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AIM: The study was designed to generate real-world evidence on IDegLira in the Italian clinical practice in two groups of patients with type 2 diabetes (T2D), switching to IDegLira either from a basal only (basal group) or basal-bolus insulin regimen (BB group). MATERIALS AND METHODS: This was a non-interventional, multicentre, single-cohort, prospective study assessing the long-term glycaemic control in patients with T2D, who switched to IDegLira from a basal insulin ± glucose-lowering medication regimen with or without a bolus insulin component for approximately 18 months, conducted in 28 Italian diabetes centres. The primary endpoint was the change in glycated haemoglobin (HbA1c) levels from baseline to 6 months after IDegLira initiation. RESULTS: The study included 358 patients with a mean age 67.2 years and diabetes duration of 15.7 years. HbA1c significantly decreased from IDegLira start to all study time points in the overall population (basal group -1.19%; BB group -0.60% at the end of observation). Patients achieving HbA1c <7% levels increased from 12.9% (n = 43) to 40.3% (n = 110) at 18 months. Fasting blood glucose and body weight also significantly decreased in both groups, although more in the BB group. Overall, 14.3% of completed patients had an intensification of treatment (mainly in the basal group) and 48.6% had a simplification of treatment (mainly in the BB group). CONCLUSIONS: Switching to IDegLira in a real-world clinical setting is a valid therapeutic option for patients with T2D with inadequate glycaemic control on basal or BB insulin regimen and/or need to simplify their insulin therapy, with specific reasons and therapeutic goals according to different T2D management trajectories.
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Diabetes Mellitus Tipo 2 , Humanos , Anciano , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/epidemiología , Hipoglucemiantes/uso terapéutico , Hemoglobina Glucada , Estudios Prospectivos , Glucemia , Insulina de Acción Prolongada , Liraglutida/uso terapéutico , Combinación de Medicamentos , Insulina/uso terapéutico , Italia/epidemiología , Insulina Regular Humana/uso terapéuticoRESUMEN
BACKGROUND: Major Depressive Disorder (MDD) with suicidal ideation, intent, or behavior is a psychiatric emergency with controversial care management. Our study describes the comprehensive treatment pathways of this population in Italian routine clinical practice. METHODS: ARIANNA [NCT04463108] is an observational prospective and retrospective cohort study involving both primary data collection and secondary data extract. A total of 137 adult MDD patients with suicidality were enrolled from 24 Italian care sites and followed for 90 days. Other than the description of treatment patterns, the impact of treatment on depressive symptoms and suicidality, the burden on the patient's and caregiver's quality of life, healthcare resource utilization and costs were described. RESULTS: Of the 133 eligible patients, 68.4% were female, and the median age was 47. Approximately half of the study population had a current severe major depressive episode. Treatment strategies at the time of active suicidal ideation with intent definition/confirmation (t0) were heterogeneous, increasing in complexity during observation. According to the MADRS, patients with remission at t0+1 day were 2.6%, with the mean total score decreasing from 37.2 at t0 to 32.3. LIMITATIONS: The study sites were not randomly selected. CONCLUSIONS: To the best of our knowledge, this is the first cohort study that prospectively describes the characteristics of patients with MDD and suicide risk in Italy, and how they are treated in clinical practice. The study confirms this is a difficult-to-treat population. In addition, a lack of rapid, effective treatment for reducing depressive symptoms and suicidality is observed.
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Trastorno Depresivo Mayor , Suicidio , Adulto , Humanos , Femenino , Persona de Mediana Edad , Masculino , Trastorno Depresivo Mayor/diagnóstico , Trastorno Depresivo Mayor/epidemiología , Trastorno Depresivo Mayor/terapia , Ideación Suicida , Suicidio/psicología , Estudios de Cohortes , Estudios Prospectivos , Depresión , Calidad de Vida , Estudios RetrospectivosRESUMEN
In this post-hoc analysis of the AXEPT study, 855 patients were analyzed, 544 (63.6%) females. The mean (± SD) MMSE score in women vs men was 20.8 ± 2.6 vs. 21.2 ± 2.5; p = 0.0087, and women were more likely affected by psychiatric disorders (n = 76, 14.0% women vs. n = 21, 6.8% men; p = 0.0015). Men were mainly assisted by their wives (n = 207, 66.6%), women mainly by their daughters (n = 243, 44.7%) and only in a minority of cases by their husbands (n = 92, 16.9%). Women less frequently cohabited with their caregivers than men (n = 233, 43.1% vs. n = 240, 77.9%, p < 0.0001), and received less daily time of caregiving (mean (± SD): 10.0 ± 7.2 vs. 15.2 ± 8.2; p < 0.0001). No gender differences were highlighted in compliance to treatment and caregiver satisfaction, while gender differences in caregiving were found at disadvantage of women affected by more severe cognitive and psychiatric conditions.
