MUSKARDIA shows protective trend in stable CAD with reduced eGFR

This subgroup analysis of a phase IV randomized controlled trial evaluated the effects of Shexiang Baoxin pill (MUSKARDIA) in patients with stable coronary artery disease and reduced baseline estimated glomerular filtration rate (eGFR < 90 ml/min/1.73m²). The multicenter study enrolled 1,354 patients and compared MUSKARDIA against placebo over a 12-month follow-up period. The primary outcome was the incidence of major adverse cardiovascular events, a composite efficacy endpoint.

The main results indicated a numerical advantage for MUSKARDIA, with a hazard ratio of 0.713 (95% CI: 0.379-1.342; p = 0.292) for the primary composite endpoint, suggesting a trend toward a protective effect after 12 months. For the secondary composite efficacy endpoint, the hazard ratio was 0.840 (95% CI: 0.608-1.161; p = 0.290), also favoring MUSKARDIA, with a significant improvement noted after 14 months in the broader trial context.

Safety profiles were comparable between the MUSKARDIA and placebo groups, with adverse events similar and no clinically meaningful differences in liver and kidney function indicators. Serious adverse events and discontinuations were not reported, and tolerability was deemed acceptable. These findings are based on hazard ratios with wide confidence intervals and non-significant p-values, indicating low certainty in the results.

The study population included patients with stable coronary artery disease and reduced eGFR, a group at elevated cardiovascular risk. Secondary outcomes such as all-cause mortality, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or heart failure, and coronary revascularization were monitored, though specific absolute numbers were not reported.

Limitations of this subgroup analysis include the lack of reported absolute numbers, the non-significant p-values, and the inherent caution required when interpreting associations from subgroup analyses. The funding and conflicts of interest were not reported, which may introduce potential bias.

From a clinical practice perspective, 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. However, this is a subgroup analysis of an RCT, so results show association, not definitive causation.

Clinicians should avoid overinterpreting the non-significant p-values and the subgroup nature of the analysis. The results suggest a potential benefit, but further research is needed to confirm efficacy and establish causality in this specific patient population.