Prostatic Hyperplasia
Conditions
Keywords
Enlarged prostate, 5-alpha-reductase inhibitor, alpha-blocker, adherence
Brief summary
Patient-based surveys will be conducted to evaluate the drivers of medication adherence in patients treated with either 5-alpha-reductase inhibitor (5ARI) therapy, alpha-blocker (AB) therapy, or combination therapy for enlarged prostate (EP). Adherence with EP therapy will be evaluated. The researchers believe that the majority of participants will report that they are compliant with therapy. The data source is a cross-sectional patient survey administered at one time point.
Interventions
DRUG5ARI or AB or Combination Therapy (5ARI + AB)
5ARI: Dutasteride or Finasteride; AB: Doxazosin, Silodosin, Tamsulosin, Terazosin, or Alfuzosin
Sponsors
GlaxoSmithKline
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males * Aged 50 years or older * Residents of the United States * Receiving a prescription for an enlarged prostate (EP) treatment within 12 months prior to survey initiation
Exclusion criteria
* Patients with prostate cancer * no health/prescription insurance * patients receiving medication(s) for EP on a PRN basis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Compliance With Medication | Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010) | Compliance was calculated based on the participant's response to the following question: In general, how many times did you miss taking your prostate medication? Responses were measured on a 5-point scale. Participants who answered I never miss a dose of my medication were considered compliant. All other responses were considered non-compliant. |
Participant flow
Pre-assignment details
Participants were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a participant cohort. All diagnoses and treatment are recorded in the course of routine medical practice.
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Participants Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker \[AB\], 5-alpha reductase inhibitor \[5-ARI\], combination therapy) | 400 |
| Total | 400 |
Baseline characteristics
| Characteristic | All Enrolled Participants |
|---|---|
| Age, Customized at least 50 years old | 400 Participants |
| Age, Customized less than 50 years old | 0 Participants |
| Race/Ethnicity, Customized African American | 2 participants |
| Race/Ethnicity, Customized Caucasian | 391 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants |
| Race/Ethnicity, Customized Other | 6 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 400 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Participants Reporting Compliance With Medication
Compliance was calculated based on the participant's response to the following question: In general, how many times did you miss taking your prostate medication? Responses were measured on a 5-point scale. Participants who answered I never miss a dose of my medication were considered compliant. All other responses were considered non-compliant.
Time frame: Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)
Population: All enrolled participants taking 5-alpha reductase inhibitors and/or alpha blockers
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Enrolled Participants | Number of Participants Reporting Compliance With Medication | Compliant | 239 participants |
| All Enrolled Participants | Number of Participants Reporting Compliance With Medication | Non-Compliant | 161 participants |