Trial Outcomes & Findings for Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan (NCT NCT01323998)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

35032 participants

Primary outcome timeframe

4 years

Results posted on

2017-07-06

Participant Flow

Participants were neither recruited nor enrolled in this retrospective observational study. Data from medical records or insurance claims databases were anonymized.

Participant milestones

Participant milestones
Measure	Alpha-blocker (AB) Monotherapy Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 milligram (mg), or a procedure code for prostate surgery	5 Alpha Reductase Inhibitor (5ARI) Monotherapy Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	AB Plus 5ARI Combination Therapy, Early 5ARI Starters Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	5ARI Plus AB Combination Therapy Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
Overall Study STARTED	200631	18681	10294	12052	6735
Overall Study COMPLETED	200631	18681	10294	12052	6735
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alpha-blocker (AB) Monotherapy n=200631 Participants Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	5 Alpha Reductase Inhibitor (5ARI) Monotherapy n=18681 Participants Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	AB Plus 5ARI Combination Therapy, Early 5ARI Starters n=10294 Participants Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters n=12052 Participants Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	5ARI Plus AB Combination Therapy n=6735 Participants Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery	Total n=248393 Participants Total of all reporting groups
Age, Continuous	67.2 Years STANDARD_DEVIATION 10.4 • n=5 Participants	67.6 Years STANDARD_DEVIATION 10.4 • n=7 Participants	68.8 Years STANDARD_DEVIATION 10.3 • n=5 Participants	68.0 Years STANDARD_DEVIATION 10.1 • n=4 Participants	68.9 Years STANDARD_DEVIATION 10.1 • n=21 Participants	67.4 Years STANDARD_DEVIATION 10.4 • n=10 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Sex: Female, Male Male	200631 Participants n=5 Participants	18681 Participants n=7 Participants	10294 Participants n=5 Participants	12052 Participants n=4 Participants	6735 Participants n=21 Participants	248393 Participants n=10 Participants

PRIMARY outcome

Timeframe: 4 years

Population: Males aged 50 and older with a new pharmacy claim for AB, 5ARI or a combination of both. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 milligram, or a procedure code for prostate surgery.

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.