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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Heart failure (HF) is a global, public health issue that affects more than 63 million people worldwide. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality. Dapagliflozin has been approved by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in May 2020 and November 2020 respectively, for HF with reduced ejection fraction (HFrEF). The overall aim of this study is to describe the characteristics of patients initiating dapagliflozin for the treatment of HFrEF and to provide early insights into real-world dapagliflozin treatment patterns as well as patient-reported outcomes (PROs) including quality of life.

Real-world dapagliflozin experience in patients with heart failure in Greece

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Early treatment of heart failure: a non-interventional observational study program of patients with heart failure and initiated on dapagliflozin (EVOLUTION-HF - GREECE)

To describe the baseline demographic and clinical characteristics of patients newly prescribed dapagliflozin for the treatment of Heart Failure with reduced Ejection Fraction

Time from dapagliflozin treatment initiation until the time at which participants stop taking the medication for any reason.

Number of reasons for dapagliflozin treatment discontinuation as noted by a health care professional will be extracted and described as the number and proportion of participants who have discontinued dapagliflozin according to each reasons presented.

The number of participants who switch from dapagliflozin to another Heart Failure medication.

Time from initiation of heart failure medication other than dapagliflozin until the time at which participants discontinued treatment with that medication.

The number of participants with dosage changes for heart failure medication other than dapagliflozin.

The number of participants who initiate new heart failure medication other than dapagliflozin.

The KCCQ is a 23-item questionnaire that quantifies physical limitations, self-efficacy, social interference and quality of life. Summary scores will be examined at each assessment point during follow-up. For each of the assessment periods, descriptive statistics for the observed value, change from baseline and the 95% two-sided confidence interval for the mean change will be presented. The proportions of participants with overall health status classified as poor, fair, good, and excellent will be examined at each assessment point. Additionally, the proportions of participants who experience clinically meaningful changes in overall health status: improvement (≥5 point increase), deterioration (≥5 point decrease), and stable (<5 point increase or decrease) will be examined at each assessment point.

The MARS-5 is five-item self-report adherence scale which assesses both intentional and non-intentional non-adherence. Respondents rate the frequency with which the five different medication-taking behaviors occur, scoring each item on a 1-5-point scale with higher scores indicating higher reported adherence.

Real-world dapagliflozin experience in patients with heart failure in Greece - EVOLUTION-HF

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