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Article: Management of patients with phenylketonuria (PKU) under enzyme replacement therapy: An Italian model (expert opinion).

Scala, Iris / Brodosi, Lucia / Rovelli, Valentina / Noto, Davide / Burlina, Alberto

Molecular genetics and metabolism reports

2024 Volume 39, Page(s) 101065

Abstract: Objective: Phenylketonuria (PKU) is a metabolic disorder necessitating lifelong management to prevent severe neurological impairments. This paper synthesises clinical practices from Italian specialist centres to delineate a unified approach for ... ...

Abstract	Objective: Phenylketonuria (PKU) is a metabolic disorder necessitating lifelong management to prevent severe neurological impairments. This paper synthesises clinical practices from Italian specialist centres to delineate a unified approach for administering pegvaliase, a novel enzyme replacement therapy for PKU. Methods: Virtual meetings convened in September 2022, gathering a steering committee (SC) of experts from five Italian centres specialising in PKU. The SC reviewed, and discussed clinical practices, and formulated recommendations for pegvaliase treatment. Results: The SC outlined a comprehensive treatment roadmap for PKU management with pegvaliase, emphasising the importance of multidisciplinary care teams, patient selection, pre-treatment evaluation, and education. Recommendations include initial hospital-based pegvaliase administration, regular monitoring of phenylalanine and tyrosine levels, dietary adjustments, and management of adverse events. A consensus was reached on the need for a digital database to manage treatment plans and enhance communication between healthcare professionals and patients. Conclusion: The expert panel's consensus highlights the complexity of PKU management and the necessity for a coordinated, patient-centred approach. The recommendations aim to standardise care across Italian centres and provide a framework for integrating pegvaliase therapy into clinical practice, potentially informing international guidelines. Further research is warranted to evaluate the long-term impact of these practices on patient outcomes and quality of life.
Language	English
Publishing date	2024-02-22
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2821908-9
ISSN	2214-4269
ISSN	2214-4269
DOI	10.1016/j.ymgmr.2024.101065
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Article ; Online: Erdheim-Chester disease as complex clinical presentation and diagnosis: A case report and concise review of literature.

Gagliardo, Carola M / Giammanco, Antonina / Vaglio, Augusto / Pegoraro, Francesco / Cefalù, Angelo B / Averna, Maurizio / Noto, Davide

Medicine

2024 Volume 103, Issue 17, Page(s) e37870

Abstract: Rationale: Erdheim-Chester disease (ECD) is a rare multisystemic disease characterized by the infiltration of multiple organs by foamy CD68 + CD1a-histiocytes. The genetic background consists of gain-of-function somatic mutations in the mitogen- ... ...

Abstract	Rationale: Erdheim-Chester disease (ECD) is a rare multisystemic disease characterized by the infiltration of multiple organs by foamy CD68 + CD1a-histiocytes. The genetic background consists of gain-of-function somatic mutations in the mitogen-activated protein kinase pathway. The purpose of the present paper is to make a contribution to the scientific literature on ECD by reporting our experience with a complex clinical case report, along with a concise review of the literature. We discussed the unusual clinical presentation, the complex diagnostic process and the comparison with other published cases. Patient concerns: A 70-year-old man presented with arthralgia due to multiple bone areas of sclerosis, first diagnosed with metastases of a prostatic neoplasm. Sequential thorax-abdomen, femoral and homer contrast-enhanced computed tomography (CT) showed pericardial effusion, pulmonary fibrosis, and perirenal fibrous tissue as "hairy kidneys." He underwent. Three bone biopsies were unsuccessful to reach diagnosis. Diagnoses: A xanthelasma biopsy showed histopathological signs compatible with ECD; genetic analysis showed the mutation BRAFV600E. Interventions: The patient underwent targeted therapy with vemurafenib (BRAF-inhibitor), discontinued 2 weeks later due to the onset of a diffuse erythematous papular rash on the trunk and limbs. Outcomes: At the 1-year follow-up, there was only progression of chronic kidney disease (CKD). Lessons: The present case report describes how ECD diagnosis could represent a challenge for clinicians, owing to its heterogeneous clinical presentation. Early diagnosis followed by prompt therapy is essential for modifying the natural history of the disease.
MeSH term(s)	Humans ; Erdheim-Chester Disease/diagnosis ; Erdheim-Chester Disease/genetics ; Male ; Aged ; Proto-Oncogene Proteins B-raf/genetics ; Vemurafenib/therapeutic use
Chemical Substances	Proto-Oncogene Proteins B-raf (EC 2.7.11.1) ; Vemurafenib (207SMY3FQT) ; BRAF protein, human (EC 2.7.11.1)
Language	English
Publishing date	2024-05-02
Publishing country	United States
Document type	Journal Article ; Case Reports ; Review
ZDB-ID	80184-7
ISSN	1536-5964 ; 0025-7974
ISSN (online)	1536-5964
ISSN	0025-7974
DOI	10.1097/MD.0000000000037870
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Article ; Online: Derivation and validation of a predictive mortality model of in-hospital patients with Acinetobacter baumannii nosocomial infection or colonization.

Gagliardo, Carola Maria / Noto, Davide / Giammanco, Antonina / Catanzaro, Andrea / Cimino, Maria Concetta / Presti, Rosalia Lo / Tuttolomondo, Antonino / Averna, Maurizio / Cefalù, Angelo Baldassare

European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology

2024

Abstract: Purpose: Acinetobacter baumannii (Ab) is a Gram-negative opportunistic bacterium responsible for nosocomial infections or colonizations. It is considered one of the most alarming pathogens due to its multi-drug resistance and due to its mortality rate, ... ...

Abstract	Purpose: Acinetobacter baumannii (Ab) is a Gram-negative opportunistic bacterium responsible for nosocomial infections or colonizations. It is considered one of the most alarming pathogens due to its multi-drug resistance and due to its mortality rate, ranging from 34 to 44,5% of hospitalized patients. The aim of the work is to create a predictive mortality model for hospitalized patient with Ab infection or colonization. Methods: A cohort of 140 sequentially hospitalized patients were randomized into a training cohort (TC) (100 patients) and a validation cohort (VC) (40 patients). Statistical bivariate analysis was performed to identify variables discriminating surviving patients from deceased ones in the TC, considering both admission time (T0) and infection detection time (T1) parameters. A custom logistic regression model was created and compared with models obtained from the "status" variable alone (Ab colonization/infection), SAPS II, and APACHE II scores. ROC curves were built to identify the best cut-off for each model. Results: Ab infection status, use of penicillin within 90 days prior to ward admission, acidosis, Glasgow Coma Scale, blood pressure, hemoglobin and use of NIV entered the logistic regression model. Our model was confirmed to have a better sensitivity (63%), specificity (85%) and accuracy (80%) than the other models. Conclusion: Our predictive mortality model demonstrated to be a reliable and feasible model to predict mortality in Ab infected/colonized hospitalized patients.
Language	English
Publishing date	2024-04-12
Publishing country	Germany
Document type	Journal Article
ZDB-ID	603155-9
ISSN	1435-4373 ; 0934-9723 ; 0722-2211
ISSN (online)	1435-4373
ISSN	0934-9723 ; 0722-2211
DOI	10.1007/s10096-024-04818-7
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Article ; Online: DeepSRE: Identification of sterol responsive elements and nuclear transcription factors Y proximity in human DNA by Convolutional Neural Network analysis.

Noto, Davide / Giammanco, Antonina / Spina, Rossella / Fayer, Francesca / Cefalù, Angelo B / Averna, Maurizio R

PloS one

2021 Volume 16, Issue 3, Page(s) e0247402

Abstract: SREBP1 and 2, are cholesterol sensors able to modulate cholesterol-related gene expression responses. SREBPs binding sites are characterized by the presence of multiple target sequences as SRE, NFY and SP1, that can be arranged differently in different ... ...

Abstract	SREBP1 and 2, are cholesterol sensors able to modulate cholesterol-related gene expression responses. SREBPs binding sites are characterized by the presence of multiple target sequences as SRE, NFY and SP1, that can be arranged differently in different genes, so that it is not easy to identify the binding site on the basis of direct DNA sequence analysis. This paper presents a complete workflow based on a one-dimensional Convolutional Neural Network (CNN) model able to detect putative SREBPs binding sites irrespective of target elements arrangements. The strategy is based on the recognition of SRE linked (less than 250 bp) to NFY sequences according to chromosomal localization derived from TF Immunoprecipitation (TF ChIP) experiments. The CNN is trained with several 100 bp sequences containing both SRE and NF-Y. Once trained, the model is used to predict the presence of SRE-NFY in the first 500 bp of all the known gene promoters. Finally, genes are grouped according to biological process and the processes enriched in genes containing SRE-NFY in their promoters are analyzed in details. This workflow allowed to identify biological processes enriched in SRE containing genes not directly linked to cholesterol metabolism and possible novel DNA patterns able to fill in for missing classical SRE sequences.
MeSH term(s)	CCAAT-Binding Factor/genetics ; CCAAT-Binding Factor/metabolism ; DNA ; DNA-Binding Proteins/genetics ; DNA-Binding Proteins/metabolism ; Humans ; Models, Genetic ; Sequence Analysis, DNA ; Serum Response Element ; Sp1 Transcription Factor/genetics ; Sp1 Transcription Factor/metabolism ; Transcription Factors/genetics ; Transcription Factors/metabolism
Chemical Substances	CCAAT-Binding Factor ; DNA-Binding Proteins ; SRE protein, human ; Sp1 Transcription Factor ; Transcription Factors ; nuclear factor Y ; DNA (9007-49-2)
Language	English
Publishing date	2021-03-04
Publishing country	United States
Document type	Journal Article
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0247402
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Article ; Online: An unusual case of chronic diarrhea: a case report.

Gagliardo, Carola Maria / Noto, Davide / Giammanco, Antonina / Savoja, Annalisa / Panzica, Marcella / Lavatura, Giuseppe / Presti, Rosalia Lo / Cefalù, Angelo Baldassare / Averna, Maurizio

Internal and emergency medicine

2022 Volume 17, Issue 8, Page(s) 2343–2347

MeSH term(s)	Humans ; Octreotide ; Positron-Emission Tomography ; Diarrhea/etiology ; Positron Emission Tomography Computed Tomography
Chemical Substances	Octreotide (RWM8CCW8GP)
Language	English
Publishing date	2022-07-30
Publishing country	Italy
Document type	Case Reports ; Journal Article
ZDB-ID	2454173-4
ISSN	1970-9366 ; 1828-0447
ISSN (online)	1970-9366
ISSN	1828-0447
DOI	10.1007/s11739-022-03055-0
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Article: Lifestyle versus ezetimibe plus lifestyle in patients with biopsy-proven non-alcoholic steatohepatitis (LISTEN): A double-blind randomised placebo-controlled trial

Noto, Davide / Petta, Salvatore / Giammanco, Antonina / Spina, Rossella / Cabibbi, Daniela / Porcasi, Rossana / Caldarella, Rosalia / Ciaccio, Marcello / Muratore, Roberto / Cefalù, Angelo B. / Craxi, Antonio / Averna, Maurizio

The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University Nutrition, metabolism, and cardiovascular diseases. 2022 Jan. 18,

2022

Abstract: The LISTEN trial (ClinicalTrial.gov accession: NCT01950884) is a phase IV 52 weeks double blind parallel randomized controlled trial that evaluated the effect of ezetimibe plus lifestyle and dietary intervention (eze) vs. lifestyle and dietary ... ...

Abstract	The LISTEN trial (ClinicalTrial.gov accession: NCT01950884) is a phase IV 52 weeks double blind parallel randomized controlled trial that evaluated the effect of ezetimibe plus lifestyle and dietary intervention (eze) vs. lifestyle and dietary intervention alone (placebo) on progression and complications of non-alcoholic steatohepatitis (NASH) evaluated by liver histology. Forty patients with NASH ascertained by histology were randomly allocated on the two study groups and subjected to a follow-up of 52 weeks, when they underwent a second liver biopsy. Main composite end point (EP) was based on the histological improvement in the severity of NASH. Thirty patients completed the study, Eze treatment was not able to improve the primary EP in comparison with placebo, with and odds ratio of 1.029 (0.18–6.38), p = 0.974. Treatment emergent adverse events registered during the study were not more prevalent in the treatment arm. ezetimibe administered on top of lifestyle and dietary modification failed to improve the histology of NASH in comparison with lifestyle and dietary modification alone. ClinicalTrial.gov: NCT01950884.
Keywords	biopsy ; fatty liver ; histology ; lifestyle ; liver ; metabolism ; nutrition ; nutritional intervention ; odds ratio ; placebos
Language	English
Dates of publication	2022-0118
Publishing place	Elsevier B.V.
Document type	Article
Note	Pre-press version
ZDB-ID	1067704-5
ISSN	0939-4753
ISSN	0939-4753
DOI	10.1016/j.numecd.2022.01.024
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Article ; Online: Therapeutic Options for Homozygous Familial Hypercholesterolemia: The Role of Lomitapide.

Giammanco, Antonina / Cefalù, Angelo B / Noto, Davide / Averna, Maurizio R

Current medicinal chemistry

2019 Volume 27, Issue 23, Page(s) 3773–3783

Abstract: Background: Lomitapide (Juxtapid® in US and Lojuxta® in Europe) is the first developed inhibitor of the Microsomal Triglyceride Transfer Protein (MTP) approved as a novel drug for the management of Homozygous Familial Hypercholesterolemia (HoFH). It ... ...

Abstract	Background: Lomitapide (Juxtapid® in US and Lojuxta® in Europe) is the first developed inhibitor of the Microsomal Triglyceride Transfer Protein (MTP) approved as a novel drug for the management of Homozygous Familial Hypercholesterolemia (HoFH). It acts by binding directly and selectively to MTP thus decreasing the assembly and secretion of the apo-B containing lipoproteins both in the liver and in the intestine. Aims: The present review aims at summarizing the recent knowledge on lomitapide in the management of HoFH. Results: The efficacy and safety of lomitapide have been evaluated in several trials and it has been shown a reduction of the plasma levels of Low-Density Lipoprotein Cholesterol (LDL-C) by an average of more than 50%. Although the most common side effects are gastrointestinal and liver events, lomitapide presents generally with a good tolerability and satisfactory patients compliance. Recently, in Europe, to evaluate the long-term safety and efficacy of lomitapide, the LOWER registry (ClinicalTrials.gov Identifier: NCT02135705) has been established in order to acquire informations on HoFH lomitapidetreated patients from "real life" clinical practice. Furthermore, the observation that lomitapide decreases triglyceride levels may be considered for patients affected by severe forms of hypertriglyceridemia who undergo recurrent episodes of pancreatitis and are poor responders to conventional treatment. Conclusion: Lomitapide represents an innovative and efficacious drug for the treatment of HoFH. Longterm safety data, treatment of pediatric and pregnant HoFH patients and management of severe hypertriglyceridemia still require further investigations.
MeSH term(s)	Anticholesteremic Agents ; Benzimidazoles/therapeutic use ; Europe ; Humans ; Hyperlipoproteinemia Type II
Chemical Substances	Anticholesteremic Agents ; BMS201038 ; Benzimidazoles
Language	English
Publishing date	2019-01-19
Publishing country	United Arab Emirates
Document type	Journal Article ; Review
ZDB-ID	1319315-6
ISSN	1875-533X ; 0929-8673
ISSN (online)	1875-533X
ISSN	0929-8673
DOI	10.2174/0929867326666190121120735
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Article ; Online: Consensus document on Lipoprotein(a) from the Italian Society for the Study of Atherosclerosis (SISA)

Chiesa, Giulia / Zenti, Maria Grazia / Baragetti, Andrea / Barbagallo, Carlo M. / Borghi, Claudio / Colivicchi, Furio / Maggioni, Aldo P. / Noto, Davide / Pirro, Matteo / Rivellese, Angela A. / Sampietro, Tiziana / Sbrana, Francesco / Arca, Marcello / Averna, Maurizio / Catapano, Alberico L.

Nutrition, Metabolism and Cardiovascular Diseases. 2023 July 19,

2023

Abstract: In view of the consolidating evidence on the causal role of Lp(a) in cardiovascular disease, the Italian Society for the Study of Atherosclerosis (SISA) has assembled a consensus on Lp(a) genetics and epidemiology, together with recommendations for its ... ...

Abstract	In view of the consolidating evidence on the causal role of Lp(a) in cardiovascular disease, the Italian Society for the Study of Atherosclerosis (SISA) has assembled a consensus on Lp(a) genetics and epidemiology, together with recommendations for its measurement and current and emerging therapeutic approaches to reduce its plasma levels. Data on the Italian population are also provided. Lp(a) is constituted by one apo(a) molecule and a lipoprotein closely resembling to a low-density lipoprotein (LDL). Its similarity with an LDL, together with its ability to carry oxidized phospholipids are considered the two main features making Lp(a) harmful for cardiovascular health. Plasma Lp(a) concentrations vary over about 1,000 folds in humans and are genetically determined, thus they are quite stable in any individual. Mendelian Randomization studies have suggested a causal role of Lp(a) in atherosclerotic cardiovascular disease (ASCVD) and aortic valve stenosis and observational studies indicate a linear direct correlation between cardiovascular disease and Lp(a) plasma levels. Lp(a) measurement is strongly recommended once in a patient's lifetime, particularly in FH subjects, but also as part of the initial lipid screening to assess cardiovascular risk. The apo(a) size polymorphism represents a challenge for Lp(a) measurement in plasma, but new strategies are overcoming these difficulties. A reduction of Lp(a) levels can be currently attained only by plasma apheresis and, moderately, with PCSK9 inhibitor treatment. Awaiting the approval of selective Lp(a)-lowering drugs, an intensive management of the other risk factors for individuals with elevated Lp(a) levels is strongly recommended.
Keywords	atherosclerosis ; epidemiology ; genetics ; low density lipoprotein ; metabolism ; nutrition ; oxidation ; patients ; phospholipids ; risk ; therapeutics ; Lipoprotein(a) ; oxidized phospholipids ; mendelian randomization ; familial hypercholesterolemia ; atherosclerotic cardiovascular disease ; aortic valve stenosis ; antisense oligonucleotides ; small interfering RNA
Language	English
Dates of publication	2023-0719
Publishing place	Elsevier B.V.
Document type	Article ; Online
Note	Pre-press version
ZDB-ID	1067704-5
ISSN	0939-4753
ISSN	0939-4753
DOI	10.1016/j.numecd.2023.07.019
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Article ; Online: Statin-induced autoimmune myositis: a proposal of an "experience-based" diagnostic algorithm from the analysis of 69 patients.

Gagliardo, Carola Maria / Noto, Davide / Giammanco, Antonina / Maltese, Silvia / Vecchio, Luca / Lavatura, Giuseppe / Cacciatore, Valentina / Barbagallo, Carlo Maria / Ganci, Antonina / Nardi, Emilio / Ciaccio, Marcello / Lo Presti, Rosalia / Cefalù, Angelo Baldassare / Averna, Maurizio

Internal and emergency medicine

2023 Volume 18, Issue 4, Page(s) 1095–1107

Abstract: Statin-induced autoimmune myositis (SIAM) represents a rare clinical entity that can be triggered by prolonged statin treatment. Its pathogenetic substrate consists of an autoimmune-mediated mechanism, evidenced by the detection of antibodies directed ... ...

Abstract	Statin-induced autoimmune myositis (SIAM) represents a rare clinical entity that can be triggered by prolonged statin treatment. Its pathogenetic substrate consists of an autoimmune-mediated mechanism, evidenced by the detection of antibodies directed against the 3-hydroxy-3-methylglutaryl-coenzyme A reductase (anti-HMGCR Ab), the target enzyme of statin therapies. To facilitate the diagnosis of nuanced SIAM clinical cases, the present study proposes an "experience-based" diagnostic algorithm for SIAM. We have analyzed the clinical data of 69 patients diagnosed with SIAM. Sixty-seven patients have been collected from the 55 available and complete case records regarding SIAM in the literature; the other 2 patients represent our direct clinical experience and their case records have been detailed. From the analysis of the clinical features of 69 patients, we have constructed the diagnostic algorithm, which starts from the recognition of suggestive symptoms of SIAM. Further steps provide for CK values dosage, musculoskeletal MR, EMG/ENG of upper-lower limbs and, Anti-HMGCR Ab testing and, where possible, the muscle biopsy. A global evaluation of the collected clinical features may suggest a more severe disease in female patients. Atorvastatin proved to be the most used hypolipidemic therapy.
MeSH term(s)	Humans ; Female ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects ; Autoantibodies/adverse effects ; Myositis/chemically induced ; Myositis/diagnosis ; Autoimmune Diseases/diagnosis ; Autoimmune Diseases/drug therapy ; Algorithms
Chemical Substances	Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Autoantibodies
Language	English
Publishing date	2023-05-05
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2454173-4
ISSN	1970-9366 ; 1828-0447
ISSN (online)	1970-9366
ISSN	1828-0447
DOI	10.1007/s11739-023-03278-9
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Article: Hyperalphalipoproteinemia and Beyond: The Role of HDL in Cardiovascular Diseases.

Giammanco, Antonina / Noto, Davide / Barbagallo, Carlo Maria / Nardi, Emilio / Caldarella, Rosalia / Ciaccio, Marcello / Averna, Maurizio Rocco / Cefalù, Angelo Baldassare

Life (Basel, Switzerland)

2021 Volume 11, Issue 6

Abstract: Hyperalphalipoproteinemia (HALP) is a lipid disorder characterized by elevated plasma high-density lipoprotein cholesterol (HDL-C) levels above the 90th percentile of the distribution of HDL-C values in the general population. Secondary non-genetic ... ...

Abstract	Hyperalphalipoproteinemia (HALP) is a lipid disorder characterized by elevated plasma high-density lipoprotein cholesterol (HDL-C) levels above the 90th percentile of the distribution of HDL-C values in the general population. Secondary non-genetic factors such as drugs, pregnancy, alcohol intake, and liver diseases might induce HDL increases. Primary forms of HALP are caused by mutations in the genes coding for cholesteryl ester transfer protein (CETP), hepatic lipase (HL), apolipoprotein C-III (apo C-III), scavenger receptor class B type I (SR-BI) and endothelial lipase (EL). However, in the last decades, genome-wide association studies (GWAS) have also suggested a polygenic inheritance of hyperalphalipoproteinemia. Epidemiological studies have suggested that HDL-C is inversely correlated with cardiovascular (CV) risk, but recent Mendelian randomization data have shown a lack of atheroprotective causal effects of HDL-C. This review will focus on primary forms of HALP, the role of polygenic inheritance on HDL-C, associated risk for cardiovascular diseases and possible treatment options.
Language	English
Publishing date	2021-06-18
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2662250-6
ISSN	2075-1729
ISSN	2075-1729
DOI	10.3390/life11060581
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