Observational study on the QUality of life of Italian Axial SpondyloARthritis patients (QUASAR): baseline data.

OBJECTIVES: To describe the baseline characteristics of the patients enrolled in the QUality of life in patients with Axial SpondyloARthritis (QUASAR) study in terms of quality of life (QoL), disease activity, therapy adherence, and work ability in a real-world setting. METHODS: QUASAR is an Italian multicentre, prospective 12-month observational study, including consecutive adult patients classified as axial spondyloarthritis (axSpA) according to the Assessment of SpondyloArthritis international Society criteria for axSpA. RESULTS: Of 512 patients enrolled in 23 rheumatology centres, 80.7% had ankylosing spondylitis (AS) and 19.3% had non-radiographic axSpA (nr-axSpA). Mean ages were 34.1±13.3 years at axSpA symptoms onset and 39.5±13.0 years at diagnosis. Of the patients, 51.4% presented with ≥1 extra articular manifestation (EAM); the most common were psoriasis (17.8%) and uveitis (16.4%). Patients with nr-axSpA and AS had similar EAM rates, disease activity, and QoL. Biologic disease-modifying anti-rheumatic drugs (bDMARDs; 83.2%) were the most commonly received medication, followed by conventional synthetic DMARDs (22.9%) and non-steroidal anti-inflammatory drugs (NSAIDs; 16.6%). At baseline, higher treatment satisfaction was reported with bDMARDs which, together with NSAIDs, were associated with the best overall scores for disease activity, function, and QoL in the overall population and AS subgroup. CONCLUSIONS: QUASAR is the first Italian prospective study that comprehensively evaluated a large axSpA patient sample in a real-world setting. This interim analysis at baseline confirmed that i) patients with AS and nr-axSpA have similar QoL and disease burden, ii) nearly all axSpA patients receive treatment, and iii) bDMARDs and NSAIDs, overall, yield better disease activity and QoL.

Motor outcomes in patients with advanced Parkinson's disease treated with levodopa/carbidopa intestinal gel in Italy: an interim analysis from the GREENFIELD observational study.

Several levodopa/carbidopa intestinal gel (LCIG) studies showed a significant reduction of OFF time and a significant increase of ON time, as well as a reduction of dyskinesia, and improvement of non-motor symptoms and quality of life. However, few studies have been conducted in a large population for more than 3 years. Interim outcomes from GREENFIELD observational study on a large Italian cohort of advanced PD patients who started LCIG in routine care between 2007 and 2014, still on treatment at the enrollment, are presented. Comparison between baseline (before LCIG start) and visit 1 (at enrollment) is reported. Primary endpoint was Unified Parkinson's Disease Rating Scale (UPDRS) IV Item 39; secondary endpoints were UPDRS I and II, as outcome of quality of life. Overall, 145 of 148 enrolled patients from 14 Movement Disorder Centers in Italy were evaluable with a mean LCIG treatment period of 1.38 ± 1.66 years at enrollment. Compared with baseline, the mean score regarding daily time spent in OFF (UPDRS IV Item 39) at visit 1 significantly decreased from 2.1 ± 0.8 to 0.9 ± 0.7 (57 % reduction vs baseline, P < 0.0001); UPDRS IV improved by 39 % (P < 0.0001); scores for dyskinesia duration and disability were reduced by 28 % (1.8 ± 1.0-1.3 ± 0.9; P < 0.0001) and 33 % (1.5 ± 1.1 to 1.0 ± 1.0; P < 0.0001), respectively; and the scores for painful dyskinesia and early morning dystonia were reduced by 56 % (0.9 ± 1.0-0.4 ± 0.7; P < 0.0001) and 25 % (0.4 ± 0.5-0.3 ± 0.5; P < 0.001), respectively. The preliminary results of this interim analysis support the efficacy of LCIG on motor complications and activities of daily living.

Incidence of Respiratory Disease During the First Two Years of Life in Children with Hemodynamically Significant Congenital Heart Disease in Italy: A Retrospective Study.

