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Vacuum-assisted breast biopsy (VABB) guided by digital breast tomosynthesis (DBT) represents one of the best instruments to obtain a histological diagnosis of suspicious lesions with no ultrasound correlation or those which are visible only on DBT. After a review of the literature, we retrospectively analyzed the DBT-guided VABBs performed from 2019 to 2022 at our department. Descriptive statistics, Pearson's correlation and χ 2 test were used to compare distributions of age, breast density (BD) and early performance measures including histopathology. We used kappa statistics to evaluate the agreement between histological assessment and diagnosis. Finally, we compared our experience to the literature to provide indications for clinical practice. We included 85 women aged 41-84 years old. We identified 37 breast cancers (BC), 26 stage 0 and 11 stage IA. 67.5% of BC was diagnosed in women with high BD. The agreement between VABB and surgery was 0.92 (k value, 95% CI: 0.76-1.08). We found a statistically significant inverse correlation between age and BD. The post-procedural clip was correctly positioned in 88.2%. The post-procedural hematoma rate was 14.1%. No infection or hemorrhage were recorded. When executed correctly, DBT-guided VABB represents a safe and minimally invasive technique with high histopathological concordance, for detecting nonpalpable lesions without ultrasound correlation.

Background: The assessment of breast density is one of the main goals of radiologists because the masking effect of dense fibroglandular tissue may affect the mammographic identification of lesions. The BI-RADS 5th Edition has revised the mammographic breast density categories, focusing on a qualitative evaluation rather than a quantitative one. Our purpose is to compare the concordance of the automatic classification of breast density with the visual assessment according to the latest available classification., Methods: A sample of 1075 digital breast tomosynthesis images from women aged between 40 and 86 years (58 ± 7.1) was retrospectively analyzed by three independent readers according to the BI-RADS 5th Edition. Automated breast density assessment was performed on digital breast tomosynthesis images with the Quantra software version 2.2.3. Interobserver agreement was assessed with kappa statistics. The distributions of breast density categories were compared and correlated with age., Results: The agreement on breast density categories was substantial to almost perfect between radiologists (κ = 0.63-0.83), moderate to substantial between radiologists and the Quantra software (κ = 0.44-0.78), and the consensus of radiologists and the Quantra software (κ = 0.60-0.77). Comparing the assessment for dense and non-dense breasts, the agreement was almost perfect in the screening age range without a statistically significant difference between concordant and discordant cases when compared by age., Conclusions: The categorization proposed by the Quantra software has shown a good agreement with the radiological evaluations, even though it did not completely reflect the visual assessment. Thus, clinical decisions regarding supplemental screening should be based on the radiologist's perceived masking effect rather than the data produced exclusively by the Quantra software.

Aim: To evaluate the local impact of the coronavirus disease 2019 (COVID-19) pandemic on breast cancer (BC) care, with particular attention to the economical and psychological consequences of the possible delay of new diagnoses and treatments., Methods: Three years' activity (from 2019 to 2021) has been compared. The number of BCs diagnosed from the total amount of mammographic and ultrasound (US) examinations performed in women aged more than 40 years old has been considered. A Pearson's chi-squared test was performed to verify differences between results. Statistical significance was set at P ≤ 0.01., Results: A statistically significant difference was found in the number of BC diagnosed between screening and ambulatory care patients in both the 2019-2020 (χ 2 = 24.93, P < 0.01) and 2019-2021 (χ 2 = 29.93, P < 0.01) comparisons. No statistically significant difference was found in the data recorded between 2020 and 2021 (χ 2 = 2.35, P > 0.01). By evaluating the specific age groups for each year, a statistically significant difference ( P < 0.01) was found in the number of BC diagnosed in screening patients aged 50-69 years old in both 2019-2020 and 2019-2021 comparisons. The percentages of early BC diagnosed in 2019, 2020, and 2021 were 80.9%, 91.7%, and 89.8%, respectively. The adherence rates to screening in 2019, 2020, and 2021 were 67.5%, 45.2%, and 56.9%, respectively., Conclusions: Results showed a reduction of new diagnoses in the screening range during the pandemic in comparison with the previous period. The high percentage of early BC would seem to have prevented worsening outcomes. Nevertheless, women who have not undergone screening could present a more advanced stage disease in the following years. Consequently, the evaluation of possible solutions to guarantee an essential level of care with the purpose to avoid worsening patients' outcomes and the increase in healthcare costs is mandatory., Competing Interests: The authors declare that they have no conflicts of interest., (© The Author(s) 2022.)

