Jun 06, 2025
HEArt failure Treatment patterns: A pharmacoepidemiological descriptive study in COlombia (the HEATCO study)
- Jorge Machado Alba1
- 1Universidad Tecnologica de Pereira - Audifarma SA
- Jorge Machado Alba
Protocol Citation: Jorge Machado Alba 2025. HEArt failure Treatment patterns: A pharmacoepidemiological descriptive study in COlombia (the HEATCO study). protocols.io https://dx.doi.org/10.17504/protocols.io.4r3l2pkp4g1y/v1
Manuscript citation:
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License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: May 30, 2025
Last Modified: June 06, 2025
Protocol Integer ID: 219243
Keywords: Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists; Pharmacoepidemiology; Heart Failure; Mineralocorticoid Receptor Antagonists, Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists; Pharmacoepidemiology; Heart Failure; Mineralocorticoid Receptor Antagonists, heart failure treatment pattern, heart failure, hospitalizations for heart failure, pharmacoepidemiological descriptive study in colombia, patients from colombia, ischemic heart disease, ventricular ejection fraction, prescription patterns of medication, pharmacoepidemiological descriptive study, aldosterone system inhibitor, arterial hypertension, prescription pattern
Funders Acknowledgements:
Bayer
Grant ID: 21798
Disclaimer
Funding (Grant Support): This
work was supported by Bayer AG, (Bogotá, Colombia). The funders participated in the design of the
study and approval of the final manuscript.
Abstract
Introduction: Heart failure is a common condition associated with significant mortality. Objective:
to determine the prescription patterns of medications for the treatment of
heart failure in a cohort of patients from Colombia.
Methods: This was a retrospective study based on the clinical records of patients diagnosed with
heart failure between 2019 and 2020. Sociodemographic, clinical, paraclinical, and pharmacological
variables and the specialty of the treating physician were identified. Patients were classified according
to functional class, stage, and left ventricular ejection fraction (LVEF).
Results: A total of 4742 patients were evaluated, with a mean age of 68.2±13.8 years and
a male predominance (61.3%). A total of 92.0% were classified as stage C and 54.8% as functional class I, the mean LVEF was 42.9±14.8%, and 32.53% had reduced LVEF. 30.7% did not have LVEF data. The most common causes were ischemic heart disease (44.0%) and arterial hypertension (29.7%). A total of 5.2% had
hospitalizations for heart failure in the last year, and 75.6% were attended by a general practitioner. These patients were treated with β-blockers (88.3%), renin-angiotensin-aldosterone system inhibitors (RAASis) (83.1%), loop diuretics (46.8%), and mineralocorticoid receptor antagonists (MRAs) (46.5%). Triple
therapy with RAASis+β-blockers+MRAs was received by 56.4% of patients with
reduced LVEF, 32.8% with mildly reduced LVEF and19.5% with preserved LVEF,
while quadruple therapy adding a sodium-glucose cotransporter-2 inhibitor
(SGLT2i) was given just to 4.6% with reduced LVEF.
Conclusion:
The treatment that patients with heart failure with preserved LVEF is
relatively simpler and is closer to the recommendations, while the proportion
of indicated therapies according to guidelines is lower among those with
reduced LVEF.
Attachments
DB-HEATCO.xlsx
2.3MB
Materials
Materials and
methods
A
descriptive, retrospective study was carried out on the prescription patterns
of drugs used in the treatment of HF from a population-based drug dispensing
database and clinical records. The prescriptions of adult patients diagnosed
with HF from June 01, 2019, to May 31, 2020, were analyzed.
The
initial information was obtained from the drug dispensing database of Audifarma
S.A., the main pharmaceutical manager in Colombia for the delivery of
institutional drugs to outpatients and hospital patients, including patients
diagnosed with HF, according to the International Classification of Diseases,
Tenth Revision (ICD-10), with the dispensing of some medications during the
observation period in outpatient context. Subsequently, individuals who were affiliated
with one insurer of the contributory scheme were selected (The insurer provided
authorization for access to the clinical record), and their clinical records
were reviewed for clinical variables of HF and comorbidities. No exclusion
criteria were considered for this study.
From the information on the
dispensing of drugs to the included population, the data from the electronic
clinical records of the patients were obtained by a group of trained
physicians. In addition, two researchers consolidated and validated the
information for inconsistent data and errors. The following groups of variables
were recorded:
- Sociodemographic: Sex, age, city where health care was sought, and department or region of the country (Bogotá-Cundinamarca, Caribbean region, Central region, Eastern region, Pacific region and Amazon-Orinoquía region)
- Diagnosis and comorbidities: Primary and secondary diagnoses of heart failure according to ICD-10 codes (I50.0; I50.1; I50.9; I11.0; I11.9; I13.0; I13.1; I13.2; I13.9; I42.0; I42.1; I42.2; I51.0; I51.1-I51.9). Each patient was identified according to the classification of a) the NYHA, b) the ACC/AHA, and c) reduced or preserved LVEF. Information on comorbidities was obtained during the entire observation period, including the etiology of heart failure.
- Hospitalizations: The number of hospitalizations and visits to the emergency department during the study period was recorded from the outpatient primary care clinical record.
- Prescribing physician: The specialty of the prescribing physician was identified: general practitioner, internist, cardiologist, pulmonologist, or other.
- Symptoms and signs/paraclinical parameters: a) Symptoms and signs included dyspnea, fatigue, lower limb edema, etc. b) Paraclinical parameters included LVEF (reduced (HFrEF) ≤40%, Mildly reduced (HFmrEF) 41-49% and preserved (HFpEF) ≥50%, no data recorded) – (Left ventricular ejection fraction value was obtained from the report in the medical record of the first echocardiogram recorded during the observation period), creatinine and glomerular filtration rate (GFR), which was calculated by CKD-EPI equation.
·
Drugs used for HF: The information
of drugs used in the treatment of HF was collected, including active substance, mean
dose, dosage form and frequency of use by LVEF classification. The defined daily dose (DDD) was used as the unit of
measurement for drug use, according to the recommendations of the World Health
Organization (WHO).
a.
Comedications: The following were identified: a)
antidiabetics, b) antihypertensives and diuretics, c) lipid-lowering agents, d) antiulcer
agents, e) antidepressants, f) anxiolytics and hypnotics, g) thyroid hormone,
h) antipsychotics, i) antiepileptics, j) analgesics and anti-inflammatories, k)
bronchodilators and/or inhaled corticosteroids, l) antiplatelet agents, and m) anticoagulants,
among others.
Statistical analysis
The data were analyzed with the statistical package
SPSS Statistics, version 28.0 for Windows (IBM, USA). A descriptive analysis
was performed with frequencies and proportions expressing qualitative variables
and central trend and dispersion measures for quantitative variables. For
quantitative variables, normality was initially tested using the
Kolmogorov‒Smirnov test; for those variables with a normal distribution, means
and standard deviations are reported, and for those with asymmetrical
distribution, medians and interquartile ranges are reported. A division of the
sociodemographic, clinical, and comorbidity characteristics was made according
to LVEF. Regarding the use of medications, the average dose, relationship with
the daily dose defined by the WHO, and frequency of use by LVEF classification
were identified for those prescribed for HF. UpSet library version 0.6.1 in
Python was used to generate the combined drug consumption figure.[10]
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