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Enfermedad de Alzheimer , Masculino , Humanos , Femenino , Enfermedad de Alzheimer/psicología , Enfermedad de Alzheimer/terapia , Cuidadores/psicología , Vida Independiente , Núcleo Familiar , Satisfacción PersonalRESUMEN
BACKGROUND: Data from phase 3 trials have demonstrated the efficacy and safety of benralizumab in patients with severe eosinophilic asthma (SEA). We conducted a real-world study examining the baseline characteristics of a large SEA population treated with benralizumab in clinical practice and assessed therapy effectiveness. METHODS: ANANKE is an Italian multi-center, retrospective cohort study including consecutive SEA patients who had started benralizumab therapy ≥ 3 months before enrolment (between December 2019 and July 2020), in a real-world setting. Data collection covered (1) key patient features at baseline, including blood eosinophil count (BEC), number and severity of exacerbations and oral corticosteroid (OCS) use; (2) clinical outcomes during benralizumab therapy. We also conducted two post-hoc analyses in patients grouped by body mass index and allergic status. Analyses were descriptive only. RESULTS: Of 218 patients with SEA enrolled in 21 Centers, 205 were evaluable (mean age, 55.8 ± 13.3 years, 61.5% females). At treatment start, the median BEC was 580 cells/mm3 (interquartile range [IQR]: 400-850); all patients were on high-dose inhaled controller therapy and 25.9% were on chronic OCS (median dose: 10 mg/die prednisone-equivalent [IQR: 5-25]); 92.9% experienced ≥ 1 exacerbation within the past 12 months (annualized exacerbation rate [AER] 4.03) and 40.3% reported ≥ 1 severe exacerbation (AER 1.10). During treatment (median duration: 9.8 months [IQR 6.1-13.9]; ≥ 12 months for 34.2% of patients), complete eosinophil depletion was observed; exacerbation-free patients increased to 81% and only 24.3% reported ≥ 1 severe event. AER decreased markedly to 0.27 for exacerbations of any severity (- 93.3%) and to 0.06 for severe exacerbations (- 94.5%). OCS therapy was interrupted in 43.2% of cases and the dose reduced by 56% (median: 4.4 mg/die prednisone-equivalent [IQR: 0.0-10.0]). Lung function and asthma control also improved. The effectiveness of benralizumab was independent of allergic status and body mass index. CONCLUSIONS: We described the set of characteristics of a large cohort of patients with uncontrolled SEA receiving benralizumab in clinical practice, with a dramatic reduction in exacerbations and significant sparing of OCS. These findings support benralizumab as a key phenotype-specific therapeutic strategy that could help physicians in decision-making when prescribing biologics in patients with SEA. Trial registration ClinicalTrials.gov Identifier: NCT04272463.
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Anticuerpos Monoclonales Humanizados/uso terapéutico , Asma/tratamiento farmacológico , Eosinófilos/patología , Antiasmáticos/uso terapéutico , Asma/diagnóstico , Ensayos Clínicos Fase III como Asunto , Progresión de la Enfermedad , Femenino , Estudios de Seguimiento , Humanos , Recuento de Leucocitos , Masculino , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: An obserVAtional (CANOVA) study was aimed at providing real-world evidence of the effectiveness of biologics in Italian patients with moderate-severe psoriasis. It was an observational, retro-prospective cohort study conducted in 17 Italian dermatology clinics. Adult patients with moderate-severe plaque psoriasis, who started a biologic treatment between 24 weeks and 24 months before enrolment, were included. With a follow-up visit at 6 months after enrolment, each patient had at least 12 months of observation. The primary objective was to describe the clinical response rates (PASI 75) after 16/24/52 weeks from biologic treatment start. Secondary outcomes were sustained response, quality of life, and treatment satisfaction. Of the 669 eligible patients (64% males), 52% were naïve to biologics, though a mean duration of psoriasis since first diagnosis of 18.6 years (SD 13.2). The most frequently prescribed biologics were secukinumab (41%), ustekinumab (25%), TNF-inhibitors (22%) and ixekizumab (12%). PASI 75 was achieved by 86% of patients (95% CI: 82%-89%) at 16 weeks, 90% (87%-93%) at 24 weeks, and 91% (89%-94%) at 52 weeks. Patients achieving PASI 90 and PASI 100 at 52 weeks were 75% (71%-79%) and 53% (49%-57%), respectively. Sustained PASI 75 response after 1 year from treatment start was achieved by 78% (74%-82%) of patients. Mean DLQI total score was 2.3 (SD 3.9) at enrollment and decreased at the final visit to 1.8 (3.6). A high level of treatment satisfaction was expressed by patients over the study period. This large real-world study confirms in the clinical practice the good effectiveness and acceptability of biologics in psoriasis patients.
