30 research outputs found

    An open-label study on the short-term effects of a novel EFSA-compliant nutraceutical combination in mild-to-moderate hypercholesterolemia

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    OBJECTIVE: Recently, the European Food Safety Authority (EFSA) has recommended to limit the use of total monacolins in red yeast rice (RYR) products to a dose <3 mg/day. However, data concerning the lipid lowering efficacy of the reduced dosage remain limited. A monacolin dose reduced due to safety issues may be expected to be less effective as a lipid lowering strategy and, for this reason, nutraceutical combinations with other active compounds may offer a viable solution as they can act synergistically through different mechanisms. MATERIALS AND METHODS: This 8-week open-label study was designed to investigate the safety and efficacy of a novel ESFA-compliant lipid lowering nutraceutical combination (Colestarmony Plus(®); containing total monacolins from RYR at a dose of 2.9 mg/day, a highly bioavailable berberine formulation, and pomegranate extract) in subjects (n=40) with mild-to-moderate hypercholesterolemia and no history of cardiovascular disease. RESULTS: After 8 weeks of supplementation, Colestarmony Plus(® )significantly reduced total cholesterol (−10.4%, p<0.05), low-density lipoprotein cholesterol (−14.8%, p<0.05), oxidized low-density lipoprotein cholesterol (−12.0%, p<0.05), and high-sensitivity C-reactive protein (−14.0%, p<0.05) compared with baseline values. A subgroup of 22 patients underwent measurements of flow-mediated dilation, with values increasing by 18.0% at 8 weeks with respect to baseline (p<0.05). The supplement was generally well-tolerated. CONCLUSION: Our short-term results indicate that the tested ESFA-compliant nutraceutical is effective in a primary prevention setting, even by providing only <3 mg/day of monacolins

    The T393C polymorphism of the GNAS1 gene is associated with deficit schizophrenia in an Italian population sample

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    Programmed cell death and alterations in intracellular G-protein signaling may be involved in the pathophysiology of schizophrenia. The Galphas subunit of heterotrimeric G-proteins, encoded by the gene GNAS1, may play a role in both of these processes. Additionally, transgenic mice expressing a constitutively active form of Galphas provide a reliable model of certain endophenotypes of schizophrenia. To investigate whether the functional single nucleotide polymorphism T393C in GNAS1 gene could affect risk of schizophrenia, we examined its distribution in Italian subjects with (n=383) and without (n=400) schizophrenia. We also evaluated whether a specific association could exist between the deficit (n=108) and nondeficit (n=275) forms of the disorder. The alleles and genotypes frequency in the entire cohort of schizophrenic patients did not differ from that of controls. However, the frequency of the homozygous 393TT genotype was significantly higher in deficit schizophrenic patients (37.1%) compared to both nondeficit schizophrenic (22.5%, p=0.011) and controls (22.8%, p=0.015). This association with deficit schizophrenia persisted even after allowance for potential confounders [adjusted odds ratio (OR) for deficit schizophrenia: 2.06 (95% confidence interval (CI): 1.21-3.47), p=0.007]. Altogether, our data suggest that the GNAS1 T393C status could influence susceptibility for deficit schizophrenia in Italian subjects

    [Ozone therapy: a potential adjunct approach to lower urinary tract infection? A case series report]

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    Multi-resistant drug bacteria are an emerging health care concern around the world. A decreased resistance to infection as seen in Chronic Kidney Disease (CKD) and kidney transplanted patients as well as some metabolic abnormalities such as hyperglycemia and glycosuria or clinical conditions such as the neurogenic bladder may indeed portend a great risk of recurrent urinary tract infections (UTI). The common and indiscriminate use of antibiotics often provides the patients with only a transient or partial amelioration of the urinary tract discomforts and increases the risk of multi-resistant drug bacteria selection. Thus a great effort is made in order to develop new antibacterial approaches especially in the setting of multi- antibiotic resistant pathogens. We herein report on some promising yet preliminary results of the use of ozone therapy in UTI

    Single-center open-label randomized study of anemia management improvement in ESRD patients with secondary hyperparathyroidism

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    Whether anemia and mineral bone abnormalities (chronic kidney disease–mineral bone disorder [CKD-MBD]) are associated still remains to be elucidated. Both anemia and CKD-MBD have been associated with adverse cardiovascular outcome and poor quality of life. However, recent evidence suggests that use of large doses of erythropoietin-stimulating agents (ESAs) to correct hemoglobin (Hb) may be detrimental in CKD. The Optimal Anemia Treatment in End Stage Renal Disease (ESRD) (Optimal ESRD Treatment) study will assess whether lowering of parathyroid hormone (PTH) is associated with a reduction in ESA consumption. The Optimal ESRD Treatment study is a pilot single-center open-label study with blinded end point (a prospective randomized open blinded end-point [PROBE] design) enrolling 50 patients on maintenance dialysis. Eligible patients with intact PTH (iPTH) 300-540 pg/mL and Hb 10-11.5 g/dL will be randomized 1:1 to strict PTH control (150-300 pg/mL) versus standard care (PTH range 300-540 pg/mL). Available drugs for CKD-MBD and anemia treatment will be managed by the attending physician to maintain the desired levels of PTH (according to study arm allocation) and Hb (10-11.5 g/dL). Echocardiographic data for cardiac structure and function as well as arterial stiffness will be assessed at study inception and completion. The Optimal ESRD Treatment study should shed light on the complicated interplay of anemia and CKD-MBD and on the feasibility of clinical trials in this domain. The study results are expected in the spring of 2017

    Effect of the functional toll-like receptor 4 Asp299Gly polymorphism on susceptibility to late-onset Alzheimer's disease

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    Experimental data have shown an upregulated expression of toll-like receptors, particularly toll-like receptor 4 (TLR4), in neurodegeneration. The Asp299Gly polymorphism of the TLR4 gene has been associated with an attenuated receptor signalling and a blunted inflammatory response. In the present study, we sought to determine whether this common genetic variant could influence susceptibility to late-onset Alzheimer's disease (LOAD) in an Italian population sample. A cohort of 277 LOAD patients and 300 cognitively healthy controls were genotyped for the TLR4 Asp299Gly polymorphism using restriction isotyping. The frequency of the minor 299Gly allele was significantly higher in the controls than in the LOAD cases (7.2% versus 3.1%, respectively, P = 0.003). Additionally, the frequency of the variant genotypes (Asp/Gly and Gly/Gly) was 13.0% in the controls and 5.4% in LOAD patients (P = 0.002). After adjustment for age, gender, and the APOE ε4 carrier status, the odds ratio for the development of LOAD associated with the Asp/Gly and Gly/Gly versus Asp/Asp genotype was 0.37 (95% CI: 0.20-0.69, P = 0.002). Our data further support a role for innate immunity in neurodegeneration and give the first evidence that the TLR4 Asp299Gly variant may be protective toward the development of LOAD

    I nuovi Anti-Coagulanti Orali (NOAC) : cosa deve sapere un Nefrologo = New oral anticoagulants (NOAC) in nephrology

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    I nuovi anticoagulanti orali (New Oral Anticoagulants - NOAC) o anticoagulanti orali diretti (Direct Oral Anticoagulants - DOAC) sono stati introdotti in commercio in Italia dal 2013. Pur condividendo buona parte delle indicazioni degli antagonisti della vitamina K (warfarin o acenocumarolo), presentano meccanismo d’azione differente, non prevedono continui prelievi per verificarne l’attività anticoagulante e risultano avere una efficacia superiore con minori rischi emorragici. Per questo motivo l’uso di queste molecole (Dabigatran, Apixaban, Rivaroxaban, Betrixaban, Edoxaban) si sta sempre più diffondendo nella pratica clinica. Sebbene i dati clinici disponibili depongano per una sostanziale sicurezza di queste molecole, sono comunemente suggeriti aggiustamenti posologici in base alla funzione renale e/o epatica e, da considerare, i comuni esami di laboratorio [tempo di protrombina (PT) e protrombina parziale- (PTT)] non sono in grado di valutare in modo accurato l’effetto anti-coagulante del NOAC/DOAC. A differenza degli antagonisti della vitamina K, solo per il dabigatran esiste ed è disponibile da marzo 2016 un antidoto specifico (idarucizumab) in grado di correggere eventuali sovradosaggi di questo farmaco mentre, per gli altri NOAC/DOAC, non si prevede la disponibilità di un antidoto specifico in tempi brevi. Obiettivo di codesto articolo è di riassumere quanto evidenziato dagli studi clinici disponibili sulla cinetica dei NOAC/DOAC in insufficienza renale, sui potenziali fattori di rischio di sovradosaggio/sanguinamento, sulla gestione di queste terapie in caso di procedure chirurgiche e sui potenziali interventi terapeutici per correggere eventuali sovradosaggi o complicanze.The new or direct oral anticoagulants [new oral anticoagulants (NOAC) or direct oral anticoagulants (DOAC)] were launched in the Italian market in 2013. Although these compounds share common pharmacological indications with vitamin K antagonists (warfarin or acenocumarol), they have different mechanisms of action, do not require a constant anticoagulant monitoring but are more efficacious and safer than vitamin K antagonists. The use of these molecules (Dabigatran, Apixaban, Rivaroxaban, Betrixaban, Edoxaban) is constantly rising in daily practice. However, while available data suggest that NOAC/DOAC use is safe, dosage should be adjusted based on renal or liver function. It should be acknowledged that commonly available blood tests [Prothrombin Time (PT) and partial thromboplastin time (PTT)] are not indicated to monitor the anticoagulant activity of these compounds. With the exception of dabigatran, we currently lack of an antidote to reverse the anticoagulant effect of NOAC/DOAC. We herein review available evidence on NOAC/DOAC pharmacokinetic, risk factors for bleeding, interventions to reverse the anticoagulant activity in case of hemorrhages or need of urgent surgery and/or NOAC/DOAC overdose or side effects
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