Validation of a US Health Care Claims Database for the Study of Cardiovascular and Neoplasm Events among Users of Treatments for Overactive Bladder

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Validation of the Humana database for the study of cardiovascular and neoplasm events in users of treatments for overactive bladder
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (G04BD04) oxybutynin

  oxybutynin

  (G04BD07) tolterodine

  tolterodine

  (G04BD08) solifenacin

  solifenacin

  (G04BD09) trospium

  trospium

  (G04BD10) darifenacin

  darifenacin

  (G04BD11) fesoterodine

  fesoterodine
• Medical condition to be studied:
  Hypertonic bladder

Population studied

• Short description of the study population:
  Users of antimuscarinic medications for the treatment of Overactive Bladder (OAB). Patients newly initiated on antimuscarinic OAB medication between 2007 and 2013 were identified based on pharmacy claims data, and date of initiation of OAB medication was the index date for cohort entry.; ; Patients must follow the following criteria:; 1. Medicare Advantage Prescription Drug (MAPD) or commercial health plan members with first dispensing for an antimuscarinic OAB drug (oxybutynin, tolterodine, darifenacin, solifenacin, trospium, fesoterodine) between 01 January 2007 through 31 December 2013.; 2. Member had both pharmacy and medical benefit coverage during their health plan enrollment period.; 3. Age 18 years or older at the time of first prescription of a drug of interest.; 4. Member had at least 6 months of continuous enrollment (defined as gap = 0 days) in the health plan prior to the index date. Member should have no prior dispensings of that same medication in the previous 6 months.
• Age groups:
  • Adult and elderly population (≥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)
• Special population of interest:
  Other
• Special population of interest, other:
  Overactive Bladder patients
• Estimated number of subjects:
  160000

Study design details

• Main study objective:
  To characterize users of antimuscarinic OAB medications. To estimate incidence rates of cardiovascular and neoplasm outcomes among initiators of antimuscarinic OAB medications.To validate claims-based identification algorithms for cardiovascular and neoplasm events.
• Outcomes:
  CV endpoints: AMI, stroke, CV mortality, all-cause mortality, major adverse cardiac events (MACE)Composite cancer endpoints: lung & bronchus, colon & rectum, melanoma of skin, urinary bladder, non-Hodgkin lymphoma, kidney & renal pelvis, pancreas, prostate (males), breast (females), corpus uteri (females)
• Data analysis plan:
  Descriptive summaries of patient demographic, plan enrollment, baseline clinical characteristics, health service utilization, and healthcare costs measures will be produced. Incidence of cardiovascular and neoplasm outcomes will be assessed. Positive and negative predictive values for claims-based identification algorithms will be deteremined.