Purpose of Review: To revise the clinical evidence supporting the use of volanesorsen as new lipid-lowering drug and to assess the efficacy and safety of volanesorsen (ISIS 304801) through a systematic review of the literature and a meta-analysis of the available phase 2 and phase 3 clinical studies. Recent Findings: The meta-analysis of three clinical studies comprising 11 arms (N = l 156 subjects, with 95 in the active-treated arm and 61 in the control one) shows that volanesorsen significantly affects plasma levels of triglycerides (TG) [MD = − 67.90%, 95%CI = − 85.32, − 50.48, P < 0.001], high-density lipoprotein cholesterol (HDL-C) [MD = 40.06%, 95%CI: 32.79, 47.34, P < 0.001], very-low-density lipoprotein cholesterol (VLDL-C) [MD = − 72.90%, 95%CI = − 82.73, − 63.07, P < 0.001], apolipoprotein B (Apo B) [MD = 8%, 95%CI = 2.17, 13.84, P = 0.007], Apo B-48 [MD = − 64.63, 95%CI = − 105.37, − 23.88, P = 0.002], ApoCIII [MD = − 74.83%, 95%CI = − 85.93, − 63.73, P < 0.001], and VLDL ApoCIII [MD = − 83.69%, 95%CI = − 94.08, − 73.29, P < 0.001], without significant impact on LDL-C [MD = 47.01%, 95%CI = − 1.31, 95.33, P = 0.057] levels. Treatment with volanesorsen was associated with an higher risk of injection site reaction (OR = 32.89, 95%CI = 7.97,135,74, P < 0.001) and with an increased risk of upper respiratory tract infections (OR = 10.58, 95%CI = 1.23, 90.93, P < 0.05) when compared to placebo. Summary: Volanesorsen has a relevant impact on plasma TG and related parameters without affecting LDL cholesterolemia and is associated with an acceptable safety profile.
Efficacy and safety of Volanesorsen (ISIS 304801) : the evidence from phase 2 and 3 clinical trials / F. Fogacci, G.D. Norata, P.P. Toth, M. Arca, A.F.G. Cicero. - In: CURRENT ATHEROSCLEROSIS REPORTS. - ISSN 1523-3804. - 22:5(2020 May 26), pp. 18.1-18.9. [10.1007/s11883-020-00836-w]
Efficacy and safety of Volanesorsen (ISIS 304801) : the evidence from phase 2 and 3 clinical trials
G.D. Norata;
2020
Abstract
Purpose of Review: To revise the clinical evidence supporting the use of volanesorsen as new lipid-lowering drug and to assess the efficacy and safety of volanesorsen (ISIS 304801) through a systematic review of the literature and a meta-analysis of the available phase 2 and phase 3 clinical studies. Recent Findings: The meta-analysis of three clinical studies comprising 11 arms (N = l 156 subjects, with 95 in the active-treated arm and 61 in the control one) shows that volanesorsen significantly affects plasma levels of triglycerides (TG) [MD = − 67.90%, 95%CI = − 85.32, − 50.48, P < 0.001], high-density lipoprotein cholesterol (HDL-C) [MD = 40.06%, 95%CI: 32.79, 47.34, P < 0.001], very-low-density lipoprotein cholesterol (VLDL-C) [MD = − 72.90%, 95%CI = − 82.73, − 63.07, P < 0.001], apolipoprotein B (Apo B) [MD = 8%, 95%CI = 2.17, 13.84, P = 0.007], Apo B-48 [MD = − 64.63, 95%CI = − 105.37, − 23.88, P = 0.002], ApoCIII [MD = − 74.83%, 95%CI = − 85.93, − 63.73, P < 0.001], and VLDL ApoCIII [MD = − 83.69%, 95%CI = − 94.08, − 73.29, P < 0.001], without significant impact on LDL-C [MD = 47.01%, 95%CI = − 1.31, 95.33, P = 0.057] levels. Treatment with volanesorsen was associated with an higher risk of injection site reaction (OR = 32.89, 95%CI = 7.97,135,74, P < 0.001) and with an increased risk of upper respiratory tract infections (OR = 10.58, 95%CI = 1.23, 90.93, P < 0.05) when compared to placebo. Summary: Volanesorsen has a relevant impact on plasma TG and related parameters without affecting LDL cholesterolemia and is associated with an acceptable safety profile.File | Dimensione | Formato | |
---|---|---|---|
Full paper_REVISED_Final.doc
accesso aperto
Tipologia:
Pre-print (manoscritto inviato all'editore)
Dimensione
142.5 kB
Formato
Microsoft Word
|
142.5 kB | Microsoft Word | Visualizza/Apri |
Fogacci2020_Article_EfficacyAndSafetyOfVolanesorse.pdf
accesso riservato
Tipologia:
Publisher's version/PDF
Dimensione
1.55 MB
Formato
Adobe PDF
|
1.55 MB | Adobe PDF | Visualizza/Apri Richiedi una copia |
Pubblicazioni consigliate
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.