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1. Treating statin-intolerant patients

Author

Pigna G and Arca M

Subjects
Specialties of internal medicine, RC581-951
Abstract

Marcello Arca, Giovanni PignaAtherosclerosis Unit, Department of Internal Medicine and Allied Medical Specialities, Sapienza University of Rome, Rome, ItalyAbstract: Statins are effective in reducing cardiovascular events and are safe for almost all patients. Nevertheless, intolerance to statins is frequently faced in clinical practice. This is mostly due to muscular symptoms (myalgia with or without increase of plasma creatinine kinase) and/or elevation of hepatic aminotransferases, which overall constitutes approximately two-thirds of reported adverse events during statin therapy. These side effects raise concerns in patients as well as in doctors and are likely to reduce patients' adherence and, as a consequence, the cardiovascular benefit. Therefore, it is mandatory that clinicians improve their knowledge on the clinical aspects of muscular and hepatic side effects of statin therapy as well as their ability to manage patients with statin intolerance. Besides briefly examining the clinical aspects and the mechanisms that are proposed to be responsible for the most common statin-associated side effects, the main purpose of this article is to review the available approaches to manage statin-intolerant patients. The first step is to determine whether the adverse events are indeed related to statin therapy. If so, lowering the dosage or changing statin, alternate dosing options, or the use of nonstatin compounds may be practical strategies. The cholesterol-lowering potency as well as the usefulness of these different approaches in treating statin-intolerant patients will be examined based on currently available data. However, the cardiovascular benefit of these strategies has not been well established, so their use has to be guided by a careful clinical assessment of each patient.Keywords: statin therapy, atorvastatin, rosuvastatin, aminotransferase levels, myopathy

Published
2011

4. OC 10.4 Proprotein Convertase Subtilisin Kexin Type 9 Inhibitors Reduce Platelet Nets Release Driver Thrombosis in Familial Hypercholesterolemia

Author

Cammisotto, V., primary, Baratta, F., additional, Nocella, C., additional, Bartimoccia, S., additional, Castellani, V., additional, D’Erasmo, L., additional, Barale, C., additional, Scicali, R., additional, Russo, I., additional, Purrello, F., additional, Arca, M., additional, Pastori, D., additional, Carnevale, R., additional, Violi, F., additional, and Pignatelli, P., additional

Published
2023
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5. Lipid management in patients with high and very high cardiovascular risk: Data from routine clinical practice in Europe (SANTORINI study)

Author

Ray, K., primary, Aguiar, C., additional, Arca, M., additional, Connolly, D., additional, Eriksson, M., additional, Ferrieres, J., additional, Laufs, U., additional, Mostaza, J., additional, Nanchen, D., additional, Blackburn, C., additional, Soronen, J., additional, Lamparter, M., additional, Rietzschel, E., additional, Strandberg, T., additional, Toplak, H., additional, Visseren, F., additional, and Catapano, A., additional

Published
2023
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7. The smash program: An initiative for greater access to innovations for rare or severe hyperlipidemia

Author

Larouche, M., primary, Catapano, A., additional, Arca, M., additional, Moulin, P., additional, Soran, H., additional, Bergeron, J., additional, Bernard, S., additional, Brisson, D., additional, Bruckert, E., additional, D'Erasmo, L., additional, Di Costanzo, A., additional, Gallo, A., additional, Raal, F., additional, and Gaudet, D., additional

Published
2023
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10. Long-term efficacy and safety of lomitapide in patients with familial chylomicronemia syndrome (FCS): Data from the LOCHNES study

Author

Giammanco, A., primary, Cefalù, A., additional, D'Erasmo, L., additional, Iannuzzo, G., additional, Noto, D., additional, Montali, A., additional, Zambon, A., additional, Forte, F., additional, Suppressa, P., additional, Giannini, S., additional, Barbagallo, C.M., additional, Ganci, A., additional, Nardi, E., additional, Brancatelli, G., additional, Caldarella, R., additional, Ciaccio, M., additional, Arca, M., additional, and Averna, M., additional

Published
2023
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11. The contemporary management of patients with homozygous familial hypercholesterolemia: The experience of the Italian Lipigen registry and a systematic review of the literature

Author

D'Erasmo, L., primary, Bini, S., additional, Casula, M., additional, D'Elia, S., additional, Gazzotti, M., additional, Bertolini†, S., additional, Calandra, S., additional, Tarugi, P., additional, Averna, M., additional, Catapano, A., additional, and Arca, M., additional

Published
2023
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15. New and Emerging Therapies for Dyslipidemia

Author

Zambon, A., Averna, M., D'Erasmo, L., Arca, M., and Catapano, A.

Subjects
Angiopoietin-like protein 3, Selective PPAR alpha modulators, Atherosclerotic cardiovascular disease (ASCVD), Inclisiran, SiRNA, Selective PPAR alpha modulators, SPPARM, Volanesorsen, Angiopoietin-like protein 3, ANGPTL3, Endocrinology, Diabetes and Metabolism, Inclisiran, Atherosclerosis, Volanesorsen, Lipids, Endocrinology, ANGPTL3, Diabetes Mellitus, Type 2, SPPARM, SiRNA, Humans, Atherosclerotic cardiovascular disease (ASCVD), Hydroxymethylglutaryl-CoA Reductase Inhibitors, Dyslipidemias
Abstract

Atherosclerotic cardiovascular disease (ASCVD) continues to represent a growing global health challenge. Despite guideline-recommended treatment of ASCVD risk, including antihypertensive, high-intensity statin therapy, and antiaggregant agents, high-risk patients, especially those with established ASCVD and patients with type 2 diabetes, continue to experience cardiovascular events. Recent years have brought significant developments in lipid and atherosclerosis research. Several lipid drugs owe their existence, in part, to human genetic evidence. Here, the authors briefly review the mechanisms, the effect on lipid parameters, and safety profiles of some of the most promising new lipid-lowering approaches that will be soon available in our daily clinical practice.

Published
2022

18. Reported muscle symptoms during statin treatment amongst Italian dyslipidaemic patients in the real‐life setting: the PROSISA Study

Author

Casula, M., Gazzotti, M., Bonaiti, F., Oimastroni, E., Arca, M., Averna, M., Zambon, A., Catapano, A. L., Montali, A., Giammanco, A., Biolo, G., Vinci, P., Borghi, C., D'Addato, S., Bossi, A. C., Meregalli, G., Branchi, A., Squiccimarro, G., Cavalot, F., Ramadori, L., Cipollone, F., Bucci, M., Del Ben, M., Angelico, F., Fiorenza, A. M., Colombo, E., Grigore, L., Zampoleri, V., Lupattelli, G., Gandolfo, V., Mandraffino, G., Savarino, F., Mombelli, G., Pavanello, C., Pisciotta, L., Pasta, A., Purrello, F., Scicali, R., Rubba, P., Fortunato, G., Sabba, C., Suppressa, P., Sarzani, R., Di Pentima, C., Vigna, G. B., Colangiulo, A., Werba, J. P., Vigo, L. M., Zambon, S., Previato, L., Zenti, M. G., Maneschi, C., Casula, M., Gazzotti, M., Bonaiti, F., Oimastroni, E., Arca, M., Averna, M., Zambon, A., Catapano, A. L., Montali, A., Giammanco, A., Biolo, G., Vinci, P., Borghi, C., D'Addato, S., Bossi, A. C., Meregalli, G., Branchi, A., Squiccimarro, G., Cavalot, F., Ramadori, L., Cipollone, F., Bucci, M., Del Ben, M., Angelico, F., Fiorenza, A. M., Colombo, E., Grigore, L., Zampoleri, V., Lupattelli, G., Gandolfo, V., Mandraffino, G., Savarino, F., Mombelli, G., Pavanello, C., Pisciotta, L., Pasta, A., Purrello, F., Scicali, R., Rubba, P., Fortunato, G., Sabba, C., Suppressa, P., Sarzani, R., Di Pentima, C., Vigna, G. B., Colangiulo, A., Werba, J. P., Vigo, L. M., Zambon, S., Previato, L., Zenti, M. G., Maneschi, C., Casula M, Gazzotti M, Bonaiti F, OImastroni E, Arca M, Averna M, Zambon A, Catapano AL, PROSISA Study Group, Borghi C, Casula M., Gazzotti M., Bonaiti F., OImastroni E., Arca M., Averna M., Zambon A., Catapano A.L., Montali A., Giammanco A., Biolo G., Vinci P., Borghi C., D'Addato S., Bossi A.C., Meregalli G., Branchi A., Squiccimarro G., Cavalot F., Ramadori L., Cipollone F., Bucci M., Del Ben M., Angelico F., Fiorenza A.M., Colombo E., Grigore L., Zampoleri V., Lupattelli G., Gandolfo V., Mandraffino G., Savarino F., Mombelli G., Pavanello C., Pisciotta L., Pasta A., Purrello F., Scicali R., Rubba P., Fortunato G., Sabba C., Suppressa P., Sarzani R., Di Pentima C., Vigna G.B., Colangiulo A., Werba J.P., Vigo L.M., Zambon S., Previato L., Zenti M.G., and Maneschi C.

Subjects
0301 basic medicine, Male, medicine.medical_specialty, Settore MED/09 - Medicina Interna, adverse effects, myopathy, statin-associated muscle symptoms, statins, 030204 cardiovascular system & hematology, Medication Adherence, 03 medical and health sciences, 0302 clinical medicine, Muscular Diseases, Internal medicine, adverse effect, Internal Medicine, medicine, Prevalence, Humans, statin‐associated muscle symptoms, Adverse effect, Dechallenge, Creatine Kinase, Dyslipidemias, Female, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Italy, Middle Aged, Retrospective Studies, business.industry, Retrospective cohort study, Odds ratio, Original Articles, Confidence interval, Discontinuation, 030104 developmental biology, Concomitant, Cohort, Original Article, business, statin-associated muscle symptom
Abstract

Aim: Statin-associated muscle symptoms (SAMS) are a major determinant of poor treatment adherence and/or discontinuation, but a definitive diagnosis of SAMS is challenging. The PROSISA study was an observational retrospective study aimed to assess the prevalence of reported SAMS in a cohort of dyslipidaemic patients. Methods: Demographic/anamnestic data, biochemical values and occurrence of SAMS were collected by 23 Italian Lipid Clinics. Adjusted logistic regression was performed to estimate odds ratio (OR) and 95% confidence intervals for association between probability of reporting SAMS and several factors. Results: Analyses were carried out on 16717 statin-treated patients (mean±SD, age 60.5±12.0years; 52.1% men). During statin therapy, 9.6% (N=1599) of patients reported SAMS. Women and physically active subjects were more likely to report SAMS (OR 1.23 [1.10–1.37] and OR 1.35 [1.14–1.60], respectively), whist age≥65 (OR 0.79 [0.70–0.89]), presence of type 2 diabetes mellitus (OR 0.62 [0.51–0.74]), use of concomitant nonstatin lipid-lowering drugs (OR 0.87 [0.76–0.99]), use of high-intensity statins (OR 0.79 [0.69–0.90]) and use of potential interacting drugs (OR 0.63 [0.48–0.84]) were associated with lower probability of reporting SAMS. Amongst patients reporting SAMS, 82.2% underwent dechallenge (treatment interruption) and/or rechallenge (change or restart of statin therapy), with reappearance of muscular symptoms in 38.4% (3.01% of the whole cohort). Conclusions: The reported prevalence of SAMS was 9.6% of the whole PROSISA cohort, but only a third of patients still reported SAMS after dechallenge/rechallenge. These results emphasize the need for a better management of SAMS to implement a more accurate diagnosis and treatment re-evaluation.

Published
2020

19. Long-term hepatic safety of lomitapide in homozygous familial hypercholesterolaemia

Author

Larrey, D., D'Erasmo, L., O'Brien, S., Arca, M., Italian Working Group on Lomitapide: Angelo Baldassare Cefalù, Alessia Di Costanzo, Simone, B., Antonina, G., Maurizio, A., Gabriella, I., Giuliana, F., Marco, G., Maria Donata Di Taranto, Arturo, P., Tiziana, M., Pavanello, C., Calabresi, L., Giovanni Battista Vigna, Marco, B., Katia, B., Tiziana, S., Francesco, S., Patrizia, S., Carlo, S., Fabio, F., Arturo, C., Paolo, C., Fulvio, V., Sergio, D., Livia, P., Stefano, B., Larrey, Dominique, D'Erasmo, Laura, O'Brien, Sallyann, Arca, Marcello, Cefalù, Angelo Baldassare, Di Costanzo, Alessia, Bini, Simone, Giammanco, Antonina, Averna, Maurizio, Iannuzzo, Gabriella, Fortunato, Giuliana, Gentile, Marco, Di Taranto, Maria Donata, Pujia, Arturo, Montalcini, Tiziana, Pavanello, Chiara, Calabresi, Laura, Vigna, Giovanni Battista, Bucci, Marco, Bonomo, Katia, Sampietro, Tiziana, Sbrana, Francesco, Suppressa, Patrizia, Sabbà, Carlo, Fimiani, Fabio, Cesaro, Arturo, Calabrò, Paolo, Ventura, Fulvio, D’Addato, Sergio, Pisciotta, Livia, Bertolini, Stefano, and Angelo Baldassare Cefalu', Alessia Di Costanzo, Simone Bini, Antonina Giammanco, Maurizio Averna, Gabriella Iannuzzo, Giuliana Fortunato, Marco Gentile, Maria Donata Di Taranto, Arturo Pujia, Tiziana Montalcini, Chiara Pavanello, Laura Calabresi, Giovanni Battista Vigna, Marco Bucci, Katia Bonomo, Tiziana Sampietro, Francesco Sbrana, Patrizia Suppressa, Carlo Sabbà, Fabio Fimiani, Arturo Cesaro, Paolo Calabrò, Fulvio Ventura, Sergio D'Addato, Livia Pisciotta, Stefano Bertolini

Subjects
Settore MED/09 - Medicina Interna, hepatic steatosis, liver, Lomitapide, hepatic biomarkers, hepatic steatosi, Settore BIO/18 - Genetica, hepatic biomarker, Settore BIO/14 - Farmacologia, liver fibrosis, hepatic, homozygous familial hypercholesterolaemia, lomitapide
Abstract

Introduction: Lomitapide is a microsomal triglyceride transfer protein inhibitor for patients with homozygous familial hypercholesterolaemia. Due to its mechanism of action, potential hepatic effects of lomitapide are of clinical interest. This study aimed to determine the long-term hepatic safety of lomitapide. Methods: Data were aggregated from the pivotal phase 3 and extension phase clinical trial with lomitapide (median 5.1 years; serum total bilirubin, transaminases, cytokeratin-18 [CK-18] and enhanced liver fibrosis [ELF] score, fat-soluble vitamins and essential fatty acids), 8-year data from the Lomitapide Observational Worldwide Evaluation Registry (LOWER) and real-world evidence from a cohort of patients treated with lomitapide in Italy (hepatic elastography, and FIB-4 score for hepatic fibrosis). Results: In the phase 3 trial and the LOWER registry, any asymptomatic excursions in liver transaminase levels were not associated with elevations in bilirubin, and no Hy's law cases were detected in up to 8 years follow-up. There were no clinically relevant increases among hepatic biomarkers CK-18, CK-18 fragments or ELF score and fat-soluble vitamins and essential fatty acids remained above normal levels. In 34 patients treated in Italy with lomita pide for more than 9 years, elevations in hepatic fat were mild-to-moderate; hepatic stiffness remained normal, and the mean FIB-4 score remained below the fibrosis threshold value of 2.67. Conclusions: These data indicate that the hepatic safety of lomitapide remains favourable with no clinically significant elevations in hepatic biomarkers and hepatic stiffness remained normal for more than 9 years follow-up. PHASE 3 TRIAL: NCT00730236; extension phase: NCT00943306; LOWER: NCT02135705.

Published
2023

30. Twelve Variants Polygenic Score for Low-Density Lipoprotein Cholesterol Distribution in a Large Cohort of Patients With Clinically Diagnosed Familial Hypercholesterolemia With or Without Causative Mutations

Author

Olmastroni, E., Gazzotti, M., Arca, M., Averna, M., Pirillo, A., Catapano, A. L., Casula, M., Marcello, A., Maurizio, A., Stefano, B., Sebastiano, C., Luigi, C. A., Patrizia, T., Fabio, P., Andrea, B., Giacomo, B., Gianni, B., Luca, B., Katia, B., Claudio, B., Carlo, B. A., Adriana, B., Paolo, C., Francesca, C., Francesco, C., Nadia, C., Maria, D. B., Massimo, F., Claudio, F., Maria, F. A., Andrea, G., Ornella, G., Arcangelo, I., Gabriella, I., Lorenzo, I., Graziana, L., Alessandro, L., Giuseppe, M., Rossella, M., Lorenzo, M., Giuliana, M., Sandro, M., Valerio, P., Cristina, P., Antonio, P., Livia, P., Arturo, P., Francesco, P., Elena, R., Carlo, S., Riccardo, S., Chiara, T., Battista, V. G., Pablo, W. J., Sabina, Z., Grazia, Z. M., Alessia, D. C., Giuliana, F., Rossella, S., Davide, B., Giuseppe, B., Francesco, B., Guglielmo, B., Sandra, B., Patrizia, B., Marco, B., Sabrina, B. P., Elena, C. M., Iris, C., Baldassarre, C. A., Maria, C., Emanuela, C., Giuseppe, C., Laura, C. A., Ada, C., Sergio, D., Vincenzo, D., Giuseppe, D. C., Chiara, D. P., Fabio, F., Marco, G., Omar, G., Betti, G., Davide, G., Liliana, G., Giulia, M., Giancarla, M., Ilenia, M., Simona, M., Tiziana, M., Fabio, N., Alberto, N. E., Chiara, P., Lucia, P., Rita, R. A., Elena, S., Alon, S., Roberto, S., Patrizia, S., Michele, T., Pierandrea, V., Manuela, C., Enzo, M., Elena, T., Veronic, Z., Olmastroni, Elena, Gazzotti, Marta, Arca, Marcello, Averna, Maurizio, Pirillo, Angela, Catapano, Alberico Luigi, Casula, Manuela, Stefano, Bertolini, Sebastiano, Calandra, Patrizia, Tarugi, Fabio, Pellegatta, Andrea, Bartuli, Andrea, Benso, Giacomo, Biasucci, Gianni, Biolo, Luca, Bonanni, Katia, Bonomo, Claudio, Borghi, Antonio Carlo Bossi, Adriana, Branchi, Paolo, Calabrò, Francesca, Carubbi, Francesco, Cipollone, Nadia, Citroni, Maria Del Ben, Massimo, Federici, Claudio, Ferri, Anna Maria Fiorenza, Andrea, Giaccari, Ornella, Guardamagna, Arcangelo, Iannuzzi, Iannuzzo, Gabriella, Lorenzo, Iughetti, Graziana, Lupattelli, Alessandro, Lupi, Giuseppe, Mandraffino, Rossella, Marcucci, Lorenzo, Maroni, Giuliana, Mombelli, Sandro, Muntoni, Valerio, Pecchioli, Cristina, Pederiva, Antonio, Pipolo, Livia, Pisciotta, Antonio, Pujia, Francesco, Purrello, Elena, Repetti, Carlo, Sabbà, Riccardo, Sarzani, Chiara, Trenti, Giovanni Battista Vigna, Josè Pablo Werba, Sabina, Zambon, Maria Grazia Zenti, Alessia Di Costanzo, Fortunato, Giuliana, Rossella, Spina, Davide, Baldera, Giuseppe, Banderali, Francesco, Baratta, Guglielmo, Beccuti, Sandra, Bertocco, Patrizia, Bruzzi, Marco, Bucci, Paola Sabrina Buonuomo, Maria Elena Capra, Iris, Cardolini, Angelo Baldassarre Cefalù, Maria, Cinquegrani, Emanuela, Colombo, Giuseppe, Covetti, Anna Laura Cremonini, Ada, Cutolo, Sergio, D'Addato, Vincenzo, D'Ambrosio, Giuseppe De Corrado, Chiara Di Pentima, Fabio, Fimiani, Gentile, Marco, Omar, Ghirardello, Betti, Giusti, Davide, Grassi, Liliana, Grigore, Giulia, Massini, Giancarla, Meregalli, Ilenia, Minicocci, Simona, Moffa, Tiziana, Montalcini, Fabio, Nascimbeni, Emanuele Alberto Negri, Chiara, Pavanello, Lucia, Prati, Anna Rita Roscini, Elena, Sani, Alon, Schaffer, Roberto, Scicali, Patrizia, Suppressa, Michele, Tedeschi, Pierandrea, Vinci, Enzo, Manzato, Elena, Tragni, Veronica, Zampoler, and Bertolini Stefano, Calandra Sebastiano, Tarugi Patrizia, Pellegatta Fabio, Bartuli Andrea, Benso Andrea, Biasucci Giacomo, Biolo Gianni, Bonanni Luca, Bonomo Katia, Borghi Claudio, Bossi Antonio Carlo, Branchi Adriana, Calabrò Paolo, Carubbi Francesca, Cipollone Francesco, Citroni Nadia, Del Ben Maria, Federici Massimo, Ferri Claudio, Fiorenza Anna Maria, Giaccari Andrea, Guardamagna Ornella, Iannuzzi Arcangelo, Iannuzzo Gabriella, Iughetti Lorenzo, Lupattelli Graziana, Lupi Alessandro, Mandraffino Giuseppe, Marcucci Rossella, Maroni Lorenzo, Mombelli Giuliana, Muntoni Sandro, Pecchioli Valerio, Pederiva Cristina, Pipolo Antonio, Pisciotta Livia, Pujia Arturo, Purrello Francesco, Repetti Elena, Sabbà Carlo, Sarzani Riccardo, Trenti Chiara, Vigna Giovanni Battista, Werba Josè Pablo, Zambon Sabina, Zenti Maria Grazia. Di Costanzo Alessia, Fortunato Giuliana, Spina Rossella, Baldera Davide, Banderali Giuseppe, Baratta Francesco, Beccuti Guglielmo, Bertocco Sandra, Bruzzi Patrizia, Bucci Marco, Buonuomo Paola Sabrina, Capra Maria Elena, Cardolini Iris, Cefalù Angelo Baldassare, Cinquegrani Maria, Colombo Emanuela, Covetti Giuseppe, Cremonini Anna Laura, Cutolo Ada, D’Addato Sergio, D’Ambrosio Vincenzo, De Corrado Giuseppe, Di Pentima Chiara, Fimiani Fabio, Gentile Marco, Ghirardello Omar, Giusti Betti, Grassi Davide, Grigore Liliana, Massini Giulia, Meregalli Giancarla, Minicocci Ilenia, Moffa Simona, Montalcini Tiziana, Nascimbeni Fabio, Negri Emanuele Alberto, Pavanello Chiara, Prati Lucia, Roscini Anna Rita, Sani Elena, Schaffer Alon, Scicali Roberto, Suppressa Patrizia, Tedeschi Michele, Vinci Pierandrea, Manzato Enzo, Tragni Elena, Zampoleri Veronica

Subjects
Male, Adult, Multifactorial Inheritance, Settore MED/09 - Medicina Interna, familial hypercholesterolemia, molecular diagnosis, polygenic risk score, Cholesterol, LDL, Female, Humans, Middle Aged, Mutation, Gene Regulatory Networks, Hyperlipoproteinemia Type II, LDL, Cholesterol, molecular diagnosi
Abstract

Background A significant proportion of individuals clinically diagnosed with familial hypercholesterolemia (FH), but without any disease-causing mutation, are likely to have polygenic hypercholesterolemia. We evaluated the distribution of a polygenic risk score, consisting of 12 low-density lipoprotein cholesterol (LDL-C)-raising variants (polygenic LDL-C risk score), in subjects with a clinical diagnosis of FH. Methods and Results Within the Lipid Transport Disorders Italian Genetic Network (LIPIGEN) study, 875 patients who were FH-mutation positive (women, 54.75%; mean age, 42.47±15.00 years) and 644 patients who were FH-mutation negative (women, 54.21%; mean age, 49.73±13.54 years) were evaluated. Patients who were FH-mutation negative had lower mean levels of pretreatment LDL-C than patients who were FH-mutation positive (217.14±55.49 versus 270.52±68.59 mg/dL, P

Published
2022

31. Efficacy and safety of lomitapide in homozygous familial hypercholesterolaemia: the pan-European retrospective observational study

Author

D'Erasmo L, Steward K, Cefalu A, Di Costanzo A, Boersma E, Bini S, Arca M, van Lennep J, REAL J, and Italian and European Working Group on Lomitapide in HoFH

Subjects
Homozygous familial hypercholesterolaemia, Medium-term efficacy, Atherosclerosis, Medium-term safety, Lomitapide
Abstract

Aims Lomitapide is a lipid-lowering agent indicated as an adjunct therapy for adult homozygous familial hypercholesterolaemia (HoFH). This study evaluated the medium-term effectiveness and safety of lomitapide in a large cohort of HoFH patients in Europe. Methods and results In a multicentre retrospective, observational study including 75 HoFH patients treated with lomitapide in a real-world clinical setting from 9 European countries, low-density lipoprotein cholesterol (LDL-C) changes, adverse events (AEs), and major adverse cardiovascular events (MACE) were assessed. After a median 19 months (interquartile range 11-41 months) of treatment with a mean dosage of 20 mg of lomitapide. Low-density lipoprotein cholesterol decreased by 60%, from baseline 280.5 mg/dL (191.8-405.0 mg/dL) to 121.6 mg/dL (61.0-190.5 mg/dL). At the last visit, 32.0% of patients achieved LDL-C

Published
2022

36. Appropriateness criteria for the management of lipid-lowering therapy with alirocumab in high cardiovascular risk patients. The opinion of a multidisciplinary group of Italian experts

Author

Lettino, M., Zambon, A., Musumeci, G., Arca, M., Bilato, C., Brunetti, N. D., Calabro, P., Casu, G., Chiarella, F., Faggiano, P., Ferlini, M., Guardigli, G., Imbalzano, E., Indolfi, C., Marcucci, R., Menozzi, A., Mureddu, G. F., Filardi, P. P., Pirro, M., Pisciotta, L., Scherillo, M., Suppressa, P., Uguccioni, M., Varbella, F., Gentile, L., Rapezzi, C., Averna, M., Lettino, Maddalena, Zambon, Alberto, Musumeci, Giuseppe, Arca, Marcello, Bilato, Claudio, Brunetti, Natale Daniele, Calabrò, Paolo, Casu, Gavino, Chiarella, Francesco, Faggiano, Pompilio, Ferlini, Marco, Guardigli, Gabriele, Imbalzano, Egidio, Indolfi, Ciro, Marcucci, Rossella, Menozzi, Alberto, Mureddu, Gian Francesco, Filardi, Pasquale Perrone, Pirro, Matteo, Pisciotta, Livia, Scherillo, Marino, Suppressa, Patrizia, Uguccioni, Massimo, Varbella, Ferdinando, Gentile, Luigi, Rapezzi, Claudio, Averna, Maurizio, Lettino M., Zambon A., Musumeci G., Arca M., Bilato C., Brunetti N.D., Calabro P., Casu G., Chiarella F., Faggiano P., Ferlini M., Guardigli G., Imbalzano E., Indolfi C., Marcucci R., Menozzi A., Mureddu G.F., Filardi P.P., Pirro M., Pisciotta L., Scherillo M., Suppressa P., Uguccioni M., Varbella F., Gentile L., Rapezzi C., and Averna M.

Subjects
Settore MED/09 - Medicina Interna, Consensus, PCSK9 inhibitor, Familial hypercholesterolemia, Hypercholesterolemia, Antibodies, Monoclonal, Humanized, Anticholesteremic Agents, Atherosclerosis, Cholesterol, LDL, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Italy, Risk Assessment, Risk Factors, Cardiovascular Diseases, Consensu, Antibodies, LDL, Acute coronary syndrome, Alirocumab, Cardiovascular risk, PCSK9 inhibitors, Anticholesteremic Agent, Monoclonal, Humanized, Cholesterol, Atherosclerosi
Abstract

High levels of LDL cholesterol (LDL-C) represent a causal factor for cardiovascular diseases on an atherosclerotic basis, with a direct correlation between these and mortality or cardiovascular events, such that the reduction of both is associated proportionally and linearly with the reduction of LDL-C.Statins and ezetimibe are used for LDL-C lowering but may not be sufficient to achieve the targets defined by the ESC/EAS guidelines, which recommend use of PCSK9 inhibitors for further LDL-C reduction in patients not at goal.This project submitted 86 clinical scenarios to a group of experts, cardiologists, internists and lipidologists, collecting their opinion on the appropriateness of different behaviors and decisions. We used the RAND/UCLA method of assessing the appropriateness of clinical interventions, validated to combine the best scientific evidence available with expert judgment. To this end, the benefit-risk ratio was evaluated in the proposed clinical scenarios. Each indication was classified as "appropriate", "uncertain" or "inappropriate" based on the average score given by the participants.This document presents the results of a consensus process that led to the development of recommendations for the management of clinical scenarios on the treatment of patients with dyslipidemia, which cannot always be solved with scientific evidence alone.

Published
2020

45. Genomic analyses of the extinct Sardinian dhole (Cynotherium sardous) reveal its evolutionary history

Author

Ettore Randi, Erika Rosengren, Arca M, Shyam Gopalakrishnan, Enrico Cappellini, Guojie C, C. Tuveri, Marco Galaverni, Marta Maria Ciucani, Mikkel-Holger S. Sinding, Oliver Smith, Guojie Zhang, Lorenzo Rook, Bartolini Lucentini S, Thomas Sicheritz-Pontén, Love Dalén, Gilbert Mtp, and Jensen Jk

Subjects
education.field_of_study, Taxon, Extinction, Phylogenetic tree, Extant taxon, Evolutionary biology, Population, Sardinian dhole, Biology, education, Endemism, biology.organism_classification, Gene flow
Abstract

SummaryThe Sardinian dhole (Cynotherium sardous)1 was an iconic and unique canid species of canid that was endemic of Sardinia and Corsica until it became extinct at the end of the Late Pleistocene2–5. Given its peculiar dental morphology, small body size and high level of endemism, several canids have been proposed as possible ancestors of the Sardinian dhole, including the Asian dhole and African hunting dog ancestor 3,6–9. Morphometric analyses3,6,8–12 have failed to clarify the evolutionary relationship with other canids.We sequenced the genome of a ca 21,100 year old Sardinian dhole in order to understand its genomic history and clarify its phylogenetic position. We found it represents a separate taxon from all other living canids from Eurasia, Africa and North America, and that the Sardinian and Asian dhole lineages diverged ca 885 ka. We additionally detected historical gene flow between the Sardinian and Asian dhole lineages, that ended approximately 500-300 ka, when the landbridge between Sardinia and mainland Italy was broken, severing their population connectivity. Our sample showed low genome-wide diversity compared to other extant canids - probably a result of the long-term isolation - that could have contributed to the subsequent extinction of the Sardinian dhole.

Published
2021

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