Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

Completed

• Conditions: Cardiovascular Diseases; Erectile Dysfunction; Male Urogenital Diseases
• Interventions: Other: no intervention

• Registration Number: NCT01150903
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-24
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Results First Submitted: 2012-04-03
• Results First Submitted QC: 2012-04-03
• Results First Posted: 2012-05-11
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 98832

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Age-matched Control	no intervention	-
PDE5 inhibitor prescription	no intervention	-

Primary Outcome Measures

Name	Time	Method
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.
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 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 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 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.

Secondary Outcome Measures

Name	Time	Method
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 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 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.