N/A
Completed N=98,832
Identification of Underlying Conditions in Men Prescribed a PDE5 Inhibitor
Erectile Dysfunction · Cardiovascular Disease · Male Urogenital Diseases
Source: ClinicalTrials.gov NCT01150903 ↗
Enrolled (actual)
98,832
Serious AEs
—
Results posted
May 2012
Primary outcomePrimary: Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription — 70.23; 55.73 Percentage of participants — p=<0.001
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?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Underlying Condition Until Day -1 of the Index PDE5i Prescription |
70.23; 55.73 | <0.001 sig |
| PRIMARY Cumulative Percentage of Participants With New Diagnosis of Underlying Condition Between Index PDE5i Prescription (Day 0) and Day 91 |
11.53; 7.49 | <0.001 sig |
| PRIMARY Percentage of Participants With New Diagnosis of Underlying Condition Between Day -92 and Day -1 Prior to the Index PDE5i Prescription |
11.08 | — |
| PRIMARY Percentage of Participants With New Diagnosis of Underlying Condition Between Day 366 and Day 457 Post the Index PDE5i Prescription |
5.65 | — |
| PRIMARY Percentage of Participants With Underlying Condition at PDE5i Market Introduction During the Early Study Period |
67.49 | — |
| SECONDARY Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Market Introduction During the Early Study Period |
11.32 | — |
| SECONDARY Percentage of Participants With Underlying Condition at PDE5i Establishment During the End of Study Period |
72.14 | — |
| SECONDARY Percentage of Participants With New Diagnosis of Underlying Condition at PDE5i Establishment During the End of Study Period |
11.06 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01150903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.