PMID- 36386372
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20221118
IS  - 2297-055X (Print)
IS  - 2297-055X (Electronic)
IS  - 2297-055X (Linking)
VI  - 9
DP  - 2022
TI  - Shexiang Baoxin Pill (MUSKARDIA) reduces major adverse cardiovascular events in 
      women with stable coronary artery disease: A subgroup analysis of a phase IV 
      randomized clinical trial.
PG  - 1002400
LID - 10.3389/fcvm.2022.1002400 [doi]
LID - 1002400
AB  - BACKGROUND: A previous phase IV trial revealed sex as a potential effect modifier 
      of MUSKARDIA efficacy in stable coronary artery disease (CAD). OBJECTIVE: To 
      assess the clinical effect of MUSKARDIA as a supplemental treatment to optimal 
      medical therapy (OMT) in stable CAD cases. METHODS: This study was a subgroup 
      analysis of a multicenter, randomized, double-blinded, placebo-controlled phase 
      IV clinical study. Eligible individuals underwent randomization to the oral 
      MUSKARDIA and placebo groups and were treated for 24 months. All participants 
      received OMT according to existing guidelines. The primary composite outcome was 
      the major adverse cardiovascular event (MACE), included cardiovascular death, 
      non-fatal myocardial infarction (MI), or non-fatal stroke. The secondary 
      composite outcome encompassed all-cause mortality, non-fatal MI, non-fatal 
      stroke, hospitalization for unstable angina and/or heart failure, and undergoing 
      coronary procedure/surgery during treatment. Safety signals, especially 
      cardiovascular adverse events (AEs), were analyzed. RESULTS: The female subgroup 
      included 776 participants (384 and 392 in the MUSKARDIA and placebo groups, 
      respectively). The occurrence of the primary composite outcome was lower in the 
      MUSKARDIA group compared with placebo-treated individuals (HR = 0.27, 95%CI: 
      0.09-0.83; P = 0.02), but the secondary composite outcome showed no significant 
      difference (HR = 0.77, 95%CI: 0.47-1.25; P = 0.29). The MUSKARDIA group had 
      reduced incidence of cardiovascular AEs compared with placebo-treated cases (2.9% 
      vs. 5.6%). CONCLUSION: As a supplemental treatment to OMT, 24-month 
      administration of MUSKARDIA is effective and safe in female stable CAD cases. 
      CLINICAL TRIAL REGISTRATION: [https://clinicaltrials.gov/], identifier 
      [NCT01897805].
CI  - Copyright (c) 2022 Shi, Zhou, Ma, Ji, Wu, Zhao, Qian and Wang.
FAU - Shi, Haiming
AU  - Shi H
AD  - Department of Cardiology, Huashan Hospital, Fudan University, Shanghai, China.
FAU - Zhou, Jingmin
AU  - Zhou J
AD  - Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.
FAU - Ma, Changsheng
AU  - Ma C
AD  - Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, 
      Beijing, China.
FAU - Ji, Fusui
AU  - Ji F
AD  - Department of Cardiology, Beijing Hospital of the Ministry of Health, Beijing, 
      China.
FAU - Wu, Yang
AU  - Wu Y
AD  - Department of Cardiology, Dongfang Hospital Affiliated to Beijing University of 
      Chinese Medicine, Beijing, China.
FAU - Zhao, Yulan
AU  - Zhao Y
AD  - Department of Cardiology, The Second Affiliated Hospital of Zhengzhou University, 
      Zhengzhou, China.
FAU - Qian, Jun
AU  - Qian J
AD  - Department of Cardiology, The Center Hospital of Ma'anshan, Ma'anshan, China.
FAU - Wang, Xiaolong
AU  - Wang X
AD  - Department of Cardiovascular, Shuguang Hospital, Shanghai University of 
      Traditional Chinese Medicine, Shanghai, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT01897805
PT  - Journal Article
DEP - 20221021
PL  - Switzerland
TA  - Front Cardiovasc Med
JT  - Frontiers in cardiovascular medicine
JID - 101653388
PMC - PMC9651060
OTO - NOTNLM
OT  - MUSKARDIA
OT  - angina
OT  - major adverse cardiovascular event
OT  - stable coronary artery disease
OT  - women
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/11/18 06:00
MHDA- 2022/11/18 06:01
PMCR- 2022/01/01
CRDT- 2022/11/17 11:42
PHST- 2022/07/25 00:00 [received]
PHST- 2022/09/30 00:00 [accepted]
PHST- 2022/11/17 11:42 [entrez]
PHST- 2022/11/18 06:00 [pubmed]
PHST- 2022/11/18 06:01 [medline]
PHST- 2022/01/01 00:00 [pmc-release]
AID - 10.3389/fcvm.2022.1002400 [doi]
PST - epublish
SO  - Front Cardiovasc Med. 2022 Oct 21;9:1002400. doi: 10.3389/fcvm.2022.1002400. 
      eCollection 2022.