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
BackgroundA previous phase IV trial revealed sex as a potential effect modifier of MUSKARDIA efficacy in stable coronary artery disease (CAD).ObjectiveTo assess the clinical effect of MUSKARDIA as a supplemental treatment to optimal medical therapy (OMT) in stable CAD cases.MethodsThis study was a s...
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| Format: | Article |
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Frontiers Media S.A.
2022-10-01
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| Series: | Frontiers in Cardiovascular Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fcvm.2022.1002400/full |
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| author | Haiming Shi Jingmin Zhou Changsheng Ma Fusui Ji Yang Wu Yulan Zhao Jun Qian Xiaolong Wang |
| author_facet | Haiming Shi Jingmin Zhou Changsheng Ma Fusui Ji Yang Wu Yulan Zhao Jun Qian Xiaolong Wang |
| author_sort | Haiming Shi |
| collection | DOAJ |
| description | BackgroundA previous phase IV trial revealed sex as a potential effect modifier of MUSKARDIA efficacy in stable coronary artery disease (CAD).ObjectiveTo assess the clinical effect of MUSKARDIA as a supplemental treatment to optimal medical therapy (OMT) in stable CAD cases.MethodsThis 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.ResultsThe 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%).ConclusionAs 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]. |
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| institution | Directory Open Access Journal |
| issn | 2297-055X |
| language | English |
| last_indexed | 2024-04-13T14:48:12Z |
| publishDate | 2022-10-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Cardiovascular Medicine |
| spelling | doaj.art-9fc45e59f931449b9bec308002c0e3d12022-12-22T02:42:41ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2022-10-01910.3389/fcvm.2022.10024001002400Shexiang Baoxin Pill (MUSKARDIA) reduces major adverse cardiovascular events in women with stable coronary artery disease: A subgroup analysis of a phase IV randomized clinical trialHaiming Shi0Jingmin Zhou1Changsheng Ma2Fusui Ji3Yang Wu4Yulan Zhao5Jun Qian6Xiaolong Wang7Department of Cardiology, Huashan Hospital, Fudan University, Shanghai, ChinaDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, ChinaDepartment of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, ChinaDepartment of Cardiology, Beijing Hospital of the Ministry of Health, Beijing, ChinaDepartment of Cardiology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, ChinaDepartment of Cardiology, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, ChinaDepartment of Cardiology, The Center Hospital of Ma’anshan, Ma’anshan, ChinaDepartment of Cardiovascular, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaBackgroundA previous phase IV trial revealed sex as a potential effect modifier of MUSKARDIA efficacy in stable coronary artery disease (CAD).ObjectiveTo assess the clinical effect of MUSKARDIA as a supplemental treatment to optimal medical therapy (OMT) in stable CAD cases.MethodsThis 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.ResultsThe 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%).ConclusionAs 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].https://www.frontiersin.org/articles/10.3389/fcvm.2022.1002400/fullMUSKARDIAwomenstable coronary artery diseaseanginamajor adverse cardiovascular event |
| spellingShingle | Haiming Shi Jingmin Zhou Changsheng Ma Fusui Ji Yang Wu Yulan Zhao Jun Qian Xiaolong Wang 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 Frontiers in Cardiovascular Medicine MUSKARDIA women stable coronary artery disease angina major adverse cardiovascular event |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | MUSKARDIA women stable coronary artery disease angina major adverse cardiovascular event |
| url | https://www.frontiersin.org/articles/10.3389/fcvm.2022.1002400/full |
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