[Use of rivaroxaban in real-life treatment of venous thromboembolism: results of the TEV Survey, an Italian epidemiological study]. / Esperienza clinica con rivaroxaban nel trattamento del tromboembolismo venoso: risultati dell'indagine epidemiologica italiana Survey TEV.

BACKGROUND: Rivaroxaban is a direct and selective inhibitor of factor Xa. The randomized clinical trials EINSTEIN evaluated the efficacy and safety of rivaroxaban for the treatment of venous thromboembolism (VTE) proving that the drug was non-inferior to standard treatment. The aim of this survey was to describe how rivaroxaban was used in a group of "real-life" patients with VTE. METHODS: Between June and October 2014, physicians collected aggregate data, through an online questionnaire, on consecutive patients affected by VTE and treated with rivaroxaban in the previous 6 months. Descriptive statistics were performed on the collected data. RESULTS: A total of 345 questionnaires were filled out. The mean age of patients was 62 years, with a low prevalence of concomitant diseases and/or pharmacological treatments. Deep vein thrombosis was diagnosed in 90% of patients and pulmonary embolism in 47%; only 48% was hospitalized. Rivaroxaban was prescribed at the recommended doses and/or regimen in no more than 60% of cases. In 96% of patients, the initial therapeutic plan did not require changes. Adherence to the therapeutic plan and overall patient satisfaction with therapy were high. CONCLUSIONS: Rivaroxaban was found easy to use and was highly appreciated by patients.

Prulifloxacin vs Levofloxacin for Exacerbation of COPD after Failure of Other Antibiotics.

The chronic course and evolution of chronic obstructive pulmonary disease (COPD) is often characterized by periods of exacerbation of symptoms, which have a negative impact on the quality of life of patients, as well as on the evolution of COPD, and represent a significant cause of medical intervention and hospitalization. Very few data are available on the efficacy of rescue antibiotics in patients with acute exacerbation of COPD (AECOPD) unresponsive to previous treatment. The aim of this study was to evaluate the efficacy of two fluoroquinolones in AECOPD previously treated without success. The FADOI-FLOR study is a randomized, single-blind, non-inferiority comparison between levofloxacin and prulifloxacin. Primary end-point was "therapeutic success" at Day 10 of treatment, defined as disappearance of signs/symptoms or decrease of at least three points of a global score of symptomatology (maximum score = 15). 258 patients were enrolled (128 levofloxacin and 130 prulifloxacin), in 25 centers. A very high proportion of patients in the two groups had therapeutic success at Day-10 (levofloxacin 93.0% vs prulifloxacin 96.7%, population intention-to-treat; 94.6% vs 99.1%, population per-protocol). Earlier therapeutic success (within 7 days) was achieved in 32.0% and 36.2% of patients receiving levofloxacin or prulifloxacin, respectively. At 3-month follow-up, re-exacerbations occurred in 17.8% of patients treated with levofloxacin and 14.2% of those receiving prulifloxacin (p = 0.44). In conclusion, fluoroquinolones are very effective in the treatment of AECOPD resistant to other antibiotics.

High prevalence of fragility vertebral fractures in patients hospitalised in Internal Medicine Units. Results of the POINT (Prevalence of Osteoporosis in INTernal medicine) study.

BACKGROUND: Osteoporotic vertebral fractures (VFs) often go unrecognised in both healthy individuals and in pathological conditions. Few data exist on VFs in patients hospitalised in Internal Medicine Units (IMUs), who often suffer from multiple concomitant chronic disorders. AIM OF THE STUDY: This multicentre cross-sectional study was aimed at assessing the prevalence of VFs in an unselected population of patients referring to IMUs. Correlations between VFs and the main coexisting diseases were also investigated. METHODS: Information on demographic, clinical and laboratory findings, and on the presence of known risk factors for osteoporosis was recorded. The Genant's semi-quantitative method was used to evaluate, in a central reading centre, the presence and severity of VFs in the thoracic and lumbar spine. RESULTS: A cohort of 995 patients was evaluated. At least one VF of any grade was found in 47.5% of patients, with similar prevalence between females (48.1%) and males (46.7%). Older age, chronic obstructive pulmonary disease, and previous diagnosis of osteoporosis showed a significant association with VFs in multivariable analysis. However, 79.7% of the VFs were observed in patients without previous diagnosis of osteoporosis. Moreover, a VF of grade 2 or greater was found in 20.8% of patients. CONCLUSIONS: Fragility VFs is a very frequent finding in patients hospitalised in IMUs. Consequently, more attention should be devoted in this clinical setting to this comorbidity, which is known to be an additional factor for mortality and, when localised in the thoracic part of the spine, may negatively influence a concomitant respiratory insufficiency.

Identification and management of invasive mycoses in internal medicine: a road-map for physicians.

Invasive mycoses are a rising problem, not only in traditional categories of patients like hematologic or neutropenic ones, but also in elderly non-neutropenic patients admitted to internal medicine wards. Patients being admitted to medical wards are usually older, have multiple comorbidities, e.g., liver cirrhosis or chronic obstructive respiratory disease, may be malnourished or receive peripheral or total parenteral nutrition, and frequently are undergoing chronic corticosteroid therapy, chemotherapy for cancer or monoclonal antibodies for autoimmune diseases. Such risk factors may be contemporarily present in a single patient increasing the risk for the development of invasive mycoses. Diagnosis of candidemia and invasive aspergillosis is particularly difficult in patients hospitalized on medical wards, since symptoms and signs have low specificity, and most diagnostic tests have been only validated in neutropenic hematologic patients, but not in those without neutropenia. Both candidemia and invasive aspergillosis carry significant morbidity and mortality. The aim of this paper is to provide a simple guide to physicians for a prompt identification and treatment of patients with possible or suspected invasive mycoses.

[A Censis survey on atrial fibrillation awareness in the general population and among general practitioners and affected patients in Italy]. / Indagine Censis sulla conoscenza in Italia della fibrillazione atriale a livello dei cittadini, dei medici di medicina generale e dei pazienti.

BACKGROUND: Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, particularly in the elderly. AF is considered an independent predictor of mortality and risk factor for stroke. AF-related stroke is usually severe and associated with a high rate of mortality and disability. Despite its prevalence, AF is a poorly known disease and it is underestimated by the general population. The aim of the Censis survey was to analyze the levels of AF knowledge and information in the Italian population and the level of AF risk awareness by general practitioners and AF patients. METHODS: The survey included structured interviews with a sample of 1000 Italian citizens aged ≥18 years, 300 general practitioners, and 1200 AF patients. RESULTS: The analysis confirmed low levels of knowledge of AF. In particular, the results showed that only one third of Italians know AF that is however perceived as a severe disease. In this subgroup, the risk of stroke associated with AF is known by 65%, but it is also widespread the wrong concept that AF is associated with an increased risk of myocardial infarction. The lack of knowledge of AF and its complications by the Italian population is due to educational gaps of general practitioners. In particular, only 50% of the Italian general practitioners perceive the thromboembolic risk of paroxysmal AF as comparable to that of permanent AF. In addition, there is an underuse of the scores for thromboembolic and hemorrhagic risk stratification recommended by current guidelines and a frequent use of antiplatelet therapy rather than oral anticoagulant therapy. There is also a low level of knowledge and awareness of the disease among AF patients. However, the majority of AF patients are aware of the importance of antithrombotic prophylaxis for stroke prevention. CONCLUSIONS: This study demonstrates limited knowledge and awareness of AF in the general population and also among general practitioners and affected patients.

Incidence and predictors of venous thromboembolism in post-acute care patients. A prospective cohort study.

Few studies have addressed the topic of venous thromboembolism (VTE) in patients hospitalised in rehabilitation facilities. This patient population is rapidly growing, and data aimed to better define VTE risk in this setting are needed. Primary aim of this prospective observational study was to evaluate the frequency of symptomatic, objectively confirmed VTE in a cohort of unselected consecutive patients admitted to rehabilitation facilities, after medical diseases or surgery. Further objectives were to assess overall mortality, to identify risk factors for VTE and mortality, and to assess the attitude of physicians towards thromboprophylaxis. A total of 3,039 patients were included in the study, and the median duration of hospitalisation was 26 days. Seventy-two patients (2.4%) had symptomatic VTE. The median time to VTE from admission to the long-term care unit was 13 days. According to multivariable analysis, previous VTE (hazard ratio 5.67, 95% confidence interval 3.30-9.77) and cancer (hazard ratio 2.26, 95% confidence interval 1.36-3.75) were significantly associated to the occurrence of VTE. Overall in-hospital mortality was 15.1%. Age over 75 years, male gender, disability, cancer, and the absence of thromboprophylaxis were significantly associated to an increased risk of death (multivariable analysis). In-hospital antithrombotic prophylaxis was administered to 75.1% of patients, and low-molecular-weight heparin was the most widely used agent. According to our study, patients admitted to rehabilitation facilities remain at substantially increased risk for VTE. Because this applies to the majority of these patients, there is a great need for clinical trials assessing optimal prophylactic strategies.

In-hospital symptomatic venous thromboembolism and antithrombotic prophylaxis in Internal Medicine. Findings from a multicenter, prospective study.

Hospitalised medical patients are at increased risk of venous thromboembolism (VTE), but the incidence of hospitalisation-related VTE in unselected medical inpatients has not been extensively studied, and uncertainties remain about the optimal use of thromboprophylaxis in this setting. Aims of our prospective, observational study were to assess the prevalence of VTE and the incidence of symptomatic, hospitalisation-related events in a cohort of consecutive patients admitted to 27 Internal Medicine Departments, and to evaluate clinical factors associated with the use of thromboprophylaxis. Between March and September 2006, a total of 4,846 patients were included in the study. Symptomatic VTE with onset of symptoms later than 48 hours after admission ("hospital-acquired" events, primary study end-point) occurred in 26 patients (0.55%), while the overall prevalence of VTE (including diagnosis prior to or at admission) was 3.65%. During hospital stay antithrombotic prophylaxis was administered in 41.6% of patients, and in 58.7% of those for whom prophylaxis was recommended according to the 2004 Guidelines of the American College of Chest Physicians. The choice of administering thromboprophylaxis or not appeared qualitatively adherent to indications from randomised clinical trials and international guidelines, and bed rest was the strongest determinant of the use of prophylaxis. Data from our real-world study confirm that VTE is a relevant complication in patients admitted to Internal Medicine Departments, and recommended tromboprophylaxis is still under-used, in particular in some patients groups. Further efforts are needed to better define risk profile and to optimise prophylaxis in the heterogeneous setting of medical inpatients.

Survey of cardiovascular risk factors in overweight and obese patients (SCOOP study) six-month changes in risk factor levels and cardiovascular risk.

BACKGROUND: Obesity is considered a major threat to health worldwide, and its treatment is difficult. The SCOOP project is aimed at describing the effects of treating obesity in everyday clinical practice, following a standard protocol of weight reduction. METHODS: A total of 2472 obese or overweight men and women (with a body mass index of 27 units or more), aged between 35 and 74, were enrolled in different clinical facilities. Treatment included a 25% average reduction in caloric intake and a recommendation to take a brisk walk for at least 150 min per week. After 6 months, a second survey was then carried out. RESULTS: At the entry examination, patients exhibited high levels of most cardiovascular risk factors and estimated cardiovascular risks, and a high prevalence of cardiovascular diseases (14.1% in men; 6.3% in women), diabetes (30.5% in men; 25.2% in women) and metabolic syndrome (25.6% in men; 22.8% in women). After 6 months, 69% of all enrolled patients reported for a final examination. Levels of all cardiovascular risk factors were significantly reduced, including estimated cardiovascular risks (-20.4% in men and -12.6% in women). A targeted 10% reduction in body weight was achieved by 19% of patients. Changes in weight and cardiovascular risk factors were highly correlated with the self-reported compliance to prescriptions, and graded with the observed weight reduction. Benefits should be lowered by 30% if it is assumed that the patients who did not show up at the follow-up did not change their characteristics. CONCLUSION: Short term positive effects of treatment of obesity can be obtained in everyday clinical practice using a simple protocol.

[Skin and soft tissue infections: classification and epidemiology]. / Infezioni della cute e dei tessuti molli: classificazione ed epidemiologia.

In the present review, authors take into consideration the classification and the epidemiology of the skin and soft tissue infections (SSTIs), a set of commonly observed pathologies, which can present different features, relatively to site and localization, clinical characteristics, and aetiological agent, their severity being related to the depth of the interested sites. Given the variable presentation of SSTIs, an assessment of their incidence and prevalence is difficult. In general, the incidence of SSTIs has increased due to the ageing of the general population, the increased number of critically ill patients, the increased number of immunocompromised patients (HIV, cancer and organ transplant patients) and the recent emergence of multi-drug resistant pathogens.

[Infected pressure ulcers: evaluation and management]. / Valutazione e gestione delle infezioni delle ulcere da pressione.

Pressure ulcers in elderly individuals can cause significant morbidity and mortality and are a major economic burden to the health care system. Prevention should be the ultimate objective of pressure ulcer care, and it requires an understanding of the pathophysiology leading to pressure ulcers and the means of reducing both intrinsic and extrinsic risk factors. Clinical examination often underestimates the degree of deep-tissue involvement, and its findings are inadequate for the detection of associated osteomyelitis. Microbiological data, if obtained from deep-tissue biopsy, are useful for directing antimicrobial therapy, but they are insufficient as the sole criterion for the diagnosis of infection. Imaging studies, such as computed tomography and magnetic resonance imaging, are useful, but bone biopsy and histopathological evaluation remain the "gold standard" for the detection of osteomyelitis. The goals of treatment of pressure ulcers should be resolution of infection and promotion of wound healing. A combination of surgical debridement and medical interventions may be required. Systemic antimicrobial therapy should be used for patients with serious pressure ulcers infections, including those with spreading cellulitis, bacteremia or osteomyelitis.

Co-morbidity does not reflect complexity in internal medicine patients.

Internal medicine patients are mostly elderly; they have multiple co-morbidities, which are usually chronic, rather than self-limiting or acute diseases. Neither administrative indicators nor co-morbidity indexes, though validated in elderly patients, are able to completely define these "complex" patients or to allow physicians to correctly "cope" with them. For the complex patients found in internal medicine wards, internists need not only to find the best diagnosis and treatment, but also to apply a complex intervention (i.e., a comprehensive assessment and both continuous and multi-disciplinary care) in order to maintain their health and ability to function and to prevent or delay disability, frailty, and displacement from home and community. The aim of this review is to underscore the differences between the concepts of co-morbidity and complexity, to discuss instruments for their measurement, and to highlight related implications, areas of uncertainty, and the responsibilities of internists in the assessment and management of inpatients of their wards. The conclusion we come to is that it is mandatory to shift from a finance/administrative-based management system to a clinical process model (clinical governance) driven by the quality of the medical outcome and the cost of achieving that outcome. From a "complexity theory" standpoint, patient-centered care and collaboration can be seen as simple rules that guide desirable behaviors in a complex system. By exploring the real complexity of our patients, we exercise the holistic, anthropologic medicine of the person that is internal medicine.

The assessment of complexity in internal medicine patients. The FADOI Medicomplex Study.

BACKGROUND: Although the number of elderly people is progressively increasing in the world, old and very old patients have been under-represented and understudied in trials evaluating the efficacy of chronic illness management models. The usual hospital indicators and practice guidelines do not consider the effects of complexity - co-morbidity, social support, functional and cognitive status, patient adherence to therapy, risk of adverse drug reactions - in these subjects. The aim of this observational, multi-centric cohort study was to carefully assess factors contributing to the complexity of care for patients admitted to internal medicine wards. This was done by evaluating the severity of disease and degree of stability at admission, co-morbidity, age-related impairments, and the need for discharge planning plus post-discharge support. METHODS: A total of 386 patients from 11 internal medicine wards in Emilia-Romagna and Marche, Italy, enrolled in a given week were evaluated. At admission, the following variables were recorded: demographic characteristics, medical history, global clinical-social prognostic evaluation, co-morbidity, severity of illness, presence of shock or hemodynamic instability, coma, and frequencies and causes of unscheduled hospital re-admission. RESULTS: Cancer, congestive heart failure, pneumonia, stroke, and chronic obstructive pulmonary disease were the most frequent primary diagnoses. The complexity of our case study was characterized by several concomitant diseases. Over 50% of the patients were considered severe or more than severe, and over 20% extremely severe, with very high co-morbidity indices and illness severity scores. Some 55% of our patients were in need of partial or total care; 10% had some speech impairment, and 63% needed in-home health care after hospital discharge. CONCLUSIONS: The increasing numbers of elderly patients admitted to internal medicine departments suggests the need for a chronic illness management model, integrating gerontological and geriatric care to improve outcomes. For effective care, future protocols need to take a multi-dimensional, interdisciplinary approach to these patients and to develop a coordinated, integrated plan for treatment and long-term follow-up.

Time trends in three triennial surveys of cardiovascular risk factors and their treatment among patients discharged from divisions of internal medicine The FAPOI-1, FADOI-2, and FADOI-3 studies.

BACKGROUND: There is increasing interest in monitoring cardiovascular risk factor levels and their treatment. We decided to study this in patients discharged from Divisions of Internal Medicine. METHODS: In three studies conducted in 1996, 1999, and 2002, data was collected on diagnoses of cardiovascular diseases and cardiovascular risk factor levels and treatment in 5904, 7476, and 9649 patients, respectively, aged 35 years or older, who were discharged within a week from 235, 345, and 517 Divisions of Internal Medicine in Italy. RESULTS: Between the first and third surveys, a relative decrease in atherosclerotic cardiovascular diseases was recorded, but heart failure showed a definite increase, reaching 11% of all cases. Mean levels of most cardiovascular risk factors decreased significant; only obesity did not. The proportion of treated hypertensives increased slightly (from 65% to 83% among men, and from 69% to 85% among women). The proportion of controlled hypertensives also rose, reaching around 37%. The proportion of treated dyslipidemics increased from 10% to 28% in men and from 12% to 25% in women, due to an increase in the use of statins. CONCLUSIONS: It is essential to focus attention on cardiovascular risk factors in order to optimize their treatment and to reduce cardiovascular disease.

Factor V Leiden and prothrombin gene G20210A mutations in Italian patients with Behçet's disease and deep vein thrombosis.

OBJECTIVE: To evaluate the frequency and type of vascular lesions and to study the association of factor V gene G1691A (Leiden) and prothrombin gene G20210A polymorphisms with venous thrombosis in Italian patients with Behçet's disease (BD). METHODS: Included were 118 consecutive Italian BD patients followed over a 3-year period (1997-1999) who satisfied the International Study Group criteria for BD. The control group consisted of 132 healthy Italian blood donors. All BD patients and controls were genotyped by polymerase chain reaction and allele-specific restriction enzyme techniques for factor V Leiden and prothrombin gene G20210A polymorphisms. RESULTS: Vascular lesions were observed in 37 (31.4%) patients. The 2 most common lesions were subcutaneous thrombophlebitis (10.2%) and deep vein thrombosis (DVT) of the legs (22.8%). No significant demographic and clinical differences between patients with and without DVT were present. The distribution of allele and genotype frequencies of prothrombin gene G20210A and factor V Leiden polymorphisms did not differ significantly between BD patients and healthy controls. The frequencies of carriage rates of prothrombin gene G20210A and factor V Leiden polymorphisms in BD patients with and without DVT were similar. However, the frequency of 20210A allele was significantly higher in BD patients with ocular disease than in those without, particularly in the patients with posterior uveitis/retinal vasculitis. CONCLUSIONS: The frequency and types of vascular lesions in Italian BD patients were similar to those reported in studies from other countries. No association between factor V Leiden mutation and G20210A mutation in the 3'-untranslated region of the prothrombin gene with DVT was found. However, a prothrombin gene G20210A mutation may influence the development and severity of ocular involvement in BD.

Trends in cardiovascular risk factors and their treatment among patients discharged from divisions of internal medicine. The FAPOI-1 and FADOI-2 studies.

BACKGROUND: There is an increasing interest in monitoring cardiovascular risk factor levels and their treatment. Two studies were run in patients discharged from Divisions of Internal Medicine. METHODS: Two studies, respectively conducted in 1996 and 1999, have collected data on the diagnoses of cardiovascular diseases and cardiovascular risk factor levels and treatment in 6450 and 8133 patients (age > or = 35 years) discharged during 1 week from 235 and 345 Italian Divisions of Internal Medicine. RESULTS: The second survey revealed: a relative increase in heart failure and cerebrovascular disease diagnoses; lower serum levels of total cholesterol and triglycerides, lower systolic and diastolic blood pressure mean levels, and a decreased incidence of the habit of smoking among males. The proportion of treated hypertensives (blood pressure > or = 140/90 mmHg, or the use of antihypertensive drugs) increased slightly (65 to 68% among men and 69 to 71% among women). A reduction in the use of ACE-inhibitors was observed, balanced by an increase in the use of angiotensin II antagonists. The proportion of treated dyslipidemic patients (total cholesterol levels > or = 250 mg/dl, or HDL cholesterol levels < 35 mg/dl or triglyceride levels > or = 200 mg/dl or the use of hypolipidemic drugs) significantly increased from 10 to 25% among males and from 12 to 25% among females, due to a substantial increase in the use of statins. CONCLUSIONS: During a 3-year period increasing attention for cardiovascular risk factors and their treatment among patients discharged from Divisions of Internal Medicine has been documented. In particular, there has been a large increase in the use of statins, although large segments of patients may need further attention and drug treatment.

Is duplex ultrasonography useful for the diagnosis of giant-cell arteritis?.

BACKGROUND: Evidence of a dark halo on ultrasonography has been considered a specific sign of giant-cell arteritis and may replace temporal artery biopsy for the diagnosis of giant-cell arteritis in patients with typical clinical manifestations. OBJECTIVE: To assess the usefulness of temporal artery duplex ultrasonography and to compare this mode of ultrasonography with physical examination of temporal arteries for the diagnosis of giant-cell arteritis in patients with suspected giant-cell arteritis or polymyalgia rheumatica. DESIGN: Diagnostic test study. SETTING: Several divisions of Reggio Emilia Hospital, Reggio Emilia, Italy. PATIENTS: 86 consecutive patients with a suspected diagnosis of giant-cell arteritis or polymyalgia rheumatica identified over a 22-month period. MEASUREMENTS: The temporal arteries were examined in all 86 patients. Duplex ultrasonography of the temporal arteries was then performed by two ultrasonographers who were unaware of the clinical diagnosis. Before corticosteroid therapy was started, temporal artery biopsies were performed in all patients at the site targeted by the ultrasonographer. RESULTS: A hypoechoic halo around the lumen of the temporal arteries had a sensitivity of only 40% (95% CI, 16% to 68%) and a specificity of 79% (CI, 68% to 88%) for the diagnosis of biopsy-proven giant-cell arteritis. The negative likelihood ratio was 0.8 (CI, 0.5 to 1.2), and the positive likelihood ratio was 1.9 (CI, 0.9 to 4.1). When the thickness of the halo was at least 1 mm, specificity increased to 93% (CI, 84% to 98%) and the positive likelihood ratio increased to 5.7 (CI, 2.0 to 16.2); however, sensitivity remained low at 40% (CI, 16% to 68%). On physical examination, temporal artery abnormalities had a higher sensitivity of 67% (CI, 38% to 88%), a higher specificity of 99% (CI, 92% to 100%), and a higher positive likelihood ratio of 47.3 (CI, 6.5 to 342.4) than did ultrasonographic findings. None of the patients with giant-cell arteritis had a normal temporal artery inspection and a hypoechoic halo on ultrasonography. CONCLUSION: Evidence on ultrasonography of a halo around temporal arteries, either any halo or a halo 1 mm or greater in thickness, only modestly increased the probability of biopsy-proven giant-cell arteritis but did not improve the diagnostic accuracy of a careful physical examination.