Last update 01 Nov 2024

Hyperlipoproteinemia Type IIb

Last update 01 Nov 2024

Basic Info

Synonyms

2bｶﾞﾀｺｳﾘﾎﾟﾀﾝﾊﾟｸｹｯｼｮｳ, 2bｶﾞﾀｺｳﾘﾎﾟﾀﾝﾊﾟｸｹﾂｼｮｳ, APOLIPOPROTEIN B-100, FAMILIAL DEFECTIVE

+ [50]

Introduction

Type IIb hyperlipoproteinemia is caused by mutation in the receptor-binding domain of APOLIPOPROTEIN B-100 which is a major component of LOW-DENSITY LIPOPROTEINS and VERY-LOW-DENSITY LIPOPROTEINS resulting in reduced clearance of these lipoproteins. It is characterized by both hypercholesterolemia and HYPERTRIGLYCERIDEMIA (combined hyperlipidemia).

Drugs associated with Hyperlipoproteinemia Type IIb

Rosuvastatin Calcium

Target

HMG-CoA reductase

Mechanism

HMG-CoA reductase inhibitors

Active Org.

IPR Pharmaceuticals, Inc. [+5]

Originator Org.

Shionogi & Co., Ltd.

Active Indication

Atherosclerosis [+8]

Inactive Indication

Acute Coronary Syndrome [+17]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date06 Nov 2002

Atorvastatin Calcium

Target

HMG-CoA reductase

Mechanism

HMG-CoA reductase inhibitors

Active Org.

Upjohn Manufacturing Ireland Unlimited Co. [+7]

Originator Org.

Pfizer Inc.

Active Indication

Heart Failure [+15]

Inactive Indication

Alzheimer Disease [+20]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date17 Dec 1996

Clinical Trials associated with Hyperlipoproteinemia Type IIb

CTR20242786 / CompletedNot Applicable

阿昔莫司胶囊生物等效性试验

[Translation] Bioequivalence study of acipimox capsules

主要研究目的评价中国健康成年受试者空腹及餐后条件下单次单剂量口服阿昔莫司胶囊受试制剂（规格：0.25g，申办者：天津掌心医药科技有限公司）和参比制剂（商品名：Olbetam®，规格：0.25g，持证商：Pfizer Limited）后的药代动力学特点和生物等效性。次要研究目的研究阿昔莫司胶囊受试制剂（规格：0.25g）和参比制剂（商品名：Olbetam®，规格：0.25g）在中国健康成年受试者中的安全性。

[Translation]

Main study objectives To evaluate the pharmacokinetic characteristics and bioequivalence of acipimox capsule test formulation (specification: 0.25g, applicant: Tianjin Palm Pharmaceutical Technology Co., Ltd.) and reference formulation (trade name: Olbetam®, specification: 0.25g, licensee: Pfizer Limited) after single oral dose in healthy Chinese adult subjects under fasting and postprandial conditions. Secondary study objectives To study the safety of acipimox capsule test formulation (specification: 0.25g) and reference formulation (trade name: Olbetam®, specification: 0.25g) in healthy Chinese adult subjects.

Start Date29 Aug 2024

Sponsor / Collaborator

Tianjin Holder Pharmaceutical Technology Co. Ltd.

CTR20242573 / CompletedNot Applicable

以中国健康受试者为试验对象，采用自身交叉对照的试验设计，测定安徽佳和药业有限公司研制的阿昔莫司胶囊给药后血浆中的阿昔莫司在健康受试者体内的血药浓度经时过程，估算相应的药代动力学参数，并以 Pfizer Limited 持证，Pharmacia Italia SpA 生产的阿昔莫司胶囊（商品名：Olbetam®;，规格：0.25g）为参比，评价制剂间的生物等效性，并观察阿昔莫司胶囊在中国健康受试者中的安全性

[Translation] The study used healthy Chinese subjects as the test subjects and adopted a self-crossover design to determine the time course of the plasma concentration of acipimox in healthy subjects after administration of acipimox capsules developed by Anhui Jiahe Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. The acipimox capsules (trade name: Olbetam®;, specification: 0.25g) produced by Pharmacia Italia SpA and licensed by Pfizer Limited were used as reference to evaluate the bioequivalence between the preparations and observe the safety of acipimox capsules in healthy Chinese subjects.

