Cardiovascular Diseases, Erectile Dysfunction, Male Urogenital Diseases
Conditions
Keywords
erectile dysfunction, phosphodiesterase inhibitor, cardiovascular diseases
Brief summary
Erectile dysfunction (ED) has been identified as an independent risk factor for existing cardiovascular disease, preceding a major cardiovascular event by an average of about 5 years. Are men prescribed a PDE5 inhibitor for ED more likely to have a new diagnosis of underlying medical conditions compared to men of a similar age not receiving PDE5 inhibitor treatment?
Interventions
OTHERno intervention
non-interventional study
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Records of men aged \>18 years with an index PDE5 inhibitor (sildenafil, tadalafil or vardenafil) prescription between January 1st, 1999, and June 30th, 2008 * no prior PDE5 inhibitor prescription before the index prescription * continuous enrolment with medical history for ≥60 months prior to the index prescription date
Exclusion criteria
* Records of female subjects and any male subjects not meeting the inclusion criteria will be excluded * A subject can only be selected once independent of the assignment to the target or the control populations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period | Up to 3 years (Early study period - January 1999 to December 2001) | Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. |
| Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91 | Day 0 to Day 91 post index prescription | New diagnosis of underlying condition at prescription was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. |
| Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription | Day -92 up to Day -1 of index prescription | New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. |
| Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription | Day 366 up to Day 457 post index prescription | New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. |
| Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription | Day -92 up to Day -1 of index prescription | Underlying conditions were defined as any diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period | Up to 2 years (End of study period - July 2006 to June 2008) | Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. |
| Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period | Up to 2 years (End of study period - July 2006 to June 2008) | New diagnosis of underlying condition at PDE5i establishment was defined as any new diagnosis of interest between day 0 (index prescription) and day 91 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two-years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. |
| Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period | Up to 3 years (Early study period - January 1999 to December 2001) | New diagnosis of underlying condition at PDE5i market introduction was defined as any new diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Index PDE5i Prescription Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population). | 24,708 |
| Control (Without PDE5i Prescription) Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population). | 74,124 |
| Total | 98,832 |
Baseline characteristics
| Characteristic | Index PDE5i Prescription | Control (Without PDE5i Prescription) | Total |
|---|---|---|---|
| Age, Continuous | 59.0 Years | 59.0 Years | 59.0 Years |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 24708 Participants | 74124 Participants | 98832 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
Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91
New diagnosis of underlying condition at prescription was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.
Time frame: Day 0 to Day 91 post index prescription
Population: Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population) and age-matched participants without any PDE5i prescription during the study period (control population). Last observation carried forward method was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Index PDE5i Prescription | Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91 | 11.53 Percentage of participants |
| Control (Without PDE5i Prescription) | Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91 | 7.49 Percentage of participants |
Comparison: Chi-square test was used to calculate p-value.p-value: <0.001Chi-squared
Primary
Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription
New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.
Time frame: Day 366 up to Day 457 post index prescription
Population: Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Index PDE5i Prescription | Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription | 5.65 Percentage of participants |
Primary
Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription
New diagnosis of underlying condition was defined as any new diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.
Time frame: Day -92 up to Day -1 of index prescription
Population: Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Index PDE5i Prescription | Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription | 11.08 Percentage of participants |
Primary
Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period
Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.
Time frame: Up to 3 years (Early study period - January 1999 to December 2001)
Population: Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Index PDE5i Prescription | Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period | 67.49 Percentage of participants |
Primary
Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription
Underlying conditions were defined as any diagnosis of interest recorded in the relevant time period. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.
Time frame: Day -92 up to Day -1 of index prescription
Population: Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population) and age-matched participants without any PDE5i prescription during the study period (control population). Last observation carried forward method was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Index PDE5i Prescription | Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription | 70.23 Percentage of participants |
| Control (Without PDE5i Prescription) | Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription | 55.73 Percentage of participants |
Comparison: Chi-square test was used to calculate p-value.p-value: <0.001Chi-squared
Secondary
Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period
New diagnosis of underlying condition at PDE5i establishment was defined as any new diagnosis of interest between day 0 (index prescription) and day 91 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two-years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.
Time frame: Up to 2 years (End of study period - July 2006 to June 2008)
Population: Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Index PDE5i Prescription | Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period | 11.06 Percentage of participants |
Secondary
Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period
New diagnosis of underlying condition at PDE5i market introduction was defined as any new diagnosis of interest until day -1 in participants who received the index prescription between January 1, 1999 and December 31, 2001 for the three years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.
Time frame: Up to 3 years (Early study period - January 1999 to December 2001)
Population: Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Index PDE5i Prescription | Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period | 11.32 Percentage of participants |
Secondary
Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period
Underlying condition at PDE5i market introduction was defined as any diagnosis of interest until day -1 in participants who received the index prescription between July 1, 2006 and June 30, 2008 for the two years period combined. Diagnoses of interest were coded and categorized in to vasculogenic, urologic, neurogenic, hormonal, drug induced and psychogenic disorders.
Time frame: Up to 2 years (End of study period - July 2006 to June 2008)
Population: Evaluable analysis population included all participants who received an index PDE5i prescription (sildenafil, tadalafil or vardenafil) during the study period (target population). Last observation carried forward method was used. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Index PDE5i Prescription | Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period | 72.14 Percentage of participants |