Introduction: Since breast imaging requires very close contact with patients, a protocol is needed to perform safe daily screening activities during the COVID-19 pandemic. Materials and methods: Patients were triaged and separated into three different clinical scenarios by performing a telephone questionnaire before each diagnostic exam or a nasopharyngeal swab before every recovery. Specific procedures for each scenario are described. Results: From July to October 2020, 994 exams were performed. A total of 16 cancers and 7 suspected COVID-19 patients were identified. No medical staff were infected. Conclusion: This protocol is an example of the practical use of guidelines applied to a breast unit to assist specialists in preventing COVID-19 infection and optimizing resources for breast cancer diagnosis.

Ductal carcinoma in situ (DCIS) of male breast is a rare lesion, often associated with invasive carcinoma. When the in situ component is present in pure form, histological grade is usually low or intermediate. Imaging is difficult as gynaecomastia is often present and can mask underlying findings. We report a rare case of pure high-grade DCIS in a young male patient, with associated intraductal papilloma and atypical ductal hyperplasia. Digital breast tomosynthesis (DBT) showed an area of architectural distortion at the union of outer quadrants of the left breast without gynaecomastia. Triple assessment suggested performing a nipple-sparing mastectomy, which revealed the presence of a focal area of high-grade DCIS of 2 mm. DCIS, even of high grade, is difficult to detect with mammography and even more rare, especially when associated with other proliferative lesions. DBT with 2D synthetic reconstruction is useful as the imaging step of a triple assessment and it should be performed in both symptomatic and asymptomatic high-risk men to differentiate between malignant and benign lesions. We propose a diagnostic model to early detect breast cancer in men, optimizing resources according to efficiency, effectiveness and economy, and look forward to radiomics as a powerful tool to help radiologists.

Background: During the COVID-19 public health emergency, our breast cancer screening activities have been interrupted. In June 2020, they resumed, calling for mandatory safe procedures to properly manage patients and staff., Methods: A protocol supporting medical activities in breast cancer screening was created, based on six relevant articles published in the literature and in the following National and International guidelines for COVID-19 prevention. The patient population, consisting of both screening and breast ambulatory patients, was classified into one of four categories: 1. Non-COVID-19 patient; 2. Confirmed COVID-19 in an asymptomatic screening patient; 3. suspected COVID-19 in symptomatic or confirmed breast cancer; 4. Confirmed COVID-19 in symptomatic or confirmed breast cancer. The day before the radiological exam, patients are screened for COVID-19 infection through a telephone questionnaire. At a subsequent in person appointment, the body temperature is checked and depending on the clinical scenario at stake, the scenario-specific procedures for medical and paramedical staff are adopted., Results: In total, 203 mammograms, 76 breast ultrasound exams, 4 core needle biopsies, and 6 vacuum-assisted breast biopsies were performed in one month. Neither medical nor paramedical staff were infected on any of these occasions., Conclusion: Our department organization model can represent a case of implementation of National and International guidelines applied in a breast cancer screening program, assisting hospital personnel into COVID-19 infection prevention.

Purpose: Erythropoiesis-stimulating agents (ESAs), are used for treating chronic kidney disease (CKD)-related anemia, contributing to CKD costs. The study was aimed at investigating direct healthcare costs of CKD patients treated with ESAs and the potential savings achievable by increasing the use of biosimilars and preventing inappropriate ESA use., Methods: A multi-center, cohort study was conducted using claims databases of five large Italian geographic areas. Yearly mean direct healthcare costs per patient were estimated, stratifying by CKD stage. The total yearly cost and potential savings related to ESA use were estimated: (a) considering 25/50/75% of originator ESA substitution with biosimilars; (b) eliminating inappropriate ESA dispensing., Results: During the study period, the ESA-related yearly mean cost represented 17% of total yearly costs in stage I-III, decreasing to 13% in stage IV-V and 6% in dialysis. Among originator users, assuming a 25% of biosimilar uptake, the annual cost-savings of ESA treatment would represent 10.5% of total ESA costs in CKD stage I-V and 7.7% in dialysis. Among incident ESA users for which hemoglobin levels were available, 9% started inappropriately ESA treatment, increasing to 62.0% during the first year of maintenance therapy. Hypothesizing prevention of the first inappropriate ESA dispensing, the total yearly cost-savings would amount to €35 772, increasing to €167 641 eliminating the inappropriate dispensing during maintenance therapy., Conclusions: Higher use of lowest cost ESA, prevention of inappropriate ESA use as well as other strategies aimed at slowing down the progressive renal impairment are essential for minimizing clinical and economic burden of CKD., (© 2020 John Wiley & Sons Ltd.)

