Calcium channel blocker treatments and cancer risk. A methodological protocol to compare the results between databases, across designs: Evaluation of the impact of design/database/population differences on the outcome of the studied association

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Other
• If ‘other’, further details on the scope of the study:
  Analysis of discrepancies in results between different databases

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Case-crossover, Descriptive study = description of exposure and/or outcome in the whole database during a defined period of time

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C08C) SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS

  SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS

  (C08D) SELECTIVE CALCIUM CHANNEL BLOCKERS WITH DIRECT CARDIAC EFFECTS

  SELECTIVE CALCIUM CHANNEL BLOCKERS WITH DIRECT CARDIAC EFFECTS

  (C08E) NON-SELECTIVE CALCIUM CHANNEL BLOCKERS

  NON-SELECTIVE CALCIUM CHANNEL BLOCKERS
• Medical condition to be studied:
  Colorectal cancer metastatic

  Breast cancer

  Prostate cancer stage I

  Malignant melanoma

  Renal cancer

  Colon cancer stage II

  Benign soft tissue neoplasm

  Bone cancer metastatic

  Hepatic neoplasm

  Non-small cell lung cancer recurrent

Population studied

• Age groups:
  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 < 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:
  55700000

Study design details

• Main study objective:
  To assess the association between the use of calcium channel blockers and the risk of cancer with different study designs across different primary care databases and to compare the results between databases, across designs to evaluate the impact of design/database/population differences on the outcome of the studied association.
• Data analysis plan:
  Preliminary analyses will use non-parametric univariate and bivariate analysesCox proportional hazard models with time-dependent covariates adjusted on confounders ill be used to calculate the association between CCB exposure and risk of cancer. RR and 95 % CI will be established. CCB first-time and non-users between 01/01/1996 and 31/12/2009 will be followed from entry to the study until the earliest of: diagnosis date of study outcome (cancer), date of disenrollment from database, reaching 80 years of age, date of death, or end of study periodThree models will be performed One model will be with at least 1 prescription One model with pooled data with cumulated exposure Analysis based on the main treatment groupsPropensity score will also be computed for the previous analyses