Study identification

EU PAS number

EUPAS13266

Study ID

18651

Official title and acronym

Observational Study Description H6D-MC-LVHQ(b) A Prospective Case-Crossover Study to Evaluate the Possible Association Between the Use of PDE5 inhibitors and the Risk of Acute Nonarteritic Anterior Ischaemic Optic Neuropathy (NAION)

DARWIN EU® study

No

Study countries

United States

Study description

This is an observational multicentre, case-crossover study design to evaluate the possible association between PDE5 inhibitor exposure and the risk of acute NAION in adult males. All subjects included in the analysis populations had adjudication-confirmed NAION and intermittent PDE5 inhibitor use. A subject was considered an exposed case if their exposure occurred in the predefined time period immediately preceding NAION symptom onset (hazard period). The remaining time was the control period, that time in which exposure occurred without subsequent NAION onset. The exposure window was defined as 5 times the half-life of the PDE5 inhibitor (4 days for tadalafil and 1 day for sildenafil and vardenafil). In the primary analysis, the person-time method was used to calculate a Mantel Haenszel rate ratio for the risk of NAION, comparing PDE5 inhibitor exposure in the 30 days before NAION onset by exposed case definition (ie, exposure within the hazard period). Secondary analyses conducted as part of this study evaluated the Mantel Haenszel rate ratio for person-time for NAION comparing PDE5 inhibitor exposure in the 12 months before NAION onset by exposed case definition. A matched interval analysis method was also conducted assessing PDE5 inhibitor exposure occurring in the hazard periods and matched control periods during the 42 days prior to the acute NAION onset.The study did not examine the risk of NAION in association wtih any particular PDE5 inhibitor individually, therefore results can be considered applicable to the class.

Study status

Finalised
Research institutions and networks

Institutions

Syneos Health
United Kingdom
First published:
06/03/2024
Institution Non-Pharmaceutical company ENCePP partner

Contact details

Eva Flahavan

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)