Background and Objectives: Switching between different erythropoiesis-stimulating agents (ESAs) during the first year of therapy is frequent (15-20%), much more so toward reference products than biosimilars. The objectives of this study were to investigate the frequency and identify the potential predictors of switching between biosimilar and originator ESAs during the first year of treatment in patients with chronic kidney disease (CKD), or chemotherapy-related anemia from six large Italian geographic areas in the years 2009-2015., Methods: A retrospective cohort study was conducted using six Italian regional claims databases (≥ 13 million inhabitants) during 2009-2015. Among incident epoetin users, the frequency of single, multiple, and backward switch during the first year of treatment was evaluated. Using frailty Cox models, potential predictors of first switch were identified. All analyses were stratified by the main indications for use., Results: Among 102,240 incident epoetin users, 15,853 (15.5%) switched to another epoetin during the first year of therapy; only 18% of these switched to biosimilars. Single switch was more common (62.2% of the switchers) than multiple (23.5%) or backward switch (14.3%). In cancer, the cumulative number of transfusions and iron preparations dispensed, as well as hyperparathyroidism, were predictors of switching. In CKD, the cumulative number of transfusions, number of vitamin A/D preparations dispensed, and CKD severity increased the probability of switching., Conclusions: Switching between ESAs was frequent in both CKD and cancer patients. The number of cumulative transfusions and severity of disease seemed to affect the switch.

Introduction: Analgesics such as non-steroidal anti-inflammatory drugs (NSAIDs), weak and strong opioids are commonly used among elderly persons. The aim of this study was to describe the demographic and clinical characteristics of elderly analgesic users and to measure the frequency of analgesic use, including the frequency of potentially inappropriate analgesic use., Methods: The Arianna database was used to carry out this study. This database contains prescription data with associated indication of use for 1,076,486 inhabitants registered with their general practitioners (GPs) in the Caserta Local Health Unit (Caserta district, Campania region in Italy). A cohort of persons aged ≥65 years old with >1 year of database history having at least one analgesic drug (NSAIDs, strong or weak opioids) between 2010 and 2014 were identified. The date of the first analgesic prescription in the study period was considered the index date (ID)., Results: From a source population of 1,076,486 persons, 116,486 elderly persons were identified. Of these, 94,820 elderly persons received at least one analgesic drug: 36.6% were incident NSAID users (N = 36,629), while 13.2% were incident weak opioid users (N = 12,485) and 8.1% were incident strong opioid users (N = 7,658). In terms of inappropriate analgesic use, 9.2% (N = 10,763) of all elderly users were prescribed ketorolac/indomethacin inappropriately, since these drugs should not be prescribed to elderly persons. Furthermore, at least half all elderly persons with chronic kidney disease or congestive heart failure were prescribed NSAIDs, while these drugs should be avoided., Conclusion: Analgesics are commonly used inappropriately among elderly persons, suggesting that prescribing practice in the catchment area may yet be improved., Competing Interests: YI, JS, FG, EM, AS, MT, DUT, GB and GT have no conflict of interest related to the study. GT has attended advisory boards on topics not related to this paper in the last 10 years, organized by Sandoz, Hospira, Sanofi, Biogen, Ibsen, Shire, and is consultant for Otsuka. He is the principal investigator of observational studies funded by several pharmaceutical companies (e.g. Amgen, AstraZeneca, Daiichi Sankyo, IBSA) to University of Messina as well as scientific coordinator of the Master program “Pharmacovigilance, pharmacoepidemiology and pharmacoeconomics: real-world data evaluations” at University of Messina which is partly funded by several pharmaceutical companies.

Purpose: The aim of the present study was to describe antipsychotic utilization patterns among patients with schizophrenic disorder in Italy, Spain, the UK, and the USA., Methods: A retrospective cohort study was conducted. Patients aged 15 and over with schizophrenic disorder were identified in the Caserta claims database (Italy), the Valencia electronic medical record (EMR) database (Spain), in The Health Improvement Network EMR database (UK), and in databases of publicly and privately insured populations in the United States (US)., Results: The frequency of first-generation or second-generation antipsychotic use and of long-acting or other formulations was described. Persistence to antipsychotics was estimated. Overall, 1,403,240 patients with schizophrenic disorder having a total of 765,573 new antipsychotic treatment episodes were identified. The median follow-up time ranged from 0.8 (IQR 0.2-1.9) years in the US commercially-insured population to 1.2 (IQR 0.1-1.7) years in the Spanish population. Second-generation antipsychotics were more frequently used than first-generation antipsychotics in all countries (on average, from 64.4% in the UK to 87% in US): the use of this class increased over time in Italy, Spain, and US (Medicaid). The use of long-acting formulations was heterogeneous across countries, but generally much lower than other formulations. Persistence to antipsychotic treatment at 1 year was low in all countries, ranging from 40 in Spain to 30% in Italy., Conclusions: Antipsychotic utilization was heterogeneous among persons with schizophrenic disorder. Nevertheless, low persistence was an issue in all the countries, as less than half of the patients continued their treatment beyond 1 year.

