Incidence of tolerance, dependence, drug abuse and misuse of Targin in patients with Restless Legs Syndrome

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:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prescription event monitoring

Study drug and medical condition

• Name of medicine, other:
  Targin
• Medical condition to be studied:
  Restless legs syndrome

Population studied

• Short description of the study population:
  Patients with Restless Legs Syndrome.
• 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:
  2757

Study design details

• Main study objective:
  To estimate the incidence of problematic Targin prescription use and abuse in patients treated with Targin for RLS.
• Outcomes:
  confirmed problematic Targin use had a low incidence rate and high doses and long prescribing were also reasonably uncommon while there was a moderate proportion of patients using other opioids during Targin exposure. While confirmed opioid abuse/dependency may be underreported in a routine healthcare database such as InGef, not all of the identified occurrences may be attributed to Targin. To characterise Targin for RLS treatment patterns in patients To estimate the incidence of “suspected doctor shopping” in patients treated with Targin for RLS To estimate the amount of off-label use of Targin in RLS patients To determine concomittant treatment in patients treated with Targin for RLS. To estimate incidences of pre-specified adverse events during treatment
• Data analysis plan:
  Statistical analysis were carried out using the data environment used by InGef.