Prostatic Hyperplasia
Conditions
Keywords
enlarged prostate, Benign prostatic hyperplasia, alpha-blocker, 5-alpha-reductase inhibitor
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)
Interventions
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis | 4 years | 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. |
Participant flow
Pre-assignment details
Participants were neither recruited nor enrolled in this retrospective observational study. Data from medical records or insurance claims databases were anonymized.
Participants by arm
| Arm | Count |
|---|---|
| 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 mg, or a procedure code for prostate surgery | 200,631 |
| 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 | 18,681 |
| 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 | 10,294 |
| 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 | 12,052 |
| 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 | 6,735 |
| Total | 248,393 |
Baseline characteristics
| Characteristic | Alpha-blocker (AB) Monotherapy | 5 Alpha Reductase Inhibitor (5ARI) Monotherapy | AB Plus 5ARI Combination Therapy, Early 5ARI Starters | AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters | 5ARI Plus AB Combination Therapy | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 67.2 Years STANDARD_DEVIATION 10.4 | 67.6 Years STANDARD_DEVIATION 10.4 | 68.8 Years STANDARD_DEVIATION 10.3 | 68.0 Years STANDARD_DEVIATION 10.1 | 68.9 Years STANDARD_DEVIATION 10.1 | 67.4 Years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 200631 Participants | 18681 Participants | 10294 Participants | 12052 Participants | 6735 Participants | 248393 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alpha-blocker (AB) Monotherapy | Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis | Participants without a diagnosis code for BPH | 122307 participants |
| Alpha-blocker (AB) Monotherapy | Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis | Participants with a diagnosis code for BPH | 78324 participants |
| 5 Alpha Reductase Inhibitor (5ARI) Monotherapy | Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis | Participants without a diagnosis code for BPH | 9456 participants |
| 5 Alpha Reductase Inhibitor (5ARI) Monotherapy | Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis | Participants with a diagnosis code for BPH | 9225 participants |
| AB Plus 5ARI Combination Therapy, Early 5ARI Starters | Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis | Participants without a diagnosis code for BPH | 3293 participants |
| AB Plus 5ARI Combination Therapy, Early 5ARI Starters | Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis | Participants with a diagnosis code for BPH | 7001 participants |
| AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters | Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis | Participants with a diagnosis code for BPH | 8378 participants |
| AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters | Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis | Participants without a diagnosis code for BPH | 3674 participants |
| 5ARI Plus AB Combination Therapy | Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis | Participants without a diagnosis code for BPH | 2625 participants |
| 5ARI Plus AB Combination Therapy | Number of Participants by Treatment Cohort With and Without a Benign Prostatic Hypertrophy (BPH) Diagnosis | Participants with a diagnosis code for BPH | 4110 participants |