Prostatic Hyperplasia
Conditions
Keywords
Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, acute urinary retention, surgery, early, costs, benign prostatic hyperplasia
Brief summary
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).
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Progression | 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
| Measure | Time frame | Description |
|---|---|---|
| Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 264 |
| Delayed Cohort Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users) | 68 |
| Total | 332 |
Baseline characteristics
| Characteristic | Early Cohort | Delayed Cohort | Total |
|---|---|---|---|
| Age, Customized <50 years old | 0 participants | 0 participants | 0 participants |
| Age, Customized >=50 years old | 264 participants | 68 participants | 332 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 264 Participants | 68 Participants | 332 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants With Clinical Progression
Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Early Cohort | Number of Participants With Clinical Progression | 14 participants |
| Delayed Cohort | Number of Participants With Clinical Progression | 5 participants |
p-value: 0.012895% CI: [1.297, 8.941]Regression, Cox
Secondary
Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month
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.
Time frame: 3 months prior to and 12 months following index date
Population: Enrolled Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Early Cohort | Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month | 129.14 dollars |
| Delayed Cohort | Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month | 254.51 dollars |
p-value: 0.0002Generalized linear model