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Productos Biológicos , Psoriasis , Adulto , Productos Biológicos/efectos adversos , Femenino , Humanos , Estudios Longitudinales , Masculino , Estudios Prospectivos , Psoriasis/diagnóstico , Psoriasis/tratamiento farmacológico , Calidad de Vida , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND: Psoriatic arthritis (PsA) is a chronic, immune-mediated, spondyloarthropathy characterised by musculoskeletal signs and symptoms with associated joint pain and tenderness. The average worldwide PsA prevalence is 133/100,000, while in the Italian population is 90-420/100,000. Traditionally, nonsteroidal anti-inflammatory drugs, glucocorticoid, and disease-modifying antirheumatic drugs have been used in the treatment of PsA. However, for those patients who are not adequately controlled with conventional therapies, the new biologics compounds represent a valid option. Biologic therapies have been shown to be more effective but also more expensive than conventional systemic treatments. Based on the CHRONOS study, the economic analyses presented in this paper aim to assess the annualised direct costs and the cost-per-responder of biologics in a real-world context assuming the Italian National Health System perspective. METHODS: The economic assessments were carried out on the overall cohort of patients, and on the tumour necrosis factor alpha inhibitors (TNFi) and the secukinumab subgroup, the most prescribed biologic therapies within the CHRONOS study. RESULTS: The annual economic impact of PsA in the overall group was 12,622, 11,725 in the secukinumab subgroup, and 12,791 in the TNFi subgroup. Biologics absorbed the main expenditure costs in the treatment of PsA accounting for about the 93% of total costs. At 6 months, secukinumab performed better in all the considered outcomes: cost-per-responder according to EULAR DAS28 and ACR50 response criteria were 12,661- 28,975, respectively, while they were 13,356 - 33,368 in the overall cohort and 13,138 - 35,166 in the TNFi subgroup. At 12 months secukinumab remained the subgroup with the lowest cost-per-responder ratio in EULAR DAS28 and ACR50 response criteria, while TNFi subgroup was the lowest one considered the ACR20. CONCLUSION: Despite some potential methodological limitations, our cost-per-response analysis provides physicians and payers additional insights which can complement the traditional risk-benefit profile assessment and drive treatment decisions.
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Antirreumáticos , Artritis Psoriásica , Productos Biológicos , Humanos , Artritis Psoriásica/tratamiento farmacológico , Artritis Psoriásica/inducido químicamente , Estudios Longitudinales , Antirreumáticos/uso terapéutico , Productos Biológicos/uso terapéutico , Terapia Biológica , Resultado del TratamientoRESUMEN
BACKGROUND: Psoriasis is a chronic immune-mediated inflammatory skin disease which can also involve joints. It is often associated with burdensome comorbidities which negatively impact prognosis and quality of life (QoL). Biologic agents have been shown to be effective in controlling disease progression, but their use is associated with higher costs compared with traditional systemic treatments. The economic analysis of the CANOVA (EffeCtiveness of biologic treAtmeNts for plaque psOriasis in Italy: an obserVAtional longitudinal study of real-life clinical practice) study aims to assess the costs and cost-effectiveness of biologics in a real-world context in Italy. METHODS: The annualised overall direct costs of moderate-to-severe plaque psoriasis management, the annualised cost of biologic drugs and the cost per responder in the Italian National Health System perspective were assessed. More specifically, the cost per response and cost per sustained response of the most prescribed biologic therapies for the treatment of moderate-to-severe plaque psoriasis within the CANOVA study were assessed using the Psoriasis Area Severity Index (PASI) at several score levels (75, 90 and 100%). RESULTS: The most frequently used biologic therapies for plaque psoriasis were secukinumab, ustekinumab, adalimumab originator, and ixekizumab. Cost of biologics was the driver of expenditure, accounting for about 98% of total costs. Adalimumab originator was the biologic with the lowest cost per responder ratio (range: 7848 - 31,378), followed by secukinumab (range: 9015 - 33,419). Ustekinumab (range: 11,689 - 39,280) and ixekizumab (range: 11,092 - 34,289) ranked respectively third and fourth, in terms of cost-effectiveness ratio. As concerns the cost per sustained response analysis, secukinumab showed the lowest value observed (21,375) over the other options, because of its high response rate (86% vs. 60-80%), which was achieved early in time. CONCLUSION: Biologic therapy is a valuable asset for the treatment of moderate-to-severe plaque psoriasis. Concomitant assessment of treatment costs against the expected therapeutic response over time can provide physicians and payers additional insights which can complement the traditional risk-benefit profile assessment and drive treatment decisions.
