​The standard Chinese medicine qiliqiangxin reduces hospitalization for heart failure and cardiovascular death in patients with heart failure and a reduced ejection fraction (HFrEF), in response to late breaking research presented in a Hot Line session today at ESC Congress 2023.

Qiliqiangxin is a conventional Chinese medicine extract obtained from 11 sorts of herbs (Table 1). In a pilot study, qiliqiangxin reduced N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and improved heart failure symptoms in patients with HFrEF when added to established heart failure treatment. Preclinical studies have also indicated that qiliqiangxin has useful effects on attenuating myocardial fibrosis and cardiac remodeling.

The QUEST trial evaluated the clinical efficacy and safety of qiliqiangxin on major heart failure outcomes in HFrEF patients. The trial was conducted at 133 hospitals in mainland China and Hong Kong SAR of China.

The trial enrolled adult HFrEF patients with a left ventricular ejection fraction of 40% or below and NT-proBNP of 450 pg/ml or higher who had been on a stable standardized baseline treatment regimen for at the very least two weeks prior to enrolment. Patients were randomized in a 1:1 fashion to receive qiliqiangxin (4 capsules, thrice day by day) or placebo on top of normal medications for chronic heart failure. The first endpoint was a composite of rehospitalization for worsening heart failure or cardiovascular death.

A complete of three,110 patients were included within the evaluation, with 1,555 randomized to qiliqiangxin and 1,555 randomized to placebo. The typical age was 62 years and 72.1% were men. At baseline, the mean left ventricular ejection fraction was 32%, and the median NT-proBNP was 1730.80 pg/ml.

During a median follow-up of 18.3 months, the first endpoint occurred in 389 patients (25.02%) within the qiliqiangxin group and in 467 patients (30.03%) within the placebo group (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.68 to 0.90; p<0.001). This effect was related to each lower risks of rehospitalization for worsening heart failure (HR, 0.76; 95% CI, 0.64 to 0.90; p=0.002) and cardiovascular death (HR, 0.83; 95% CI, 0.68 to 0.996; p=0.045) within the qiliqiangxin group. The effect of qiliqiangxin on the first final result was generally consistent across prespecified subgroups including within the subgroups defined in response to age and NT-proBNP level, and in patients with or without angiotensin receptor/neprilysin inhibitors (ARNIs).

By way of secondary endpoints, the decrease in serum NT-proBNP between baseline and three-month follow-up was greater within the qiliqiangxin group (-444.00 [interquartile range -1401.00 to 85.00]) than within the placebo group (-363.00 [interquartile range -1280.00 to 183.00]) (p=0.047), which was consist with the previous pilot study.

Evaluation of safety endpoints demonstrated no significant difference in all-cause mortality, which occurred in 221 patients (14.21%) within the qiliqiangxin group and 262 patients (16.85%) within the placebo group (HR, 0.84; 95% CI, 0.70 to 1.01; p=0.058). Qiliqiangxin capsules were well-tolerated, with no major differences between the 2 groups in opposed events including gastrointestinal symptoms, worsening renal function and increased liver enzymes.

To our knowledge, this was the primary randomized, double-blind controlled trial of a conventional Chinese medicine for the treatment of chronic heart failure. Our findings reveal meaningful clinical profit with qiliqiangxin in patients with HFrEF, which support the usage of qiliqiangxin as an adjunct therapy for treating heart failure.”

Xinli Li, Principal Investigator Professor, First Affiliated Hospital of Nanjing Medical University, Nanjing, China

Table 1: Ingredients of qiliqiangxin

Source:

European Society of Cardiology (ESC)