Efficacy and Safety of Shexiang Baoxin Pill (MUSKARDIA) in Patients with Stable Coronary Artery Disease Across Different Weight Subgroups

Jingmin Zhou; Haiming Shi; Yulan Zhao; Yuanzhe Jin; Yingwu Liu; Shenghuang Wang; Shenghu He; Feng Lu; Rong Li; Shangquan Xiong; Ji Yan; Qiming Liu; Zhirong Wang; Hongliang Cong; Qinghua Han; Junbo Ge

doi:10.1016/j.jep.2025.119341

Efficacy and Safety of Shexiang Baoxin Pill (MUSKARDIA) in Patients with Stable Coronary Artery Disease Across Different Weight Subgroups

J Ethnopharmacol. 2025 Jan 8:119341. doi: 10.1016/j.jep.2025.119341. Online ahead of print.

Authors

Jingmin Zhou¹, Haiming Shi², Yulan Zhao³, Yuanzhe Jin⁴, Yingwu Liu⁵, Shenghuang Wang⁶, Shenghu He⁷, Feng Lu⁸, Rong Li⁹, Shangquan Xiong¹⁰, Ji Yan¹¹, Qiming Liu¹², Zhirong Wang¹³, Hongliang Cong¹⁴, Qinghua Han¹⁵, Junbo Ge¹⁶

Affiliations

¹ Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China. Electronic address: zhou.jingmin@zs-hospital.sh.cn.
² Department of Cardiology, Huashan Hospital, Fudan University, Shanghai 200040, China.
³ Department of Cardiology, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou 450014, China.
⁴ Department of Cardiology, The Fourth Affiliated Hospital of China Medical University.
⁵ Department of Cardiology, Tianjin Third Central Hospital, Tianjin 300000, China.
⁶ Department of Cardiovascular Medicine, Ningbo First Hospital, Ningbo 315010, China.
⁷ Department of Cardiology, Northern Jiangsu People's Hospital, Yangzhou 225000, China.
⁸ Department of Cardiology, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Ji'nan 250014, China.
⁹ Department of Cardiovascular Medicine, The First Affiliated Hospital of Guangdong University of Traditional Chinese Medicine, Guangzhou 510000, China.
¹⁰ Department of Cardiovascular Medicine, Fujian Province People's Hospital, Fuzhou 350004, China.
¹¹ Department of Cardiovascular, The First Affiliated Hospital of China University of Science and Technology, Hefei 230000, China.
¹² Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha 410000, China.
¹³ Department of Cardiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou 221000, China.
¹⁴ Department of Cardiology, Tianjin Chest Hospital, Tianjin 300000, China.
¹⁵ Department of Cardiology, The First Hospital of Shanxi Medical University, Taiyuan 030001, China.
¹⁶ Department of Cardiovascular Internal Medicine, Zhongshan Hospital, Fudan University, Shanghai 200000, China.

PMID: 39793776
DOI: 10.1016/j.jep.2025.119341

Abstract

Ethnopharmacological relevance: Shexiang Baoxin Pill (MUSKARDIA), a traditional Chinese patent medicine, plays a crucial role in both preventing and treating diverse cardiovascular diseases, including coronary heart disease, myocardial infarction (MI), and heart failure. Preclinical research has demonstrated that the cardioprotective effects of MUSKARDIA are achieved through multiple pathways, such as enhancing coronary artery dilation, fostering new blood vessel growth, reducing inflammation and oxidative stress, improving lipid metabolism, and protecting vascular endothelium.

Aim of the study: This subgroup analysis aimed to evaluate the efficacy and safety of Shexiang Baoxin Pill (MUSKARDIA) plus optimal medical therapy (OMT) across different weight categories in treating stable coronary artery disease (CAD).

Methods: This investigation was a subgroup analysis of a multicenter, randomized, double-blind, placebo-controlled phase IV clinical study. Patients receiving OMT were randomly assigned to either MUSKARDIA or placebo group for a 24-month period. This analysis focused on body weight as a distinguishing factor, using 65kg as the cutoff. The primary efficacy endpoint was the composite of major adverse cardiovascular events (MACEs), including cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke. Secondary efficacy endpoint comprised a composite of all-cause mortality, non-fatal MI, non-fatal stroke, hospitalizations for unstable angina or heart failure, and coronary revascularization procedures.

Results: A total of 2,646 patients were included in the analysis, with 916 patients weighing less than 65 kg and 1,730 patients weighing 65 kg or more. The median ages were 68 (range: 35-90) years and 62 (range: 29-90) in these two subgroups, respectively. For patients weighing less than 65kg, the MUSKARDIA group exhibited a significantly lower incidence of the primary efficacy endpoint (0.65%) compared to the placebo group (2.64%) (P=0.018), with a reduced risk of MACEs (HR=0.241, 95%CI: 0.068-0.856; P=0.0168). Conversely, in patients weighing 65kg or more, no significant differences were observed in the incidence rates or risks of primary or secondary efficacy endpoints between the MUSKARDIA and placebo groups (All P > 0.05). Adverse events were similar between two groups across both weight subgroups.

Conclusions: MUSKARDIA plus OMT demonstrated promising efficacy and acceptable safety in CAD patients weighing less than 65kg, potentially reducing the risk of MACEs. For patients weighing 65kg or more, further investigation is needed to optimize dosing strategies.

Keywords: MUSKARDIA; body weight; coronary artery disease; major adverse cardiovascular events; subgroup analysis.