A post-marketing database surveillance to investigate the risk of diagnosed peripheral neuropathy and optic nerve disorder events in MRSA patients treated with tedizolid or linezolid in Japan (MK-1986-047)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  SIVEXTRO

  LINEZOLID
• Study drug International non-proprietary name (INN) or common name:
  TEDIZOLID PHOSPHATE
• Anatomical Therapeutic Chemical (ATC) code:
  (J01XX08) linezolid

  linezolid

  (J01XX11) tedizolid

  tedizolid
• Medical condition to be studied:
  Optic nerve disorder
• Additional medical condition(s):
  Peripheral neuropathy

Population studied

• Short description of the study population:
  Methicillin-resistant Staphylococcus aureus (MRSA) participants who are treated with tedizolid or linezolid between 21-Aug- 2018 and 31-Mar-2025.; ; Key inclusion criteria include but are not limited to:; 1. Has a new prescription date (index date) for tedizolid or linezolid during the cohort entry period 21-Aug-2018 to 31-Mar-2025.; 2. Confirmed diagnosis of MRSA and confirmed diagnosis of indications for both tedizolid and linezolid in the same month or previous month of the index date.; ; Key exclusion criteria include but are not limited to:; 1. Do not have 60 days lookback period prior to the index date.; 2. Have prescriptions for both tedizolid and linezolid on the same index date.; 3. Have one or more events of peripheral neuropathy and optic nerve disorder within 60 days lookback period.; 4. Have prescription records for tedizolid or linezolid only on the index date.
• Age groups:
  • In utero
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 65 years)

    • Adults (18 to < 46 years)
    • Adults (46 to < 65 years)
  • Elderly (≥ 65 years)

    • Adults (65 to < 75 years)
    • Adults (75 to < 85 years)
    • Adults (85 years and over)
• Estimated number of subjects:
  200

Study design details

• Study design:
  This is an observational cohort study with active comparator new user design, using MID-NET. The study will be conducted using only structured secondary data.
• Main study objective:
  To compare the risk of diagnosed peripheral neuropathy and optic nerve disorder between participantsnts taking tedizolid and those taking linezolid.
• Setting:
  The study population is MRSA participants who were treated with tedizolid or linezolid between 21-Aug-2018 and 31-Mar-2025 in Japan. The study will be conducted using only structured secondary data collected from MED-NET.
• Comparators:
  The group of participants who are newly prescribed/exposed to tedizolid during the cohort entry period (21-Aug-2018 to 31-Mar-2025) will be considered as the tedizolid group. The group of participants who newly start linezolid during the cohort entry period (21-Aug-2018 to 31-Mar-2025) will be considered as the linezolid group.
• Outcomes:
  The primary outcomes of interest are as follows:; Peripheral neuropathy is defined as cases meeting the following two conditions.; 1. A confirmed diagnosis of peripheral neuropathy(ICD-10 code).; 2. In the same month as, the month prior to, or the month after the confirmed diagnosis of peripheral neuropathy, a treatment drug for peripheral neuropathy or pain was prescribed, a test related to peripheral neuropathy was; performed, or blood purification therapy for immune neuropathy was performed.; ; Optic nerve disorder is defined as cases meeting the following two conditions.; 1. A confirmed diagnosis of optic nerve disorder(ICD-10 code).; 2. In the same month as, the month prior to, or the month after the confirmed diagnosis of optic nerve disorder, vitamin B12 or corticosteroids were prescribed, or any of the relevant tests for optic nerve disorder (general, outpatient, or imaging tests) were performed.
• Data analysis plan:
  Incidence rates of peripheral neuropathy and optic nerve disorder and binomial confidence intervals will be calculated descriptively for tedizolid and linezolid groups separately. The number and percentage of participants with peripheral neuropathy and optic nerve disorder will be calculated. For all participants , the exposure time starts the day after the initiation of treatment date.; If there are 10 or more events observed for each treatment group, crude odds ratios and 95% confidence interval (CI) will be estimated to be using logistic regression models, to compare the risk of peripheral neuropathy and optic nerve disorder between the tedizolid group and linezolid group