Children affected by hemodynamically significant congenital heart disease (HSCHD) experience severe respiratory complications that can increase the frequency of hospitalizations. The aim of the SINERGY study was to describe the incidence of respiratory diseases and to collect information on active and passive immunoprophylaxis in the first 2 years of life. In this retrospective, multicenter, and epidemiologic study, children with HSCHD were enrolled across 11 Italian sites. Children born between December 31, 2007, and December 31, 2012, were observed during their first 2 years of life. Data were collected through hospital database searches and parent interviews. Four hundred twenty children were enrolled: 51.7 % were female, 79.5 % were born full-term (≥37 weeks), and 77.6 % weighed >2500 g at birth. The most frequent heart defects were ventricular septal defect (23.1 %) and coarctation of the aorta (14.3 %). The incidence of respiratory diseases was 63.1 %. Frequent respiratory diseases not requiring hospitalization were upper respiratory tract infections (76.4 %), acute bronchitis (43.3 %), and influenza (22.1 %), while those requiring hospitalization were bronchitis and bronchiolitis (8.3 % each one). While active immunoprophylaxis was applied with wide compliance (diphtheria/pertussis/tetanus, 99.5 %; Haemophilus influenzae type b, 72.5 %; pneumococcus, 79.9 %; meningococcus, 77.4 %), only 54 % of children received respiratory syncytial virus (RSV) passive prophylaxis (palivizumab). Of the 35 hospitalizations due to bronchiolitis, 27 (77.1 %) did not receive prophylaxis against RSV, compared with 8 (22.9 %) who received prophylaxis (P < 0.0001). Children with HSCHD are at major risk of respiratory diseases. Passive immunoprophylaxis can help to prevent hospitalizations for bronchiolitis.

Effect of VDRA on survival in incident hemodialysis patients: results of the FARO-2 observational study.

BACKGROUND: Mortality rate among patients with stage five chronic kidney disease (CKD) maintained on hemodialysis (HD) is high. Although evidence suggests that use of Vitamin D Receptor Activators (VDRA) in CKD patients increases survival, few studies have examined the effect of VDRA in incident HD patients. The FARO-2 study evaluated the clinical outcome of VDRA therapy on mortality in incident HD patients. METHODS: FARO-2 was a longitudinal epidemiological study performed on 568 incident HD patients followed prospectively from 26 dialysis centers over a 3-year period. Data were collected every 6 months using a questionnaire, obtaining clinical, biochemical and therapeutic parameters. Kaplan-Meier curves and Cox proportional hazard regression models were used to determine cumulative probability of time-to-death and adjusted hazard ratios. RESULTS: 568 patients (68% male) with an average age of 65.5 years were followed up. Mean dialysis duration at study entry was 3 months. VDRA use increased from 46% at 6 months to 54.7% at 36 months of follow-up (p = 0.08). No difference was observed in the presence of comorbid diseases at baseline in patients with and without VDRA therapy. Cumulative probability of survival at 24 months was 74.5% (95% CI: 70.2-78.3). Patients receiving VDRA therapy showed a significant increase in survival at 24 months (80.7%; 95% CI: 75.7-84.8) compared to those without (63.3%; 95% CI: 54.8-70.7, p <0.01). The presence of vascular disease, decreased hemoglobin, increased P and lack of VDRA treatment were significantly associated with an increased risk of mortality. Lack of VDRA treatment still remained significant as a predictor of mortality after adjusting for levels of PTH, P and Ca (HR = 2.16, 95% CI: 1.09-4.30, p = 0.03). CONCLUSIONS: Findings from FARO-2 indicate that in incident HD patients VDRA therapy was associated with increased survival.

VDRA therapy is associated with improved survival in dialysis patients with serum intact PTH ≤ 150 pg/mL: results of the Italian FARO Survey.

BACKGROUND: Chronic kidney disease (CKD) patients affected by mineral bone disorders (MBD) have higher rates of all-cause and cardiovascular-related mortality. Approximately, one-third of dialysis patients have low serum parathyroid hormone (PTH) levels (≤ 150 pg/mL). However, the reason why these patients have higher mortality compared to patients with normal PTH levels has not yet been fully elucidated. METHODS: The FARO study was performed on 2453 Italian patients followed prospectively from 28 dialysis centres over a 2-year period. Data were collected every 6 months and end points included time-to-death cumulative probability in patients with serum intact PTH (iPTH) ≤ 150 pg/mL and the effect of vitamin D receptor activation (VDRA) therapy. Kaplan-Meier curves and proportional hazards regression models stratified by PTH levels (i.e. ≤ 150 and >150 pg/mL) were used to determine cumulative probability of time-to-death and adjusted hazard ratios (HRs) for demographic, clinical and CKD-MBD treatment characteristics. RESULTS: The cumulative probability of death was higher (P < 0.01) for patients with serum iPTH levels ≤ 150 pg/mL [25.1%, 95% confidence interval (CI): 22.1-28.5 at 18 months] versus those with serum iPTH levels within the normal range (18.0%, 95% CI: 16.1-20.1). In a model with time-dependent covariates restricted to time periods when patients had iPTH levels ≤ 150 pg/mL, lower mortality was observed in patients treated with VDRA [i.e. HR = 0.62, 95% CI: 0.42-0.92 for oral or intravenous (IV) calcitriol; HR = 0.18, 95% CI: 0.04-0.8 for IV paricalcitol] versus those not receiving any VDRA (P < 0.01) independently of other variables. Patients who received IV paricalcitol, compared with either oral or IV calcitriol, showed reduced mortality, but this was not statistically significant (HR = 0.3, 95% CI: 0.07-1.31, P = 0.11). CONCLUSION: Results from this observational study suggest that VDRA therapy was associated with improved survival in dialysis patients, even with low serum iPTH levels.

A consensus-based approach on the management of patients with both psoriasis and psoriatic arthritis in the dermatological and rheumatological settings in Italy: The ADOI PSO-Amore Project.

Psoriasis is a complex disease often needing a multidisciplinary approach. In particular, the collaboration between dermatologist and rheumatologist is crucial for the management of patients suffering from both psoriasis (PSO) and psoriatic arthritis (PsA). Here we report a series of recommendations from a group of experts, as a result of a Consensus Conference, defining the circumstances in which it is preferable or even mandatory, depending on the available settings, to rely on the opinion of the two specialists, jointly or in a deferred manner. Indications are given on how to organize a 3rd level joint Dermatology- Rheumatology care unit, in connection with 1st and 2nd level clinicians of both specialties, GPs, and other specialists involved in the management of psoriasis. A potential patient journey is suggested, that can be used as a basis for future design and validation of national and/or local diagnostic therapeutic and assistance pathways.

Secondary hyperparathyroidism in chronic dialysis patients: results of the Italian FARO survey on treatment and mortality.

INTRODUCTION: Vitamin D receptor activator (VDRA) therapy has been shown to be associated with reduced mortality rates in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (SHPT). However, differences between VDRAs in their ability to reduce both all-cause and cardiovascular-related mortality rates are not yet fully elucidated. METHODS: The objective of the current analysis was to determine the effect of VDRA therapy on mortality in an Italian dialysis population, observed prospectively every 6 months for 18 months. Patients were investigated for all-cause and cardiovascular-related mortality risk adjusted for various demographic, clinical, and/or SHPT treatment variables. RESULTS: The cumulative probabilities of all-cause and cardiovascular-related mortality were lower for patients who received any VDRA treatment compared with those who did not (p < 0.001) regardless of all measured variables. Additionally, patients who received paricalcitol and/or cinacalcet (with or without VDRAs) compared with calcitriol showed a significant improvement in both all-cause and cardiovascular-related mortality (p < 0.001). Cinacalcet with or without VDRAs was not associated with a further decrease of mortality hazard ratios compared with paricalcitol monotherapy. CONCLUSIONS: VDRA therapy (associated or not with cinacalcet) was associated with improved survival in dialysis patients, independent of demographic and clinical variables.

Correction to: Caregiver burden and its related factors in advanced Parkinson's disease: data from the PREDICT study.

The original version of this article unfortunately contained a mistake. In the Figure.

Ultrasonographic and Clinical Assessment of Peripheral Enthesitis in Patients with Psoriatic Arthritis, Psoriasis, and Fibromyalgia Syndrome: The ULISSE Study.

OBJECTIVE: The purpose of the ULISSE study was to evaluate the prevalence of clinical and ultrasonographic (US) entheseal involvement in patients with psoriatic arthritis (PsA), psoriasis, and fibromyalgia syndrome (FMS). METHODS: In this cross-sectional multicenter study, patients with PsA and psoriasis (not taking systemic therapy) and FMS underwent a clinical evaluation of the entheses, and a B-mode and power Doppler examination of 6 pairs of entheses. RESULTS: The study analyzed 140 patients with PsA, 51 with psoriasis, and 51 with FMS. Clinical and US examinations were performed in 1960 and 1680 entheses in the PsA group, and 714 and 612 entheses both in the psoriasis group and in the FMS group. In both per-patient and per-enthesis evaluation, the frequency of entheseal tenderness was higher in patients with FMS (92% of the patients and 46% of the entheses, compared with 66%/23% in the PsA group and 59%/18% in the psoriasis group). With US examination, signs of entheseal involvement were more frequent in both the per-patient and per-enthesis evaluation in PsA and psoriasis (about 90% of patients in both the PsA and psoriasis groups and 75% of patients in the FMS group had at least 1 site affected, and 54%, 41%, and 27% of the pairs of entheses in, respectively, PsA, psoriasis, and FMS patients showed at least 1 enthesis involved). CONCLUSION: The ULISSE study indicated that enthesitis is a common feature in patients with PsA, those with psoriasis, and in those with FMS if only clinical examination is used. US entheseal assessment showed findings more consistent with the 3 disorders.

The Cost of Patients with Chronic Kidney Failure Before Dialysis: Results from the IRIDE Observational Study.

BACKGROUND: Chronic kidney disease (CKD) is an important public health problem. Most of the evidence on its costs relates to patients receiving dialysis or kidney transplants, which shows that, in these phases, CKD poses a high burden to payers. Less evidence is available on the costs of the predialytic phase. OBJECTIVE: The aim of this study was to estimate the annual cost of patients with CKD not receiving dialysis treatment, using the Italian healthcare system perspective and a prospective approach. METHODS: A 3-year observational study (December 2010-September 2014) was carried out to collect data on resource consumption for 864 patients with CKD. Costs were estimated for both patients who completed the follow-up and dropouts. RESULTS: The mean annual total (healthcare) cost per patient equalled €2723 (95% confidence interval 2463.0-2983.3). Disease severity (higher CKD stage), multiple comorbidities, dropout status and belonging to the southern region are predictive of higher costs. Pharmaceuticals, hospitalisation, and outpatient services account for 71.5, 18.8 and 9.7% of total healthcare expenditure, respectively. Recent estimates of Italian costs of patients receiving dialysis are nine times the unit costs of CKD for patients estimated in this study. Unit costs at stage 5 CKD (the highest level of severity) equals 4.7 times the costs for patients at stage 1 CKD. CONCLUSION: Despite its limitations, this study provides further evidence on the opportunity to invest in the first phases of CKD to avoid progression and an increase in healthcare costs.

Clinical management of patients on peritoneal dialysis in Italy: results from the ATENA study.

BACKGROUND: In Italy, few studies have examined the clinical management of peritoneal dialysis (PD) patients, resulting in a lack of information and awareness. METHODS: A total of 378 PD patients (64.7 ± 14.3 years, 58.9% males) were enrolled across 15 centres in a 12-month retrospective and 6-month prospective study. The primary objective was to evaluate the achievement of Kidney Disease Outcomes Quality Initiative and Kidney Disease Improving Global Outcomes guidelines on recommended target values for anaemia, high blood pressure and mineral metabolism. Comorbidities, hospitalizations, treatment and quality of life were also assessed. RESULTS: Frequent comorbidities included hypertension (87.8%) and cardiovascular disease (39.7%). Peritonitis was the leading cause of hospitalization [12 admissions per 100 person-years (95% confidence interval 9.3-15.2)]. At 6 months, anaemia corrected by erythropoiesis-stimulating agents was observed in 30% of patients and 73% received erythropoiesis-stimulating agents. Systolic and diastolic blood pressures were recorded in 50% and 20% of patients, respectively. Sixty-four percent of echocardiograms revealed left ventricular hypertrophy and 30% of patients had vitamin D <10 ng/mL. Medication to treat intact parathyroid hormone (PTH) included calcitriol (36.3%), paricalcitol (29.2%), cholecalciferol (23.6%) and cinacalcet (21.5%). In a subgroup of patients matched for baseline PTH treated for 1 year, a significant reduction in PTH with paricalcitol (-41%; P < 0.001) but not cinacalcet (+2%; P = 0.63) was observed. Comparison of quality of life domains revealed significant differences for symptoms (P = 0.049), cognitive function (P = 0.019) and social support (P = 0.04) (baseline versus 6 months). CONCLUSIONS: Hypertension and cardiovascular diseases were frequent comorbidities and peritonitis was the leading cause of hospitalization. Secondary hyperparathyroidism and anaemia were common, thus necessitating frequent monitoring of PTH, calcium, phosphorus and haemoglobin.

Clinical Management of Chronic Kidney Disease Patients in Italy: Results from the IRIDE Study.

BACKGROUND: Lack of adequate management of chronic kidney disease (CKD) often results in delayed diagnosis and inadequate treatment. This study assessed the clinical management and outcome of stages 1-5 CKD patients. METHODS: Patients were prospectively followed for 3 years in 25 nephrology centers across Italy. Clinical characteristics were measured at baseline and every 6 months. Outcome measures included CKD staging, presence of comorbidities, treatment, mineral bone disorder (MBD) parameters, and patient outcomes. RESULTS: Of 884 enrolled patients (59.7% males, aged 66.2 ± 14.6 years), 587 (66.4%) completed the study. The majority of patients were referred by a general practitioner (44.7%) and had stage 3 or 4 CKD (40.9 and 23.8% respectively). Data reveal that 91.3% of patients had at least 1 concomitant disease, most frequently hypertension (80.1%) and dyslipidemia (42.5%); 94.6% of patients were receiving cardiovascular medication and 52.6% were receiving lipid-lowering medication. Approximately 40% of patients had proteinuria and intact parathyroid hormone levels outside the normal range. As expected, stages 4 and 5 CKD patients had a higher prevalence of proteinuria (68 and 74%), MBD (59 and 88%) and anemia (28 and 73%), as well as a higher risk of hospitalization (34.3 and 51.9%) and need for dialysis (69.5 and 70%). The overall probability of survival over 36 months was 90.6%. CONCLUSIONS: This is the first Italian prospective study performed with a large cohort of CKD patients over a 3-year period. Considering the multifactorial burden of diseases associated with CKD patients, the need for greater attention to CKD and related disorders is paramount.

Caregiver burden and its related factors in advanced Parkinson's disease: data from the PREDICT study.

INTRODUCTION: Caring for a person with Parkinson's disease (PD) is associated with an increased risk of psychiatric morbidity and persistent distress. The objective of this study was to describe the burden and the related factors of caregivers of advanced PD (APD) patients either treated with continuous dopaminergic delivery systems or standard therapy. METHODS: This cross-sectional, epidemiologic study conducted in 13 Italian sites enrolled PD patients treated with continuous dopaminergic delivering systems [either levodopa/carbidopa intestinal gel (LCIG) infusion or continuous subcutaneous apomorphine infusion (CSAI)] or continuation of standard of care (SOC) with a caregiver. Patient quality of life (QoL) and caregiver burden were assessed using the Parkinson's Disease Questionnaire (PDQ-8) and Zarit Burden Inventory (ZBI), respectively. RESULTS: 126 patients (mean age 69.3 ± 8 years) and their caregivers (mean age 57.9 ± 12.9) were enrolled. Most caregivers were spouses. Fifty-three patients were treated with LCIG, 19 with CSAI, and 54 with SOC. Mean ZBI scores were 29.6 ± 14.4 for LCIG, 35.8 ± 20.2 for CSAI, and 31.4 ± 16.0 for SOC. Caregivers of LCIG, CSAI, and SOC patients showed no burden or mild/moderate burden in 74, 53, and 63% of the cases, respectively. Mean PDQ-8 scores were 11.25 ± 5.67, 11.26 ± 5.55, and 14.22 ± 6.51 in LCIG, CSAI, and SOC patients. Neurologists considered patients "very much or much improved" in 89, 58, and 13% of the LCIG, CSAI, and SOC groups using the Clinical Global Impression-Global Improvement Scale. Predictors significantly associated with caregiver burden were patients and caregivers' judgment of QoL and caregivers' need to change work. CONCLUSIONS: Caregiver burden showed a tendency to be lower when patients are treated with LCIG than with CSAI or SOC.

Respiratory Syncytial Virus-associated hospitalization in premature infants who did not receive palivizumab prophylaxis in Italy: a retrospective analysis from the Osservatorio Study.

BACKGROUND: Due to different social and epidemiological factors, the eligibility criteria to receive palivizumab prophylaxis may be different between countries, especially in "otherwise healthy" late preterm infants. METHODS: We analyzed an Italian database of young children referred to emergency departments for acute lower respiratory tract infection (ALRI) during the RSV season over a four year period, when the use of palivizumab as prophylaxis for RSV disease was not widespread in premature infants. The demographic and environmental characteristics and the RSV positivity (RSV(+)) in hospitalized and not-hospitalized patients were compared. In the data analysis we divided children according to their chronologic age (age) and their week gestational age (wGA). RESULTS: Out of the 100 children evaluated, 68 were infants (≤12 month-age): 7.5 and 20.6 % were in the <29 and 29- < 32 wGA groups respectively, and 72.0 % in the 32- < 35 wGA group. Positive hospitalized-to-not-hospitalized ratios were found in all three wGA groups, progressively decreasing (from 4.0 to 1.2), with increasing wGA (p = 0.35). The percentage of hospitalized infants that were also RSV(+) was also progressively decreasing (from 40.0 to 28.6 % and 18.4 %) with increasing wGA (p = 0.43). In the >12 month-age group (N = 32), there was positive hospitalized-to-not-hospitalized ratio only in the <29 wGA group with a low RSV(+) frequency (<29 %) in all wGA groups. In the ≤12 month-age group, 41 infants were evaluated with a ≤6 month-age and 27 with a >6-12 month-age. A positive hospitalized-to-not-hospitalized ratios was found in all wGA groups in ≤6 month-age infants, despite a low RSV(+) frequency in the 29- < 32 and 32- < 35 wGA group. In the >6-12 month-age group, all infants with a <29 and 29- < 32 wGA were hospitalized with a relatively high RSV(+) frequency whilst the 32- < 35 wGA group showed a negative hospitalized-to-not-hospitalized ratio with a lower RSV(+) frequency. CONCLUSIONS: The hospitalized-to-not-hospitalized ratios and RSV(+) frequency in the first 12 months of age in infants born prematurely confirm the vulnerability of these children for clinically important RSV infection, most notably in the <32 wGA category.

Evaluating targets and costs of treatment for secondary hyperparathyroidism in incident dialysis patients: the FARO-2 study.

BACKGROUND: The aim of this analysis was to estimate biochemical parameters and the costs of treatment of secondary hyperparathyroidism (SHPT) in a subpopulation of the FARO-2 study. METHODS: The FARO-2 observational study aimed at evaluating the patterns of treatment for SHPT in naïve hemodialysis patients. Data related to pharmacological treatments and biochemical parameters (parathyroid hormone [PTH], calcium, phosphate) were recorded at entry to hemodialysis (baseline) and 6 months later (second survey). The analysis was performed from the Italian National Health Service perspective. RESULTS: Two prominent treatment groups were identified, ie, one on oral calcitriol (n=105) and the other on intravenous paricalcitol (n=33); the intravenous calcitriol and intravenous paricalcitol + cinacalcet combination groups were not analyzed due to low patient numbers. At baseline, serum PTH levels were significantly higher in the intravenous paricalcitol group (P<0.0001). At the second survey, the intravenous paricalcitol group showed a higher percentage of patients at target for PTH than in the oral calcitriol group without changing the percentage of patients at target for phosphate. Moreover, between baseline and the second survey, intravenous paricalcitol significantly increased both the percentage of patients at target for PTH (P=0.033) and the percentage of patients at target for the combined endpoint PTH, calcium, and phosphate (P=0.001). The per-patient weekly pharmaceutical costs related to SHPT treatment, erythropoietin-stimulating agents and phosphate binders accounted for 186.32€ and 219.94€ at baseline for oral calcitriol and intravenous paricalcitol, respectively, while after 6 months, the costs were 180.51€ and 198.79€, respectively. Either at the beginning of dialysis or 6 months later, the total cost of SHPT treatment was not significantly lower in the oral calcitriol group compared with the intravenous paricalcitol group, with a difference among groups that decreased by 46% between the two observations. The cost of erythropoietin stimulating agents at the second survey was lower (-22%) in the intravenous paricalcitol group than in the oral calcitriol group (132.13€ versus 168.36€, respectively). CONCLUSION: Intravenous paricalcitol significantly increased the percentage of patients at target for the combined endpoint of PTH, calcium, and phosphate (P=0.001). The total cost of treatment for the patients treated with intravenous paricalcitol 6 months after entry to dialysis was not significantly higher than the cost for patients treated with oral calcitriol.

Clinical management of nondialysis patients with chronic kidney disease: a retrospective observational study. Data from the SONDA study (Survey Of Non-Dialysis outpAtients).

BACKGROUND: A lack of awareness of chronic kidney disease (CKD) often results in delayed diagnosis and inadequate treatment. PURPOSE: The objective of this study was to assess the therapeutic management and outcome of nondialysis CKD patients. METHODS: Three hundred ninety-seven patients (54.9% males aged 67.5 ± 14.6 years) were retrospectively screened at the Nephrology Department, GB Grassi Hospital, Rome, Italy. After a baseline visit, patient data were collected every 6 months for a total of 24 months. Clinical characteristics were measured at baseline, then the following outcomes were measured every 6 months: staging of CKD, presence of concomitant diseases, treatment and adherence to Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines for anemia management. RESULTS: Three hundred sixty-eight (92.7%) patients attended at least one visit and 92 (23.2%) patients attended all four visits. Patients were mainly referred to a nephrologist for chronic renal failure (61.7%) or hypertension (42.8%). At baseline, 79.6% of patients had previous hospitalization and 79.1% were receiving antihypertensive medication. Serum creatinine and/or glomerular filtration rate was examined in >90% of patients, whereas parathyroid hormone was rarely examined (5.5%). Vitamin D supplementation was received by 6.5% of patients. The majority of patients were staged at 3 or 4 CKD (32% and 23.9%, respectively) and did not significantly change over time. The use of antithrombotic, antilipidemic and erythropoietin medication increased over the four surveys. The majority of patients (86.8%) achieved hemoglobin K/DOQI target levels. CONCLUSION: These findings demonstrate a current lack of attention of CKD and related disorders (mineral metabolism, electrolyte balance, and anemia) at the level of the general practitioner (GP) and non-nephrology specialist, which can result in both delayed referral and inadequate treatment. By increasing both awareness of CKD and the coordinated relationship between GPs and nephrologists, patient clinical and therapeutic outcome may be improved.

Renal status in adult volunteers in central Italy: results from Family Abbott Renal Disease Monitoring Project (FARM) study.

BACKGROUND: Chronic kidney disease (CKD) is a major worldwide problem. A lack of CKD awareness and knowledge of associated risk factors may delay diagnosis and treatment. The purpose of this epidemiological study was to assess the presence and awareness of CKD, in addition to evaluating associated clinical characteristics. METHODS: This cross-sectional observational study included 573 healthy volunteers (aged 21-62 years) based in central Italy. All participants underwent a nephrological visit, providing data on medical history, anamnesis and CKD awareness. Blood and urine samples were also collected. RESULTS: Estimated glomerular filtration rate (eGFR) calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) study formula revealed that 55% of participants had an eGFR of <90 ml/min per 1.73 m2 compared with 24.6% by the Cockcroft-Gault formula (C-G; p<0.0001). Approximately 45% of participants showed an awareness of CKD, these subjects also having a significantly lower Framingham score (p<0.046). Approximately half of participants (51%) had insufficient levels (<30 ng/mL) of serum 25-hydroxyvitamin D (25(OH)D), with a higher proportion observed in female (58.3%) than male participants (45.6%, p=0.0016). Levels of 25(OH)D were negatively correlated with eGFR, measured by either MDRD or C-G (r=-0.12, p=0.0039 and r=-0.09, p=0.029 respectively). Logistic regression analysis revealed that male sex and increased serum creatinine levels were predictors associated with study outcomes (clinical risk factors). CONCLUSIONS: This study suggests that screening for CKD in the general population by eGFR calculations (MDRD or C-G) is unreliable; therefore, the monitoring of serum creatinine and other risk factors may be more appropriate. The presence of vitamin D insufficiency in apparently healthy individuals warrants further investigation.

Pharmacological control of secondary hyperparathyroidism in hemodialysis subjects: a cost consequences analysis of data from the FARO study.

BACKGROUND AND OBJECTIVES: Secondary hyperparathyroidism (SHPT) is a frequent complication of CKD with incidence, prevalence, and costs increasing worldwide. The objective of this analysis was to estimate therapy cost of SHPT in a sub-population of the FARO study. MATERIALS AND METHODS: In the FARO study, an observational survey aimed to evaluate patterns of treatment in patients with SHPT who had undergone hemodialysis, pharmacological treatments and biochemical parameters evolution data were collected in four surveys. Patients maintaining the same treatment in all sessions were grouped by type of treatment and evaluated for costs from the Italian National Health Service perspective. RESULTS: Four cohorts were identified: patients treated with oral (PO) calcitriol (n=182), intravenous (IV) calcitriol (n=34), IV paricalcitol (n=62), and IV paricalcitol+cinacalcet therapy (n=20); the cinacalcet monotherapy group was not analysed due to low number of patients (n=9). Parathyroid hormone (PTH) level at baseline and effectiveness of treatments in suppressing PTH level were assessed to test comparability among cohorts: calcitriol PO patients were significantly less severe than others (PTH level at baseline lower than 300 pg/ml; p<0.0001); calcitriol IV patients did not reach significant reduction in PTH level. Paricalcitol and paricalcitol+cinacalcet treatment groups results were comparable, while only the IV paricalcitol cohort's PTH level, weekly dosage, and cost decreased significantly from the first to the fourth survey (p=0.020, p=0.012, and p=0.0124, respectively). Total costs per week of treatment (including calcium-based phosphate binder and sevelamer) were significantly lower in the paricalcitol vs paricalcitol+cinacalcet cohort (p<0.001). Major limitations of this study are related to the survey design: not controlled and lack of comparability between cohorts; however, reflective of true practice patterns. CONCLUSIONS: The IV Paricalcitol cohort had significantly lower treatment costs compared with patients treated with paricalcitol+calcimemtics (p<0.001), without a significant difference in terms of baseline severity and PTH control.

Management of secondary hyperparathyroidism in Italy: results of the Italian FARO survey.

AIMS: In recent years, treatment options for secondary hyperparathyroidism (SHPT) have increased (e.g., paricalcitol, calcimimetics). To determine the impact these new treatments have on achieving K/DOQI targets, an observational, prospective survey was undertaken. METHODS: Four 6-month time-spaced surveys of 2,637 patients in 28 Italian dialysis units were performed. Patient demographic information; use of vitamin D or calcimimetics; and changes in parathyroid hormone (PTH), calcium (Ca) and phosphate (P) levels were evaluated. RESULTS: Over the course of the survey, use of calcitriol decreased (from 62.1% at baseline to 44.5% at month 18; p<0.001), while use of paricalcitol (from 19.9% to 36.9%; p<0.001) and calcimimetics (from 6.4% to 10.8%; p<0.001) increased. This was associated with a decrease in mean PTH values (from 310.3 ± 292.4 pg/mL at baseline to 279.5 ± 250.1 pg/mL at month 18; p=0.0002), while mean Ca and P remained steady. The percentage of patients achieving K/DOQI ranges for PTH (from 26.8% at baseline to 32.0% at month 18, p<0.001), Ca (from 50.4% at baseline to 55.9% at month 18, p<0.001) and the 3 targets combined (PTH, Ca and P; from 8.8% at baseline to 11.5% at month 18, p=0.003) significantly increased (p<0.05). Despite the introduction of newer agents, two thirds of patients did not achieve target levels. CONCLUSIONS: Increased awareness and newer treatment options for chronic kidney disease patients with SHPT have changed treatment policy and number of patients achieving K/DOQI target levels in Italy. However, the majority of patients did not meet the target ranges, suggesting that new drugs and strategies are still warranted for optimal management of SHPT in chronic kidney disease.

Effects of sibutramine-induced weight loss on cardiovascular system in obese subjects.

BACKGROUND AND AIM: To assess efficacy of sibutramine in obese subjects, and influence on hemodynamics, valve function and left ventricular (LV) geometry and performance. METHODS AND RESULTS: Three-month double-blind, parallel groups, randomized, placebo-controlled of 15 mg o.i.d. sibutramine administration combined with diet. Twenty-five to 65 year-old males or postmenopausal females, were enrolled if their BMI was between 30 and 40 kg/m(2), without evidence of concomitant diseases. Body weight, BMI, blood pressure (BP), echocardiographic LV mass, cardiac output, and diastolic function were measured. Body weight and BMI were better reduced with sibutramine (weight loss of 5% or more in 9 of 11 patients) than placebo group (weight loss of 5% or more in 5 of 9 patients; all p<0.05). Systolic and diastolic BP decreased similarly in both arms. No difference in mean heart rate was detected between treatments. The two groups had slightly different LV geometry at baseline. LV mass decreased with weight loss, more in the sibutramine group (p<0.05), due to reduction in LV chamber size. Stroke volume tended to be reduced in the sibutramine group, influencing diastolic pattern. E/A ratio tended to decrease in the sibutramine group without changes in isovolumic relaxation time and deceleration time of E velocity. No onset or increased severity of valve regurgitation was detected. CONCLUSIONS: Combined to hypocaloric diet, sibutramine increases weight loss in obese individuals. Weight changes have positive effect on reduction of BP and contribute to reduce LV mass, the hallmark of markers of preclinical cardiovascular disease and most powerful predictor of adverse outcome.