Adherence to GLP1-RA and SGLT2-I affects clinical outcomes and costs in patients with type 2 diabetes.

AIMS: To evaluate the impact of adherence to glucagon like peptide-1 receptor agonists (GLP1-RA) and sodium-glucose transporter two inhibitors (SGLT2-I) on clinical outcomes and costs in patients with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: The 121,115 residents of the Lombardy Region (Italy) aged ≥40 years newly treated with metformin during 2007-2015 were followed to identify those who started therapy with GLP1-RA or SGLT2-I. Adherence to drug therapy over the first year was defined as the proportion of days covered >80%. Within each drug class, for each adherent patient, one non-adherent patient was matched for age, sex, duration, adherence to metformin treatment and propensity score. The primary clinical outcome was a composite of insulin initiation, hospitalisation for micro- and macrovascular complications and all-cause mortality after the first year of drug treatment. Costs were evaluated based on reimbursements from the national healthcare system. RESULTS: After matching, 1182 pairs of adherent and non-adherent GLP1-RA users and 1126 pairs of adherent and non-adherent SGLT2-I users were included. In both groups, adherent patients experienced a significantly lower incidence of the primary outcome (HR: 0.85, 95% CI 0.72-0.98 for GLP1-RA and HR: 0.69, 95% CI 0.55-0.87 for SGLT2-I). A significant reduction in hospitalizations was found for adherent patients in the GLP1-RA group but not for the SGLT2-I group. Results were consistent when analyses were stratified by age and sex. While higher drug-related costs in the adherent group were counterbalanced by decreased hospitalisation costs in SGLT2-I treated patients, this was not the case for GLP1-RA. CONCLUSIONS: Higher adherence to drug treatment with GLP1-RA and SGLT2-I during the first year of the drug intake is associated with a lower incidence of adverse clinical outcomes in a real-world setting.

Time trends in liver-related mortality in people with and without diabetes: Results from a population based study.

CONTEXT: Patients with diabetes are at increased risk of dying from liver-related events, but little is known on whether this increased risk changed in recent years. OBJECTIVE: The aim of the present study is to describe time trends in cause-specific liver-related mortality in people with and without diabetes from the general Italian population. METHODS: Data were retrieved from the healthcare utilization databases of Lombardy, a region of Italy that accounts for about 16% (almost ten million) of its population. Annual cause-specific mortality rates and proportionate mortality were computed among individuals with and without diabetes from 2010 to 2019. Liver-related deaths were categorized as viral, alcohol related and non-viral non-alcohol related (NVNA). RESULTS: Liver diseases were responsible for 2% and 1% of deaths in people with and without diabetes (2019). Among patients with diabetes, the crude mortality rate for liver diseases decreased from 1.13 to 0.64 deaths per 1,000 person-years from 2010 to 2019. The largest proportion of liver-related deaths was attributable to NVNA diseases and it increased from 63% in 2010 to 68% in 2019, with a corresponding relative reduction of viral causes (from 27% to 23%). The Standardized Mortality Ratio for patients with diabetes was 3.35 (95% CI 2.96-3.76) for NVNA, 1.66 (95% CI 1.33-2.01) for viral hepatitis and 1.61 (95% CI 1.13-2.17) for alcoholic liver disease and it remained relatively stable over time. Excess mortality risk in patients with diabetes for liver-related mortality was higher than for cardiovascular mortality and cancer. CONCLUSION: While liver-related mortality rates decreased significantly among patients with diabetes, NVNA causes comprised the majority of cases. Excess mortality for liver-related causes in patients with diabetes compared with controls remained constant in the studied period.

Patients' Radiation Exposure During Endovascular Abdominal Aortic Aneurysm Repair.

BACKGROUND: To investigate associations between patient characteristics, intraprocedural complexity factors, and radiation exposure to patients during endovascular abdominal aortic aneurysm repair (EVAR). METHODS: Elective standard EVAR procedures between January 2015 and December 2020 were retrospectively analyzed. Patient characteristics and intraprocedural data (i.e., type of device, endograft configuration, additional procedures, and contralateral gate cannulation time [CGCT]) were collected. Dose area product (DAP) and fluoroscopy time were considered as measurements of radiation exposure. Furthermore, effective dose (ED) and doses to internal organs were calculated using PCXMC 2.0 software. Descriptive statistics, univariable, and multivariable linear regression were applied to investigate predictors of increased radiation exposure. RESULTS: The 99 patients were mostly male (90.9%) with a mean age of 74 ± 7 years. EVAR indications were most frequently abdominal aortic aneurysm (93.9%), penetrating aortic ulceration (2.0%), focal dissection (2.0%), or subacute rupture of infrarenal abdominal aortic aneurysm (2.0%). Median fluoroscopy time was 19.6 minutes (interquartile range [IQR], 14.1-29.4) and median DAP was 86,311 mGy cm2 (IQR, 60,160-130,385). Median ED was 23.2 mSv (IQR, 17.0-34.8) for 93 patients (93.9%). DAP and ED were positively correlated with body mass index (BMI) and CGCT. Kidneys, small intestine, active bone marrow, colon, and stomach were the organs that received the highest equivalent doses during EVAR. Higher DAP and ED values were observed using the Excluder endograft, other bi- and tri-modular endografts, and EVAR with ≥2 additional procedures. Multivariable linear regression analysis revealed that BMI, ≥2 additional procedures during EVAR, and CGCT were independent positive predictors of DAP and ED levels after accounting for endograft type. CONCLUSIONS: Patient-related and procedure-related factors such as BMI, ≥2 additional procedures during EVAR, and CGCT resulted predictors of radiation exposure for patients undergoing EVAR, as quantified by higher DAP and ED levels. The main intraprocedural factor that increased radiation exposure was CGCT. These data can be of importance for better managing radiation exposure during EVAR.

Adherence and related cardiovascular outcomes to single pill vs. separate pill administration of antihypertensive triple-combination therapy.

OBJECTIVE: To compare adherence to antihypertensive treatment between patients prescribed a three-drug single-pill combination (SPC) of perindopril/amlodipine/indapamide (P/A/I) vs. the combination of an angiotensin-converting enzyme inhibitor (ACEI), a calcium-channel blocker (CCB), and a diuretic (D) as a two-drug SPC plus a third drug given separately. METHODS: Using the healthcare utilization database of the Lombardy Region (Italy), the 28 210 patients, aged at least 40 years, who were prescribed P/A/I SPC during 2015-2018 were identified and the date of the first prescription was defined as the index date. For each patient prescribed the SPC, a comparator who started ACEI/CCB/D treatment as a two-pill combination was considered. Adherence to the triple combination was assessed over the year after the index date as the proportion of the follow-up days covered by prescription (PDC). Patients who had a PDC >75% were defined as highly adherent to drug therapy. Log-binomial regression models were fitted to estimate the risk ratio of treatment adherence in relation to the drug treatment strategy. RESULTS: About 59 and 25% of SPC and two-pill combination users showed high adherence, respectively. Compared with patients under a three-drug two-pill combination, those who were treated with the three-drug SPC had a higher propensity to be highly adherent to the triple combination (2.38, 95% confidence interval: 2.32-2.44). This was the case regardless of the sex, age, comorbidities, and number of co-treatments. CONCLUSIONS: In a real-life setting, patients under three-drug SPC exhibited more frequently a high adherence to antihypertensive treatment than those prescribed a three-drug two-pill combination.

Capturing the variety of clinical pathways in patients with schizophrenic disorders through state sequences analysis.

BACKGROUND: Care pathways are increasingly being used to enhance the quality of care and optimize the use of resources for health care. Nevertheless, recommendations regarding the sequence of care are mostly based on consensus-based decisions as there is a lack of evidence on effective treatment sequences. In a real-world setting, classical statistical tools were insufficient to consider a phenomenon with such high variability adequately and have to be integrated with novel data mining techniques suitable for identifying patterns in complex data structures. Data-driven techniques can potentially support empirically identifying effective care sequences by extracting them from data collected routinely. The purpose of this study is to perform a state sequence analysis (SSA) to identify different patterns of treatment and to asses whether sequence analysis may be a useful tool for profiling patients according to the treatment pattern. METHODS: The clinical application that motivated the study of this method concerns the mental health field. In fact, the care pathways of patients affected by severe mental disorders often do not correspond to the standards required by the guidelines in this field. In particular, we analyzed patients with schizophrenic disorders (i.e., schizophrenia, schizotypal or delusional disorders) using administrative data from 2015 to 2018 from Lombardy Region. This methodology considers the patient's therapeutic path as a conceptual unit, composed of a succession of different states, and we show how SSA can be used to describe longitudinal patient status. RESULTS: We define the states to be the weekly coverage of different treatments (psychiatric visits, psychosocial interventions, and anti-psychotic drugs), and we use the longest common subsequences (dis)similarity measure to compare and cluster the sequences. We obtained three different clusters with very different patterns of treatments. CONCLUSIONS: This kind of information, such as common patterns of care that allowed us to risk profile patients, can provide health policymakers an opportunity to plan optimum and individualized patient care by allocating appropriate resources, analyzing trends in the health status of a population, and finding the risk factors that can be leveraged to prevent the decline of mental health status at the population level.

Editor's Choice - Comparison of the Reproducibility of Ultrasound Calliper Placement Methods in Abdominal Aortic Diameter Measurements: A Systematic Review and Meta-Analysis of Diagnostic Test Accuracy Studies.

OBJECTIVE: To assess which ultrasound (US) method of maximum anteroposterior (AP) abdominal aortic diameter measurement can be considered most reproducible. DATA SOURCES: MEDLINE, Scopus, and Web of Science were searched (PROSPERO ID: 276694). Eligible studies reported intra- and or interobserver agreement according to Bland-Altman analysis (mean ± standard deviation [SD]) for abdominal aortic diameter AP US evaluations with an outer to outer (OTO), inner to inner (ITI), and or leading edge to leading edge (LELE) calliper placement. REVIEW METHODS: The Preferred Reporting Items for a Systematic Review and Meta-Analysis of Diagnostic Test Accuracy Studies statement was followed. The QUADAS-2 tool and QUADAS-C extension were used for risk of bias assessment and the GRADE framework to rate the certainty of evidence. Pooled estimates (fixed effects meta-analysis, after a test of homogeneity of means) for each US method were compared with pairwise one sided t tests. Sensitivity analyses (for studies published in 2010 or later) and meta-regression were also performed. RESULTS: 21 studies were included in the qualitative analysis. Twelve were eligible for quantitative analysis. Studies showed heterogeneity in the US model and transducer used, sex of participants, and observer professions, expertise, and training. Included studies shared a common mean for each US method (OTO: p = 1.0, ITI: p = 1.0, and LELE: p = 1.0). A pooled estimate of interobserver reproducibility for each US method was obtained, combining the mean ± SD (Bland-Altman analysis) from each study: OTO: 0.182 ± 0.440; ITI: 0.170 ± 0.554; and LELE: 0.437 ± 0.419. There were no statistically significant differences between the methods (OTO vs. ITI: p = .52, OTO vs. LELE: p = .069, ITI vs. LELE: p = .17). Considering studies published in 2010 and later, the pooled estimate for LELE was the smallest, without statistically significant differences between the methods. Despite the low risk of bias, the certainty of the evidence for both meta-analysed outcomes remained low. CONCLUSION: The interobserver reproducibility for OTO and ITI was 2.5 times smaller (indicating better reproducibility) than LELE; however, without statistically significant differences between the methods and low GRADE evidence certainty. Additional data are needed to validate these findings, while inherent differences between the methods need to be emphasised.

Adherence to antidiabetic drug therapy and reduction of fatal events in elderly frail patients.

BACKGROUND: To evaluate the protective effect of oral antidiabetic drugs in a large cohort of elderly patients with type 2 diabetes differing for age, clinical status, and life expectancy, including patients with multiple comorbidities and short survival. METHODS: A nested case-control study was carried out by including the cohort of 188,983 patients from Lombardy (Italy), aged ≥ 65 years, who received ≥ 3 consecutive prescriptions of antidiabetic agents (mostly metformin and other older conventional agents) during 2012. Cases were the 49,201 patients who died for any cause during follow-up (up to 2018). A control was randomly selected for each case. Adherence to drug therapy was measured by considering the proportion of days of the follow-up covered by the drug prescriptions. Conditional logistic regression was used to model the risk of outcome associated with adherence to antidiabetic drugs. The analysis was stratified according to four categories of the clinical status (good, intermediate, poor, and very poor) differing for life expectancy. RESULTS: There was a steep increase in comorbidities and a marked reduction of the 6-year survival from the very good to the very poor (or frail) clinical category. Progressive increase in adherence to treatment was associated with a progressive decrease in the risk of all-cause mortality in all clinical categories and at all ages (65-74, 75-84 and ≥ 85 years) except for the frail patient subgroup aged ≥ 85 years. The mortality reduction from lowest to highest adherence level showed a tendency to be lower in frail patients compared to the other categories. Similar although less consistent results were obtained for cardiovascular mortality. CONCLUSIONS: In elderly diabetic patients, increased adherence to antidiabetic drugs is associated with a reduction in the risk of mortality regardless of the patients' clinical status and age, with the exception of very old patients (age ≥ 85 years) in the very poor or frail clinical category. However, in the frail patient category the benefit of treatment appears to be less than in patients in good clinical conditions.

Detecting early signals of COVID-19 outbreaks in 2020 in small areas by monitoring healthcare utilisation databases: first lessons learned from the Italian Alert_CoV project.

BackgroundDuring the COVID-19 pandemic, large-scale diagnostic testing and contact tracing have proven insufficient to promptly monitor the spread of infections.AimTo develop and retrospectively evaluate a system identifying aberrations in the use of selected healthcare services to timely detect COVID-19 outbreaks in small areas.MethodsData were retrieved from the healthcare utilisation (HCU) databases of the Lombardy Region, Italy. We identified eight services suggesting a respiratory infection (syndromic proxies). Count time series reporting the weekly occurrence of each proxy from 2015 to 2020 were generated considering small administrative areas (i.e. census units of Cremona and Mantua provinces). The ability to uncover aberrations during 2020 was tested for two algorithms: the improved Farrington algorithm and the generalised likelihood ratio-based procedure for negative binomial counts. To evaluate these algorithms' performance in detecting outbreaks earlier than the standard surveillance, confirmed outbreaks, defined according to the weekly number of confirmed COVID-19 cases, were used as reference. Performances were assessed separately for the first and second semester of the year. Proxies positively impacting performance were identified.ResultsWe estimated that 70% of outbreaks could be detected early using the proposed approach, with a corresponding false positive rate of ca 20%. Performance did not substantially differ either between algorithms or semesters. The best proxies included emergency calls for respiratory or infectious disease causes and emergency room visits.ConclusionImplementing HCU-based monitoring systems in small areas deserves further investigations as it could facilitate the containment of COVID-19 and other unknown infectious diseases in the future.

The impact of renal denervation procedure on use of antihypertensive drugs in the real-life setting.

Purpose. Randomised controlled trials have shown that renal denervation lowers office and ambulatory blood pressure. The aim of the present study was to evaluate whether patients undergoing renal denervation procedure in a real-life setting have a reduction in antihypertensive drug prescription over the subsequent years.Material and methods. Using the healthcare utilisation database of the Lombardy Region (Italy), the 136 patients who, during the period 2011-2016, were prescribed four or more antihypertensive drugs and underwent renal denervation were included in the study cohort. The number and type of antihypertensive drugs were assessed over the year before and during the three-year period after renal denervation.Results. The median age of the patients was 67 years and 68% of them were men. Based on a multisource comorbidity score, about 40% of patients showed a poor or very poor clinical status. Before renal denervation, the majority of the patients were prescribed four or five antihypertensive drugs. The number of drugs decreased after the denervation and reached 55% after three years. Over the same period, patients prescribed six drugs decreased from 18% to 2%. All antihypertensive drugs were less prescribed throughout the post denervation period. Compared to the year before the denervation, after three years prescription of diuretics was reduced by 15%, calcium channel blockers by 21%, ACE-inhibitors by 32%, angiotensin receptor blockers by 22%, beta-blockers by 20%, and alfa-blockers by 30%. Use of antihypertensive drugs exhibited a reduction also in an age, sex, and clinically matched control group with no renal denervation to an extent, however, much lower than in denervated patients (p-value = 0.013).Conclusion. In the real-life setting, patients who underwent renal denervation had a clearcut reduction in antihypertensive drug prescription over the following years.Plain Language SummaryPatients exhibited a reduction in the prescription of antihypertensive drugs during the three years that followed the denervation procedureThe decrease in the number of antihypertensive drugs was marked, started after a relatively short time (six months), and involved all drugs prescribed before the denervationThe number of hospitalisations for a cardiovascular event was similar before and after renal denervationAlbeit blood pressure values were not recorded in our database, all these findings taken together suggest the renal denervation procedure has a favourable influence on blood pressure control and is not associated with an increase in the risk of major cardiovascular complications.

Use of initial and subsequent antihypertensive combination treatment in the last decade: analysis of a large Italian database.

OBJECTIVE: The aim of the study was to assess the use of antihypertensive combination treatment, both as the initial and as a subsequent therapeutic step, in a large Italian population. METHODS: The residents of the Lombardy Region (Italy), aged 40 years or older, who were newly treated with antihypertensive drugs during 2012, 2015 and 2018 were identified and the drug treatment strategy (monotherapy and combination of two, three and more than three antihypertensive drugs) was assessed at treatment initiation, and after 6 months, 1, 2, and 3 years of treatment. Data were also analysed after stratification for demographic and clinical categories. RESULTS: About 100 000 patients were identified for each cohort. Monotherapy was the most common initial treatment strategy (75%), followed by two-drug single-pill combination (16%), two-drug free combination (6%), and combination of at least three drugs (3%). Use of two and three or more antihypertensive drugs increased during follow-up and reached about 32% (two drugs) and 11% (>2 drugs) of the patients after 3 years from treatment initiation. Among patients prescribed a two-drug combination, the single-pill was the most common approach, whereas the use of the three-drug single-pill combination was extremely rare. There were no substantial differences in the use of combination treatment between the three cohorts and the results were similar in all demographic and clinical categories. CONCLUSION: Our data show that in a real-life population use of antihypertensive drug combinations is low. They also show that, contrary to guideline recommendations, antihypertensive combination treatment did not show any noticeable increase in recent years.

Emotion recognition and theory of mind weakness at school age in children born preterm.

BACKGROUND: Social immaturity and impaired social functioning are topical issues in recent research in the field of prematurity. Social-cognitive skills and emotional processing, the neuropsychological correlates underlying social behavior, are key aspects of these issues. METHODS: We examined 48 Italian primary school children who had been born preterm with a very low birthweight (26 males; mean age 9 years; SD 1.2). All had shown a normal neonatal cerebral ultrasound at term age, and showed a normal neurological examination and average IQ at the time of the study. Social skills and executive functions (EFs) and their correlations with a set of neonatal, sociodemographic, cognitive and adaptive parameters were investigated using standardized scales and questionnaires. RESULTS: Emotion recognition (ER) was impaired in 48% and Theory of Mind (ToM) in 8% of the children. These deficits showed no relationship with EFs or IQ, or with gestational age, birthweight, age or gender. Correlations between ER and socioeconomic status and between ToM and adaptive functioning were documented. CONCLUSIONS: We suggest that adaptive and behavioral problems in preterm children may be linked to neurocognitive dysfunction characterized by deficits in social skills, which may be driven by socioeconomic, family and environmental factors, socioeconomic status in particular. Possible neural circuitry impairments underlying these deficits are discussed.

Prolonged Use of Proton Pump Inhibitors and Risk of Type 2 Diabetes: Results From a Large Population-Based Nested Case-Control Study.

CONTEXT: It is still debated whether prolonged use of proton pump inhibitors (PPIs) might affect metabolic health. OBJECTIVE: To investigate the relationship between prolonged use of PPIs and the risk of developing diabetes. METHODS: We performed a case-control study nested into a cohort of 777 420 patients newly treated with PPIs between 2010 and 2015 in Lombardy, Italy. A total of 50 535 people diagnosed with diabetes until 2020 were matched with an equal number of controls that were randomly selected from the cohort members according to age, sex, and clinical status. Exposure to treatment with PPIs was assessed in case-control pairs based on time of therapy. A conditional logistic regression model was fitted to estimate the odds ratios and 95% CIs for the exposure-outcome association, after adjusting for several covariates. Sensitivity analyses were performed to evaluate the robustness of our findings. RESULTS: Compared with patients who used PPIs for < 8 weeks, higher odds of diabetes of 19% (95% CI, 15-24), 43% (38-49), and 56% (49-64) were observed among those who used PPIs for between 8 weeks and 6 months, 6 months and 2 years, and > 2 years, respectively. The results were consistent when analyses were stratified according to age, sex, and clinical profile, with higher odds ratios being found in younger patients and those with worse clinical complexity. Sensitivity analyses revealed that the association was consistent and robust. CONCLUSIONS: Regular and prolonged use of PPIs is associated with a higher risk of diabetes. Physicians should therefore avoid unnecessary prescription of this class of drugs, particularly for long-term use.

A Functional Data Analysis Approach to Left Ventricular Remodeling Assessment.

Left ventricular remodeling is a mechanism common to various cardiovascular diseases affecting myocardial morphology. It can be often overlooked in clinical practice since the parameters routinely employed in the diagnostic process (e.g., the ejection fraction) mainly focus on evaluating volumetric aspects. Nevertheless, the integration of a quantitative assessment of structural modifications can be pivotal in the early individuation of this pathology. In this work, we propose an approach based on functional data analysis to evaluate myocardial contractility. A functional representation of ventricular shape is introduced, and functional principal component analysis and depth measures are used to discriminate healthy subjects from those affected by left ventricular hypertrophy. Our approach enables the integration of higher informative content compared to the traditional clinical parameters, allowing for a synthetic representation of morphological changes in the myocardium, which could be further explored and considered for future clinical practice implementation.

Comparing medication persistence among patients with type 2 diabetes using sodium-glucose cotransporter 2 inhibitors or glucagon-like peptide-1 receptor agonists in real-world setting.

AIM: To assess and compare the persistence with drug therapy between patients treated with glucagon-like peptide-1 receptor agonists (GLP1-RA) and sodium-glucose cotransporter-2 inhibitors (SGLT2-I) therapy. METHODS: The 126,493 residents of the Lombardy Region (Italy) aged ≥ 40 years newly treated with metformin during 2007-2015 were followed until 2017 to identify those who started therapy with GLP1-RA or SGLT2-I. To make GLP1-RA and SGLT2-I users more comparable, a 1:1 matched cohort design was adopted. Matching variables were sex, age, and adherence to the first-line therapy with metformin. Log-binomial regression models were fitted to estimate the propensity to 1-year treatment persistence in relation to the therapeutic strategy. RESULTS: The final matched cohort was composed by 1,276 GLP1-RA─SGLT2-I pairs. About 24% and 29% of cohort members respectively on GLP1-RA and SGLT2-I discontinued the drug treatment. Compared with patients starting SGLT2-I, those on GLP1-RA had 15% (95% confidence interval, 3-25%) lower risk of discontinuation of the treatments of interest and 45% (28-57%) lower risk of discontinuing any antidiabetic drug therapy. Persistence was better among GLP1-RA users who received a once-weekly administration. CONCLUSIONS: In a real-life setting, patients who were prescribed a GLP1-RA exhibited more frequently better persistence to treatment than those prescribed a SGLT2-I therapy.

Adherence to Lipid-Lowering Treatment by Single-Pill Combination of Statin and Ezetimibe.

INTRODUCTION: Although several studies have shown that a simplified cardiovascular drug treatment leads to better treatment adherence, limited and conflicting findings have been reported on the separate or single-pill combination of the now recommended association between a statin and ezetimibe. We addressed this issue in a large cohort of patients newly treated with statins to whom ezetimibe was additionally administered, either separately or as a single-pill combination. METHODS: A total of 256,012 patients (age 40-80 years) from the Lombardy Region (Italy) newly treated with statins during 2011-2013 were followed until 2018 to identify those to whom ezetimibe was added. The 2881 and 5351 patients who started a two-pill or a single-pill combination, respectively, of statin and ezetimibe were identified and matched for propensity score. Adherence to drug therapy at 1 year was measured as the ratio between the number of days in which the drug was available and the days of follow-up (the proportion of days covered; PDC). Patients who had a PDC > 75% or < 25% were, respectively, defined as highly and poorly adherent to drug therapy. Analysis was extended to the association between adherence and the risk of fatal/non-fatal cardiovascular events. RESULTS: Compared to those prescribed a two-pill combination, those prescribed a single-pill combination had an 87% (75-99%) greater odds of being highly adherent and a 79% (72-84%) lower odds of being poorly adherent to treatment. These advantages were manifest in all strata of age, sex, and clinical profile. The risk of cardiovascular outcomes decreased by 55% in patients with high adherence compared to those with low adherence. CONCLUSION: Patients who were prescribed a single-pill combination of statin/ezetimibe more frequently exhibit a good adherence and less frequently bad adherence to treatment than those prescribed a two-pill combination of these drugs.

Adherence to Treatment by Initial Antihypertensive Mono and Combination Therapies.

BACKGROUND: Aim of our study was to compare adherence to antihypertensive drug therapy between newly treated patients in whom monotherapy or a 2-drug single-pill combination (SPC) was initially dispensed. METHODS: The 63,448 residents of Lombardy Region (Italy), aged 40-80 years, who were newly treated with antihypertensive drugs during 2016, were identified and followed for 1 year after the first prescription. The outcome of interest was adherence to drug therapy that was measured according to the "proportion of days covered" (PDC) criterion, i.e., the ratio between the number of days in which the drug was available and the days of follow-up. Patients who had a PDC >75% and <25% were defined as highly and poorly adherent to drug therapy, respectively. Log-binomial regression models were fitted to compare the propensity to treatment adherence between the initial therapeutic strategies, after adjusting for baseline demographic and clinical covariates. RESULTS: About 46% and 17% of patients showed high and poor adherence, respectively. Compared with patients under initial monotherapy (85%), those who were initially treated with a SPC (15%) had higher propensity to be highly adherent and a lower propensity to be poorly adherent to antihypertensive treatment (risk ratio: 1.18, 95% confidence interval 1.16-1.21; 0.42, 0.39-0.45, respectively). This was the case regardless the sex, the age, the patient clinical status, and with almost any type of SPC. CONCLUSIONS: In a real-life setting, patients who were initially prescribed a 2-drug SPC exhibited more frequently a good adherence to antihypertensive treatment than those starting with a single drug.

Development and validation of a clinical risk score to predict the risk of SARS-CoV-2 infection from administrative data: A population-based cohort study from Italy.

BACKGROUND: The novel coronavirus (SARS-CoV-2) pandemic spread rapidly worldwide increasing exponentially in Italy. To date, there is lack of studies describing clinical characteristics of the people at high risk of infection. Hence, we aimed (i) to identify clinical predictors of SARS-CoV-2 infection risk, (ii) to develop and validate a score predicting SARS-CoV-2 infection risk, and (iii) to compare it with unspecific scores. METHODS: Retrospective case-control study using administrative health-related database was carried out in Southern Italy (Campania region) among beneficiaries of Regional Health Service aged over than 30 years. For each person with SARS-CoV-2 confirmed infection (case), up to five controls were randomly matched for gender, age and municipality of residence. Odds ratios and 90% confidence intervals for associations between candidate predictors and risk of infection were estimated by means of conditional logistic regression. SARS-CoV-2 Infection Score (SIS) was developed by generating a total aggregate score obtained from assignment of a weight at each selected covariate using coefficients estimated from the model. Finally, the score was categorized by assigning increasing values from 1 to 4. Discriminant power was used to compare SIS performance with that of other comorbidity scores. RESULTS: Subjects suffering from diabetes, anaemias, Parkinson's disease, mental disorders, cardiovascular and inflammatory bowel and kidney diseases showed increased risk of SARS-CoV-2 infection. Similar estimates were recorded for men and women and younger and older than 65 years. Fifteen conditions significantly contributed to the SIS. As SIS value increases, risk progressively increases, being odds of SARS-CoV-2 infection among people with the highest SIS value (SIS = 4) 1.74 times higher than those unaffected by any SIS contributing conditions (SIS = 1). CONCLUSION: Conditions and diseases making people more vulnerable to SARS-CoV-2 infection were identified by the current study. Our results support decision-makers in identifying high-risk people and adopting of preventive measures to minimize the spread of further epidemic waves.

Impact of COVID-19 lockdown in children with neurological disorders in Italy.

BACKGROUND: The costs and benefits of full lockdown measures are debated. Neurologically impaired children are a vulnerable population with specific needs in terms of protection against infection and access to health services. OBJECTIVES: We investigated the effects of lockdown on the health of children with neurological disorders and on their access to care during lockdown. METHODS: Data from 514 children (282 males - 232 females) were collected through physician-administered interviews to investigate: the occurrence of viral-like physical symptoms, the correlation between the risk of developing such symptoms and several demographic and clinical variables, the occurrence of any worsening of the children's neurological conditions during lockdown, and their access to care services during this period. RESULTS: 49.1% experienced at least one symptom during the study period, but no child developed severe complications. The prevalence of symptoms was significantly lower during lockdown than during the previous two months. The underlying neurological condition worsened in 11.5% of the patients. Children who regularly left the home during lockdown were greater risk of exhibiting symptoms. During lockdown, 67.7% had a specialist appointment cancelled, 52.6% contacted their paediatrician, and 30.9% contacted their child neuropsychiatrist. Among patients who usually receive rehabilitation, 49.5% continued remotely. CONCLUSION: Lockdown protected children from infections. Telemedicine and telerehabilitation constituted a valid alternative for the care and treatment of these children, but they should not become a widespread and definitive model of care. COVID-19 and other emergency response plans must take into account the specific needs of children with disabilities.