以中国健康受试者为试验对象，采用自身交叉对照的试验设计，测定安徽佳和药业有限公司研制的阿昔莫司胶囊给药后血浆中的阿昔莫司在健康受试者体内的血药浓度经时过程，估算相应的药代动力学参数，并以 Pfizer Limited 持证，Pharmacia Italia SpA 生产的阿昔莫司胶囊（商品名：Olbetam®，规格：0.25g）为参比，评价制剂间的生物等效性，并观察阿昔莫司胶囊在中国健康受试者中的安全性。

[Translation]

Healthy Chinese subjects were used as the test subjects. A self-crossover design was used to determine the time course of acipimox in plasma after administration of acipimox capsules developed by Anhui Jiahe Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Acipimox capsules (trade name: Olbetam®, specification: 0.25g) certified by Pfizer Limited and produced by Pharmacia Italia SpA were used as reference to evaluate the bioequivalence between the preparations and to observe the safety of acipimox capsules in healthy Chinese subjects.

Start Date07 Aug 2024

Sponsor / Collaborator

Anhui Jiahe Pharmaceutical Co., Ltd.

CTR20242647 / CompletedNot Applicable

安徽美来药业股份有限公司的阿昔莫司胶囊与 Pfizer Limited 的阿昔莫司胶囊(商品名:Olbetam)在健康受试者中单中心随机、开放、单次给药、两周期、双交叉、空腹及餐后状态下的生物等效性研究

[Translation] A single-center randomized, open-label, single-dose, two-period, double-crossover, fasting and fed bioequivalence study of acipimox capsules from Anhui Meilai Pharmaceutical Co., Ltd. and acipimox capsules (trade name: Olbetam) from Pfizer Limited in healthy subjects

以中国健康受试者为试验对象，采用自身交叉对照的试验设计，测定安徽美来药业股份有限公司持证，蚌埠丰原涂山制药有限公司生产的阿昔莫司胶囊给药后血浆中的阿昔莫司在健康受试者体内的血药浓度经时过程，估算相应的药代动力学参数，并以Pfizer Limited持证，Pharmacia Italia SpA生产的阿昔莫司胶囊（商品名：Olbetam®，规格：0.25g）为参比，评价制剂间的生物等效性，并观察阿昔莫司胶囊在中国健康受试者中的安全性。

[Translation]

Healthy Chinese subjects were used as the test subjects. A self-crossover design was used to determine the time course of acipimox concentration in plasma after administration of acipimox capsules licensed by Anhui Meilai Pharmaceutical Co., Ltd. and produced by Bengbu Fengyuan Tushan Pharmaceutical Co., Ltd., and to estimate the corresponding pharmacokinetic parameters. Acipimox capsules (trade name: Olbetam®, specification: 0.25g) licensed by Pfizer Limited and produced by Pharmacia Italia SpA were used as reference to evaluate the bioequivalence between the preparations and to observe the safety of acipimox capsules in healthy Chinese subjects.

Start Date10 Jul 2024

Sponsor / Collaborator

Anhui Meilai Pharmaceutical Co., Ltd.

100 Clinical Results associated with Hyperlipoproteinemia Type IIb

100 Translational Medicine associated with Hyperlipoproteinemia Type IIb

0 Patents (Medical) associated with Hyperlipoproteinemia Type IIb

205

Literatures (Medical) associated with Hyperlipoproteinemia Type IIb

01 Mar 2019·Clinica Chimica ActaQ3 · MEDICINE

Metabolic disorders and inflammation are associated with familial combined hyperlipemia

Q3 · MEDICINE

Article

Author: Fernández-de la Cruz, Francis ; Martínez-Triguero, María L ; Bañuls, Celia ; Díaz-Ruiz, María ; López-Ruiz, Antonio ; Hernández-Mijares, Antonio

