Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Nationwide population-based comparative effectiveness cohort study based on prospective medical databases in Denmark
Study drug and medical condition

Name of medicine, other

GLP1-RA class

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

EMPAGLIFLOZIN
LIRAGLUTIDE

Medical condition to be studied

Type 2 diabetes mellitus
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)

Special population of interest

Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women

Estimated number of subjects

50000
Study design details

Main study objective

Our primary objective is to compare clinical outcomes (cardiovascular events, mortality) among empagliflozin initiators and liraglutide initiators in Denmark.

Outcomes

Primary outcome is a composite of hospitalization due to stroke, myocardial infarction, unstable angina, coronary revascularization, heart failure (HF), or all-cause death (expanded MACE). Secondary outcomes are first hospital admission with a diagnosis of HF and/or initiation of loop diuretics, hospital admission with HF and/or all-cause death, composite of all-cause hospitalization or death, all cause hospitalization, all-cause death, hospitalization for HF. In additional analyses, we will assess total healthcare resources utilization and cost.

Data analysis plan

We compute incidence rates of outcomes per 1,000 person-years (pyrs) and use Cox regression to compute adjusted hazard ratios (aHRs). We apply propensity score balancing of potential confounders across the two treatment groups by inverse probability treatment weighting (IPTW), controlling age, gender, year of inclusion, diabetes duration, number of diabetes drugs used, metformin use, insulin use, diagnoses of retinopathy, neuropathy, or nephropathy, estimated glomerular filtration rate (eGFR), history of ischemic heart disease, cerebrovascular disease, peripheral vascular disease, heart failure (further divided by duration and primary/secondary diagnosis), medical obesity, chronic obstructive pulmonary disease, cancer, use of angiotensin-converting-enzyme inhibitors (ACE-I) or angiotensin II receptor blockers (ARBs), other antihypertensives, statins, antiplatelet drugs, social and frailty markers, marital status, prescriptions for mental disorders, alcoholism, and prior admissions.
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