Purpose: Somatropin [recombinant growth hormone (rGH)] is approved in children and adults for several conditions involving growth disturbances and the corresponding biosimilar is available in Italy since 2006. No population-based data are available on the pattern of rGH use in Italian clinical practice. This study aimed at exploring the pattern of biosimilar and originator rGH use in six Italian centers, where different policy interventions promoted biosimilar use., Methods: This population-based, drug-utilization study was conducted in the years 2009-2014, using administrative databases of Umbria, Tuscany, and Lazio Regions and Local Health Units of Caserta, Treviso, and Palermo. Naïve rGH users were characterized, and prevalence of use and discontinuation were assessed over time., Results: Among 6,785 patients treated with rGH during the study years, 4,493 (66.2%) were naïve users (males/females = 1.3), mostly affected by GH deficiency. The prevalence of rGH use increased from 2009 to 2010, remaining stable thereafter, but it was heterogeneous across centers (twofold higher prevalence of use in center n.2 than centers n.4 and 1 in 2014). Biosimilar rGH uptake increased over time but was low (7.8% in 2014) and heterogeneous as well. Discontinuation of rGH therapy occurred in 54.0% of naïve users, more frequently in females than males (58.1 vs. 50.9%). During the first year of treatment, discontinuation was frequent (39.9%), but no statistically significant differences were observed in treatment persistence for biosimilar vs. originator rGH ( p  > 0.05)., Conclusion: Geographical heterogeneity in the prevalence of rGH use was observed. Similarly, the biosimilar rGH uptake was low and variable across centers. Post-marketing monitoring is required to continuously monitor the benefit-risk profile of rGH, thus guaranteeing greater savings than only promoting lowest cost rGH.

Background and Objectives: Diabetes mellitus in patients with chronic kidney disease (CKD) is known as diabetic kidney disease (DKD). Pharmacological management of DKD is challenging due to reduced renal excretion of some antidiabetic drugs. The aim of this population-based study was to explore antidiabetic drug use in DKD patients from Southern Italy., Methods: The Arianna database from Caserta Local Health Unit was used. Diabetic patients with incident CKD [first diagnosis date: index date (ID)] were identified by searching for specific ICD9-CM codes among hospital discharge diagnoses/procedures and/or indication of use associated with drug prescriptions. To evaluate any change in the use of antidiabetic drugs after the CKD diagnosis, the prevalence of antidiabetic drug use among DKD patients was calculated within 1 year prior to/after ID and after dialysis entry. A Kaplan-Meier analysis was used to assess the time to discontinuation of antidiabetic drugs after CKD diagnosis. The frequency of antidiabetic drugs contraindicated in renal disease in DKD patients was measured., Results: Overall, 725 diabetic patients (mean age 72.8 ± 11.4 years) had incident CKD from 2006 to 2011. The use of combination antidiabetic drugs, biguanides and sulphonamides decreased by approximately 10, 7 and 5%, respectively, after the ID. The use of insulins increased by 10% after the ID and by 20% after entry into dialysis. The use of antidiabetic drugs not contraindicated in CKD decreased marginally after the diagnosis of CKD., Conclusion: In a general practice of Southern Italy the management of diabetes mellitus changed only marginally in newly diagnosed CKD patients, suggesting a therapeutic inertia on the part of prescribers.

Purpose: To explore the frequency of polypharmacy, functional and cognitive capacity among the elderly in Southern Italy., Methods: Population-based retrospective cross-sectional study. Information were retrieved from electronic-geriatric-forms matched by record-linkage to outpatient pharmacy-records. The following domains were collected from geriatric forms: BMI, cognitive capacity (SPMSQ), functional status (Barthel-index), mobility, living condition. Polypharmacy status was categorized as non-polypharmacy (0-4), polypharmacy (5-9) and excessive-polypharmacy (≥10). Prevalence of all variables were stratified by age and polypharmacy group., Results: 88,878 old people received a geriatric assessment in the years 2013-2014. Mean age was 74.8 (±7.3) years, 56.6% females. Proportion of elderly in excessive-polypharmacy increased with age (18.9% in 65-75 age-group; 27.9% in >85). Referring to cognitive capacity, the proportion of lucid patients decreased with age (from 94.3% to 58.1%), while confused patient increased with age (from 4.7% to 30.9%). Proportion of subjects with a decline in cognitive status, functional status and mobility increased in polypharmacy and excessive polypharmacy group., Conclusion: Polypharmacy is common in people aged 65 years and older with difficulties in activities of daily living and impaired cognition. Furthermore, its prevalence raises with increasing age. Preventive strategies such us optimization of drug regimen should be performed routinely to reduce risk of adverse-health-events.

