Study type

Study topic

Disease /health condition

Study type

Non-interventional study
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medicinal product name, other

Tafamidis

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

TAFAMIDIS

Anatomical Therapeutic Chemical (ATC) code

(N07XX08) tafamidis
tafamidis
Population studied

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)

Estimated number of subjects

50
Study design details

Main study objective

To describe the impact of tafamidis use in Colombian patients diagnosed with ATTR-CM on quality of life during two years of follow-up

Outcomes

- To describe the clinical and demographic characteristics of the patients at the moment of prescription of tafamidis;
- To determine the treatment patterns to manage ATTR-CM before Tafamidis prescription;
- To evaluate de frequency of hospitalization and its causes during the follow up period;
- To describe the use of cardiovascular devices during follow up of patients recruited in the study.

Data analysis plan

Frequencies and percentages will be reported for binary and categorical variables, while medians, means, standard deviation, and interquartile ranges (IQRs) will be reported for continuous variables, i.e. HRU.
Finally, it will be presented through a tabular display of summary statistics and will be complemented by the generation of graphs, such as histograms, boxplots, violin plots, density plots, scatterplots, depending on the nature of the variable.
On the other hand, difference of means (Student or Welsch t-test) or medians (Wilcoxon or Kruskal-Wallis test) between subgroups will be considered (according to the variable distribution – normal or not), taking into account the sizes of these groups and trends in the behavior of the measures of centrality and dispersion