Study type

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(C07AB02) metoprolol
(C07AG02) carvedilol

Medical condition to be studied

Cardiac failure
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

30000
Study design details

Main study objective

Do women with heart failure who use metoprolol have a higher risk of adverse drug reactions compared to women using carvedilol, and is this association different in their male counterparts?

Outcomes

The outcomes of interest are all-cause and heart failure-specific mortality, hospitalisation for heart failure, and prescription discontinuation. To compare with the effectiveness findings, diagnoses of adverse events will be identified.

Data analysis plan

The analysis method used for this study will be the Active Comparator, New User (ACNU) design. ACNU study design seeks to emulate the design of a head-to-head randomized controlled trial. Specifically, ACNU study design is an effective way to avoid biases typically related to pharmacoepidemiologic studies, such as confounding by indication, healthy initiator bias and healthy adherer bias. Statistical analyses will include a main analysis (effectiveness outcomes), a secondary analysis (treatment discontinuation) and a tertiary analysis (actual ADR diagnoses). All analyses will be stratified by sex and age. Moreover, we will stratify our analysis based on whether or not hypertension is present, and a sensitivity analysis will include only patients diagnosed with heart failure with reduced ejection fraction.