Quantitative effects of sodium–glucose cotransporter-2 inhibitors dapagliflozin and empagliflozin on quality of life in heart failure patients

Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure in patients regardless of the presence or absence of diabetes. More evidence is needed regarding the effects of these drugs in patients across the broad spectrum of heart failure, including those with a markedly reduced ejection fraction.

Summary Background Large-scale and contemporary population-based studies of heart failure incidence are needed to inform resource planning and research prioritisation but current evidence is scarce. We aimed to assess temporal trends in incidence and prevalence of heart failure in a large general population cohort from the UK, between 2002 and 2014. Methods For this population-based study, we used linked primary and secondary electronic health records of 4 million individuals from the Clinical Practice Research Datalink (CPRD), a cohort that is representative of the UK population in terms of age and sex. Eligible patients were aged 16 years and older, had contributed data between Jan 1, 2002, and Dec 31, 2014, had an acceptable record according to CPRD quality control, were approved for CPRD and Hospital Episodes Statistics linkage, and were registered with their general practice for at least 12 months. For patients with incident heart failure, we extracted the most recent measurement of baseline characteristics (within 2 years of diagnosis) from electronic health records, as well as information about comorbidities, socioeconomic status, ethnicity, and region. We calculated standardised rates by applying direct age and sex standardisation to the 2013 European Standard Population, and we inferred crude rates by applying year-specific, age-specific, and sex-specific incidence to UK census mid-year population estimates. We assumed no heart failure for patients aged 15 years or younger and report total incidence and prevalence for all ages (>0 years). Findings From 2002 to 2014, heart failure incidence (standardised by age and sex) decreased, similarly for men and women, by 7% (from 358 to 332 per 100 000 person-years; adjusted incidence ratio 0·93, 95% CI 0·91–0·94). However, the estimated absolute number of individuals with newly diagnosed heart failure in the UK increased by 12% (from 170 727 in 2002 to 190 798 in 2014), largely due to an increase in population size and age. The estimated absolute number of prevalent heart failure cases in the UK increased even more, by 23% (from 750 127 to 920 616). Over the study period, patient age and multi-morbidity at first presentation of heart failure increased (mean age 76·5 years [SD 12·0] to 77·0 years [12·9], adjusted difference 0·79 years, 95% CI 0·37–1·20; mean number of comorbidities 3·4 [SD 1·9] vs 5·4 [2·5]; adjusted difference 2·0, 95% CI 1·9–2·1). Socioeconomically deprived individuals were more likely to develop heart failure than were affluent individuals (incidence rate ratio 1·61, 95% CI 1·58–1·64), and did so earlier in life than those from the most affluent group (adjusted difference −3·51 years, 95% CI −3·77 to −3·25). From 2002 to 2014, the socioeconomic gradient in age at first presentation with heart failure widened. Socioeconomically deprived individuals also had more comorbidities, despite their younger age. Interpretation Despite a moderate decline in standardised incidence of heart failure, the burden of heart failure in the UK is increasing, and is now similar to the four most common causes of cancer combined. The observed socioeconomic disparities in disease incidence and age at onset within the same nation point to a potentially preventable nature of heart failure that still needs to be tackled. Funding British Heart Foundation and National Institute for Health Research.

To create a valid, sensitive, disease-specific health status measure for patients with congestive heart failure (CHF). Quantifying health status is becoming increasingly important for CHF. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a new, self-administered, 23-item questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. To establish the performance characteristics of the KCCQ, two distinct patient cohorts were recruited: 70 stable and 59 decompensated CHF patients with ejection fractions of <40. Upon entry into the study, patients were administered the KCCQ, the Minnesota Living with Heart Failure Questionnaire and the Short Form-36 (SF-36). Questionnaires were repeated three months later. Convergent validity of each KCCQ domain was documented by comparison with available criterion standards (r = 0.46 to 0.74; p < 0.001 for all). Among those with stable CHF who remained stable by predefined criteria (n = 39), minimal changes in KCCQ domains were detected over three months of observation (mean change = 0.8 to 4.0 points, p = NS for all). In contrast, large changes in score were observed among patients whose decompensated CHF improved three months later (n = 39; mean change = 15.4 to 40.4 points, p < 0.01 for all). The sensitivity of the KCCQwas substantially greater than that of the Minnesota Living with Heart Failure and the SF-36 questionnaires. The KCCQis a valid, reliable and responsive health status measure for patients with CHF and may serve as a clinically meaningful outcome in cardiovascular research, patient management and quality assessment.