A Study of Treatments for Overactive Bladder: Incidence and Validation of Cardiovascular and Cancer Outcomes and Examination of Drug-Use Patterns in a US Health Care Claims Data Environment (OAB)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Validation of algorithms used in the ORD database for the study of CV 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

  Other
• Non-interventional study design, other:
  Database Validation Study

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:
  Urinary incontinence

Population studied

• Short description of the study population:
  Initiators of currently available antimuscarinic drugs (oxybutynin, tolterodine, darifenacin, solifenacin, trospium, or fesoterodine) from 01 January 2004 through 30 September 2012.; ; Subjects in the study were required to meet the following criteria:; 1. Have a first dispensing for an antimuscarinic drug (oxybutynin, tolterodine, darifenacin, solifenacin, trospium, or fesoterodine) during the study period of 01 January 2004 through 30 September 2012; 2. Have reached age 18 years and older at the time of first dispensing of the antimuscarinic drug during the study period; 3. Have at least 6 months of continuous enrollment in the health plan (thereby providing medical and drug dispensing history data) before the first dispensing of the antimuscarinic drug
• 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)
• Estimated number of subjects:
  205422

Study design details

• Main study objective:
  Characterize users of antimuscarinic OAB drugsDescribe patterns of usage of OAB drugsValidate algorithms used for the diagnosis of study endpoints.Estimate IRs of study endpoints in new users of antimuscarinic OAB drugsConfirm CV outcomes and selected cancer outcomes via medical record review Refine the study size and statistical power assessment for post-marketing safety studies
• 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:
  All analyses will be descriptive in nature both for the health insurance claims data and the medical record review data. Characterization of over active bladder (OAB) drug users included the summarization of the relevant baseline covariates such as demographics, plan membership characteristics, diagnosis of OAB or incontinence and other comorbidities, along with prescription drug history, and health care services.Patterns of medication use for each antimuscarinic drug were examined, including characteristics of patients who use a drug immediately after drug launch, switching between antimuscarinic drugs, use of combination therapies, and consistency of use over the study period. Incidence rates of claims-identified CV Outcomes and cancer outcomes were determined. A random sample of claims-identified CV and cancer cases was validated by review of the medical record. Similarly, a sample of claims-identified cancer-related covariates was validated.