Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Retrospective cohort study/Chart review
Study drug and medical condition

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

IVABRADINE

Anatomical Therapeutic Chemical (ATC) code

(C01EB17) ivabradine
ivabradine

Medical condition to be studied

Angina pectoris
Population studied

Short description of the study population

All patients with chronic stable angina initiating treatment with ivabradine in regular clinical practice. A patient initiating ivabradine (new user) was defined as a patient without documented use of ivabradine during the previous 6 months and who receives a first prescription for ivabradine by their prescribing physician during (one of) the study periods.
Patients with documented initiation of treatment with ivabradine during one of the study periods, diagnosis of chronic stable angina as the indication for treatment initiation, and patient (or legal representative) who has provided informed consent to participate in the study, where required were included.

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

Angina pectoris patients

Estimated number of subjects

1200
Study design details

Main study objective

To assess how ivabradine is used in chronic angina patients and to describe before and after implementation of the new RMM:-Characteristics of new users according to demographics and specific comorbidities at baseline and baseline HR at treatment initiation-Patterns of use according to the dose and the concurrent use of verapamil or diltiazem at initiation and within a 6-month follow-up period

Outcomes

For each study period:-HR at treatment initiation-Ivabradine dose at initiation and dose changes within a 6-month follow-up (FU)-Concurrent use of verapamil or diltiazem at baseline and within a 6-month FU-Ivabradine prescriptions according to the HR recommendation at baseline, no doses higher than the SmPC doses at initiation and during FU,and no concomitant use of verapamil or diltiazem, -Characteristics of participating and non-participating physicians-Patient’s characteristics and treatment patterns at start date.-Ivabradine treatment discontinuation curves by study period

Data analysis plan

All analyses (primary and secondary) will be stratified by study period, unless specified otherwise. The difference, before and after implementation of the additional RMM, between the proportions of the study outcomes defined in the main analysis will be calculated as an estimate of the change. In addition to analyses based on the overall population the primary and secondary outcomes will be presented by country, by physician specialty, and by type of setting for specialists. Ivabradine dose at start and over the 6-month FU will be stratified by age group. A chi-square test or a t-test will be used to test the differences (95% CI) in patient characteristics and observed study outcomes between the two study periods. As sensitivity analyses, the primary outcome will be:evaluated on the whole study cohort, including patients with missing data in the denominator for proportions, summarized by initiator status (initiator vs subsequent prescriber)