Prostatic Hyperplasia
Conditions
Keywords
5-alpha-reductase inhibitor, prostate surgery, alpha-blocker, enlarged prostate, acute urinary retention, Benign prostatic hyperplasia
Brief summary
This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized for this study (2000-2008).
Interventions
DRUG5ARI + AB
5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, 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 * aged 50 years or older * diagnostic claim for BPH * prescription claim for an AB and a 5ARI in the observation period (5ARI must occur within a 6-month window after the AB). * continuously eligible for 6 months prior to and 12 months after index prescription date
Exclusion criteria
* prostate or bladder cancer during the study period * any prostate-related surgical procedure within 5 months of the index prescription date * prescription claim for finasteride 1 mg for male pattern baldness during the study period * 5ARI therapy prior to initiation of AB therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Progression of Disease | Up to 5 months | The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | 6 months |
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 |
|---|---|
| Early Treatment Participants who started 5ARI therapy within 30 days of initiating AB treatment | 5,554 |
| Delayed Treatment Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment | 3,063 |
| Total | 8,617 |
Baseline characteristics
| Characteristic | Total | Early Treatment | Delayed Treatment |
|---|---|---|---|
| Age, Continuous | 68.4 Years STANDARD_DEVIATION 10.2 | 68.7 Years STANDARD_DEVIATION 10.2 | 67.8 Years STANDARD_DEVIATION 10.1 |
| Mean Benign Prostatic Hyperplasia (BPH) Disease Stage Scores | 0.86 scores on a scale STANDARD_DEVIATION 1.07 | 0.90 scores on a scale STANDARD_DEVIATION 1.11 | 0.79 scores on a scale STANDARD_DEVIATION 0.98 |
| Mean Charlson Comorbidity Index Scores | 0.97 scores on a scale STANDARD_DEVIATION 1.56 | 1.03 scores on a scale STANDARD_DEVIATION 1.63 | 0.86 scores on a scale STANDARD_DEVIATION 1.41 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8617 Participants | 5554 Participants | 3063 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 Who Experienced Progression of Disease
The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured.
Time frame: Up to 5 months
Population: Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Treatment | Number of Participants Who Experienced Progression of Disease | Acute Urinary Retention | 589 participants |
| Early Treatment | Number of Participants Who Experienced Progression of Disease | Surgery | 280 participants |
| Early Treatment | Number of Participants Who Experienced Progression of Disease | Emergency Surgery | 86 participants |
| Delayed Treatment | Number of Participants Who Experienced Progression of Disease | Acute Urinary Retention | 393 participants |
| Delayed Treatment | Number of Participants Who Experienced Progression of Disease | Surgery | 212 participants |
| Delayed Treatment | Number of Participants Who Experienced Progression of Disease | Emergency Surgery | 52 participants |
p-value: 0.002Chi-squared
p-value: 0Chi-squared
p-value: 0.597Chi-squared
Secondary
Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery
Time frame: 6 months
Population: Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP). Only those participants who were treated with surgery within 182 days of the first prescription of 5ARI were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | On the same day | 37 participants |
| Early Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Within 1 week | 54 participants |
| Early Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Within 1 month | 85 participants |
| Early Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Within 2 months | 102 participants |
| Early Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Within 3 months | 105 participants |
| Early Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Within 4 months | 105 participants |
| Early Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Within 5 months | 105 participants |
| Early Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Within 6 months (182 days) | 106 participants |
| Delayed Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Within 6 months (182 days) | 68 participants |
| Delayed Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | On the same day | 27 participants |
| Delayed Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Within 3 months | 64 participants |
| Delayed Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Within 1 week | 35 participants |
| Delayed Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Within 5 months | 68 participants |
| Delayed Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Within 1 month | 51 participants |
| Delayed Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Within 4 months | 66 participants |
| Delayed Treatment | Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery | Within 2 months | 60 participants |