Effectiveness and safety of Shexiang Baoxin Pill(MUSKARDIA)in patients with stable coronary artery disease and concomitant diabetes mellitus:a subgroup analysis of a randomized clinical trial

Background:Preliminary studies have indicated that Shexiang Baoxin Pill(MUSKARDIA)has a coronary artery dilation effect and increases the coronary blood flow,relieving the symptoms of angina.This study aimed to evaluate the benefit of MUSKARDIA on patients with stable coronary artery disease(CAD)and diabetes mellitus(DM).Methods:This was a subgroup analysis of a multicenter,randomized,placebo-controlled phase IV trial.CAD patients with a medical history of DM or baseline fasting blood glucose(FBG)≥7.0 mmol/L were grouped according to the treatment(standard therapy plus MUSKARDIA or placebo).The primary outcome was major adverse cardiovascular events(MACEs),which was the composite outcome of cardiovascular death,non-fatal myocardial infarction,and non-fatal stroke.The secondary outcome was the composite outcome of all-cause death,non-fatal myocardial infarction,non-fatal stroke,hospitalization for unstable angina or heart failure,and coronary angioplasty.Results:MACEs occurred in 2.6%(9/340)and 4.8%(18/376)of patients in the MUSKARDIA and placebo groups,respectively(P=0.192).Secondary composite outcome was significantly less frequent with MUSKARDIA than with placebo(15.3%[52/340]vs.22.6%[85/376],P=0.017).Risk of MACEs(hazard ratio[HR]=0.69,95%confidence interval[CI]:0.31-1.57)was comparable between two groups.In patients with uncontrolled DM(≥4 measurements of FBG≥7 mmol/L in five times of follow-up),the risk of secondary outcome was significantly lower with MUSKARDIA(5/83,6.0%)than with placebo(15/91,16.5%)(HR=0.35,95%CI:0.13-0.95).Conclusion:As an add-on to standard therapy,MUSKARDIA shows a trend of reduced MACEs in patients with stable CAD and DM.Furthermore,MUSKARDIA may reduce the frequency of all-cause death,hospitalization,and coronary angioplasty in this population,especially in those with uncontrolled DM.Trial Registration:ChiCTR.org.cn,ChiCTR-TRC-12003513.

Efficacy and safety of Shexiang Baoxin pill(MUSKARDIA)in patients with stable coronary artery disease:a multicenter,double-blind,placebo-controlled phase IV randomized clinical trial

Background:The Shexiang Baoxin Pill(MUSKARDIA)has been used for treating coronary artery disease(CAD)and angina for more than 30 years in China.Nevertheless,methodologically sound trials on the use of MUSKARDIA in CAD patients are scarce.The aim of the study is to determine the effects of MUSKARDIA as an add-on to optimal medical therapy(OMT)in patients with stable CAD.Methods:A total of 2674 participants with stable CAD from 97 hospitals in China were randomized 1:1 to a MUSKARDIA or placebo group for 24 months.Both groups received OMT according to local tertiary hospital protocols.The primary outcome was the occurrence of a major adverse cardiovascular event(MACE),defined as a composite of cardiovascular death,non-fatal myocardial infarction(MI),or non-fatal stroke.Secondary outcomes included all-cause mortality,non-fatal MI,non-fatal stroke,hospitalization for unstable angina or heart failure,peripheral revascularization,angina stability and angina frequency.Results:In all,99.7%of the patients were treated with aspirin and 93.0%with statin.After 2 years of treatment,the occurrence of MACEs was reduced by 26.9%in the MUSKARDIA group(MUSKARDIA:1.9%vs.placebo:2.6%;odds ratio=0.80;95%confidence interval:0.45-1.07;P=0.2869).Angina frequency was significantly reduced in the MUSKARDIA group at 18 months(P=0.0362).Other secondary endpoints were similar between the two groups.The rates of adverse events were also similar between the two groups(MUSKARDIA:17.7%vs.placebo:17.4%,P=0.8785).Conclusions:As an add-on to OMT,MUSKARDIA is safe and significantly reduces angina frequency in patients with stable CAD.Moreover,the use of MUSKARDIA is associated with a trend toward reduced MACEs in patients with stable CAD.The results suggest that MUSKARDIA can be used to manage patients with CAD.Trial registration:chictr.org.cn,No.ChiCTR-TRC-12003513.