An Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Drug Utilization in Selected European Populations

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  NALOXEGOL

Population studied

• Short description of the study population:
  The study population included new users of naloxegol (individuals newly prescribed naloxegol) in real-world practice reported from the selected European countries.; Inclusion criteria:; 1. The patient has at least 1 prescription of naloxegol in his/her medical record anytime during the study period.; 2. The patient has at least 12 months of computerized records prior to the first prescription of naloxegol (index date).; ; Exclusion criteria; No exclusion criteria will be applied.
• 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)
• Special population of interest:
  Hepatic impaired

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  17254

Study design details

• Main study objective:
  -To describe the characteristics of patients prescribed naloxegol at time of first prescription (demographics, targeted comorbidities, targeted comedications, provider characteristics, indication characteristics). -To describe any of the following treatment patterns: Discontinuation, Switching, Augmentation, Restart the prescription of naloxegol after temporary discontinuation, Change in dosing
• Outcomes:
  Treatment outcomes: - Discontinuation: no prescription of naloxegol in the period of twice the number of days of supply of the last prescription following its expiry date - Switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC) - Augmentation with other drugs potentially used by patients with OIC - Restart after temporary discontinuation
• Data analysis plan:
  All analyses for this study are descriptive and performed in each of the study countries separately, and if possible overall for all patients combined. Summary statistics (ie, mean, standard deviation, median, minimum, and maximum) are presented for continuous variables and number and proportion/percentage are presented for categorical ones. The number and proportion of patients with missing data are reported for each of the variables of interest. The 95% confidence interval (CI) for the proportion of patients having a specific characteristic are presented using the Wilson Score method. Time to events are described using estimates (eg, median) and 95% CI based on the Kaplan-Meier method. Sensitivity analyses are conducted by also describing treatment discontinuation considering a shorter allowable gap. Exploratory analyses of potential predictors of length of naloxegol use are conducted using appropriate methodology (eg, Cox regression analysis)

Documents

Study results

Naloxegol DU Report_Final_V1.0_clean_15July2021_Abstract