Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150903
• Other study ID #: A1481287
• Status: Completed
• Start date: May 2010
• Est. completion date: August 2010

Study information

• Verified date: July 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98832
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Erectile Dysfunction
• Male Urogenital Diseases

Intervention

Other:
• no intervention
non-interventional study
• no intervention
non-interventional study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day -92 up to Day -1 of index prescription
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.	Day 0 to Day 91 post index prescription
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.	Day -92 up to Day -1 of index prescription
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.	Day 366 up to Day 457 post index prescription
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.	Up to 3 years (Early study period - January 1999 to December 2001)
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.	Up to 3 years (Early study period - January 1999 to December 2001)
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.	Up to 2 years (End of study period - July 2006 to June 2008)
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.	Up to 2 years (End of study period - July 2006 to June 2008)

External Links

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