Prostatic Hyperplasia
Conditions
Keywords
Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, early, costs
Brief summary
This retrospective study aims to assess the economic impact of early initiation of 5-alpha-reductase inhibitor (5ARI) therapy in patients with enlarged prostate (EP) receiving 5ARI and alpha-blocker (AB) combination therapy. Both the Integrated Health Care Information Solutions and PharMetrics databases will be utilized for this study (2000-2007).
Interventions
DRUG5ARI + AB
5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin
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 patients aged 50 years or older * a medical claim of EP * a prescription claim for a 5ARI and AB (provided both are within 180 days of index date) * continuously eligible for 6 months prior to and at least 12 months after index prescription date.
Exclusion criteria
* diagnosis of prostate or bladder cancer * any prostate-related surgical procedure within 5 months of index date * prescription claim for finasteride indicative of male pattern baldness * 5ARI therapy initiated prior to initiating AB therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Progression | Day 1 of a 1-day study | Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes. |
| Number of Participants With Acute Urinary Retention | Day 1 of a 1-day study | Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes. |
| Number of Participants Who Needed Prostate-Related Surgery | Day 1 of a 1-day study | Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BPH-related Medical Costs | Day 1 of a 1-day study | Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx). |
| BPH-related Pharmacy Costs | Day 1 of a 1-day study | Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx). |
| Total BPH-related Costs | Day 1 of a 1-day study | All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IHCIS; Early 5ARI Initiation Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI \[dutasteride and finasteride\]) within 30 days of an alpha-blocker (AB \[doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin\]). | 1,572 |
| IHCIS; Late 5ARI Initiation Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). | 1,064 |
| PharMetrics; Early 5ARI Initiation Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). | 2,604 |
| PharMetrics; Late 5ARI Initiation Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) \> 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin). | 1,656 |
| Total | 6,896 |
Baseline characteristics
| Characteristic | Total | IHCIS; Early 5ARI Initiation | IHCIS; Late 5ARI Initiation | PharMetrics; Early 5ARI Initiation | PharMetrics; Late 5ARI Initiation |
|---|---|---|---|---|---|
| Age, Customized <50 years old | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >=50 years old | 6896 Participants | 1572 Participants | 1064 Participants | 2604 Participants | 1656 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6896 Participants | 1572 Participants | 1064 Participants | 2604 Participants | 1656 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants Who Needed Prostate-Related Surgery
Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.
Time frame: Day 1 of a 1-day study
Population: Enrolled Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IHCIS; Early 5ARI Initiation | Number of Participants Who Needed Prostate-Related Surgery | 75 participants |
| IHCIS; Late 5ARI Initiation | Number of Participants Who Needed Prostate-Related Surgery | 101 participants |
| PharMetrics; Early 5ARI Initiation | Number of Participants Who Needed Prostate-Related Surgery | 130 participants |
| PharMetrics; Late 5ARI Initiation | Number of Participants Who Needed Prostate-Related Surgery | 104 participants |
p-value: <0.001Chi-squared
p-value: 0.0699Chi-squared
Primary
Number of Participants With Acute Urinary Retention
Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.
Time frame: Day 1 of a 1-day study
Population: Enrolled Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IHCIS; Early 5ARI Initiation | Number of Participants With Acute Urinary Retention | 127 participants |
| IHCIS; Late 5ARI Initiation | Number of Participants With Acute Urinary Retention | 140 participants |
| PharMetrics; Early 5ARI Initiation | Number of Participants With Acute Urinary Retention | 182 participants |
| PharMetrics; Late 5ARI Initiation | Number of Participants With Acute Urinary Retention | 166 participants |
p-value: <0.001Chi-squared
p-value: 0.0006Chi-squared
Primary
Number of Participants With Clinical Progression
Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes.
Time frame: Day 1 of a 1-day study
Population: Enrolled Population: Men aged \>=50 years old between 7/1/2000 and 12/31/2006 with a diagnosis of benign prostatic hyperplasia and who were treated with an AB and concomitant 5-ARI therapy within 6 months of starting AB therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IHCIS; Early 5ARI Initiation | Number of Participants With Clinical Progression | 176 participants |
| IHCIS; Late 5ARI Initiation | Number of Participants With Clinical Progression | 202 participants |
| PharMetrics; Early 5ARI Initiation | Number of Participants With Clinical Progression | 266 participants |
| PharMetrics; Late 5ARI Initiation | Number of Participants With Clinical Progression | 232 participants |
p-value: <0.001Chi-squared
p-value: 0.0002Chi-squared
Secondary
BPH-related Medical Costs
Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
Time frame: Day 1 of a 1-day study
Population: Enrolled Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IHCIS; Early 5ARI Initiation | BPH-related Medical Costs | 349 United States dollars | Standard Deviation 1535 |
| IHCIS; Late 5ARI Initiation | BPH-related Medical Costs | 618 United States dollars | Standard Deviation 1812 |
| PharMetrics; Early 5ARI Initiation | BPH-related Medical Costs | 344 United States dollars | Standard Deviation 1458 |
| PharMetrics; Late 5ARI Initiation | BPH-related Medical Costs | 449 United States dollars | Standard Deviation 2001 |
p-value: <0.001Regression, Linear
p-value: <0.001Regression, Linear
Secondary
BPH-related Pharmacy Costs
Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
Time frame: Day 1 of a 1-day study
Population: Enrolled Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IHCIS; Early 5ARI Initiation | BPH-related Pharmacy Costs | 1068 United States dollars | Standard Deviation 645 |
| IHCIS; Late 5ARI Initiation | BPH-related Pharmacy Costs | 1417 United States dollars | Standard Deviation 1670 |
| PharMetrics; Early 5ARI Initiation | BPH-related Pharmacy Costs | 1392 United States dollars | Standard Deviation 851 |
| PharMetrics; Late 5ARI Initiation | BPH-related Pharmacy Costs | 1237 United States dollars | Standard Deviation 733 |
Secondary
Total BPH-related Costs
All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).
Time frame: Day 1 of a 1-day study
Population: Enrolled Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IHCIS; Early 5ARI Initiation | Total BPH-related Costs | 1417 United States dollars | Standard Deviation 1670 |
| IHCIS; Late 5ARI Initiation | Total BPH-related Costs | 1606 United States dollars | Standard Deviation 1878 |
| PharMetrics; Early 5ARI Initiation | Total BPH-related Costs | 1735 United States dollars | Standard Deviation 1687 |
| PharMetrics; Late 5ARI Initiation | Total BPH-related Costs | 1686 United States dollars | Standard Deviation 2098 |
p-value: <0.001Regression, Linear
p-value: 0.8645Regression, Linear