Aim: The aim is to evaluate prescriptive patterns of atypical antipsychotic drugs for the treatment of schizophrenia in the LHU Caserta in 2011-2013, and to indicate potentially inappropriate therapy; to plan or schedule corrective/preventive activities to support the continuous improvement of health services., Methods: Retrospective cohort study, based on integration of health records and clinical audit. The study was performed in the following steps: data retrieval and analysis; comparison of data with international literature; editing of the Diagnostic-Therapeutic Path. The analysis was performed by using the administrative database of drug prescriptions and treatment plans in the SANIARP portal, a web platform available to specialist facilities and private and public pharmacies of LHU Caserta. The subject of our analysis was to gain information about the diagnosis and treatment of users of atypical antipsychotics in the LHU of Caserta in the years 2011-2013., Results: We identified 2,768 patients with at least one prescription of atypical antipsychotics and diagnosis coded in the study period. Schizophrenia is the most frequent diagnosis (31.1%) and the most common drug in use is olanzapine (29.1%). About 70% of schizophrenics were on monotherapy with no change in drug, 23.6% were under polytherapy and 7.9% made a switch., Discussion and Conclusion: Our findings were a starting point for editing Diagnostic and Therapeutic Paths aimed at raising the awareness of the scientific community about the appropriateness of diagnosis and treatment in schizophrenia. Pharmacological treatment of schizophrenia should be focused on improving the overall quality of life aimed at remission and possible recovery, although difficult.

Purpose: To explore the prescription patterns of erythropoiesis-stimulating agents (ESAs) in four large Italian geographic areas, where different health policy interventions to promote biosimilar use in routine care are undertaken., Methods: A retrospective drug utilization study was conducted during the years 2009-2013. The data sources were the administrative databases of the Tuscany region and of the Caserta, Palermo, and Treviso Local Health Units (LHUs). The characteristics, prevalence, and switching patterns of different ESAs (biosimilars and reference products), stratified by indication for use, were calculated over time and across centers., Results: Overall, 49,491 patients were treated with ESAs during the years 2009-2013 in the four centers. Of these, 41,286 patients (83.4 %) were naive users. The prevalence of ESA use increased from 2.9 to 3.4 per 1000 inhabitants in the years 2009-2011 but decreased thereafter (3.0 per 1000 in 2013). Moreover, the proportion of biosimilar users increased overall from 1.8 % in 2010 to 33.6 % in 2013, with larger increase in Treviso (from 0.0 to 45.0 %) and Tuscany (from 0.7 to 37.6 %) than in Caserta (from 7.5 to 22.9 %) and Palermo (from 0.0 to 27.7 %). Switching between different ESAs during the first year of therapy was frequent (17.0 %), much more toward reference products than toward biosimilars., Conclusion: Overall, the prevalence of ESA use decreased slightly, while use of biosimilar ESAs, especially in naive patients, increased significantly but to different extents in these four large Italian geographic areas. Switching between different ESAs during the first year of treatment was very frequent, which may affect pharmacovigilance monitoring. New strategies are necessary to further improve market penetration of low-cost medicines, such as biosimilars, and also to harmonize effective health policy interventions that aim to reduce pharmaceutical expenses and optimize patient benefit across all regions.

Aims: The aim of the study was to analyze the prescribing pattern of both newer and older AEDs., Methods: A population of almost 150 000 individuals registered with 123 general practitioners was included in this study. Patients who received at least one AED prescription over 2005-2011 were identified. The 1 year prevalence and cumulative incidence of AED use, by drug class and individual drug, were calculated over the study period. Potential predictors of starting therapy with newer AEDs were also investigated., Results: The prevalence of use per 1000 inhabitants of older AEDs increased from 10.7 (95% CI10.1, 11.2) in 2005 to 13.0 (95% CI12.4, 13.6) in 2011, while the incidence remained stable. Newer AED incidence decreased from 9.4 (95% CI 8.9, 9.9) in 2005 to 7.0 (95% CI 6.6, 7.5) in 2011, with a peak of 15.5 (95% CI 14.8, 16.1) in 2006. Phenobarbital and valproic acid were the most commonly prescribed AEDs as starting therapy for epilepsy. Gabapentin and pregabalin accounted for most new pain-related prescriptions, while valproic acid and lamotrigine were increasingly used for mood disorders. Female gender (OR 1.36, 95% CI 1.20, 1.53), age ranging between 45-54 years (OR 1.39, 95% CI 1.16, 1.66) and pain as an indication (OR 16.7, 95% CI, 13.1, 21.2) were associated with newer AEDs starting therapy., Conclusions: Older AEDs were mainly used for epileptic and mood disorders, while newer drugs were preferred for neuropathic pain. Gender, age, indication of use and year of starting therapy influenced the choice of AED type. The decrease of newer AED use during 2007 is probably related to the restricted reimbursement criteria for gabapentin and pregabalin., (© 2015 The British Pharmacological Society.)

Background: Non-steroidal anti-inflammatory agents (NSAIDs) are known to be associated with renal damage. No clear evidence exists regarding differential risk of chronic kidney disease (CKD), specifically, across various NSAIDs., Aim: The aim of this population-based case-control study was to evaluate the association between use of individual NSAIDs and risk of CKD in a general population of Southern Italy., Methods: A nested case-control study was carried out using the general practice Arianna database, identifying incident CKD patients as cases and matched controls from 2006 to 2011. The date of first CKD diagnosis was defined as the index date (ID). Conditional logistic regressions were performed to estimate the risk of CKD associated with NSAIDs by class and individual drugs as compared to non-use during different time windows (within one year, six or three months prior to ID), with the latter being defined as current users. Among current users, the effect of cumulative exposure to these drugs was evaluated., Results: Overall, 1,989 CKD cases and 7,906 matched controls were identified. A statistically significant increase in the risk of CKD was found for current users of oxicams (adjusted OR: 1.68; 95% CI: 1.15-2.44) and concerning individual compounds, for ketorolac (adj. OR: 2.54; 95% CI: 1.45-4.44), meloxicam (adj. OR: 1.98; 95% CI: 1.01-3.87) and piroxicam (adj. OR: 1.95; 95% CI: 1.19-3.21)., Conclusions: The risk of CKD varies across individual NSAIDs. Increased risk has been found for ketorolac, which may precipitate subclinical CKD through acute renal damage, and long-term exposure to oxicams, especially meloxicam and piroxicam.

The treatment of diabetes in the elderly is a major challenge both in terms of clinical management and of public health. Evidence about prescribing patterns in the elderly diabetic population is limited. The aim was to describe trends in antidiabetic drug (AD) utilization patterns in the elderly in Southern Italy with a focus on drugs for cardiovascular prevention and pharmaceutical costs. The data used for this study were obtained from pharmacy records of Caserta Local Health Authority, a province in Southern Italy with 1 million of inhabitants, comprising urban and rural areas. Subjects above 65 years who received at least one dispensing of antidiabetic between January 2010 and December 2014 were selected. Prevalence and incidence rates (%) of AD use were calculated for each calendar year and stratified by class therapy and age group. Sub-analyses by cardiovascular co-medication therapy and pharmaceutical cost analysis were performed. The prevalence rate decreases from 22.0% in 2010 to 17.5% in 2014 (p<0.001). Proportion of subjects treated with monotherapy increases over the study period (33.9% in 2010; 38.6% in 2014; p<0.001). In particular, increases the proportion of users of metformin (18.2% in 2010; 23.7% in 2014; p<0.001), while the proportion of users of sulfonylureas dropped (11.0% in 2010; 7.2% in 2014; p< 0.001). About 90% of elderly diabetic patients are treated with drugs for cardiovascular prevention. The per/patient/yearly drug costs were 2,349 ∈: 28.5% for AD therapy and 71.5% for other treatments. Trend in drug utilization patterns showed a tendency towards treatment recommendations in older adults.

Lowering blood cholesterol levels reduces the risk of coronary heart disease. However, the effect of interventions depends on the patients' adherence to treatment. Primary care plays an important role in the detection, treatment and monitoring of disease, therefore different educational programs (EP) have been implemented to improve disease management in general practice. The present study is aimed to assess whether a general practitioner auditing and feedback EP may improve dyslipidaemia management in a primary care setting and to evaluate patients' adherence to prescribed lipid-lowering treatment. The quality of cardiovascular and cerebrovascular disease prevention before and after the implementation of an EP offered to 25 general practitioners (GPs), was evaluated. Clinical and prescription data on patients receiving at least one lipid-lowering treatment was collected. To evaluate the quality of the healthcare service provided, clinical and biochemical outcomes, and drug-utilization, process indicators were set up. Adherence was evaluated before and after the EP as the "Medication Possession Ratio" (MPR). A correlation analysis was carried out to estimate the effect of the MPR in achieving pre-defined clinical end-points. Prescription data for lipid-lowering drugs was collected in a sample of 839 patients. While no differences in the achievement of blood lipid targets were observed, a slight but significant improvement of the MPR was registered after the EP (MPR >0.8=64.2% vs 60.6%, p=0.0426). Moreover, high levels of statin adherence were associated with the achievement of total blood cholesterol target (OR=3.3 for MPR >0.8 vs MPR <0.5, 95% CI:1.7-6.7) or LDL therapeutic goal (OR=3.3 for MPR >0.8 vs MPR <0.5, 95% CI:1.5-7.2). The EP partially improved the defined clinical targets; probably, a more patient-based approach could be more appropriate to achieve the defined target. Further studies are needed to identify how healthcare services can be improved.

Background: The use of nephrotoxic drugs can further worsening renal function in chronic kidney disease (CKD) patients. It is therefore imperative to explore prescribing practices that can negatively affect CKD patients., Aim: To analyze the use of nephrotoxic drugs in CKD patients in a general population of Southern Italy during the years 2006-2011., Methods: The general practice "Arianna" database contains data from 158,510 persons, registered with 123 general practitioners (GPs) of Caserta. CKD patients were identified searching: CKD-related ICD-9 CM codes among causes of hospitalization; CKD-relevant procedures undergone in hospital (e.g. dialysis); drug prescriptions issued for a CKD-related indication. A list of nephrotoxic drugs was compiled and validated by pharmacologists and nephrologists. The summary of product characteristics was used to classify drugs as 'contraindicated' or 'to be used with caution' in renal diseases. Frequency of nephrotoxic drug use, overall, by drug class and single compounds, by GPs within one year prior or after first CKD diagnosis and within one year after dialysis entry was calculated., Results: Overall, 1,989 CKD patients and 112 dialysed patients were identified. Among CKD patients, 49.8% and 45.2% received at least one prescription for a contraindicated nephrotoxic drug within one year prior or after first CKD diagnosis, respectively. In detail, 1,119 CKD patients (56.3%) had at least one nonsteroidal anti-inflammatory drugs (NSAIDs) prescription between CKD diagnosis and end of follow-up. A large proportion of CKD patients (35.6%) were treated with NSAIDs for periods exceeding 90 days. Contraindicated nephrotoxic drugs were used commonly in CKD, with nimesulide (16.6%) and diclofenac (11.0%) being most frequently used., Conclusions: Contraindicated nephrotoxic drugs were highly prescribed in CKD patients from a general population of Southern Italy. CKD diagnosis did not seem to reduce significantly the prescription of nephrotoxic drugs, which may increase the risk of preventable renal function deterioration.

Background: Screening-based CKD estimates may not provide a sufficient insight into the impact of CKD on the use of healthcare resources in clinical practice. The aim of this study was to evaluate the epidemiology of "medicalized" CKD, that is, CKD requiring healthcare services, in an outpatient setting., Design, Setting, Participants, and Measurements: This is a retrospective, longitudinal population-based study conducted in a large general practice setting in Southern Italy (Caserta) using a healthcare database. Over 2006-2011, all patients with a CKD diagnosis, either through CKD-related indications of use associated with drug prescriptions or through CKD-related hospital discharge diagnoses/procedures, were identified using this database. The prevalence of "medicalized" CKD in the general population of Caserta was estimated by age, gender, and calendar year., Results: Overall, 1,989 (1.3%) patients with a diagnosis of CKD were identified from 2006-2011 in the Caserta general population. The one year prevalence increased from 0.9% in 2006 to 1.6% in 2011, which is much lower compared to previous screening-based studies. The prevalence was slightly higher in males and increased significantly with advancing age (in 2011, 0.2% in ≤44 years old versus 9.2% in >80 years old)., Conclusions: The findings of this study suggest that, in the general population, the prevalence of "medicalized" CKD is lower compared to the screening-based CKD prevalence.

Diabetic mastopathy represents an uncommon tumor-like proliferation of fibrous tissue of the breast that usually occurs in patients who suffered from type 1 diabetes mellitus for a long time. We report an uncommon case of diabetic mastopathy presenting in a type 2 non-insulin dependent diabetes mellitus 61-year-old postmenopausal woman. Physical examination revealed a hard, low movable mass in the upper outer quadrant of the right breast. Mammography and ultrasonography showed typical features of breast cancer. Ultrasound-guided fine-needle aspiration cytology (US-FNAC) was performed showing inflammatory infiltrate, suggesting excisional biopsy. Histological findings demonstrated typical diabetic mastopathy with fibrosis, histiocytic and limphocytic infiltration without evidence of malignancy., (Copyright © 2014. Published by Elsevier Ltd.)

