F Calado

Epidemiology of heart failure in Germany: a retrospective database study

BackgroundChronic heart failure (HF) is associated with significant healthcare expenditure, morbidity, and mortality. This study investigated the epidemiology of HF in Germany.MethodsThis retrospective study used anonymous healthcare claims data from the German Health Risk Institute on individuals with statutory health insurance. Patients with uninterrupted data from 1 January 2009 to 31 December 2013 or death (whichever occurred first), and ≥2 recorded HF-related diagnoses in 2011, were included. Patients with newly diagnosed HF were identified. Patients were followed up for 2xa0years from first diagnosis.ResultsOf 3,132,337 eligible patients, 123,925 (55.0% women; mean age 76.2xa0years) had HF: a prevalence of 3.96%. Of these, 26,368 had newly diagnosed HF: an incidence of 655/100,000 persons at risk. Incidence increased with age and was similar regardless of sex. During follow-up, there were 48,159 hospital admissions among newly diagnosed patients (1.8 hospitalizations/patient/2 years); HF accounted for 6% of these. Additionally, 20,148 patients (16.3%) overall and 5983 newly diagnosed patients (22.7%) died. Most new cases of HF were diagnosed by office-based physicians (63.2%); new cases among hospital inpatients were predominantly diagnosed by internal medicine specialists (70.7%). Overall, 94.0% received their initial prescription for HF treatment from a family practitioner.ConclusionsThe high prevalence and incidence observed in this representative sample emphasize the burden of HF in Germany. Substantial hospitalization rates and mortality highlight the need for early diagnosis and appropriate treatment, and for close cooperation between physician specialties and healthcare sectors.

Treatment of chronic heart failure in Germany: a retrospective database study

BackgroundAdherence to treatment guidelines affects outcomes in patients with chronic heart failure (HF). We investigated patient pathways and treatment patterns for HF in Germany.MethodsThis retrospective study used anonymous healthcare claims data from the German Health Risk Institute on individuals with statutory health insurance. Patients with uninterrupted data from 1 January 2009 to 31 December 2013 or death (whichever occurred first), and ≥2 recorded HF-related diagnoses in 2011, were included. Patients with newly diagnosed HF were identified. Use of treatment patterns recommended by the European Society of Cardiology (2008) and German Nationale VersorgungsLeitlinien (2011) guidelines was evaluated.ResultsOf 123,925 patients with HF, 21.3% were newly diagnosed. Overall, 63.2% of new HF diagnoses were made in the ambulatory setting; 61.6% of these were made by family practitioners and 14.8% by cardiologists. In the ambulatory setting, family practitioners were primarily responsible for treatment; specialists in internal medicine (70.3% cardiologists) were mainly responsible for performing HF-related technical diagnostics. One-fifth (20.9%) of patients received a New York Heart Association (NYHA) classification; 45.1% of these received a guideline-based treatment pattern. Application of the recommended treatment pattern decreased with advancing disease severity (NYHA class IV: 21.1% application) and older age (≥90xa0years: 28.3% application).ConclusionsFamily practitioners play a key role in the diagnosis and initial treatment of HF in Germany. A substantial proportion of patients do not receive guideline-recommended pharmacotherapy. These findings should be reflected in the planning of national disease management programmes.

Preferences and Stated Adherence for Antibiotic Treatment of Cystic Fibrosis Pseudomonas Infections

ObjectiveOur objective was to quantify preferences and stated adherence for inhaled antibiotic treatments in cystic fibrosis (CF).MethodsAdult CF patients and parents of pediatric patients in the US who were members of the Cystic Fibrosis Foundation and who had Pseudomonas aeruginosa at least twice a year completed an online, discrete-choice experiment survey (response rate 4.4xa0%). Respondents answered five treatment-choice questions evaluating pairs of hypothetical CF treatment profiles. Stated-adherence questions followed two randomly selected treatment-choice questions. Data were analyzed using random-parameters logit (RPL). For a combination of attribute levels, the utility is estimated by summing the relevant attribute-level parameter estimates. For the stated-adherence questions, we tabulated the changes in the percentages of respondents who would be 95xa0% adherent for various changes in inhaled antibiotic-medication administration features.ResultsThe final sample was 271 adult patients and 209 parents. Switching from a 30-min nebulizer twice daily to a 10-min dry powder inhaler (DPI) twice daily was 6.3 times more important for patients and 2.0 times more important for parents than an improvement in dry cough side effect from moderate to mild. Stated adherence for respondents was 20–30xa0% greater for DPIs versus nebulizers.ConclusionsLower frequency of administration, shorter administration times for a given device, and milder dry cough appear to improve stated adherence to antibiotic treatment of CF lung infections.

Cost-effectiveness of metformin plus vildagliptin compared with metformin plus sulphonylurea for the treatment of patients with type 2 diabetes mellitus: a Portuguese healthcare system perspective

Abstract Objective: To evaluate the cost-effectiveness of vildagliptin plus metformin vs generic sulphonylurea plus metformin in patients with type 2 diabetes mellitus, not controlled with metformin, from a Portuguese healthcare system perspective. Methods: A cost-effectiveness model was constructed using risk equations from the UK Prospective Diabetes Study Outcomes Model with a 10,000-patient cohort and a lifetime horizon. The model predicted microvascular and macrovascular complications and mortality in yearly cycles. Patients entered the model as metformin monotherapy failures and switched to alternative treatments (metformin plus basal-bolus insulin and subsequently metformin plus intensive insulin) when glycated hemoglobin A1c >7.5% was reached. Baseline patient characteristics and clinical variables were derived from a Portuguese epidemiological study. Cost estimates were based on direct medical costs only. One-way and probabilistic sensitivity analyses were conducted to test the robustness of the model. Results: There were fewer non-fatal diabetes-related adverse events (AEs) in patients treated with metformin plus vildagliptin compared with patients treated with metformin plus sulphonylurea (6752 vs 6815). Addition of vildagliptin compared with sulphonylurea led to increased drug acquisition costs but reduced costs of AEs, managing morbidities, and monitoring patients. Treatment with metformin plus vildagliptin yielded a mean per-patient gain of 0.1279 quality-adjusted life years (QALYs) and a mean per-patient increase in total cost of €1161, giving an incremental cost-effectiveness ratio (ICER) of €9072 per QALY. Univariate analyses showed that ICER values were robust and ranged from €4195 to €16,052 per QALY when different parameters were varied. Limitations: The model excluded several diabetes-related morbidities, such as peripheral neuropathy and ulceration, and did not model second events. Patients were presumed to enter the model with no diabetes-related complications. Conclusion: Treatment with metformin plus vildagliptin compared with metformin plus sulphonylurea is expected to result in a lower incidence of diabetes-related AEs and to be a cost-effective treatment strategy.

Early insights into the characteristics and evolution of clinical parameters in a cohort of patients prescribed sacubitril/valsartan in Germany

ABSTRACT Objectives: This study aimed to provide early insights into sacubitril/valsartan (sac/val) prescription patterns and the demographic and clinical characteristics of patients prescribed sac/val in primary care and cardiology settings in Germany. Methods: The study used electronic medical records from the German IMS® Disease Analyzer database. Patients with ≥1 prescription for sac/val during 1 January–31 December 2016 (n = 1643) were identified and followed up for ≤12 months from first prescription. Patients with ≥1 heart failure (HF) diagnosis during the study period, ≥1 additional HF diagnosis in the full history of the database, and ≥1 prescription for an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and a β-blocker during the study period, without a prescription for sac/val (n = 25,264), were included as a reference cohort. Changes in clinical parameters in the 12 months before and after sac/val initiation were investigated and compared with those from the PARADIGM-HF study. Results: The characteristics of patients prescribed sac/val more closely resembled those of patients enrolled in PARADIGM-HF (e.g. younger age, higher proportion of men than women, lower systolic blood pressure) than patients in the reference cohort. Most patients were initiated on the lowest dose of sac/val irrespective of clinical setting. Significant decreases (p < 0.001) in NT-proBNP and glycated haemoglobin levels were observed following sac/val initiation. Conclusions: Patients prescribed sac/val had similar baseline demographics and clinical characteristics to those from PARADIGM-HF, and most patients were initiated on the lowest dose. Changes in clinical parameters before and after initiation mirrored findings from the PARADIGM-HF study.

Psychometric Validation of the Heart Failure Caregiver Questionnaire (HF-CQ ® )

