Traditional Chinese medicine, Danlou tablets alleviate adverse left ventricular remodeling after myocardial infarction: results of a double-blind, randomized, placebo-controlled, pilot study

Shuai Mao, Lei Wang, Wenwei Ouyang, Yuanshen Zhou, Jianyong Qi, Liheng Guo, Minzhou Zhang, Aleksander Hinek, Shuai Mao, Lei Wang, Wenwei Ouyang, Yuanshen Zhou, Jianyong Qi, Liheng Guo, Minzhou Zhang, Aleksander Hinek

Abstract

Background: Danlou tablets, a patented Chinese Medicine, have been long approved for the treatment of ischemic heart disease in China. While numerous empirical observations suggested Danlou tablets could decrease frequency and duration of angina pectoris attacks, evidence supporting its efficacy on cardiac remodeling remains inadequate. Therefore, this pilot trial was designed to determine whether Danlou tablets would reduce adverse left ventricular (LV) remodeling in patients with myocardial infarction (MI).

Methods and results: Eligible patients with acute MI were enrolled and randomly assigned to Danlou tablets or placebo groups, superimposed on standard treatment for MI. Then, in addition to assessment of the clinical outcome, the changes in LV volumes were evaluated by a serial echocardiography. In total, 83 patients (Danlou tablets 42 and placebo 41) completed 90 days of treatment and had complete baseline and outcome data. Standard echocardiographic evaluations revealed significant differences in the change of LV end-diastolic volume index (LVEDVi) between group of patients treated with Danlou tablets and the placebo group (-4.49 ± 7.29 vs. -0.34 ± 9.01 mL/m2, P < 0.001). The reduction in LVEDVi was independent of beta-blocker, ACE inhibitors/ARBs use. Furthermore, treatment with Danlou tablets significantly reduced LV end-systolic volume index (-4.09 ± 5.85 vs. -0.54 ± 5.72 mL/m2, P < 0.001) and improved the LV ejection fraction (4.83 ± 9.23 vs. 0.23 ± 8.15 %, P < 0.001), as compared to placebo. Meaningfully, the incidence of the major adverse cardiovascular events was also lower in patients receiving Danlou tablets (P < 0.05).

Conclusion: Superimposed on the standard pharmacologic treatment, Danlou tablets significantly reversed post-MI adverse LV remodeling, thereby contributed to the overall positive clinical outcome.

Trial registration: clinicaltrials.gov identifier NCT02675322 (February 1, 2016).

Keywords: Danlou tablets; Left ventricular end-diastolic volume index; Myocardial infarction; Ventricular remodeling.

Figures

Fig. 1
Fig. 1
Trial profile. The number of patients who were enrolled in the study and included in the analyses. MI, myocardial infarction; FAS, full analysis set
Fig. 2
Fig. 2
Change in LVEDVi, LVESVi and LVEF from baseline to 90 days. Echocardiographic changes from baseline to 6 months in LVEDVi, LVESVi and LVEF (ΔLVEDVi, ΔLVESVi, ΔLVEF). Middle hash of the box indicates the median; 25 to 75 th percentiles are represented by end caps of the box; the whiskers indicate the 10 and 90 th percentiles. LVEDVi, left ventricular end-diastolic volume index; LVESVi, left ventricular end-systolic volume index; LVEF, left ventricular ejection fraction

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