Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

Study Overview
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Brief Summary
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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?

Official Title
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Prevalence and Incidence of Underlying Disease Diagnosed in Men With Erectile Dysfunction When Prescribed a PDE5i for the First Time

Conditions
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Erectile Dysfunction, Cardiovascular Diseases, Male Urogenital Diseases

Intervention / Treatment
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* Other: no intervention
* Other: no intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PDE5 inhibitor prescription<br> | Other: no intervention<br>* non-interventional study<br>|
| Age-matched Control<br> | Other: no intervention<br>* non-interventional study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day -92 up to Day -1 of index prescription | 
| 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. | Day 0 to Day 91 post index prescription | 
| 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. | Day -92 up to Day -1 of index prescription | 
| 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. | Day 366 up to Day 457 post index prescription | 
| 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. | Up to 3 years (Early study period - January 1999 to December 2001) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 3 years (Early study period - January 1999 to December 2001) | 
| 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. | Up to 2 years (End of study period - July 2006 to June 2008) | 
| 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. | Up to 2 years (End of study period - July 2006 to June 2008) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erectile dysfunction, phosphodiesterase inhibitor, cardiovascular diseases