The safety of clopidogrel

Mangalpally, Kiran Kumar R; Kleiman, Neal S.

doi:10.1517/14740338.2011.532485

Cited by 11 publications

(7 citation statements)

References 67 publications

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“…Although drug-induced immune thrombocytopenia usually occurs after multiple drug exposures, it also can occur after a first dose due to naturally occurring antibodies. In addition, use of targeted antiplatelet agents, such as ticlopidine hydrochloride (Ticlid) and clopidogrel bisulphate (Plavix), are associated with thrombotic thrombocytopenia purpura, characterized by platelet aggregation/activation and thrombocytopenia (Zakarija et al 2009; Mangalpally and Kleiman 2011).…”

Section: Introductionmentioning

confidence: 99%

Off-Target Platelet Activation in Macaques Unique to a Therapeutic Monoclonal Antibody

et al. 2012

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AMG X, a human neutralizing monoclonal antibody (mAb) against a soluble human protein, caused thrombocytopenia, platelet activation, reduced mean arterial pressure, and transient loss of consciousness in cynomolgus monkeys after first intravenous administration. In vitro, AMG X induced activation in platelets from macaque species but not from humans or baboons. Other similar mAbs against the same pharmacological target failed to induce these in vivo and in vitro effects. In addition, the target protein was known to not be expressed on platelets, suggesting that platelet activation occurred through an off-target mechanism. AMG X bound directly to cynomolgus platelets and required both the Fab and Fc portion of the mAb for platelet activation. Binding to platelets was inhibited by preincubation of AMG X with its pharmacological target or with anti-human Fc antibodies or by preincubation of platelets with AMG X F(ab')(2) or human immunoglobulin (IVIG). AMG X F(ab')(2) did not activate platelets. Thus, platelet activation required both recognition/binding of a platelet ligand with the Fab domain and interaction of platelet Fc receptors (i.e., FcγRIIa) with the Fc domain. These findings reflect the complexity of the mechanism of action of mAbs and the increasing awareness of potential for unintended effects in preclinical species.

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Section: Introductionmentioning

confidence: 99%

Off-Target Platelet Activation in Macaques Unique to a Therapeutic Monoclonal Antibody

et al. 2012

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“…However, the administration of ticlopidine was followed by severe complications, such as neutropenia (10) or thrombotic thrombocytopenic purpura (11,12). Later, the use of clopidogrel increased and its efficacy was proven in a great number of clinical settings (CLARITY-TIMI, COMMIT trial, CURE trial, CREDO trial, CHARISMA trial) (13). lopidogrel, a prodrug, is converted into its active derivative in the liver.…”

Section: Stent Thrombosismentioning

confidence: 99%

Progress in interventional cardiology: challenges for the future

Simsekyilmaz¹,

Liehn²,

Militaru³

et al. 2015

Thromb Haemost

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SummaryCardiovascular disease is the leading cause of death in the western and developing countries. Percutaneous transluminal coronary interventions have become the most prevalent treatment option for coronary artery disease; however, due to serious complications, such as stent thrombosis and in-stent restenosis (ISR), the efficacy and safety of the procedure remain important issues to address. Strategies to overcome these aspects are under extensive investigation. In this review, we summarise relevant milestones during the time to overcome these limitations of coronary stents, such as the development of polymer-free drug-eluting stents (DES) to avoid pro-inflammatory response due to the polymer coating or the developement of stents with cell-directing drugs to, simultaneously, improve re-endothelialisation and inhibit ISR amongst other techniques most recently developed, which have not fully entered the clinical stage. Also the novel concept of fully biodegradable DES featured by the lack of a permanent foreign body promises to be a beneficial and applicable tool to restore a natural vessel with maintained vasomotion and to enable optional subsequent surgical revascularisation.

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“…2 Clopidogrel is widely used in thrombotic diseases, but acute or long-term use may also cause bleeding. 3 Statins are associated with adverse reactions, ie, muscle pain. 4 For patients with CVDs, long-term medication is usually implemented, so the probability of adverse drug reactions increases.…”

Section: Introductionmentioning

confidence: 99%

Effect of Spray Drying Conditions on Physical Properties of Panax notoginseng Saponin (PNS) Powder and the Intra-Batch Dissolution Variability of PNS Hydrophilic Matrix Tablet

Yang

Wang

et al. 2021

DDDT

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Purpose: Understanding raw material variability and its impact on product quality are crucial for developing robust pharmaceutical processes. This work aimed to study the effects of spray drying conditions on properties of the spray dried Panax notoginseng saponin (PNS) powders as well as the subsequent intra-batch dissolution variability of PNS hydrophilic matrix tablets. Methods: The Plackett-Burman design was applied to screen the critical process parameters (CPPs). Then, the Box-Behnken design was used to investigate the relationship between the CPPs and the physiochemical properties of spray dried PNS powders. The PNS hydrophilic matrix tablets containing 57% spray dried PNS powders were directly compressed. The partial least squares (PLS) regression was used to uncover the hidden multivariate relationships among the CPPs, intermediate powder properties, and tablet quality attributes. Results: The identified CPPs were the feed concentration, the inlet air temperature, and the atomization pressure. It was found that the CPPs exerted little impact on chemical properties of spray dried PNS powders, but had significant impact on physical properties, such as particle size, specific surface area, bulk density, hygroscopicity, and inter-particle porosity, etc. Latent variable modeling results revealed that the high inlet air temperature of spray drying process could produce PNS powders with low moisture content and high hygroscopicity, which were beneficial to reduce the intra-batch dissolution variability of PNS hydrophilic matrix tablets. Finally, a design space of the spray drying process was built in order to ensure the dissolution consistency. Conclusion:Our research provided a reference for improving the spray drying conditions in order to ensure the dissolution consistency of the PNS hydrophilic matrix tablet.

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The safety of clopidogrel

Cited by 11 publications

References 67 publications

Off-Target Platelet Activation in Macaques Unique to a Therapeutic Monoclonal Antibody

Off-Target Platelet Activation in Macaques Unique to a Therapeutic Monoclonal Antibody

Progress in interventional cardiology: challenges for the future

Effect of Spray Drying Conditions on Physical Properties of Panax notoginseng Saponin (PNS) Powder and the Intra-Batch Dissolution Variability of PNS Hydrophilic Matrix Tablet

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