BACKGROUNDFamilial Combined Hyperlipidemia (FCH) is related to different metabolic disorders. The objective of this study was to evaluate the presence of alterations of hydrocarbonated metabolism and lipid profile together with inflammatory and adhesion molecules in subjects with FCH compared to controls.METHODS75 HFC patients and 75 healthy individuals were studied. Glucose, insulin, HOMA-IR index and lipid parameters, in addition to anti-oxidized LDL antibodies (Anti ox-LDL), small and dense LDL (sdLDL) and HDL subfractions, proinflammatory cytokines and adhesion molecules were measured.RESULTSFCH patients showed higher levels of hydrocarbonated metabolism parameters, total cholesterol, triglycerides, LDLc, Apolipoprotein B and non-HDLc (p < .001), and lower levels of HDLc (p < .001) and Apolipoprotein AI (p < .05) than controls. In addition, the inflammatory markers hsCRP, IL-6, IL-8, P-selectin, E-selectin and ICAM were all higher with (p < .05) respect to controls. The increase of sdLDL was correlated with the presence of IR and IL-6 levels. Significant differences in diameter and percentage of phenotype B LDL, small HDL subfractions and Anti ox-LDL were also detected between patients and controls.CONCLUSIONSThe lipid characteristics of FCH are confirmed by IR and a low grade inflammatory state in patients, and are associated with the predominance of sdLDL and Anti ox-LDL.

01 Mar 2015·Journal of Clinical LipidologyQ2 · MEDICINE

Changes in ultracentrifugally separated plasma lipoprotein subfractions in patients with polygenic hypercholesterolemia, familial combined hyperlipoproteinemia, and familial hypercholesterolemia after treatment with atorvastatin

Q2 · MEDICINE

Article

Author: Hayashi, Koichi ; Homma, Yasuhiko ; Hori, Shingo ; Shiina, Yutaka ; Itoh, Hiroshi ; Homma, Koichiro ; Wakino, Shu ; Yoshida, Tadashi ; Ozawa, Hideki

BACKGROUNDPlasma levels of low-density lipoproteins (LDLs) are decreased through stimulation of their hepatic uptake by statins via an LDL receptor. However, it is unclear whether statins equally stimulate the hepatic uptake of all LDL subfractions.OBJECTIVEWe compared the effects of atorvastatin on 3 LDL subfractions, and their associations with LDL-receptor activities, in Japanese patients with polygenic hypercholesterolemia (PHC), familial combined hyperlipoproteinemia (FCHL), and familial hypercholesterolemia (FH).MATERIALS AND METHODSAtorvastatin was administered to patients with PHC (n = 11), FCHL (n = 16), and FH (n = 13). We measured plasma levels of lipids, remnant-like particle cholesterol, apoproteins, and cholesterol in lipoprotein fractions. Sequential ultracentrifugation was performed to subfractionate the plasma lipoproteins, and lymphocyte LDL-receptor activities were estimated using flow cytometry.RESULTSThe average daily dosage of atorvastatin was 10, 27, and 40 mg in patients with PHC, FCHL, and FH, respectively; after 12 months of atorvastatin treatment, LDL cholesterol (LDL-C) plasma levels decreased by 44%, 50%, and 53%, respectively (all, P < .0001). Atorvastatin reduced low-density LDL-C plasma levels in patients with PHC (48% reduction), FCHL (53%), and FH (46%) (all, P < .0001). Plasma levels of medium-density and high-density LDL-C were also significantly reduced in the 3 patient groups (all, P ≤ .0147). LDL-receptor activity was negatively correlated with baseline levels of medium-density LDL-C and with the decreases in plasma md-LDL-C levels.CONCLUSIONAtorvastatin decreased the levels of the 3 LDL fractions. The md-LDL decrease appeared to be mainly because of stimulation of LDL-receptor activity.

01 Sep 2013·International Journal of Cardiology

Genetic influence in liver steatosis prevalence and proatherothrombotic/inflammatory profile in familial combined hyperlipoproteinemia

Letter

Author: Alberto Auteri ; Francesca Scarpini ; Carlo Scapellato ; Linda Ceccatelli ; Francesca Santilli ; Tiziana Avolio ; Antonio Magliocca ; Luca Puccetti ; Walter Renato Gioffrè ; Patrizia Blardi ; Silvia Cristina Ferracane ; Angela Acciavatti ; Monica Bocchia

presentation data could potentially have affected our results. Our results were also limited to in-hospital outcomes, but benefits of reduced DTB may emerge later, with a reduction in heart failure and a later mortality. In conclusion, our study found no correlation between short DTB or time to presentation and in-hospital mortality. Further investigation is needed to prove that short DTB does not have an impact onmortality in Japanese STEMI patients.

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Hyperlipoproteinemia Type IIb

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