Impact of Shexiang Baoxin Pill (MUSKARDIA) on Cardiovascular Outcomes by Baseline Hemoglobin Levels in 2,494 Patients with Chronic Stable Coronary Artery Disease: A Secondary Subgroup Analysis.

OBJECTIVE: Shexiang Baoxin Pill (MUSKARDIA) reduces major adverse cardiovascular events (MACE) and improves angina, this study aims to evaluate its differential efficacy across varying hemoglobin (Hb) levels. METHODS: This was a subgroup analysis of a multicenter, randomized, double-blind, placebo-controlled phase W trial. Patients with coronary artery disease (CAD) were stratified into two groups based on baseline Hb levels: Group A (Hb < 140 g/L, n=1,286) and Group B (Hb>140 g/L, n=1,208). The primary endpoint was MACE; secondary endpoints included non-fatal myocardial infarction (MI), non-fatal stroke, and all-cause mortality. Hazard ratios (HR) with 95% confidence intervals (CI) were estimated using Cox proportional hazards models. RESULTS: In Group A, MUSKARDIA significantly reduced MACE risk (HR=0.45, 95% CI: 0.21-0.96, P=0.038), with a 68% reduction in non-fatal MI risk (P=0.036). Non-fatal stroke and all-cause mortality showed no significant differences. Adverse events were lower in the MUSKARDIA group (15.9% vs. 17.6%). In Group B, no significant MACE benefit was observed (P=0.354), with a trend toward increased non-fatal MI risk (HR=1.88). Non-fatal stroke and all-cause mortality were similar between groups. Adverse events were slightly higher (21.2% vs. 18.3%). CONCLUSIONS: MUSKARDIA demonstrated significant cardiovascular protective effects in CAD patients with Hb < 140 g/L, particularly reducing non-fatal MI risk, while showing limited efficacy in patients with Hb>140 g/L. This highlights its cardiovascular protective role in high-risk populations characterized by greater ischemic risk and inadequate myocardial oxygen supply.