Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

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

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?

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Erectile Dysfunction; Male Urogenital Diseases
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Actual): 98832

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients with a PDE5 inhibitor prescription and within the age-match control.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PDE5 inhibitor prescription	Other: no intervention; non-interventional study
Age-matched Control	Other: no intervention; non-interventional study

What is the study measuring?

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)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Kirby MG, Schnetzler G, Zou KH, Symonds T. Prevalence and detection rate of underlying disease in men with erectile dysfunction receiving phosphodiesterase type 5 inhibitors in the United Kingdom: a retrospective database study. Int J Clin Pract. 2011 Jul;65(7):797-806. doi: 10.1111/j.1742-1241.2011.02693.x.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: June 24, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (ESTIMATE): June 25, 2010

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: cardiovascular diseases; erectile dysfunction; phosphodiesterase inhibitor
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Cardiovascular Diseases; Erectile Dysfunction
• Other Study ID Numbers: A1481287