Author + information
- Henry Sun,
- Zhixin Guo,
- Lingyan Li,
- Naifeng Wu,
- Kaijing Yan and
- Xijun Yan
T89, a 3-herb composition drug that improves microcirculation in and increase energy supply to the heart, and reduces blood viscosity in patients with chronic stable angina (A) has been shown to improve clinical outcomes in comparison to current anti-anginal drug (CAAD) such as β-blockers, Ca++ channel blockers or nitrates that only targets on coronary artery.
The objective of this FDA regulated 9-country, 127-center, double blinded, randomized and placebo controlled phase III clinical trial was to further confirm T89 add-on therapy is superior to CAAD alone previously observed from phase II trials. Eligible patients (60±9.1 years of age) at baseline had ≥ 3 bi-weekly A, abnormal EKGs, ran 3-7min on 2 Exercise Treadmill Tests (ETT) were randomized in a 1:1:1 fashion to placebo, low and high dose T89 groups. Three ETTs were performed on weeks 2, 4 and 6 during the 6 weeks treatment period. The clinical endpoints was the change in Total Exercise Duration (TED). Major adverse cardiovascular events, Quality of life, Bi-weekly frequency of A, on-demand use of nitrates were recorded.
The trial includes 1,004 patients with a low 4.5% drop off rate, the slop of the mean TED improvement over time were 20, 12 and 4 sec./wk in high, low and placebo dose groups. The absolute TED increase on week 6 was 82±69, 72±54 and 54±61 sec. for high, low and placebo groups (p=0.022 and 0.036 T89 vs. placebo, respectively). There were 85% and 92% reduction of bi-weekly A and Nitrate dose. Time to ST Depression, Time to Chest Pain, and Quality of life were all statistical significantly improved with a dose response trend. Adverse effects were all miner with similar low rates, no QTc prolongation, heart rate reduction or bleeding observations on any treatment days for all three arms.
T89 demonstrated excellent therapeutic benefit for A patients. Drugs synergistically work on microcirculation, energy metabolism and blood viscosity offers an new treatment option for patients with A.
Moderated Poster Contributions
Acute and Stable Ischemic Heart Disease Moderated Poster Theater, Poster Hall, Hall A/B
Monday, March 12, 2018, 1:30 p.m.-1:40 p.m.
Session Title: The Carousel of Progress in ASIHD
Abstract Category: 02. Acute and Stable Ischemic Heart Disease: Clinical
Presentation Number: 1325M-11
- 2018 American College of Cardiology Foundation