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)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/18651
• 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

Study timelines

Date when funding contract was signed

Actual: 02/12/2009

Study start date

Planned: 19/04/2010

Actual: 05/05/2010

Date of final study report

Planned: 18/05/2016

Actual: 26/05/2016

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)

Other study registration identification numbers and links

https://clinicaltrials.gov/show/NCT01131104