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Psoriasis , Calidad de Vida , Anticuerpos Monoclonales/uso terapéutico , Terapia Biológica , Humanos , Italia , Estudios Longitudinales , Psoriasis/tratamiento farmacológico , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND: Female sex has been reported as an independent predictor of severe post-liver transplantation (LT) chronic kidney disease. We performed a by sex post-hoc analysis of the SURF study, that investigated the prevalence of renal impairment following LT, aimed at exploring possible differences between sexes in the prevalence and course of post-LT renal damage. METHODS: All patients enrolled in the SURF study were considered evaluable for this sex-based analysis, whose primary objective was to evaluate by sex the proportion of patients with estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2 at inclusion and follow-up visit. RESULTS: Seven hundred thirty-eight patients were included in our analysis, 76% males. The proportion of patients with eGFR < 60 mL/min/1.73 m2 was significantly higher in females at initial study visit (33.3 vs 22.8%; p = 0.005), but also before, at time of transplantation (22.9 vs 14.7%; p = 0.0159), as analyzed retrospectively. At follow-up, such proportion increased more in males than in females (33.9 vs 26.0%, p = 0.04). Mean eGFR values decreased over the study in both sexes, with no significant differences. Statistically significant M/F differences in patient distribution by O'Riordan eGFR levels were observed at time of transplant and study initial visit (p = 0.0005 and 0.0299 respectively), but not at follow-up. CONCLUSIONS: Though the limitation of being performed post-hoc, this analysis suggests potential sex differences in the prevalence of renal impairment before and after LT, encouraging further clinical research to explore such differences more in depth.
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Tasa de Filtración Glomerular/fisiología , Trasplante de Hígado/efectos adversos , Insuficiencia Renal/fisiopatología , Insuficiencia Renal/cirugía , Caracteres Sexuales , Receptores de Trasplantes , Adulto , Anciano , Estudios Transversales , Femenino , Estudios de Seguimiento , Humanos , Italia/epidemiología , Trasplante de Hígado/tendencias , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Insuficiencia Renal/epidemiología , Estudios RetrospectivosRESUMEN
To assess over a period of 9 months in a sample of Italian Parkinson's disease (PD) patients reasons leading the neurologist to modify dopaminergic treatment and patients' causes of dissatisfaction with ongoing therapy. To evaluate the influence of disease severity on therapy persistence. A disease severity balanced sample of PD patients with stable anti-parkinsonian drugs (APD) treatment was enrolled and evaluated every 3 months. Patients requiring APD treatment modifications were discontinued from the study. The probability to modify APD treatment is greater for higher motor (UPDRS scores) and non-motor symptoms (NMSS score) severity. Both from neurologist's and patient's perspective, motor symptoms were the main determinants underlying APD treatment modifications. Non-motor symptoms were cause of dissatisfaction with ongoing APD treatment for 52 % of the patients, while only 36 % of the neurologists considered these as valid reasons for therapy change. REASON is the first study in PD patients that prospectively examined reasons driving APD treatment changes. Results show that the disease severity significantly increases the probability of APD treatment change. Patients attribute greater relevance than neurologists to non-motor symptoms as reason requiring treatment changes. This confirms that patient and neurologist perceptions only partially overlap.
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Enfermedad de Parkinson/terapia , Anciano , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Enfermedad de Parkinson/diagnóstico , Rol del Médico , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND: The early detection of wearing-off in Parkinson disease (DEEP) observational study demonstrated that women with Parkinson's disease (PD) carry an increased risk (80.1%) for wearing-off (WO). This post hoc analysis of DEEP study evaluates gender differences on WO and associated phenomena. METHODS: Patients on dopaminergic treatment for ≥ 1 year were included in this multicenter observational cross-sectional study. In a single visit, WO was diagnosed based on neurologist assessment as well as the use of the 19-item wearing-off questionnaire (WOQ-19); WO was defined for scores ≥ 2. Post hoc analyses were conducted to investigate gender difference for demographic and clinical features with respect to WO. RESULTS: Of 617 patients enrolled, 236 were women and 381 were men. Prevalence of WO was higher among women, according to both neurologists' judgment (61.9% versus 53.8%, P = 0.045) and the WOQ-19 analysis (72.5% versus 64.0%, P = 0.034). In patients with WO (WOQ-19), women experienced ≥ 1 motor symptom in 72.5% versus 64.0% in men and ≥ 1 nonmotor symptom in 44.5% versus 36.7%, in men. CONCLUSIONS: Our results suggest WO as more common among women, for both motor and nonmotor symptoms. Prospective studies are warranted to investigate this potential gender-effect.
