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A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population

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Abstract

Objective

To evaluate the efficacy and safety of salvianolate in elderly patients with unstable angina pectoris (UAP).

Methods

A prospective double-blind randomized placebo-controlled multicenter trial in elderly patients with UAP from 13 third-grade class-A hospitals in China was performed. A total of 318 patients were randomly allocated in a 1:1 ratio to an experimental group (160 patients) and a control group (158 patients). The experimental group was treated with salvianolate for 14 days on the basis of conventional medicine, and the control group was given a placebo for 14 days with the same criteria. Follow-up was lasted 28 days in both groups. The primary endpoint was biweekly frequency of angina pectoris attacks. The secondary endpoints included biweekly dosage of nitroglycerin, the Seattle Angina Questionnaire, angina pectoris severity and duration, myocardial injury markers, high-sensitivity C-reactive protein (hs-CRP) and N-terminal pro-B-type natriuretic peptide (NT-proBNP), as well as major adverse cardiovascular events (MACEs). Safety was assessed according to adverse events and serious adverse events.

Results

Baseline characteristics were similar between treatment groups. Compared with those in the control group, the frequency of biweekly angina attacks (2.92 vs . 4.08, P=0.025), the biweekly dosage of nitroglycerin, as well as the severity and duration of angina attacks (P<0.01) were reduced by salvianolate. The Seattle Angina Questionnaire score was also significantly improved in the experimental group than in the control group (P<0.05). No significant differences were observed between the two groups with respect to the incidence of MACEs. Salvianolate was well tolerated.

Conclusions

Salvianolate appear to have efficacy and well tolerated for elderly patients with UAP. [ClinicalTrials.gov identifier: NCT03037047]

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Acknowledgments

We thank Fudan University professionals for completing the statistical analysis.

Author information

Authors and Affiliations

  1. Department of Geriatric Cardiology, the General Hospital of the People’s Liberation Army, Beijing, 100853, China

    Hua Cui, Xiao-ying Li & Jin Zheng

  2. Department of Geriatric Clinic, Inner Mongolia People’s Hospital, Hohhot, 010017, China

    Xue-wen Gao

  3. Department of Cardiology, the Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, China

    Xiang Lu

  4. Second Department of Cadre’s Ward, the First Affiliated Hospital of Harbin Medical University, Harbin, 150001, China

    Xiu-ping Wu

  5. Department of Cadre Health Care, Tianjin First Central Hospital, Tianjin, 300192, China

    Xiao-fei Wang

  6. Department of Cardiovascular Medicine, Chongqing General Hospital, Chongqing, 400013, China

    Xiang-qing Zheng

  7. Department of Geriatrics, Shenyang Red Cross Hospital, Shenyang, 110063, China

    Kui Huang

  8. Department of Geriatric Cardiology, Guangzhou First People’s Hospital, Guangzhou, 510180, China

    Feng Liu

  9. Department of Cardiology, Beijing Geriatric Hospital, Beijing, 100095, China

    Zhi Luo

  10. the Second Department of Cardiology, the Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, Harbin, 150009, China

    Hui-shu Yuan

  11. Department of Cardiology, Guizhou Province Hospital of Traditional Chinese Medicine, Guiyang, 550001, China

    Gang Sun

  12. Department of Cadre’s Ward, the First Bethune Hospital of Jilin University, Changchun, 130021, China

    Jian Kong

  13. Department of Cadre Health Care, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, 325000, China

    Xiao-hong Du

  14. Medical Department, Shanghai Green Valley Pharmaceutical Co., Ltd., Shanghai, 201203, China

    Hong-ying Liu

  15. China Health Promotion Foundation, Beijing, 100161, China

    Wen-ju Zhang

Authors
  1. Hua Cui
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  2. Xiao-ying Li
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  3. Xue-wen Gao
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  4. Xiang Lu
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  5. Xiu-ping Wu
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  6. Xiao-fei Wang
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  7. Xiang-qing Zheng
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  8. Kui Huang
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  9. Feng Liu
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  10. Zhi Luo
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  11. Hui-shu Yuan
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  12. Gang Sun
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  13. Jian Kong
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  14. Xiao-hong Du
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  15. Jin Zheng
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  16. Hong-ying Liu
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  17. Wen-ju Zhang
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Contributions

Li XY is the guarantor of this article and contributed to the conception of scope and protocol; provided supervision, coordination and guidance for collaborating, peripheral centers; conceived and implemented the analysis plan, and drafted the initial and final manuscript. Cui H, Gao XW, Lu X, Wu XP, Wang XF, Zheng XQ, Huang K, Liu F, Luo Z, Yuan HS, Sun G, Kong J, Du XH, Liu HY, Zheng J and Zhang WJ were responsible for data acquisition and took responsibility for the integrity of the data and the accuracy of the analysis. All authors have agreed and approved the final manuscript.

Corresponding author

Correspondence to Xiao-ying Li.

Additional information

Conflicts of Interest

Shanghai Green Valley Pharmaceutical Co. Ltd. (Shanghai, China) provided the salvianolate and placebo. The Shanghai Green Valley Pharmaceutical Co. Ltd. had no participation or influence on the study design, data collection, statistical analysis, and interpretation of results.

Supported by Science and Technology Commission of Shanghai Municipality (15DZ1900300)

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Cui, H., Li, Xy., Gao, Xw. et al. A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population. Chin. J. Integr. Med. 25, 728–735 (2019). https://doi.org/10.1007/s11655-019-2710-x

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  • DOI: https://doi.org/10.1007/s11655-019-2710-x

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