PCSK9 inhibitors(China State Institute of Pharmaceutical Industry)(PCSK9 inhibitors(China State Institute of Pharmaceutical Industry))

概要

基本信息

药物类型

小分子化药

别名

Compound W6(China State Institute of Pharmaceutical Industry)

靶点

PCSK9

作用方式

抑制剂

作用机制

PCSK9抑制剂(前蛋白转化酶枯草杆菌蛋白酶Kexin-9抑制剂)

治疗领域

心血管疾病

在研适应症

动脉粥样硬化

非在研适应症-

原研机构

在研机构

非在研机构-

权益机构-

最高研发阶段临床前

首次获批日期-

最高研发阶段(中国)临床前

特殊审评-

关联

100 项与 PCSK9 inhibitors(China State Institute of Pharmaceutical Industry) 相关的临床结果

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100 项与 PCSK9 inhibitors(China State Institute of Pharmaceutical Industry) 相关的转化医学

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100 项与 PCSK9 inhibitors(China State Institute of Pharmaceutical Industry) 相关的专利（医药）

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16

项与 PCSK9 inhibitors(China State Institute of Pharmaceutical Industry) 相关的文献（医药）

2025-09-01·ATHEROSCLEROSIS

Efficacy and safety of PCSK9 monoclonal antibodies in older patients: A real-world registry

Article

作者: Galema-Boers, Annette M H ; Mattace-Raso, Francesco ; Muller, Majon ; Mulder, Janneke W C M ; Mijnster, Ruben J M ; Lafeber, Melvin ; Roeters van Lennep, Jeanine E

BACKGROUND AND AIMS:

Proprotein convertase subtilisin/kexin type 9 monoclonal antibodies (PCSK9 mAbs) have a favourable efficacy and safety profile. Advancing age may pose challenges such as increasing drug toxicity, polypharmacy, and comorbidities. This study aims to assess whether the efficacy and safety of PCSK9 mAbs are comparable between patients ≥70 years versus patients <70 years.

METHODS:

In a prospective registry of all consecutive patients who started PCSK9 mAbs as part of routine care in a university medical center-based lipid clinic, data was collected on LDL cholesterol levels, side effects, and discontinuation. Data on efficacy and safety (reported side effects and discontinuation) were stratified for patients ≥70 and < 70 years.

RESULTS:

Of the 474 patients (median age 59 [51-66] years, 51 % men) who started a PCSK9 mAb, 70 patients were ≥70 years (15 %). After 6 months, relative and absolute LDL cholesterol reduction was similar across age groups (relative decrease: 58 % [48-70] vs 59 % [44-71], p = 0.99; mean (SD) absolute decrease 2.4 (0.8) vs 2.4 (1.2) mmol/L, p = 0.90). A comparable proportion of patients ≥70 years compared to those <70 years achieved European and Dutch guideline-recommended goals (36 % vs 46 %, p = 0.18, and 54 % vs 62 %, p = 0.26, respectively). Efficacy outcomes were similar after 12 and 24 months follow-up. Reported side effects and discontinuation of PCSK9 mAbs were comparable across age groups.

CONCLUSIONS:

Efficacy and safety of PCSK9 mAbs are comparable for patients ≥70 years and patients <70 years in a real-world study.

2025-05-01·Current Drug Safety

Herbal Interactions with Cardiac Medications: A Comprehensive Review of Potential Interactions between Herbal Drugs and Commonly Prescribed Cardiac Medications

Review

作者: Dayaramani, Richa ; Panigrahy, Uttam Prasad ; Wagh, Vijay D ; VL, Ashoka Babu ; Gunjal, Sachinkumar Dnyaneshwar ; Wal, Pranay ; Jyothi, M. Vijaya ; Rasheed, Azhar

Background::

The concomitant use of herbal remedies in conjunction with conventional cardiac medications has increased significantly in recent years, primarily due to improvements in the quality standards of herbal medicines and the pervasive belief that natural products pose no harm to the human body. Contrary to this belief, multiple phytoconstituents found in herbal products have the potential to interact with conventional cardiac drugs, potentially resulting in severe adverse effects.