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Antiparkinsonianos/efectos adversos , Levodopa/efectos adversos , Enfermedad de Parkinson/tratamiento farmacológico , Anciano , Acatisia Inducida por Medicamentos/etiología , Antiparkinsonianos/uso terapéutico , Estudios Transversales , Femenino , Marcha/efectos de los fármacos , Humanos , Levodopa/uso terapéutico , Masculino , Factores de Riesgo , Índice de Severidad de la Enfermedad , Factores SexualesRESUMEN
BACKGROUND: In multiple myeloma (MM), improving our understanding of routine clinical practice and the effectiveness of agents outside of clinical trials is important. TOURMALINE-MM1 data resulted in approval of ixazomib for MM patients who have received ≥ 1 prior therapy. PATIENTS AND METHODS: UVEA-IXA comprised a retrospective chart review in the early access program, and a prospective 1-year follow-up period. Eligible patients had had a biochemical and/or symptomatic relapse after 1-3 prior lines of therapy; no anti-MM therapy for > 3 cycles at the start of ixazomib therapy; and an Eastern Cooperative Oncology Group performance score of 0-2. Lenalidomide- or proteasome inhibitor (PI)-refractory patients were ineligible. Primary endpoints were response and progression-free survival (PFS). RESULTS: Of 357 enrolled patients, 309 were evaluable; most patients received ixazomib alongside lenalidomide (98%) and dexamethasone (97%); 61% had received 2-3 prior lines of therapy. Median PFS was 15.6 months (95% confidence interval [CI]: 12.0-20.6) in all evaluable patients, and 19.6 (95% CI: 12.1-27.0) and 13.9 (95% CI: 10.1-18.1) months in patients who received 1 and ≥ 2 prior lines of therapy, respectively. The overall response rate was 67% in all evaluable patients, and 72% and 63%, respectively, in patients who received 1 and ≥ 2 prior lines of therapy. Median overall survival was 35.5 months. The ixazomib safety profile was consistent with previous reports. CONCLUSION: This study supports ixazomib-based therapy as an effective and tolerable treatment in the real-world. Outcomes were favorable in patients with 1 or ≥ 2 prior lines of therapy who were not lenalidomide- or PI-refractory.
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Compuestos de Boro , Glicina/análogos & derivados , Mieloma Múltiple , Humanos , Lenalidomida/uso terapéutico , Estudios Retrospectivos , Estudios Prospectivos , Dexametasona/uso terapéutico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , ÚveaRESUMEN
INTRODUCTION: While selected clinical and laboratory findings are taken into account to find the best therapeutic strategies for chronic obstructive pulmonary disease (COPD), it is unknown whether the circadian rhythm of respiratory symptoms, a distinctive feature of COPD, affects the prescription pattern of pharmacological therapy. The main aim of this study was to verify whether the circadian rhythm of symptoms correlates with bronchodilating therapy prescribed to COPD patients as per clinical practice. A secondary objective was to assess the relationship between Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage and circadian rhythm of symptoms and health status. METHODS: Five hundred sixty-six COPD patients were enrolled in the Italian multicenter STORICO study. Patients underwent a multidimensional assessment, and correlates of prescribed therapy were assessed through a multivariate multilevel model. RESULTS: As expected, patients in GOLD D stage were more likely to receive triple inhaled therapy than GOLD A-C patients, but the circadian rhythm of symptoms, assessed by the nighttime, morning, and daytime symptoms of the COPD questionnaire, was unrelated to the prescription pattern. The multivariate model showed that emphysematous (EM) patients had a 50% increased risk compared with patients affected by chronic bronchitis (CB) of being prescribed long-acting ß2-agonists (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combination (FDC) instead of triple therapy [relative risk (RR) EM versus CB 1.50, 95% CI 1.11, 2.03]. Symptoms, mainly in the early morning and daytime, were highly prevalent, even in GOLD B stage (76%). CONCLUSION: Even if we cannot infer about causality of the symptoms-therapy relationship, based on the structured recording of circadian symptoms clearly shows that symptoms are poorly controlled as the circadian rhythm of symptoms does not correlate with the prescription pattern, and many patients are symptomatic both at daytime and by nighttime. Thus, therapy should be better tailored to the individual needs, with special attention to control nocturnal symptoms. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03105999.
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Agonistas de Receptores Adrenérgicos beta 2 , Enfermedad Pulmonar Obstructiva Crónica , Humanos , Agonistas de Receptores Adrenérgicos beta 2/uso terapéutico , Ritmo Circadiano , Antagonistas Muscarínicos/uso terapéutico , Índice de Severidad de la Enfermedad , Fenotipo , Administración por Inhalación , Broncodilatadores/uso terapéutico , Corticoesteroides/uso terapéutico , Quimioterapia CombinadaRESUMEN
INTRODUCTION: IDegLira was shown to maintain glycemic control while reducing risk of hypoglycemia and body weight gain. The REX study was designed to generate real-world evidence on the use of IDegLira in Italian clinical practice in two different subgroups of patients, those switching to IDegLira from a basal insulin-supported oral therapy (BOT group) and those from a basal plus bolus insulin regimen (BB group). METHODS: Adult patients with T2D diagnosed for at least 12 months and having started IDegLira 2-3 months prior to enrolment, coming from a BOT or BB regimen, were enrolled in this multicenter observational prospective cohort study conducted in 28 Italian centers. This paper presents the methodological framework of the REX study and provides the interim analysis results describing the patients' baseline characteristics and the clinical reasons for IDegLira treatment initiation. RESULTS: Of the 360 patients enrolled in the REX study, 331 were considered eligible for this interim analysis, 76.4% in the BOT and 23.6% in the BB group. Mean (SD) HbA1c was 8.5% (1.4) in the BOT and 8.2% (1.7) in the BB group. The most common T2D complications were diabetic macroangiopathy and diabetic nephropathy in both groups. The median (interquartile range) insulin daily dose before IDegLira was 15.0 (10.0-20.0) units in the BOT group and 42 (30.0-52.0) in the BB group. Oral antidiabetics were taken by 98% and 51.3% of patients, respectively. The main reason for switching to IDegLira was the inadequate glycemic control in the BOT group (86% of patients), and the intent to simplify the treatment in the BB group (66.7%). CONCLUSIONS: IdegLira is initiated after BOT in inadequately controlled patients to improve glycemic control, whereas in BB patients it is used to simplify the therapeutic regimen. Final results of the REX study will shed light on patients' outcomes after IdegLira treatment under routine clinical care.
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BACKGROUND: Biologics have demonstrated efficacy in PsA in randomized clinical trials. More evidence is needed on their effectiveness under real clinical practice conditions. The aim of the present work is to provide real-world evidence of the effectiveness of biologics for PsA in the daily clinical practice. METHODS: CHRONOS was a multicenter, non-interventional, cohort study conducted in 20 Italian hospital rheumatology clinics. RESULTS: 399 patients were eligible (56.9% females, mean (SD) age: 52.4 (11.6) years). The mean (SD) duration of PsA and psoriasis was 7.2 (6.9) and 15.3 (12.2) years, respectively. The mean (SD) duration of the biologic treatment under analysis was 18.6 (6.5) months. The most frequently prescribed biologic was secukinumab (40.4%), followed by adalimumab (17.8%) and etanercept (16.5%). The proportion of overall responders according to EULAR DAS28 criteria was 71.8% (95% CI: 66.7-76.8%) out of 308 patients at 6 months and 68.0% (95% CI: 62.7-73.3%) out of 297 patients at 1 year. Overall, ACR20/50/70 responses at 6 months were 41.2% (80/194), 29.4% (57/194), 17.1% (34/199) and at 1-year were 34.9% (66/189), 26.7% (51/191), 18.4% (36/196), respectively. Secondary outcome measures improved rapidly already at 6 months: mean (SD) PASI, available for 87 patients, decreased from 3.2 (5.1) to 0.6 (1.3), the proportion of patients with dactylitis from 23.6% (35/148) to 3.5% (5/142) and those with enthesitis from 33.3% (49/147) to 9.0% (12/133). CONCLUSIONS: The CHRONOS study provides real-world evidence of the effectiveness of biologics in PsA in the Italian rheumatological practice, confirming the efficacy reported in RCTs across various outcome measures.
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Background: Severe eosinophilic asthma (SEA) in the presence of chronic rhinosinusitis with nasal polyps (CRSwNP) indicates the presence of a more extensive eosinophilic inflammation. Post-hoc analyses from a pivotal clinical trial have demonstrated the enhanced efficacy of benralizumab on asthma outcomes in patients with CRSwNP as a comorbidity. Methods: This is a post-hoc analysis from the Italian multi-center observational retrospective ANANKE study. Patients were divided into two groups based on self-reported CRSwNP. Baseline clinical and laboratory features in the 12 months prior to benralizumab prescription were collected. Data of change over time of blood eosinophils, annualized exacerbations rates (AER), asthma control, lung function, oral corticosteroids (OCS) use, and benralizumab discontinuation were collected during the observation period. Results: At baseline, the 110 patients with CRSwNP were less frequently female (50.9% vs 74.2%) and obese (9.1% vs. 22.6%) with higher eosinophils (605 vs. 500 cells/mm3) and OCS use when compared to patients without CRSwNP. Similar reductions of AER were seen (-95.8% vs. -91.5% for any exacerbation and -99.1% vs. -92.2% for severe exacerbations in patients with and without CRSwNP, respectively). During benralizumab treatment, comorbid SEA+CRSwNP was associated with a lower risk of any exacerbation (p = 0.0017) and severe exacerbations (p = 0.025). After a mean ± SD exposure of 10.3 ± 5.0 months, half of the SEA+CRSwNP patients eliminated OCS use. No discontinuation for safety reasons was recorded. Conclusions: This study helped to confirm the baseline clinical features that distinguish patients with and without CRSwNP being prescribed benralizumab. Numerically enhanced OCS reduction and lower exacerbation risk were observed in patients with SEA and comorbid CRSwNP treated with benralizumab.
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PURPOSE: The aim of this survey was to describe the attitude of Italian oncologists towards palliative care. METHODS: A survey on palliative care was carried out among 400 Italian oncologists. RESULTS: Seventy-two percent indicated that the management of patients with advanced stage cancer represents the majority of their practice. They are often involved in the management of pain (78%) and complications of chemotherapy (61%), and frequently, in the treatment of terminal patients (60%). Only 8.5% reported having frequent collaboration with psychiatrists in support of emotional and psychological patients' disturbances. About 40% are often directly involved in the management of existential or spiritual distress. Discussions on euthanasia and assisted suicide, which are illegal in Italy, took place never (68%) or occasionally (27%). CONCLUSIONS: Respondents agreed that all oncology centres should have access to palliative care service. These results are in line with those of the European Society of Medical Oncology survey and may be usefully employed to improve the organisation of palliative care.
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Actitud del Personal de Salud , Neoplasias/terapia , Cuidados Paliativos/métodos , Adulto , Anciano , Femenino , Encuestas de Atención de la Salud , Humanos , Italia , Masculino , Oncología Médica/métodos , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias/fisiopatología , Encuestas y CuestionariosRESUMEN
AIM: Describing the 1-year evolution of symptoms and health status in COPD patients enrolled in the STORICO study (observational study on characterization of 24-h symptoms in patients with COPD) classified in multidimensional phenotypes (m-phenotypes). METHODS: In our previous study, we performed an exploratory factor analysis to identify clinical and pathophysiological variables having the greatest classificatory properties, followed by a cluster analysis to group patients into m-phenotypes (mild COPD (MC), mild emphysematous (ME), severe bronchitic (SB), severe emphysematous (SE), and severe mixed COPD (SMC)). COPD symptoms were recorded at baseline, 6-, and 12-month follow-up and their evolution was described as frequency of patients with always present, always absent, arising', 'no more present symptoms. QoL and quality of sleep were evaluated using the SGRQ and CASIS questionnaires, respectively. RESULTS: We analyzed 379 subjects (144 MC, 71 ME, 96 SB, 14 SE, 54 SMC). M-phenotypes were stable over time in terms of presence of symptoms and health status with selected differences in evolution of symptoms in mild vs severe m-phenotypes. Indeed, 28.1% SB, 50.0% SE and 24.1% SMC vs 0.7% MC and 5.6% ME with night-time symptoms at baseline had no more symptoms at 6-month (p-value night-time symptom evolution MC vs SB, SE, SMC and ME vs SB, SE, SMC <0.0001). All m-phenotypes improved in quality of sleep, more markedly the severe than the mild ones (p-values CASIS score change between baseline and 6- or 12-month in MC, ME vs SB, SE, SMC <0.0001). QoL did not change during observation, irrespectively of m-phenotype. CONCLUSION: Over 1 year, severe m-phenotypes showed an improvement in night-time symptoms and quality of sleep, but not QoL. Being stable over time, m-phenotypes seem worthy of testing for classificatory and prognostic purposes.
Asunto(s)
Enfermedad Pulmonar Obstructiva Crónica , Calidad de Vida , Estudios de Seguimiento , Estado de Salud , Humanos , Fenotipo , Enfermedad Pulmonar Obstructiva Crónica/diagnóstico , Enfermedad Pulmonar Obstructiva Crónica/epidemiología , Enfermedad Pulmonar Obstructiva Crónica/terapia , Encuestas y CuestionariosRESUMEN
BACKGROUND: This paper is aimed to (i) develop an innovative classification of COPD, multi-dimensional phenotype, based on a multidimensional assessment; (ii) describe the identified multi-dimensional phenotypes. METHODS: An exploratory factor analysis to identify the main classificatory variables and, then, a cluster analysis based on these variables were run to classify the COPD-diagnosed 514 patients enrolled in the STORICO (trial registration number: NCT03105999) study into multi-dimensional phenotypes. RESULTS: The circadian rhythm of symptoms and health-related quality of life, but neither comorbidity nor respiratory function, qualified as primary classificatory variables. Five multidimensional phenotypes were identified: the MILD COPD characterized by no night-time symptoms and the best health status in terms of quality of life, quality of sleep, level of depression and anxiety, the MILD EMPHYSEMATOUS with prevalent dyspnea in the early-morning and day-time, the SEVERE BRONCHITIC with nocturnal and diurnal cough and phlegm, the SEVERE EMPHYSEMATOUS with nocturnal and diurnal dyspnea and the SEVERE MIXED COPD distinguished by higher frequency of symptoms during 24h and worst quality of life, of sleep and highest levels of depression and anxiety. CONCLUSIONS: Our results showed that properly collected respiratory symptoms play a primary classificatory role of COPD patients. The longitudinal observation will disclose the discriminative and prognostic potential of the proposed multidimensional phenotype. TRIAL REGISTRATION: Trial registration number: NCT03105999, date of registration: 10th April 2017.
Asunto(s)
Enfermedad Pulmonar Obstructiva Crónica/clasificación , Anciano , Anciano de 80 o más Años , Ansiedad/epidemiología , Ritmo Circadiano , Análisis por Conglomerados , Estudios de Cohortes , Comorbilidad , Tos/fisiopatología , Depresión/epidemiología , Disnea/fisiopatología , Análisis Factorial , Femenino , Humanos , Italia , Masculino , Memoria Episódica , Persona de Mediana Edad , Fenotipo , Enfermedad Pulmonar Obstructiva Crónica/epidemiología , Enfermedad Pulmonar Obstructiva Crónica/fisiopatología , Calidad de Vida , Sueño/fisiologíaRESUMEN
BACKGROUND: Alzheimer's disease (AD) is characterized by progressive cognitive decline, often associated with Behavioral and Psychological Symptoms of Dementia (BPSD). Acetylcholinesterase inhibitors (ChEi) may attenuate cognitive decline and mitigate BPSD. The EVOLUTION group found that the switch from oral ChEi to transdermal rivastigmine patch formulation resulted in improvement/stabilization in the frequency of clinically relevant BPSD, but gender-specific subgroup analyses were not reported. METHODS: Participants underwent Neuropsychiatric Inventory to assess the frequency and severity of neuropsychiatric symptoms at baseline and 3 and 6 months after the switch from oral ChEi to transdermal rivastigmine patch. A descriptive post hoc analysis was conducted to assess whether there were gender-based differences in BPSD profile during the 6 months after the switch. RESULTS: The entire sample consisted of 475 patients, 274 women and 201 men. Women were on average slightly older and with poorer cognitive performance (60.6% of the women had moderate-AD, defined as Mini-Mental State Examination [MMSE] score of 10-17, vs. 43.8% of men). In mild-AD patients (MMSE score 18-26), the frequency of BPSD did not change significantly over time and an association was found between gender and depression (odds ratio; OR [95% confidence interval; CI] female vs. male = 3.32 [1.44-7.67]), anxiety (2.42 [1.23-4.79]), apathy (2.25 [1.07-4.70]), nighttime behavior disturbances (3.97 [1.66-9.49]), and appetite/eating abnormalities (2.39 [1.10-5.18]). Moderate-AD female patients had euphoria more frequently than male patients (OR [95% CI] female vs. male = 3.67 [1.25-10.74]). The frequency of delusions, anxiety, and irritability decreased during the first 3 months after the switch, independently of gender. CONCLUSION: Mild-AD women tended to suffer more frequently from BPSD than men; in the 3 months after treatment switch, moderate-AD patients showed a decrease in delusions, anxiety, and irritability, with no significant differences between genders. Ad hoc studies to investigate this potential gender effect in AD could be well worthwhile.
Asunto(s)
Enfermedad de Alzheimer , Síntomas Conductuales , Rivastigmina , Administración Oral , Anciano , Enfermedad de Alzheimer/diagnóstico , Enfermedad de Alzheimer/tratamiento farmacológico , Enfermedad de Alzheimer/epidemiología , Enfermedad de Alzheimer/psicología , Síntomas Conductuales/tratamiento farmacológico , Síntomas Conductuales/etiología , Síntomas Conductuales/psicología , Inhibidores de la Colinesterasa/administración & dosificación , Inhibidores de la Colinesterasa/efectos adversos , Cognición/efectos de los fármacos , Sustitución de Medicamentos/métodos , Sustitución de Medicamentos/estadística & datos numéricos , Femenino , Humanos , Italia/epidemiología , Masculino , Competencia Mental , Pruebas de Estado Mental y Demencia , Técnicas Psicológicas , Rivastigmina/administración & dosificación , Rivastigmina/efectos adversos , Factores Sexuales , Parche Transdérmico , Resultado del TratamientoRESUMEN
INTRODUCTION: The influence of patient gender on the economic impact of health care has increasingly been examined in the recent literature. Gender appears to have an impact on healthcare resource consumption, due to possible differences in the patient's response to a chosen therapeutic management strategy or to a healthcare intervention. OBJECTIVE: The present work is aimed at collecting and reviewing evidences about the relationship between gender and economic consumption in health based on worldwide scientific literature published in the last 5 years. METHOD: We conducted a narrative review of evidence from an initial pool of 904 articles, selecting information about gender-specific economic impact in any therapeutic area. RESULTS: After title, abstract and full text review, 111 articles were relevant to the paper scope. The reviewed studies seem to be confirming that a difference exists between males and females in the economic implications of healthcare management and that those differences are particularly relevant for cardiovascular and metabolic pathologies. Preliminary evidence suggests overall healthcare costs are slightly higher in females than males, while some specific and non-quantitative items of resource consumption, such as quality of prescriptions, might favour male patients. Results do not allow to clearly claiming an overall cost shift towards males or females, since their polarization varies depending on the considered cost item or event category. CONCLUSION: Studies suggested the presence of a gender difference in overall healthcare resource consumption and costs. Nevertheless, these aspects still lack thorough examination in literature and further analyses would be required on longer time periods.