EVALUATION ON CLINICAL APPLICATION OF LOW-DOSE TRADITIONAL QUADRUPLE ANTIHYPERTENSIVE COMPOUND PREPARATION IN CHINA

Objective: To evaluate whether a relatively old multi-drug SPC prescription can be adapted to current treatments of hypertension. Design and method: 1. In a retrospective, real-world study, 22148 patients with hypertension who visited 4 hospitals in China from 2011 to May 2016 were selected as the subjects. A comparison was conducted between treatment with compound reserpine and triamterene tablets (Reserpine/Triamterene CAS) and with four other single-pill combinations (SPCs) (losartan/hydrochlorothiazide, valsartan/hydrochlorothiazide, irbesartan/hydrochlorothiazide, and amlodipine/valsartan) for 20 days. The compliance rate was analyzed after patients’ propensity score matching analysis. 2. A meta-analysis of 7 randomized controlled trials on the safety and efficacy of compound reserpine and triamterene tablets published from 2000 to 2020 was conducted. Results: 1. Treatment with 1 compound reserpine and triamterene tablet daily (R/L) resulted in a blood pressure compliance rate (BP < 140/90 mmHg) of 63 to 68%. Compared with valsartan/amlodipine, R/L achieved a compliance rate of 63% vs 50%; with valsartan/hydrochlorothiazide, of 64% vs 59%; with losartan/hydrochlorothiazide, of 67% vs 57%, and with irbesartan/hydrochlorothiazide, of 68% vs 59%. All P values were < 0.05 (Figure 1). 2. Seven studies were included in the meta-analysis. In five studies, the overall response rate of hypotensive treatment with compound reserpine and triamterene tablets was higher in efficacy study compared with other hypotensive drugs (OR = 2.23, 95% CI: 1.32 ∼ 3.75) (Figure 2), and there was no significant difference in the incidence of adverse reaction with compound reserpine and triamterene tablets in the 6 trials included in the safety study (OR = 0.91, 95% CI: 0.68 ∼ 1.22) (Figure 3). Conclusions: China is faced with high prevalence of hypertension, low control rate, and scarce medical resources and economic resources in primary medical care, but ultra-low-dose SPC (R/L) can improve the antihypertensive effect and reduce the incidence of adverse reactions (Figure 4) through the synergistic effect among different components of the drug and has good patients’ compliance and low price. We confirmed that through systematic review and meta-analysis, ultra-low-dose SPC (R/L) is suitable for the treatment of hypertension, especially those with refractory hypertension.