Aims: The aims of the study were to assess the trend of older and newer anti-epileptic drugs (AEDs) in the elderly population and to analyze the effects of a health-policy intervention with regard to AED use in general practice in a setting in Southern Italy., Methods: Data were extracted from the 'Caserta-1' Local-Health-Unit Arianna database in the years 2004-07. Patients aged over 65 years, receiving at least one AED prescription and registered in the lists of 88 general practitioners, were selected. The use of older and newer AEDs was calculated as 1 year prevalence and incidence of use and defined daily dose (DDD) per 1000 inhabitants day(-1) . Sub-analyses by gender, age and indication of use were performed., Results: Most of AED users were treated because of neuropathic pain (64.8%). However, the main indication of use for older AEDs (57.8%) was epilepsy, whereas newer AEDs (79.5%) were used for neuropathic pain. Prevalence and incidence of newer AED use increased until 2006, followed by a reduction in 2007. Newer AEDs, particularly gabapentin and pregabalin, were used in the treatment of more patients than older AEDs. However phenobarbital, accounting for more than 50% of total AED volume, was the most prescribed medication during the entire study period., Conclusions: An increasing use of AEDs has been observed during 2004-07, mostly due to the prescription of newer compounds for neuropathic pain. The fall in the use of newer AEDs during 2007 coincides with revised re-imbursement criteria for gabapentin and pregabalin. The large use of phenobarbital in the elderly should be considered in the light of a risk of adverse drug reactions., (© 2010 The Authors. British Journal of Clinical Pharmacology © 2010 The British Pharmacological Society.)

Aim: To analyse the prescribing pattern of newer and older antiepileptic drugs (AEDs) during the years 2003-2005., Methods: From the Caserta-1 Local Health Service database, 93 general practitioners (GPs) were recruited. Among 127,389 individuals aged > or =15 years registered in the lists of these GPs, we selected patients who received at least one AED prescription during the study period. Use of newer and older AEDs was calculated as 1-year prevalence and incidence as well as defined daily dose (DDD) per 1000 inhabitants/day. Sub-analyses by gender, age and indication of use were performed., Results: Overall, prevalence and incidence of use remained stable for older AEDs, while it strongly increased for newer AEDs. In particular, 25% increase of incident treatments with newer AED have been reported from 2004 to 2005. The total volume of AED use remained stable during the study years, despite the proportion of newer AEDs slightly increased (from 24.6% in 2003 to 30.1% in 2005). The main indication of use was epileptic disorders for older AEDs (56% of users), and neuropathic pain for newer AEDs (69%)., Conclusions: Prevalence and incidence of use of newer AED strongly increased during the years 2003-2005 in a general practice of Southern Italy. Significant differences are shown in the prescribing pattern of newer and older medications: older AEDs are mainly used in the treatment of epileptic disorders, while newer compounds are preferred for conditions other than epilepsy, in particular neuropathic pain.

Objective: To assess whether the prescribing pattern of lipid-lowering drugs (LLD) changed after reimbursement criteria revision in a general practice in southern Italy., Methods: From the Caserta-1 Local Health Service database, 93 general practitioners (GPs) who had consistently sent data about their patients during the years 2003-2005 were recruited. Prevalence of use and incidence of new treatments were calculated for each year, stratified by three drug cohorts: statins, omega-3 fatty acids, and fibrates. Subanalyses by gender, age, and indication of use were performed., Results: Overall, 1-year prevalence of LLD use increased from 2003 to 2004. After reimbursement criteria revision (November 2004), a slight decrease was observed for statins, from 41.1 (95% CI: 39.9-42.2) per 1,000 inhabitants in 2004 to 40.3 (39.2-41.5) in 2005, while omega-3 utilization fell markedly: 14.6 (13.9-15.3) vs. 5.4 (5.0-5.8). The use of both statins and omega-3 fatty acids was reduced particularly for primary prevention. On the other hand, utilization of statins increased in diabetic patients and as secondary prevention from 2004 to 2005. Concerning individual molecules, 1-year prevalence of use of any statin declined from 2004 to 2005, except for rosuvastatin., Conclusions: Revision of reimbursement criteria led to significant changes in the trend in LLD use in general practice in southern Italy: (1) statin utilization was slightly reduced in 2005, although it increased in certain categories, such as diabetic patients, and (2) omega-3 fatty acid use was strongly reduced even though a higher use in postinfarction cases was reported.