Trial Outcomes & Findings for A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION (NCT NCT00759174)

Results Overview

Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.

Recruitment status

COMPLETED

Target enrollment

673 participants

Primary outcome timeframe

30-day period prior to onset of NAION symptoms

Results posted on

2021-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	Potential NAION Cases With PDE5i Exposure Participants who met pre-defined potential acute nonarteritic anterior ischemic optic neuropathy (NAION) criteria and were exposed to phosphodiesterase type 5 inhibitors (PDE5i) (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.	Potential NAION Cases Without PDE5i Exposure Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
Overall Study STARTED	76	597
Overall Study COMPLETED	76	595
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Potential NAION Cases With PDE5i Exposure Participants who met pre-defined potential acute nonarteritic anterior ischemic optic neuropathy (NAION) criteria and were exposed to phosphodiesterase type 5 inhibitors (PDE5i) (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.	Potential NAION Cases Without PDE5i Exposure Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
Overall Study Other	0	2

Baseline Characteristics

A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Potential NAION Cases With PDE5i Exposure n=76 Participants Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.	Potential NAION Cases Without PDE5i Exposure n=597 Participants Participants who met pre-defined potential acute NAION criteria and were not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.	Total n=673 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 7.3 • n=39 Participants	62.3 years STANDARD_DEVIATION 10.2 • n=41 Participants	62.3 years STANDARD_DEVIATION 9.9 • n=35 Participants
Sex: Female, Male Female	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Sex: Female, Male Male	76 Participants n=39 Participants	597 Participants n=41 Participants	673 Participants n=35 Participants

PRIMARY outcome

Timeframe: 30-day period prior to onset of NAION symptoms

Population: Full Analysis Set (FAS) included all participants who signed informed consent, were eligible for study, reported exposure to PDE5i within 60 days prior to participant-reported onset of NAION symptoms. N (number of participants analyzed) represents Definite NAION cases with PDE5i exposure on at least 1 day but not all 30 days prior to symptom onset.

Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.

Outcome measures

Outcome measures
Measure	Potential NAION Cases With PDE5i Exposure/ Case Window n=43 Days Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the day preceding the symptom onset day.	Potential NAION Cases With PDE5i Exposure/ Control Window n=1247 Days Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 29 days preceding the case window.
Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases	14 exposed days	248 exposed days

OTHER_PRE_SPECIFIED outcome

Timeframe: 30-day period prior to onset of NAION symptoms

Population: FAS included all participants who signed informed consent, were eligible for study and reported exposure to PDEi within 60 days prior to participant reported-onset of NAION symptoms. N (number of participants analyzed) represents Definite or Possible NAION cases with PDE5i exposure on at least 1 day but not all 30 days prior to symptom onset.

Adjudication committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 day preceding symptom onset day; 29 control windows: 29 days preceding case window. A case or control window was considered exposed if: sildenafil/vardenafil was used on that day and/or previous day; tadalafil was used on that day and/or any of previous 4 days. In this analysis, each participant contributed exposure information for 1 case window and 29 control windows.

Outcome measures

Outcome measures
Measure	Potential NAION Cases With PDE5i Exposure/ Case Window n=64 Days Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the day preceding the symptom onset day.	Potential NAION Cases With PDE5i Exposure/ Control Window n=1856 Days Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 29 days preceding the case window.
Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite or Possible NAION Cases	22 exposed days	374 exposed days

OTHER_PRE_SPECIFIED outcome

Timeframe: 60-day period prior to onset of NAION symptoms

Population: FAS population. N (number of participants analyzed) represents Definite NAION cases with PDE5i exposure on at least 1 day but not all 30 days or every week within 60 days prior to symptom onset.

Adjudication Committee classified participants as Definite, Possible, or Non-NAION cases, or insufficient information available or unable to adjudicate. Case window: 1 week preceding symptom onset day; 7 control windows: 7 weeks preceding case window. 1-week case or control window was considered exposed if any of 7 days were classified as exposed (sildenafil/vardenafil used on given day and/or previous day, or tadalafil used on given day and/or previous 4 days). In this analysis, each participant contributed exposure information for 1 case window and 7 control windows.

Outcome measures

Outcome measures
Measure	Potential NAION Cases With PDE5i Exposure/ Case Window n=36 Weeks Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Case window is the day preceding the symptom onset day.	Potential NAION Cases With PDE5i Exposure/ Control Window n=252 Weeks Participants who met pre-defined potential acute NAION criteria and were exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed. Control windows are the 29 days preceding the case window.
Number of Weeks Exposed to PDE5i During 1-Week Case Window and 7 1-Week Control Windows Among Participants Adjudicated as Definite NAION Cases	23 exposed weeks	91 exposed weeks

Adverse Events

Potential NAION Cases

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Potential NAION Cases n=673 participants at risk All participants who met pre-defined potential acute NAION criteria and were either exposed or not exposed to PDE5i (sildenafil, vardenafil or tadalafil) during the 60 days prior to NAION symptom onset were observed.
Gastrointestinal disorders Diarrhoea	0.15% 1/673 Given retrospective data collection, adverse events may have occurred prior to informed consent.
Infections and infestations Candidiasis	0.15% 1/673 Given retrospective data collection, adverse events may have occurred prior to informed consent.
Infections and infestations Influenza	0.15% 1/673 Given retrospective data collection, adverse events may have occurred prior to informed consent.
Investigations Blood pressure decreased	0.15% 1/673 Given retrospective data collection, adverse events may have occurred prior to informed consent.
Investigations Weight decreased	0.15% 1/673 Given retrospective data collection, adverse events may have occurred prior to informed consent.
Nervous system disorders Dizziness	0.15% 1/673 Given retrospective data collection, adverse events may have occurred prior to informed consent.
Nervous system disorders Somnolence	0.15% 1/673 Given retrospective data collection, adverse events may have occurred prior to informed consent.
Vascular disorders Haemorrhage	0.15% 1/673 Given retrospective data collection, adverse events may have occurred prior to informed consent.

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER