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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 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.

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.

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 Patients exhibited a reduction in the prescription of antihypertensive drugs during the three years that followed the denervation procedure The decrease in the number of antihypertensive drugs was marked, started after a relatively short time (six months), and involved all drugs prescribed before the denervation The number of hospitalisations for a cardiovascular event was similar before and after renal denervation Albeit 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

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 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.

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.

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

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.

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.