

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.

Outcome measures

Outcome measures
Measure	Early Cohort n=264 Participants Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users \[dutasteride and finasteride\]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB \[doxazosin, tamsulosin, terazosin, and alfuzosin\]) (early combination users)	Delayed Cohort n=68 Participants Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month	129.14 dollars Interval 97.42 to 154.19	254.51 dollars Interval 178.92 to 329.41

Adverse Events

Early Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER