Cardiovascular mortality and morbidity burden in successive and age pre-stratified case-control cohorts of breast cancer women. A population-based study.

AIMS: To assess the existence, components and clinical relevance of cardiac causes of death and cardiovascular (CV) hospitalizations in a population-wide database of patients with breast cancer (BC). METHODS AND RESULTS: A population-wide database of the Puglia Region, Italy was analyzed, with a prospective comparative design. Three successive closely matched case/control cohorts representing current care in the period 2007-2014 were also stratified according to age to focus specifically on the potential interaction of treatment-related cardiac toxicity and the expected different baseline CV risk profiles. RESULTS: At 3-year follow-up, in the successive cohorts the incidence of BC-related (7.7, 7.0, 6.5%) and cardiac causes of death, specifically attributed to heart failure (HF, 1.3, 0.5, 0.5%), decreased. Significant mortality hazard ratio (HR) for HF was found in the total population (1.47, 95% CI 1.14-1.90), in particular in the 2007-2009 cohort (1.71, 95% CI 1.19-2.46) and in the 50-69 age group (7.96, 95% CI 2.81-22.55). Results at 5 years confirm the mortality findings, and a significant HR for hospitalizations for HF, non-atrial arrhythmias and ischemic heart disease in the younger than 50 subpopulation pointed to a late expression of toxicity in the youngest BC population. CONCLUSIONS: The incidence of CV causes of death 3 and 5 years after BC diagnosis was very low, even if an excess in risk of death for HF as compared with the control cohort was observed. While younger patients seems to tolerate BC and BC therapy better in the short term, HF mortality and morbidity resulted significantly increased at 5-year follow-up. As the risk for hospitalization for CV reasons increased at 5-year follow-up in particular in women aged less than 50 years, CV monitoring in this subgroup of patients seems mandatory.

The effects of the introduction of a chronic care model-based program on utilization of healthcare resources: the results of the Puglia care program.

BACKGROUND: Ageing is continuously increasing the prevalence of patients with chronic conditions, putting pressure on the sustainability of Healthcare Systems. Chronic Care Models (CCM) have been used to address the needs of frail people in the continuum of care, testifying to an improvement in health outcomes and more efficient access to healthcare services. The impact of CCM deployment has already been experienced in a selected cohort of patients affected by specific chronic illnesses. We have investigated its effects in a heterogeneous frail cohort included in a regional CCM-based program. METHODS: a retrospective population-based cohort study was carried out involving a non-oncological cohort of adult subjects with chronic diseases included in the CCM-oriented program (Puglia Care). Individuals in usual care with comparable demographic and clinical characteristics were selected for matched pair analysis. Study cohorts were defined by using a record linkage analysis of administrative databases and electronic medical records, including data on the adult population in the 6 local area health authorities of Puglia in Italy (approximately 2 million people). The effects of Puglia Care on the utilizations of healthcare resources were evaluated both in a before-after and in a case-control analysis. RESULTS: There were 1074 subjects included in Puglia Care and 2126 matched controls. In before-after analysis of the Puglia Care cohort, 240 unplanned hospitalizations occurred in the pre-inclusion period, while 239 were registered during follow-up. The incidence of unplanned hospitalization was 10.3 per 100 person/year (95% CI, 9.1-11.7) during follow-up and 12.1 per 100 person/year (95% CI, 10.7-13.8) in the pre-inclusion period (IRR, 0.84; 95% CI, 0.80-0.99). During follow-up a significant reduction in costs related to unplanned hospitalizations (IRR, 0.92; 95% CI, 0.91-0.92) was registered, while costs related to drugs (IRR, 1.14; p < 0.01), out-patient specialist visits (IRR, 1.19; p < 0.01), and planned hospitalization (IRR 1.03; p < 0.01) increased significantly. These modifications can be related to the aging of the population and modifications to healthcare delivery; for this reason, a case-control analysis was performed. The results testify to a significantly lower number (IRR, 0.79; 95% CI, 0.68-0.91), length of hospital stay (IRR, 0.80; 95% CI, 0.76-0.84), and costs related to unplanned hospitalizations (IRR, 0.80; 95% CI, 0.80-0.80) during follow-up in the intervention group. However, there was a higher increase in costs of hospitalizations, drugs and out-patients specialist visits during follow-up in Puglia Care when compared with patients in usual care. CONCLUSION: In a population-based cohort, inclusion of chronic patients in a CCM-based program was significantly associated with a lower recourse to unplanned hospital admissions when compared with patients in usual care with comparable clinical and demographic characteristics.

Treatment with insulin is associated with worse outcome in patients with chronic heart failure and diabetes.

AIMS: Up to one-third of patients with diabetes mellitus and heart failure (HF) are treated with insulin. As insulin causes sodium retention and hypoglycaemia, its use might be associated with worse outcomes. METHODS AND RESULTS: We examined two datasets: 24 012 patients with HF from four large randomized trials and an administrative database of 4 million individuals, 103 857 of whom with HF. In the former, survival was examined using Cox proportional hazards models adjusted for baseline variables and separately for propensity scores. Fine-Gray competing risk regression models were used to assess the risk of hospitalization for HF. For the latter, a case-control nested within a population-based cohort study was conducted with propensity score. Prevalence of diabetes mellitus at study entry ranged from 25.5% to 29.5% across trials. Insulin alone or in combination with oral hypoglycaemic drugs was prescribed at randomization to 24.4% to 34.5% of the patients with diabetes. The rates of death from any cause and hospitalization for HF were higher in patients with vs. without diabetes, and highest of all in patients prescribed insulin [propensity score pooled hazard ratio for all-cause mortality 1.27 (1.16-1.38), for HF hospitalization 1.23 (1.13-1.33)]. In the administrative registry, insulin prescription was associated with a higher risk of all-cause death [odds ratio (OR) 2.02, 95% confidence interval (CI) 1.87-2.19] and rehospitalization for HF (OR 1.42, 95% CI 1.32-1.53). CONCLUSIONS: Whether insulin use is associated with poor outcomes in HF should be investigated further with controlled trials, as should the possibility that there may be safer alternative glucose-lowering treatments for patients with HF and type 2 diabetes mellitus.