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 type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-crossover

Study drug and medical condition

• Name of medicine:
  CIALIS

  LEVITRA

  VIAGRA
• Medical condition to be studied:
  Optic ischaemic neuropathy

  Optic neuropathy

  Optic neuritis

Population studied

• Short description of the study population:
  Adult subjects from US who experienced abrupt visual loss (defined as visual loss typically occurring during less than a 1-day period or visual loss noted upon awakening) in one eye and presented to an ophthalmologist within 45 days of onset of NAION symptoms for an initial visit that resulted in a diagnosis of suspected NAION by the investigator.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  350

Study design details

• Main study objective:
  The objective of this noninterventional, case-crossover, observational study was to evaluate whether there is a possible association between exposure to PDE5 inhibitors and the risk of acute NAION in adult males.
• Outcomes:
  The primary objective of this case-crossover study examined the rate of acute NAION occurring in patients with PDE5 inhibitor exposure in the hazard periods (immediately preceding NAION onset) compared with exposure occurring over the 30 days before NAION onset, expressed as a Mantel Haenszel rate ratio for person-time. Secondary analyses included (1) a person-time analysis evaluating acute NAION occurring in patients with PDE5 inhibitor exposure in the hazard periods compared with exposure over the 12 months prior to NAION onset, and (2) a matched interval analysis method assessing PDE5 inhibitor exposure during hazard periods and matched controlled periods the 42 days prior to NAION onset.
• Data analysis plan:
  This case-crossover study was conducted to evaluate the possible association between PDE5 inhibitor exposure and the risk of acute NAION in adult males. Exposure was based on the PDE5 inhibitor effect period (5 times the half-life). The primary analysis used the person-time method, including subjects with adjudication-confirmed NAION who had intermittent exposure to PDE5 inhibitors. In this analysis, a Mantel Haenszel rate ratio for the risk of NAION was calculated, comparing PDE5 inhibitor exposure in the 30 days before NAION onset by exposed case definition (ie, exposure within the hazard period). A secondary analysis, using the person-time method examined this risk using PDE5 inhibitor exposure over the 12 months prior to NAION onset. Other secondary analyses, used the matched interval method to evaluate the association between PDE5 inhibitor exposure in the 42 days prior to acute NAION, evaluated using a 4-day hazard period and a series of 4 preceding 4-day control intervals.

Documents

Study results

LY450190 H6D-MC-LVHQ PASS full CSR redacted

Study publications

Flahavan EM, Li H, Gupte-Singh K, Rizk RT, Ruff DD, Francis JL and Kinchen KS. …