Trial Outcomes & Findings for A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors (NCT NCT01131104)

NCT ID: NCT01131104

Last Updated: 2018-04-05

Results Overview

Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.

• Recruitment status: COMPLETED
• Target enrollment: 345 participants
• Primary outcome timeframe: 30 days prior to NAION onset
• Results posted on: 2018-04-05

Participant Flow

Study Set were enrolled participants who met inclusion/exclusion criteria and physician-diagnosed Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)known date of onset. Adjudication-Confirmed NAION Set were confirmed participants (by adjudication committee) with inclusion/exclusion criteria and physician-diagnosed NAION known date of onset.

Participant milestones

Measure	Enrolled Set Enrolled participants who met inclusion/exclusion criteria and had physician-diagnosed NAION with a known date of onset.
Overall Study STARTED	345
Overall Study Study Set	344
Overall Study Adjudication-Confirmed NAION Set	279
Overall Study 30-Day Analysis Set	24
Overall Study 42-Day Analysis Set	28
Overall Study 12-Month Analysis Set	26
Overall Study COMPLETED	332
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Measure	Enrolled Set Enrolled participants who met inclusion/exclusion criteria and had physician-diagnosed NAION with a known date of onset.
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	4
Overall Study Information Not Available	5
Overall Study No Information on Index Date of Onset	1

Baseline Characteristics

A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors

Baseline characteristics by cohort

Measure	Cohort 1 n=279 Participants Participants with NAION who have used PDE5 inhibitors
Age, Customized	61.5 years STANDARD_DEVIATION 10.70 • n=5 Participants
Sex/Gender, Customized Female	0 Participants n=5 Participants
Sex/Gender, Customized Male	279 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	267 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	2 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	3 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	11 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	265 Participants n=5 Participants
Region of Enrollment United States	279 Participants n=5 Participants
Adjudicated NAION Participants within the 30-Day Analysis Set	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days prior to NAION onset

Population: All participants in the 30 day analysis set.

Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.

Outcome measures

Measure	Cohort 1 n=720 Participant days Participants with NAION who have used PDE5 inhibitors
30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use	2.27 Relative risk of exposure Interval 0.99 to 5.2

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60