Clinical trial NCT01150903: Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor
Official title: Prevalence and Incidence of Underlying Disease Diagnosed in Men With Erectile Dysfunction When Prescribed a PDE5i for the First Time
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Cardiovascular Diseases
Male Urogenital Diseases
Keywords: erectile dysfunction
phosphodiesterase inhibitor
cardiovascular diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-25
Enrollment: 98832
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a PDE5 inhibitor prescription and within the age-match control.

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?


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription
timeFrame: Day -92 up to Day -1 of index prescription
measure: Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91
timeFrame: Day 0 to Day 91 post index prescription
measure: Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription
timeFrame: Day -92 up to Day -1 of index prescription
measure: Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription
timeFrame: Day 366 up to Day 457 post index prescription
measure: Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period
timeFrame: Up to 3 years (Early study period - January 1999 to December 2001)
Secondary outcomes:
measure: Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period
timeFrame: Up to 3 years (Early study period - January 1999 to December 2001)
measure: Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period
timeFrame: Up to 2 years (End of study period - July 2006 to June 2008)
measure: Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period
timeFrame: Up to 2 years (End of study period - July 2006 to June 2008)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.