Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

• ClinicalTrials.gov Identifier: NCT01150903
• Recruitment Status: Completed
• First Posted: June 25, 2010
• Results First Posted: May 11, 2012
• Last Update Posted: July 19, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description

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?

Condition or disease	Intervention/treatment
Erectile Dysfunction; Cardiovascular Diseases; Male Urogenital Diseases	Other: no intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 98832 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Prevalence and Incidence of Underlying Disease Diagnosed in Men With Erectile Dysfunction When Prescribed a PDE5i for the First Time
• Study Start Date: May 2010
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: August 2010

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription [ Time Frame: 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.
2. Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91 [ Time Frame: 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.
3. Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription [ Time Frame: 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.
4. Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription [ Time Frame: 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.
5. Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period [ Time Frame: 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 :

1. Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period [ Time Frame: 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.
2. Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period [ Time Frame: 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.
3. Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

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

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT01150903
• Other Study ID Numbers: A1481287
• First Posted: June 25, 2010
• Results First Posted: May 11, 2012
• Last Update Posted: July 19, 2021
• Last Verified: July 2021

Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):

erectile dysfunction; phosphodiesterase inhibitor; cardiovascular diseases

Additional relevant MeSH terms:

Erectile Dysfunction; Cardiovascular Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders