Long-term efficacy of lipoprotein apheresis and lomitapide in the treatment of homozygous familial hypercholesterolemia (HoFH): a cross-national retrospective survey.


Journal

Orphanet journal of rare diseases
ISSN: 1750-1172
Titre abrégé: Orphanet J Rare Dis
Pays: England
ID NLM: 101266602

Informations de publication

Date de publication:
08 09 2021
Historique:
received: 21 02 2021
accepted: 24 08 2021
entrez: 9 9 2021
pubmed: 10 9 2021
medline: 7 10 2021
Statut: epublish

Résumé

Homozygous familial hypercholesterolemia (HoFH) is a rare life-threatening condition that represents a therapeutic challenge. The vast majority of HoFH patients fail to achieve LDL-C targets when treated with the standard protocol, which associates maximally tolerated dose of lipid-lowering medications with lipoprotein apheresis (LA). Lomitapide is an emerging therapy in HoFH, but its place in the treatment algorithm is disputed because a comparison of its long-term efficacy versus LA in reducing LDL-C burden is not available. We assessed changes in long-term LDL-C burden and goals achievement in two independent HoFH patients' cohorts, one treated with lomitapide in Italy (n = 30) and the other with LA in France (n = 29). The two cohorts differed significantly for genotype (p = 0.004), baseline lipid profile (p < 0.001), age of treatment initiation (p < 0.001), occurrence of cardiovascular disease (p = 0.003) as well as follow-up duration (p < 0.001). The adjunct of lomitapide to conventional lipid-lowering therapies determined an additional 58.0% reduction of last visit LDL-C levels, compared to 37.1% when LA was added (p In comparison with LA, lomitapide appears to provide a better control of LDL-C in HoFH. Further studies are needed to confirm this data and establish whether this translates into a reduction of cardiovascular risk.

Sections du résumé

BACKGROUND
Homozygous familial hypercholesterolemia (HoFH) is a rare life-threatening condition that represents a therapeutic challenge. The vast majority of HoFH patients fail to achieve LDL-C targets when treated with the standard protocol, which associates maximally tolerated dose of lipid-lowering medications with lipoprotein apheresis (LA). Lomitapide is an emerging therapy in HoFH, but its place in the treatment algorithm is disputed because a comparison of its long-term efficacy versus LA in reducing LDL-C burden is not available. We assessed changes in long-term LDL-C burden and goals achievement in two independent HoFH patients' cohorts, one treated with lomitapide in Italy (n = 30) and the other with LA in France (n = 29).
RESULTS
The two cohorts differed significantly for genotype (p = 0.004), baseline lipid profile (p < 0.001), age of treatment initiation (p < 0.001), occurrence of cardiovascular disease (p = 0.003) as well as follow-up duration (p < 0.001). The adjunct of lomitapide to conventional lipid-lowering therapies determined an additional 58.0% reduction of last visit LDL-C levels, compared to 37.1% when LA was added (p
CONCLUSIONS
In comparison with LA, lomitapide appears to provide a better control of LDL-C in HoFH. Further studies are needed to confirm this data and establish whether this translates into a reduction of cardiovascular risk.

Identifiants

pubmed: 34496902
doi: 10.1186/s13023-021-01999-8
pii: 10.1186/s13023-021-01999-8
pmc: PMC8427960
doi:

Substances chimiques

Anticholesteremic Agents 0
BMS201038 0
Benzimidazoles 0
Lipoproteins 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

381

Informations de copyright

© 2021. The Author(s).

Références

J Clin Med. 2020 Jan 14;9(1):
pubmed: 31947532
Eur Heart J. 2014 Aug 21;35(32):2146-57
pubmed: 25053660
J Clin Lipidol. 2016 Sep-Oct;10(5):1129-1136.e3
pubmed: 27678429
Circ Res. 2019 Feb;124(3):364-385
pubmed: 30702994
Lancet Diabetes Endocrinol. 2017 Apr;5(4):280-290
pubmed: 28215937
Expert Opin Pharmacother. 2017 Aug;18(12):1261-1268
pubmed: 28598687
Atherosclerosis. 2000 Oct;152(2):519-26
pubmed: 10998482
Curr Opin Lipidol. 2020 Jun;31(3):119-124
pubmed: 32332430
Lancet. 1993 Jan 2;341(8836):60-1
pubmed: 8093314
Am J Cardiol. 2008 Dec 1;102(11):1438-43
pubmed: 19026292
Vasc Health Risk Manag. 2014 May 06;10:263-70
pubmed: 24851052
Adv Ther. 2017 May;34(5):1200-1210
pubmed: 28432645
Atherosclerosis. 2006 Nov;189(1):31-8
pubmed: 16546196
Eur Heart J. 2018 Apr 7;39(14):1162-1168
pubmed: 29106543
J Clin Lipidol. 2019 Jul - Aug;13(4):608-617
pubmed: 31255589
J Clin Lipidol. 2016 Jul-Aug;10(4):1011-1021
pubmed: 27578134
Circulation. 2011 Nov 15;124(20):2202-7
pubmed: 21986285
Atherosclerosis. 2017 Feb;257:130-137
pubmed: 28131047
J Clin Lipidol. 2016 Jul-Aug;10(4):953-961
pubmed: 27578128
Atherosclerosis. 2018 Oct;277:66-71
pubmed: 30176566
J Am Coll Cardiol. 2018 Jan 23;71(3):279-288
pubmed: 29348020
Atherosclerosis. 2018 Oct;277:483-492
pubmed: 30270089
Core Evid. 2019 Jul 01;14:19-30
pubmed: 31308834
Br Heart J. 1980 Oct;44(4):361-8
pubmed: 7426196
Curr Opin Lipidol. 2010 Dec;21(6):492-8
pubmed: 20935563
Heart. 1998 Dec;80(6):583-90
pubmed: 10065027
Atherosclerosis. 2019 Nov;290:44-51
pubmed: 31563836
J Clin Lipidol. 2017 May - Jun;11(3):704-711.e2
pubmed: 28456681

Auteurs

Laura D'Erasmo (L)

Department of Translational and Precision Medicine, Sapienza University of Rome, Viale del Policlinico 155, Rome, Italy. laura.derasmo@uniroma1.it.
Department of Endocrinology and Cardiovascular Disease Prevention, Assistance Publique-Hôpitaux de Paris, La Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France. laura.derasmo@uniroma1.it.

Antonio Gallo (A)

Department of Endocrinology and Cardiovascular Disease Prevention, Assistance Publique-Hôpitaux de Paris, La Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France.
Sorbonne Université, UPMC Univ Paris 06, INSERM 1146, - CNRS 7371, Laboratoire d'imagerie Biomédicale, Paris, France.

Angelo Baldassare Cefalù (AB)

Dipartimento di Promozione Della Salute, Materno Infantile, Medicina Interna e Specialistica di Eccellenza "G. D'Alessandro" (PROMISE), Università Degli Studi Di Palermo, Palermo, Italy.

Alessia Di Costanzo (A)

Department of Translational and Precision Medicine, Sapienza University of Rome, Viale del Policlinico 155, Rome, Italy.

Samir Saheb (S)

Department of Endocrinology and Cardiovascular Disease Prevention, Assistance Publique-Hôpitaux de Paris, La Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France.

Antonina Giammanco (A)

Dipartimento di Promozione Della Salute, Materno Infantile, Medicina Interna e Specialistica di Eccellenza "G. D'Alessandro" (PROMISE), Università Degli Studi Di Palermo, Palermo, Italy.

Maurizio Averna (M)

Dipartimento di Promozione Della Salute, Materno Infantile, Medicina Interna e Specialistica di Eccellenza "G. D'Alessandro" (PROMISE), Università Degli Studi Di Palermo, Palermo, Italy.

Alessio Buonaiuto (A)

Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.

Gabriella Iannuzzo (G)

Department of Clinical Medicine and Surgery, Federico II University, Naples, Italy.

Giuliana Fortunato (G)

Department of Molecular Medicine and Medical Biotechnology, University of Naples Federico II, Naples, Italy.
CEINGE, Advanced Biotechnology, Naples, Italy.

Arturo Puja (A)

Department of Medical and Surgical Sciences, University Magna Graecia, Catanzaro, Italy.

Tiziana Montalcini (T)

Department of Medical and Surgical Sciences, University Magna Graecia, Catanzaro, Italy.

Chiara Pavanello (C)

Centro Grossi Paoletti, Dipartimento di Scienze Farmacologiche e Biomolecolari, Università Degli Studi di Milano, Milan, Italy.

Laura Calabresi (L)

Centro Grossi Paoletti, Dipartimento di Scienze Farmacologiche e Biomolecolari, Università Degli Studi di Milano, Milan, Italy.

Giovanni Battista Vigna (GB)

Medical Department, Azienda Ospedaliero-Universitaria di Ferrara, Ferrara, Italy.

Marco Bucci (M)

Dipartimento di Medicina e Scienze Dell'Invecchiamento, Università Degli Studi "G. d'annunzio" di Chieti, Pescara, Italy.

Katia Bonomo (K)

Metabolic Disease and Diabetes Unit, AOU San Luigi Gonzaga, Orbassano', Turin, Italy.

Fabio Nota (F)

Metabolic Disease and Diabetes Unit, AOU San Luigi Gonzaga, Orbassano', Turin, Italy.

Tiziana Sampietro (T)

Lipoapheresis Unit-Reference Center for Diagnosis and Treatment of Inherited Dyslipidemias, Fondazione Toscana "Gabriele Monasterio", Via Moruzzi 1, Pisa, Italy.

Francesco Sbrana (F)

Lipoapheresis Unit-Reference Center for Diagnosis and Treatment of Inherited Dyslipidemias, Fondazione Toscana "Gabriele Monasterio", Via Moruzzi 1, Pisa, Italy.

Patrizia Suppressa (P)

Department of Internal Medicine and Rare Disease Centre "C.Frugoni", University Hospital of Bari "A. Moro", Piazza G. Cesare 11, Bari, Italy.

Carlo Sabbà (C)

Department of Internal Medicine and Rare Disease Centre "C.Frugoni", University Hospital of Bari "A. Moro", Piazza G. Cesare 11, Bari, Italy.

Fabio Fimiani (F)

Division of Clinical Cardiology, Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", A.O.R.N. Sant' Anna e San Sebastiano, 81100, Caserta, Italy.

Arturo Cesaro (A)

Division of Clinical Cardiology, Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", A.O.R.N. Sant' Anna e San Sebastiano, 81100, Caserta, Italy.

Paolo Calabrò (P)

Division of Clinical Cardiology, Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", A.O.R.N. Sant' Anna e San Sebastiano, 81100, Caserta, Italy.

Silvia Palmisano (S)

Hypertension and Atherosclerosis Research Group, Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Via Albertoni 15, 40138, Bologna, Italy.

Sergio D'Addato (S)

Hypertension and Atherosclerosis Research Group, Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Via Albertoni 15, 40138, Bologna, Italy.

Livia Pisciotta (L)

Department of Internal Medicine, University of Genoa, Genoa, Italy.
IRCCS-Polyclinic Hospital San Martino, Genoa, Italy.

Stefano Bertolini (S)

Department of Internal Medicine, University of Genoa, Genoa, Italy.
IRCCS-Polyclinic Hospital San Martino, Genoa, Italy.

Randa Bittar (R)

Inserm, Institute of Cardiometabolism and Nutrition (ICAN), UMR_S1166, Department of Metabolic Biochemistry, Assistance Publique, Hôpitaux de Paris, Hôpital de La Pitié-Salpêtrière, Sorbonne University, Paris, France.

Olga Kalmykova (O)

Department of Endocrinology and Cardiovascular Disease Prevention, Assistance Publique-Hôpitaux de Paris, La Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France.

Sophie Béliard (S)

Aix Marseille University, INSERM, INRA, C2VN, Marseille, France.
Department of Nutrition, Metabolic Diseases, Endocrinology, La Conception Hospital, Marseille, France.

Alain Carrié (A)

Inserm, Institute of Cardiometabolism and Nutrition (ICAN), UMR_S1166, APHP, Department of Biochemistry, Obesity and Dyslipidemia Genetics Unit, Hôpital de La Pitié, Sorbonne University, Paris, France.

Marcello Arca (M)

Department of Translational and Precision Medicine, Sapienza University of Rome, Viale del Policlinico 155, Rome, Italy.

Eric Bruckert (E)

Department of Endocrinology and Cardiovascular Disease Prevention, Assistance Publique-Hôpitaux de Paris, La Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH