Adjuvant Hormonotherapy and Cardiovascular Risk in Post-Menopausal Women with Breast Cancer: A Large Population-Based Cohort Study.

BACKGROUND: Whether aromatase inhibitors (AIs) increase the risk of cardiovascular (CV) events, compared to tamoxifen, in women with breast cancer is still debated. We evaluated the association between AI and CV outcomes in a large population-based cohort of breast cancer women. METHODS: By using healthcare utilization databases of Lombardy (Italy), we identified women ≥50 years, with new diagnosis of breast cancer between 2009 and 2015, who started adjuvant therapy with either AI or tamoxifen. We estimated the association between exposure to AI and CV outcomes (including myocardial infarction, ischemic stroke, heart failure or any CV event) by a Cox proportional hazard model with inverse probability of treatment and censoring weighting. RESULTS: The study cohort included 26,009 women starting treatment with AI and 7937 with tamoxifen. Over a median follow-up of 5.8 years, a positive association was found between AI and heart failure (Hazard Ratio = 1.20, 95% CI: 1.02 to 1.42) and any CV event (1.14, 1.00 to 1.29). The CV risk increased in women with previous CV risk factors, including hypertension, diabetes and dyslipidemia. CONCLUSIONS: Adjuvant therapy with AI in breast cancer women aged more than 50 years is associated with increased risk of heart failure and combined CV events.

Risk of adverse events in gastrointestinal endoscopy: Zero-inflated Poisson regression mixture model for count data and multinomial logit model for the type of event.

BACKGROUND AND AIMS: We analyze the possible predictive variables for Adverse Events (AEs) during sedation for gastrointestinal (GI) endoscopy. METHODS: We consider 23,788 GI endoscopies under sedation on adults between 2012 and 2019. A Zero-Inflated Poisson Regression Mixture (ZIPRM) model for count data with concomitant variables is applied, accounting for unobserved heterogeneity and evaluating the risks of multi-drug sedation. A multinomial logit model is also estimated to evaluate cardiovascular, respiratory, hemorrhagic, other AEs and stopping the procedure risk factors. RESULTS: In 7.55% of cases, one or more AEs occurred, most frequently cardiovascular (3.26%) or respiratory (2.77%). Our ZIPRM model identifies one population for non-zero counts. The AE-group reveals that age >75 years yields 46% more AEs than age <66 years; Body Mass Index (BMI) ≥27 27% more AEs than BMI <21; emergency 11% more AEs than routine. Any one-point increment in the American Society of Anesthesiologists (ASA) score and the Mallampati score determines respectively a 42% and a 16% increment in AEs; every hour prolonging endoscopy increases AEs by 41%. Regarding sedation with propofol alone (the sedative of choice), adding opioids to propofol increases AEs by 43% and adding benzodiazepines by 51%. Cardiovascular AEs are increased by age, ASA score, smoke, in-hospital, procedure duration, midazolam/fentanyl associated with propofol. Respiratory AEs are increased by BMI, ASA and Mallampati scores, emergency, in-hospital, procedure duration, midazolam/fentanyl associated with propofol. Hemorrhagic AEs are increased by age, in-hospital, procedure duration, midazolam/fentanyl associated with propofol. The risk of suspension of the endoscopic procedure before accomplishment is increased by female gender, ASA and Mallampati scores, and in-hospital, and it is reduced by emergency and procedure duration. CONCLUSIONS: Age, BMI, ASA score, Mallampati score, in-hospital, procedure duration, other sedatives with propofol increase the risk for AEs during sedation for GI endoscopy.

Effects of SARS-CoV-2 pandemic on follow-up and pharmacological treatment of chronic diseases in undocumented migrants.

BACKGROUND: All over the world, the COVID-19 pandemic, not unlikely other epidemics, has hit harder people in low socioeconomic conditions.In Western countries, undocumented migrants are a growing component of this disadvantaged segment of the population.Their health conditions are frequently burdened by a number of chronic conditions, and they experience many difficulties in accessing public health services. Frequently, the only medical assistance they can get is provided by non-governmental organisations. METHODS: We studied the medical records (including pharmacological treatments) of all patients attending the outpatient clinics of Opera San Francesco (OSF; a big charity in Milano, Italy), in the first 5 months of 2020. These comprise the outbreak of the pandemic and the lockdown period. The 1914 patients (1814 undocumented migrants and 100 Italians) seen during the lockdown were compared with those seen in the same period of 2019 and with those seen in the preceding months of 2020. We especially focused on three chronic conditions: cardiovascular diseases, diabetes and psychiatric disorders. RESULTS: The number of consultations during the first 5 months of 2020 was much smaller than that of the same period of 2019. During the lockdown, we found 4048 consultations for 1914 patients, while they were 8051 in the same period of 2019 and 5681 in the first 2 months of 2020.The quantity of medicines dispensed by OSF showed a marked decrease in the period of the study and mainly during the lockdown.The decrease in consultations and dispensation of medicines was most evident for psychiatric patients and almost not existent for patients with diabetes. Female patients suffered a more pronounced reduction. CONCLUSIONS: Western countries need strategies to better assist the very poor during epidemics.Differences among different groups of disadvantaged persons should be taken into account when designing recovery plans.

Effectiveness and Healthcare Cost of Adding Trastuzumab to Standard Chemotherapy for First-Line Treatment of Metastatic Gastric Cancer: A Population-Based Cohort Study.

A randomized clinical trial showed that trastuzumab, added to traditional chemotherapy, significantly improved overall survival in human epidermal growth factor receptor 2 (HER2)-overexpressing metastatic gastric cancer patients. This population-based study aimed at evaluating both the clinical and economic impact of trastuzumab in a real-world setting. By using the healthcare utilization databases of Lombardy, Italy, a cohort of patients newly diagnosed with metastatic gastric cancer during the period 2011-2016 was selected. Among these, patients initially treated with either trastuzumab-based chemotherapy or standard chemotherapy alone were followed up until death, migration in other regions or June 2018. Overall survival and average cumulative costs were estimated and compared between the two treatment arms. Among the 1198 metastatic gastric cancer patients who started therapy within six months after metastasis detection, 87 were initially treated with trastuzumab-based chemotherapy and 1111 with standard chemotherapy. Median overall survival and restricted mean survival were 10.2 and 7.4 months, and 14.9 and 11.4 months, respectively, in the two treatment arms. The adjusted hazard ratio of death was 0.73 (95% CI 0.57-0.93). The average per capita cumulative healthcare costs were, respectively, EUR 39,337 and 26,504, corresponding to an incremental cost-effectiveness ratio of EUR 43,998 for each year of survival gained. Our study shows that adding trastuzumab to conventional chemotherapy is effective and cost-effective.