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.
10.1097/CM9.0000000000002527
- Author:
Jingmin ZHOU
1
;
Haiming SHI
2
;
Fusui JI
3
;
Yang WU
4
;
Yulan ZHAO
5
;
Jun QIAN
6
;
Junbo GE
1
Author Information
1. Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
2. Department of Cardiology, Huashan Hospital, Fudan University, Shanghai 200040, China.
3. Department of Cardiology, Beijing Hospital, Beijing 100005, China.
4. Department of Cardiology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100078, China.
5. Department of Cardiology, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450014, China.
6. Department of Cardiology, The Center Hospital of Ma'anshan, Ma'anshan, Anhui 243099, China.
- Publication Type:Journal Article
- MeSH:
Humans;
Coronary Artery Disease/complications*;
Diabetes Mellitus, Type 2/drug therapy*;
Myocardial Infarction/complications*;
Stroke/epidemiology*
- From:
Chinese Medical Journal
2023;136(1):82-87
- CountryChina
- Language:English
-
Abstract:
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.