Objective::

This review aimed to elucidate the intricacies of these interactions highlighting herbal medications that interact with established pharmaceuticals used for the treatment of cardiovascular disorders. Moreover, the review draws attention to safety concerns and preventative steps that should be taken by patients and medical professionals. This endeavor is vital to avert adverse events stemming from such interactions.

Methods::

Our approach entailed a comprehensive literature review employing keywords such as "mechanisms of herb-drug interactions,” “herbal medications,” and “cardiovascular disorders”. The drugs presented in this review were selected based on their popularity among the general population, frequency of their employability, and potential to manifest drug interactions. We sourced pertinent information from reputable databases, including PubMed, Scopus, and Elsevier.

Results::

Heart or blood vessel disorders are referred to as cardiovascular diseases (CVDs), which include conditions such as heart failure, stroke, hypertensive heart disease, and peripheral arterial disease. The primary underlying factor for the development of CVDs is dyslipidemia, which can be treated with classical antihyperlipidemic drugs such as statins, ezetimibe, and PCSK9-inhibitors. The use of herbal remedies is often unregulated, and there is a lack of scientific evidence supporting their use, particularly in the management of heart failure. Patients may not disclose their use of herbal remedies to health care practitioners, which can result in potential harm.

Conclusion::

Uncontrolled dyslipidemia leads to hypercholesterolemia, which can result in atherosclerotic plaques and blocked arteries and veins. Herbal remedies and botanical products are also used to prevent or treat illnesses, and many prescription pharmaceuticals are made from plant compounds. Herbal remedies are often preferred because of the belief that they are safe and have no potential to cause harm. However, there is insufficient scientific data to support the use of herbal remedies, especially when treating heart disease. Using herbal remedies in conjunction with medicinal pharmaceuticals may result in unfavorable effects.

2024-07-01·Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

Flexible Approaches Based on Multistate Models and Microsimulation to Perform Real-World Cost-Effectiveness Analyses: An Application to Proprotein Convertase Subtilisin-Kexin Type 9 Inhibitors

Article

作者: Barbati, Giulia ; Ieva, Francesca ; Di Lenarda, Andrea ; Cappelletto, Chiara ; Rea, Federico ; Indennidate, Carla ; Gregorio, Caterina ; Scagnetto, Arjuna

OBJECTIVES:

This study aims to show the application of flexible statistical methods in real-world cost-effectiveness analyses applied in the cardiovascular field, focusing specifically on the use of proprotein convertase subtilisin-kexin type 9 inhibitors for hyperlipidemia.

METHODS:

The proposed method allowed us to use an electronic health database to emulate a target trial for cost-effectiveness analysis using multistate modeling and microsimulation. We formally established the study design and provided precise definitions of the causal measures of interest while also outlining the assumptions necessary for accurately estimating these measures using the available data. Additionally, we thoroughly considered goodness-of-fit assessments and sensitivity analyses of the decision model, which are crucial to capture the complexity of individuals' healthcare pathway and to enhance the validity of this type of health economic models.

RESULTS:

In the disease model, the Markov assumption was found to be inadequate, and a "time-reset" timescale was implemented together with the use of a time-dependent variable to incorporate past hospitalization history. Furthermore, the microsimulation decision model demonstrated a satisfying goodness of fit, as evidenced by the consistent results obtained in the short-term horizon compared with a nonmodel-based approach. Notably, proprotein convertase subtilisin-kexin type 9 inhibitors revealed their favorable cost-effectiveness only in the long-term follow-up, with a minimum willingness to pay of 39 000 Euro/life years gained.

CONCLUSIONS:

The approach demonstrated its significant utility in several ways. Unlike nonmodel-based or alternative model-based methods, it enabled to (1) investigate long-term cost-effectiveness comprehensively, (2) use an appropriate disease model that aligns with the specific problem under study, and (3) conduct subgroup-specific cost-effectiveness analyses to gain more targeted insights.

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