scholarly journals Empagliflozin, Health Status, and Quality of Life in Patients with Heart Failure and Preserved Ejection Fraction: The EMPEROR-Preserved Trial

Author(s):  
Javed Butler ◽  
Gerasimos Filippatos ◽  
Tariq Jamal Siddiqi ◽  
Martina Brueckmann ◽  
Michael Böhm ◽  
...  

Background: Patients with heart failure and preserved ejection fraction (HFpEF) have significant impairment in health-related quality of life (HRQoL). In EMPEROR-Preserved, we evaluated the efficacy of empagliflozin on HRQoL in patients with HFpEF and whether the clinical benefit observed with empagliflozin varies according to baseline health status. Methods: HRQoL was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 12, 32 and 52 weeks. Patients were divided by baseline KCCQ Clinical Summary Score (CSS) tertiles and the effect of empagliflozin on outcomes were examined. The effect of empagliflozin on KCCQ-CSS, Total Symptom Score (TSS) and Overall Summary Score (OSS) were evaluated. Responder analyses were performed to compare the odds of improvement and deterioration in KCCQ related to treatment with empagliflozin. Results: The effect of empagliflozin on reducing the risk of time to cardiovascular death or HF hospitalization was consistent across baseline KCCQ-CSS tertiles (HR 0.83 [0.69-1.00], HR 0.70 [0.55-0.88] and HR 0.82 [0.62-1.08] for scores <62.5, 62.5-83.3 and ≥83.3, respectively; P trend=0.77). Similar results were seen for total HF hospitalizations. Patients treated with empagliflozin had significant improvement in KCCQ-CSS versus placebo (+1.03, +1.24 and +1.50 at 12, 32 and 52 weeks, respectively P<0.01); similar results were seen for TSS and OSS. At 12 weeks, patients on empagliflozin had higher odds of improvement ≥5 points (OR 1.23; 95%CI 1.10, 1.37), ≥10 points (1.15; 95%CI 1.03, 1.27), and ≥15 points (1.13; 95%CI 1.02, 1.26) and lower odds of deterioration ≥5 points in KCCQ-CSS (0.85; 95%CI 0.75, 0.97). A similar pattern was seen at 32 and 52 weeks, and results were consistent for TSS and OSS. Conclusions: In patients with HFpEF, empagliflozin reduced the risk for major HF outcomes across the range of baseline KCCQ scores. Empagliflozin improved HRQoL, an effect that appeared early and was sustained for at least one year.

Author(s):  
Natalie Jayaram ◽  
Harlan M Krumholz ◽  
Sarwat I Chaudhry ◽  
Jennifer Mattera ◽  
Fengming Tang ◽  
...  

Background: Although telemonitoring in patients with heart failure is not effective in reducing mortality or hospitalizations, less is known regarding its effect on patients’ health status, their symptoms, functioning and quality of life. Methods: The TeleHF study randomized 1,653 patients with recent heart failure hospitalization to telephonic monitoring (n=826) or usual care (n=827). Patients in the telemonitoring arm phoned in daily and responded to a series of automated questions regarding their symptoms and daily weight. Health status information, using the Kansas City Cardiomyopathy Questionnaire (KCCQ), was collected at baseline, 3 months, and at 6 months. The primary endpoint was change in KCCQ score from baseline to 3 and 6 months. Results: The baseline characteristics of the two treatment arms were similar; 42% were female and 39% were black. At baseline, there were no significant differences in KCCQ scores between the telemedicine and the usual care group. Both groups reported significant quality of life limitations with median KCCQ score of 59.9, and median scores of 75.0, 87.5 and 56.3 on the physical limitation, self-efficacy and social limitation subscales respectively. At 3 and 6 month follow-up, there were no significant differences between the two treatment groups with respect to the primary endpoint, change in KCCQ overall summary score or subscale scores from baseline (see table). Conclusion: Telemonitoring in a large group of patients with heart failure did not improve health status when compared to usual care. Failure to improve readmission or mortality rates combined with lack of effect on quality of life suggests that alternative solutions for management of this complex population should be sought.


BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053216
Author(s):  
Raül Rubio ◽  
Beatriz Palacios ◽  
Luis Varela ◽  
Raquel Fernández ◽  
Selene Camargo Correa ◽  
...  

ObjectivesTo gather insights on the disease experience of patients with heart failure (HF) with reduced ejection fraction (HFrEF), and assess how patients’ experiences and narratives related to the disease complement data collected through standardised patient-reported outcome measures (PROMs). Also, to explore new ways of evaluating the burden experienced by patients and caregivers.DesignObservational, descriptive, multicentre, cross-sectional, mixed-methods study.SettingSecondary care, patient’s homes.ParticipantsTwenty patients with HFrEF (New York Heart Association (NYHA) classification I–III) aged 38–85 years.MeasuresPROMs EuroQoL 5D-5L (EQ-5D-5L) and Kansas City Cardiomyopathy Questionnaire and patient interview and observation.ResultsA total of 20 patients with HFrEF participated in the study. The patients’ mean (SD) age was 72.5 (11.4) years, 65% were male and were classified inNYHA functional classes I (n=4), II (n=7) and III (n=9). The study showed a strong impact of HF in the patients’ quality of life (QoL) and disease experience, as revealed by the standardised PROMs (EQ-5D-5L global index=0.64 (0.36); Kansas City Cardiomyopathy Questionnaire total symptom score=71.56 (20.55)) and the in-depth interviews. Patients and caregivers often disagreed describing and evaluating perceived QoL, as patients downplayed their limitations and caregivers overemphasised the poor QoL of the patients. Patients related current QoL to distant life experiences or to critical moments in their disease, such as hospitalisations. Anxiety over the disease progression is apparent in both patients and caregivers, suggesting that caregiver-specific tools should be developed.ConclusionsPROMs are an effective way of assessing symptoms over the most recent time period. However, especially in chronic diseases such as HFrEF, PROM scores could be complemented with additional tools to gain a better understanding of the patient’s status. New PROMs designed to evaluate and compare specific points in the life of the patient could be clinically more useful to assess changes in health status.


JAMA ◽  
2020 ◽  
Vol 324 (15) ◽  
pp. 1512 ◽  
Author(s):  
Paul W. Armstrong ◽  
Carolyn S. P. Lam ◽  
Kevin J. Anstrom ◽  
Justin Ezekowitz ◽  
Adrian F. Hernandez ◽  
...  

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