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Cost-effectiveness of Empagliflozin, in Addition to Metformin, in Patients with Type 2 Diabetes in Italy
Full text linkBACKGROUND: Cardiovascular diseases represent the main cause of mortality and morbidity in type 2 diabetes mellitus (T2DM) patients. Empagliflozin is used as a treatment for T2DM because of its association with reduced risk of hospitalization for heart failure (hHF). Recently oral semaglutide, in association with metformin, has shown better results. This study analyzes the cost-effectiveness of empagliflozin versus oral semaglutide, in addition to metformin, in patients with T2DM who are inadequately controlled on metformin alone in Italy.METHODS: This analysis was conducted from the Italian National Health Service (SSN) perspective using the IQVIA Core Diabetes Model. For the base case analysis, a 50-year time horizon was chosen to capture the complications, their associated costs, and the final impact on life-years (LYs) and quality-adjusted life-years (QALYs) gained. Cohort baseline characteristics and efficacy data, were mainly sourced from the PIONEER 2 study. Health-state utilities and event disutilities were based on published sources. Drug acquisition and administration costs and patient management inputs were sourced from Italian-specific data. A sensitivity analysis and a range of scenario analyses were carried out.RESULTS: In the base case analysis treatment cost of empagliflozin plus metformin were significantly lower compared to oral semaglutide plus metformin both including and excluding the effect of empagliflozin on hHF (€-13.371/€-13.580; LYs -0.004/0.109 and QALYs -0.037/0.038). The sensitivity analysis confirmed the robustness of the model with empagliflozin plus metformin that was dominant in 63% and in 42% of simulations considering and non-considering the treatment effect on hHF, respectively.CONCLUSIONS: Empagliflozin 25 mg plus metformin is a cost-effective option versus oral semaglutide 14 mg plus metformin for patients with T2DM uncontrolled on metformin alone in Ital
Risk of Colorectal Cancer in Inflammatory Bowel Disease: Prevention and Monitoring Strategies According With Risk Factors
No full textColorectal cancer (CRC) is slightly increased in inflammatory bowel disease (IBD) patients, with roughly a 2.5-fold increase compared to the general population. Clinical features associated to CRC risks are extent and severity of colonic involvement, disease duration, concomitant primary sclerosing cholangitis (PSC) and/or familial history of CRC in first-degree relatives. Colonic Crohn’s disease (CD) and ulcerative colitis (UC) share similar risks when similar colonic extent is affected. Risk stratification affects outcomes and surveillance programs.Newer endoscopic techniques substantially ameliorated diagnostic performance of endoscopy, and nowadays the standard for CRC surveillance in IBD patients is high-definition endoscopy, with dye-spray or virtual colonoscopy, oriented at targeted (+ random) colonic biopsies.Visible dysplastic lesions should be considered for endoscopic resection, while invisible dysplasia is still a mandatory proctocolectomy indication.Newer endoscopic interventional techniques (endoscopic mucosa resection, EMR, and endoscopic submucosal dissection, ESD) are appropriate therapeutic techniques to be delivered, but long-term risks of cancer should be balanced towards proctocolectomy
[The Multidisciplinary Management of Type 2 Diabetes: an Integrated Care Model]
No full textOver the past 20 years, the prevalence of diabetes in Italy has been growing, up to the current estimated proportion of about 8.5%, which accounts also for undiagnosed patients. As most of these subjects are >65 years of age, the probability of having comorbidities is high. In addition, diabetes itself exposes patients to a wide spectrum of complications, that cover several therapeutic areas. This is why the optimal management of diabetes necessarily involves a multidisciplinary team.Several models of integrated care of chronic diseases may be set: for instance, the role assigned to GPs and specialists may differ among models. Indeed, a disequilibrium between GPs and specialists is deemed to be the main cause of the low patients’ participation in Progetto Cronicità (chronic diseases project), which started in Lombardia (a Northern region in Italy) in 2018.A help to understand how to build a proper integrated care model in diabetes comes from the experience of the Authors, that describe in detail their experience in IRCCS MultiMedica (Sesto San Giovanni, MI, Italy).This Supplement ends with a review of the evidence found in literature about the advantages of a multidisciplinary management of diabetes in terms of outcomes, costs, and patients’ satisfaction
[A rare case of sepsis from Citrobacter koseri in adults]
No full textWe describe the case of a 53-year-old man, recently diagnosed with decompensated type II diabetes mellitus, admitted to our Department for fever, asthenia, and detection of multiple lung abscesses and pulmonary embolism at chest tomography.His clinical history revealed just a recent orthopedic surgery of osteosynthesis on the left wrist with normal clinical and instrumental post-surgical evolution. Empirical antibiotic therapy with piperacillin/tazobactam and clindamycin was initiated. During hospital stay, swelling and functional impotence in the right knee occurred. They were investigated by arthrocentesis and magnetic resonance, and diagnosed as septic arthritis.Blood culture performed at admission tested positive for Citrobacter koseri on several samples where meropenem was added according to antibiogram. On the other hand, the cultures of bronchoaspirate, pulmonary fine needle aspiration, and arthrocentesis were negative.Antibiotic therapy was administered up to two weeks after discharge and radiological and physical features progressively improved
Osteoarthritis in Italy: Impact on Health-Related Quality of Life and Health Care Resources
Full text linkOBJECTIVE: To determine how osteoarthritis (OA) severity correlates with self-reported outcomes relevant from the patient’s perspective in the Italian clinical setting.METHODS: Data were drawn from the 2017-18 Adelphi OA Disease Specific ProgrammeTM (DSP). Data were collected in the Italian clinical practice settings by primary care physicians, rheumatologists, orthopedists, and their patients with OA, during their regular office visits. Physicians completed information about OA-related visits to healthcare professionals (HCPs), tests/scans conducted, emergency room (ER) visits, surgeries, and OA-related treatment. Physicians also rated patients’ functioning on a 0 to 10 scale (0 = fully functional; 10 = completely impaired). Outcomes included Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, functional limitations, treatment needs, EuroQoL-5 Dimension (EQ-5D) visual analogue scale (VAS), the work productivity and activity impairment. Descriptive statistics (numbers and percent for categorical variables; means with standard deviations [SD] for continuous variables) were used to evaluate the different variables as appropriate.RESULTS: The study population comprised 900 patients from Italy with knee (40.9%), back (38.7%), hip (27.9%), and/or shoulder (20.3%) OA. Mean age was 66.6 years with a prevalence of female (63%) patients. Patients had mild (26%), moderate (54%), severe (20%) disease severity. Patients with severe disease reported higher functional limitations, greater use of treatments, reduced quality of life, and impaired work productivity and activity. The burdens were higher among elderly and obese patients and in patients with highest pain severity score.CONCLUSIONS: The results from this cross-sectional study show the impact of OA disease severity on all dimensions of health-related quality of life (HRQoL), as well as in OA-related health care resource use
Iatrogenic Hypoglycemia Induced by Valproic Acid in an Adult Patient
Full text linkLiterature on antiepileptic induced iatrogenic hypoglycemia is scanty. Due to its broad spectrum of activity and mechanisms of action, valproic acid (VPA), a fatty acid, is the most widely prescribed epilepsy treatment worldwide.Herein, we describe an adult epileptic patient, where persistent, otherwise unexplained hypoglycemia, was most likely induced by VPA, as suggested by the VPA time course and glucose blood levels. Indeed, no further hypoglycemic episodes occurred after VPA discontinuation and the diagnostic work-up ruled out other possible causes of hypoglycemia.This case supports the hypothesis that VPA may induce hypoglycemia, due to still not well-defined metabolic mechanisms of action. Moreover, it emphasizes the fact that an iatrogenic pathogenesis should be considered if an apparently unexplained hypoglycemia occurs in a patient on chronic therapy with antiepileptics, even at a therapeutical dosage
A Budget Impact Analysis of the VENTANA PD-L1 SP142 Immunohistochemistry Assay Versus the Dako PD-L1 IHC 22C3 Assay in Patients With Advanced or Metastatic Triple-Negative Breast Cancer Treated With Atezolizumab in Combination With Nab-Paclitaxel
Full text linkOBJECTIVE: To estimate the budget impact determined by the adoption of two different diagnostic strategies, SP142 assay or 22C3 assay, in the identification (in terms of PD-L1 status) of patients with mTNBC eligible for treatment with atezolizumab in combination with nab-paclitaxel.METHODS: The budget impact analysis (BIA) was conducted using a budget impact model (BIM) considering the Italian National Health Service’s (iNHS) perspective. The analysis assessed only the direct medical cost (tissue biopsy, PD-L1 assay, specialist visit, pharmacological treatment with atezolizumab in combination with nab-paclitaxel) of patients with PD-L1 positive mTNBC, and management of the adverse events associated with the pharmacological treatment administered. The BIM also considered the clinical benefits (progression free survival, PFS) resulting from the drug therapy administered on the basis of the results of the post-hoc analysis of the IMpassion130 clinical trial. The BIA was conducted over a 1-year time horizon. The median cost per patient in the progression-free state was also calculated. The costs were calculated using the net ex-factory prices (cancer drugs) and regional or national tariffs (tissue biopsy, PD-L1 assay, specialist visit and adverse events management). A sensitivity analysis was conducted to evaluate the base case result.RESULTS: The SP142 assay diagnostic pathway would result in a reduction of the iNHS expenditure of approximately 5.6 million euros (-12%). Almost all of the reduction in iNHS expenditure would be determined by the lower number of patients treated (SP142: 689 patients vs 22C3: 786 patients) with immunotherapy (-€ 5,530,871). Compared with 22C3 assay, the SP142 assay shows a cost per PFS month reduction of € 736 (€ 7,010 vs € 7,746).CONCLUSIONS: The use of the SP142 assay proved to be cost-effective compared to the 22C3 assay; the SP142 assay can support the choice of the most appropriate cancer drug, maximizing the effectiveness and minimizing the waste of healthcare resources
Familial Gullo’s Syndrome: a clinical case report
Full text linkThis case report describes a male patient born in 1953 presenting an occasional increase in serum amylase and lipase forty years ago. The monitoring of enzymes was accompanied by radiological investigations, which did not reveal pancreatic pathology. In his family, including 10 siblings, half were carriers of this isolated anomaly; multiple cysts in pancreas, kidneys, and liver were present in some family members, in addition to a pancreatic neoplasia in a sister who did not carry the enzymatic abnormality. Our patient developed colon adenocarcinoma at the age of 67.Here we examine the characteristics of non-pathological chronic pancreatic hyperenzymemia defined as such by the main Italian pioneer Professor Gullo
Cost-Effectiveness Analysis of Alirocumab in High Cardiovascular-Risk Patients in Italy
Full text linkOBJECTIVE: Dyslipidemia, in particular elevated total and low-density lipoprotein cholesterol (LDL-C), results in atherosclerosis and increases the risk of cardiovascular (CV) events. Despite treatment with statins, many patients fail to reduce their LDL-C enough to optimally minimize their risk. Novel therapy alirocumab, on top of background statin therapy, resulted efficacious in lowering CV risk by reducing LDL-C levels. Aim of the present paper is to evaluate the cost-effectiveness of alirocumab in high cardiovascular-risk patients in ItalyMETHODS: A 1-year cycles Markov model was developed to evaluate the cost-effectiveness of statins at maximum dose tolerated plus ezetimibe (MDTS+E) with or without alirocumab. Target population consisted of patients with high baseline risk of CV events. Patients entered the model in stable disease and could experience a non- fatal CV event (acute coronary syndrome, elective revascularization or ischemic stroke) or die. Results from the ODYSSEY trial were used to evaluate CV risk reduction due to alirocumab add-on. Pharmaceutical, CV events, and LDL-C levels’ detection costs are considered in the analysis from the perspective of Italian National Health Service.RESULTS: Simulated cohort was 75 years old on average, 66% male, 42% diabetes mellitus and baseline LDL-C level equal to 121mg/dl. Furthermore, 96% of subjects were hospitalized in the last 12 months. Alirocumab used as an add-on to MDTS+E was more costly (€ 45,358 vs € 13,208) but more effective (8.01LY vs 6.33LY) than MDTS+E, leading to an incremental cost effectiveness ratio of € 19,158 per LY. At a willingness to pay threshold of € 30,000 per LY, alirocumab had 96% probability to be cost effective vs. MDTS+E alone. Results were relatively more favorable in the patient subset with recent CV event (<12 months from index).CONCLUSION: The results indicate that alirocumab in addition to MDTS+E is cost-effective versus MDTS+E alone in a representative cohort of high CV risk patients in Italy