Phytomedicine : international journal of phytotherapy and phytopharmacology · 2026
Shexiang Baoxin pill in patients with stable coronary artery disease and reduced eGFR: Subgroup analysis of phase IV randomized trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование IV фазыНазвание и аннотация: Перевод в очереди
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Zhou Jingmin, Chen Yanqiu, Shi Haiming, Jin Yuanzhe, Li Xinli, Wu Jianguang, Pan Chaoxin, Qian Jun, Wu Yang, Wang Xiaolong, Wang Yan, Lu Feng, Ge Junbo
Аннотация
BACKGROUND: Shexiang Baoxin pill (MUSKARDIA) is a well-known traditional Chinese medicine that has demonstrated protective effects in coronary artery disease (CAD).
PURPOSE: To evaluate MUSKARDIA in patients with stable CAD and reduced estimated glomerular filtration rate (eGFR).
STUDY DESIGN: This was a subgroup analysis of the multicenter, double‑blind, placebo‑controlled phase IV randomized clinical trial (MUST, ChiCTR-TRC-12,003,513). The MUST trial randomly assigned patients with stable CAD to MUSKARDIA or placebo group in a 1:1 ratio. The primary composite efficacy endpoint was the incidence of major adverse cardiovascular events. The secondary composite efficacy endpoint included all‑cause mortality, non‑fatal MI, non‑fatal stroke, hospitalization for unstable angina or heart failure, and coronary revascularization.
METHODS: This subgroup analysis included patients with reduced baseline eGFR (< 90 ml/min/1.73m²).
RESULTS: Among the 1354 participants with reduced baseline eGFR, there were numerical advantages with MUSKARDIA in improving the primary (hazard ratio=0.713; 95% CI: 0.379-1.342; p = 0.292) and secondary (hazard ratio=0.840; 95% CI: 0.608-1.161; p = 0.290) composite efficacy endpoints. Multivariable adjustment confirmed these benefits. The primary composite efficacy endpoint showed a trend toward a protective effect of MUSKARDIA after 12 months. MUSKARDIA significantly improved the secondary composite efficacy endpoint after 14 months. The profiles of adverse events were comparable between groups. There were no clinically meaningful differences in liver and kidney function indicators.
CONCLUSION: Long-term MUSKARDIA shows a protective trend against cardiovascular events in patients with stable CAD and reduced eGFR, and may be a consideration for clinical management.
PURPOSE: To evaluate MUSKARDIA in patients with stable CAD and reduced estimated glomerular filtration rate (eGFR).
STUDY DESIGN: This was a subgroup analysis of the multicenter, double‑blind, placebo‑controlled phase IV randomized clinical trial (MUST, ChiCTR-TRC-12,003,513). The MUST trial randomly assigned patients with stable CAD to MUSKARDIA or placebo group in a 1:1 ratio. The primary composite efficacy endpoint was the incidence of major adverse cardiovascular events. The secondary composite efficacy endpoint included all‑cause mortality, non‑fatal MI, non‑fatal stroke, hospitalization for unstable angina or heart failure, and coronary revascularization.
METHODS: This subgroup analysis included patients with reduced baseline eGFR (< 90 ml/min/1.73m²).
RESULTS: Among the 1354 participants with reduced baseline eGFR, there were numerical advantages with MUSKARDIA in improving the primary (hazard ratio=0.713; 95% CI: 0.379-1.342; p = 0.292) and secondary (hazard ratio=0.840; 95% CI: 0.608-1.161; p = 0.290) composite efficacy endpoints. Multivariable adjustment confirmed these benefits. The primary composite efficacy endpoint showed a trend toward a protective effect of MUSKARDIA after 12 months. MUSKARDIA significantly improved the secondary composite efficacy endpoint after 14 months. The profiles of adverse events were comparable between groups. There were no clinically meaningful differences in liver and kidney function indicators.
CONCLUSION: Long-term MUSKARDIA shows a protective trend against cardiovascular events in patients with stable CAD and reduced eGFR, and may be a consideration for clinical management.