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Safety of belimumab in association with denosumab in a patient affected by Lupus Erythematosus: a case report
Full text linkSystemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by multisystemic involvement. Owing to multifactorial etiologies, low bone mineral density (BMD) osteoporosis (OP) and fragility fractures (FFx) have been very frequently documented in these patients. Appropriate treatments to minimize underlying immunologic disease activity remain mandatory, and the development of strategies to prevent and treat important complications as osteoporosis is needed.We present the clinical case of a female SLE patient treated simultaneously with belimumab (anti-BLyS) for the underlying disease, and denosumab (anti-RANKL) for concomitant severe osteoporosis. As these monoclonal antibodies have been recently introduced into the market, their combination has not been reported in literature yet. In this case, the combined administration proved a viable option for a SLE patient with osteoporosis and bisphosphonates contraindications
The cost of a combination Anti-Retroviral Therapy (cART) optimization pathway as maintenance therapy in HIV-1 infected patients
Full text linkBACKGROUND: In order to reduce/prevent combination Anti-Retroviral Therapy (cART)-related toxicity, while maintaining its therapeutic effectiveness over time, the optimization of the antiretroviral therapy could be performed.AIM: To estimate the economic impact on the Italian National Health Service (NHS) of a cART optimization pathway as maintenance therapy in HIV-1 infected patients over one-year period.METHODS: Patient data were retrieved from the electronic medical record system in use (year 2015) in a reference HIV Center in Northern Italy. The analysis considered naïve patients and non-naïve patients. To estimate the actual ART expenditure charged to the Center we calculated the cost of cART received during 12 months for each patient. Subsequently, referring to the same patients, a "potential" cART expenditure was estimated. This potential expenditure was estimated taking in consideration the adoption of a specific optimization pathway aimed at maintaining over the time the cART efficacy. Lastly, to assess the sustainability of the optimization pathway, we compared the actual cART expenditure with the potential one. We considered only drug costs (ex-factory prices, included all discounts and VAT) from the perspective of the Italian NHS.RESULTS: In the 2015, the total expenditure for 564 enrolled HIV-1 patients treated with cART was € 4,042,983. The mean treatment cost per patient was € 7,168. If the Center adopted a specific optimization pathway, the total expenditure would be € 3,914,855 (€ -128,128).CONCLUSIONS: From the Italian NHS’s perspective, the adoption of a specific cART optimization pathway represents a cost-saving option as maintenance antiretroviral therapy in HIV-1 infected patients
Recently approved recombinant factor VIII (rFVIII) for the replacement treatment in patients with hemophilia A in Italy
Full text linkLa tutela previdenziale della tubercolosi extra-lavorativa: sorpassati concetti medico-legali a fondamenta delle indennità per una malattia ancora in auge
No full textThe Author briefly summaries the legislative history of Italian social security cover for extra-occupational tuberculosis, and lists the economic benefits that the National Institute of Social Security (INPS) reserves for the individuals who are insured with it and suffer from this disease, describing both the administrative and health requirements. Thus, the publication attempts to place the purely conceptual medical-legal aspects on which social security for extra-occupational tuberculosis is based under the microscope of rational criticism; in this way, the medical and legal foundations for the prevalence of morbidity are examined, to reveal the anachronistic principles of a protection that, with current changes in social, geopolitical and labour dynamics, remains based on laws from the 1930s and 1970s, and the principles they expressed
The role of psychological interventions in chronic headache management: a case report
Full text linkAccording to the biopsychosocial model, biological, psychological, and social factors entwine and influence each other bi-directionally concerning health conditions. Therefore, especially in disorders such as chronic headache, where behavioral and environmental factors are prominent risk factors and triggers, psychosocial interventions might contribute to reduce the burden of the health condition and related affective disorders and disability.We present the case of a Medication Overuse Headache patient self-reporting psychosocial and cognitive issues, that prompted further clinical-psychological and neuro-cognitive assessment and eventually psychological interventions targeted at headache management in conjunction with medical treatment. Psychological interventions were tailored to the patient’s features and presentation and were successful in reducing headache attacks in terms of intensity, frequency, and debilitation, thereby resulting also in a better perceived general health
From laboratory to bedside: a case report of a concise and pragmatic approach on heart failure
Full text linkHeart failure is one of the most common and intensely studied diseases in the world. Nevertheless, it is considered a difficult condition to diagnose and manage.This case report, starting from the description of a brief clinical case, aims to directly and concisely explain the most important steps, from laboratory to bedside, in the diagnosis and management of heart failure disease. Physicians can rely on some laboratory tests (e.g., natriuretic peptides) and instrumental exams to diagnose and manage the patients in everyday medical practice. Finally, this article highlights that a multidisciplinary team management can improve the clinical status and the quality of life, thus preventing hospital admission and reducing mortality in patients with heart failure
[Use of Kovaltry® in patients with Hemophilia A: clinical and economical aspects from the pivotal clinical trials]
Full text link[Article in Italian
Budget impact analysis of dabigatran compared with rivaroxaban in the prevention of the thromboembolic risk in patients with non-valvular atrial fibrillation
Full text linkBACKGROUND: Dabigatran 150 mg BID (D150) and rivaroxaban 20 mg (R20) are indicated for the prevention of thromboembolic events in patients with Non-Valvular Atrial Fibrillation (NVAF). Outcomes from observational study demonstrated that D150 and R20 reduced the rate of thromboembolic events.OBJECTIVE: This analysis estimated the budget impact of the use of D150 and R20 for the treatment of NAFV patients in Italy.METHODS: A budget-impact model (BIM) was developed to estimate the direct costs up to 12 months from an Italian NHS perspective. The resource utilization (drugs and intracranial hemorrhage or major extracranial bleeding event) was derived from an observational study. Only direct medical costs were considered. Ex-factory prices and National Tariffs were considered to estimate the costs of drugs and medical resource used, respectively. The BIM showed the difference of expenditure and clinical events (intracranial hemorrhage or major extracranial bleeding) generated by the base case calculated for current prescription volumes (D150 30%, R20 100%), and for different prescription volume scenarios (D150 at 70% and 100%). Key variables were tested in the sensitivity analysis.RESULTS: D150 was associated with a medical cost offset driven by fewer intracranial hemorrhage and major extracranial bleeding event, these offset the incremental drug cost and results in an annual saving per patient treated (D150: € 1,052.78; R20: € 1,161.23). The present scenario determines an annual cost of € 262,543,583. The impact of total annual costs for the Italian NHS would be lower if D150 prescription volumes would be higher. The total cost is predicted to decrease by 3.8% if the D150 prescription increase to 70% and it is predicted to decrease by 6.7% if the D150 prescription increase to 100%.CONCLUSION: The use of D150, as an alternative to R20 to prevent events in patients with NVAF, could represent a cost-saving option for the Italian NHS
La malattia comune nei lavoratori agli albori di un cambiamento epocale: l\u27INPS quale gestore unico della malattia indennizzabile
No full textThe article looks at the history of medical inspection visits in Italy, and describes in detail, the regulations that have been passed over the years relating to the management and control of common compensable illnesses: in the private sector, which has always been run by the National Institute for Social Security (INPS) which manages the system using its own "listed" occupational health physicians; and in the department of public administration which, until August 2017, saw management entrusted to the same public administrations with the help of medical staff from the Local Health Authority (so called Aziende Sanitarie Locali - ASL), who were operating in the capacity of official medical inspectors.As of 1 September 2017, in accordance with Legislative Decree No. 75 of 27 May 2017, the INPS will conduct all management and inspection of compensable common illnesses, in both the private and the public sectors. A nascent "single official medical inspection center" is thus taking its first insecure steps, against a backdrop of organizational uncertainties and the recognition of an increased workload for an entity which, for many years, has handled invalidity support in Italy