BackgroundThe Heart Failure Caregiver Questionnaire (HF-CQ®) was developed to assess subjective outcomes of heart failure caregivers. The HF-CQ® comprises 21 questions on three domains, namely physical, emotional/psychological and lifestyle. The objective of this study was to evaluate the psychometric properties of the HF-CQ®.MethodsPatients (nxa0=xa0150) with heart failure and their primary caregivers (nxa0=xa0150) were recruited from 11 sites in USA. Caregivers completed the HF-CQ® and additional questionnaires, namely Caregiver Reaction Assessment, Work Productivity and Activity Impairment questionnaire, EuroQol-5 domain, and the Hospital Anxiety and Depression Scale. Patient-completed Global Impression of Severity, construct validity, concurrent validity, reliability and responsiveness of the HF-CQ® were also assessed.ResultsIn the physical and lifestyle domains, all items showed acceptable validity. No high correlations between HF-CQ® scores and other caregiver-completed instruments, including the Hospital Anxiety and Depression Scale, Work Productivity and Activity Impairment questionnaire, EuroQol-5 domain or Caregiver Reaction Assessment, were reported. The intra-class correlation coefficient exceeded the threshold for reliability (>0.7) across the physical well-being (0.785), emotional/psychological (0.797), lifestyle (0.787) and total scores (0.850), indicating acceptable reliability. Internal consistency results using Cronbach’s alpha showed the total aggregate score of 0.942 to be reliable. In the responsiveness analyses, each of the three scales and the total score showed responsiveness to changes defined by the Caregiver Global Impression of Severity. The overall caregiver burden score increased with increased severity of illness in the cared-for patients.ConclusionsThe study provides initial evidence for the acceptable validity of the HF-CQ® as an instrument to measure heart failure caregiver burden.

Characteristics of early sacubitril/valsartan patients and considerations for studies in electronic health record data

AIMnWe examined characteristics of early sacubitril/valsartan users in a large US electronic health records database.nnnPATIENTS & METHODSnWe identified three cohorts of patients with heart failure (HF): sacubitril/valsartan patients with a prior HF diagnosis; patients with HF with reduced ejection fraction; and patients with HF treated with an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker and a β-blocker.nnnRESULTSnSacubitril/valsartan patients were younger than patients in the other cohorts; the mean age of sacubitril/valsartan patients increased by 2 years in the first 15 months of marketing. Most sacubitril/valsartan patients had prior use of HF treatment.nnnCONCLUSIONnOverall, sacubitril/valsartan patients resembled those in the HF with reduced ejection fraction cohort, and commonly used other drugs for HF.

Burden of heart failure on patients from China: results from a cross-sectional survey

Purpose Little evidence exists on the burden that chronic heart failure (HF) poses specifically to patients in China. The objective of this study, therefore, was to describe the burden of HF on patients in China. Materials and methods A cross-sectional survey of cardiologists and their patients with HF was conducted. Patient record forms were completed by 150 cardiologists for 10 consecutive patients. Patients for whom a patient record form was completed were invited to complete a patient questionnaire. Results Most of the 933 patients (mean [SD] age 65.8 [10.2] years; 55% male; 80% retired) included in the study received care in tier 2 and 3 hospitals in large cities. Patients gave a median score of 4 on a scale from 1 (no disruption) to 10 (severe disruption) to describe how much HF disrupts their everyday life. Patients in paid employment (8%) missed 10% of work time and experienced 29% impairment in their ability to work due to HF in the previous week. All aspects of patients’ health-related quality of life (QoL) were negatively affected by their condition. Mean ± SD utility calculated by the 3-level 5-dimension EuroQol questionnaire was 0.8±0.2, and patients rated their health at 70.3 (11.5) on a 100 mm visual analog scale. Patients incurred costs associated with HF treatment, travel, and professional caregiving services. Conclusion HF is associated with poor health-related QoL and considerable disruption in patients’ lives. Novel and improved therapies are needed to reduce the burden of HF on patients and the health care system.

Burden of heart failure on caregivers in China: results from a cross-sectional survey

Purpose Family and friends play a pivotal role in caring for patients with heart failure (HF); however, evidence of the impact of caregiving is limited. The objectives of this study were to describe the burden of caregiving on informal caregivers of patients with chronic HF in China. Materials and methods A cross-sectional survey of cardiologists, their patients with HF, and those patients’ caregivers was conducted. Patient record forms were completed by 150 cardiologists for 10 consecutive patients. Caregivers of these patients were invited to complete a questionnaire. Results Overall, 458 caregivers completed a questionnaire (mean ± standard deviation age 60.1±10.6 years; 60% female; 77% spouses; 74% retired). Caregivers spent a mean of 24.5 (16.9) hours caregiving per week, and a third reported a reduction in their social activity, time for themselves, or time for family. Caregivers in employment took several days off work in the past 3 months owing to caregiving, sometimes resulting in reduced income. Up to 79% of caregivers reported an impact on their physical or emotional well-being, and 57% reported deterioration in their objective health status. Inconsistencies stemming from differences in the three-level five-dimension EuroQol questionnaire and HF Caregiver Questionnaire were observed for the impact of caregiving on caregivers’ health-related quality of life. Conclusion Assisting patients with HF is associated with caregiver burden. Addressing the needs of caregivers may help to promote their continued support and improve patient outcomes.