Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor

Viatris

Status: Completed

Conditions: Erectile Dysfunction; Male Urogenital Diseases; Cardiovascular Diseases

Treatments: Other: no intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01150903

A1481287

Details and patient eligibility

About

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?

Enrollment: 98,832 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

98,832 participants in 2 patient groups

PDE5 inhibitor prescription

Treatment:

Other: no intervention

Other: no intervention

Age-matched Control

Treatment:

Other: no intervention

Other: no intervention