Impact of medication adherence on mortality and cardiovascular morbidity: a population-based retrospective cohort study. IMPACT study

Study type

• Study topic:
  Disease /health condition

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

  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  ADHERENCE
• 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:
  (B01AC) Platelet aggregation inhibitors excl. heparin

  Platelet aggregation inhibitors excl. heparin

  (C07) BETA BLOCKING AGENTS

  BETA BLOCKING AGENTS

  (C09) AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

  AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

  (C10) LIPID MODIFYING AGENTS

  LIPID MODIFYING AGENTS
• Medical condition to be studied:
  Acute coronary syndrome

Population studied

• Short description of the study population:
  All adult patients from SIDIAP population who have a first episode of ACS registered in CMBD-HA of the Catalan Health Institute (ICS).; ; Inclusion criteria; • Individuals ≥ 18 years with an incident diagnosis of ACS during the study period 2006-2015.; • Patients with at least two months of follow-up in SIDIAP after the index date.; ; Exclusion criteria; • Pregnant women on the index date; • Patients with a recorded diagnosis of ischaemic stroke in the six months prior to index date.; • Patients living in a nursing home on the index date.; • Patients with Alzheimer’s disease or other dementias.
• 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:
  Acute coronary syndrome patients
• Estimated number of subjects:
  3400

Study design details

• Main study objective:
  To assess the relationship between adherences to the four pharmacological groups recommended for secondary prevention and the clinical outcomes of cardiovascular morbidity and mortality in patients with established CHD. The outcomes which are included as components of the composite endpoint are: all-cause mortality, ACS, and ischaemic stroke.
• Outcomes:
  To assess the relationship between adherences to the four pharmacological groups recommended for secondary prevention and the clinical outcomes of cardiovascular morbidity and mortality in patients with established CHD. The outcomes which are included as components of the composite endpoint are: all-cause mortality, ACS, and ischaemic stroke. Incidence of the composite endpoint. Relationship between baseline socio-demographic and clinical characteristics and adherence to drug therapy. Number of days on sickness leave due to any cause according to adherence to drug therapy. Prevalence of use of the four drugs. Posology prescribed.
• Data analysis plan:
  Demographic and baseline characteristics of the participants will be described using frequencies and percentages for categorical variables and mean, standard deviation or median and interquartile range for continuous variables, as appropriate. Bivariate analyses will be performed using the Chi-square test for categorical variables and t-Student test or Mann-Whitney U test for continuous variables, according to their distribution. Multiple imputations by chained equations will be used to replace baseline missing values. Case-complete and imputed data results will be compared as a sensitivity analysis. The raw and adjusted HRs for adherences will be calculated for outcome events using Cox proportional hazard regression models, and proportionality of hazards assumption will be tested.