Efficacy and safety of low dose sublingual nifedipine dripping pills (5 mg) in the acute treatment of moderate and severe hypertension: a randomized, double-blind, positive-drug parallel-controlled, multi-center clinical study

Jihai Liu; Yaling Han; Shuyang Zhang; Yan Wei; Zhanquan LI; Yukai Wang; Yao Qing; Ying Huang; Xiaoping Chen; Ximing Chen; Hong Wang; Yingjie LI; Yunqiu MO; Danming WU; Keshan Liang

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Efficacy and safety of low dose sublingual nifedipine dripping pills (5 mg) in the acute treatment of moderate and severe hypertension: a randomized, double-blind, positive-drug parallel-controlled, multi-center clinical study

VernacularTitle: 小剂量硝苯地平滴丸舌下含服治疗中、重度高血压的随机、双盲、阳性药物平行对照、多中心研究
Author: Jihai LIU ¹ ; Yaling HAN ² ; Shuyang ZHANG ³ ; Yan WEI ⁴ ; Zhanquan LI ⁵ ; Yukai WANG ⁶ ; Yao QING ⁷ ; Ying HUANG ⁸ ; Xiaoping CHEN ⁹ ; Ximing CHEN ¹⁰ ; Hong WANG ¹¹ ; Yingjie LI ¹² ; Yunqiu MO ¹³ ; Danming WU ¹⁴ ; Keshan LIANG ¹⁵
Author Information

1. Department of Emergency, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China
2. Department of Cardiology, General Hospital of Northern War Zone, Shenyang 110016, China
3. Department of Cardiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China
4. Department of Neurology, Harrison International Peace Hospital, Hengshui053000, China
5. Department of Cardiology, Liaoning People′s Hospital, Shenyang 110015, China
6. Department of Neurology, Foshan First People′s Hospital, Foshan 528000, China
7. Department of Integrated TCM & Western Medicine, Nanning First People′s Hospital, Nanning 530022, China
8. Department of Cardiology, Shanghai Pudong New Area People′s Hospital, Shanghai 201200, China
9. Department of Cardiology, Sichuan University West China Hospital, Chengdu 610000, China
10. Department of Cardiology, Third Affiliated Hospital of Guangzhou Medical University, Guangzhou 510150, China
11. Department of Cardiology, Liuzhou Workers Hospital, Liuzhou 545005, China
12. Department of Neurology, No. 251 Hospital of People′s Libration Army, Zhangjiakou 075000, China
13. Department of Traditional Chinese Medicine Cardiology, Ruikang Hospital Affiliated to Guangxi University, Nanning 530000, China
14. Department of Vascular Surgery, Liaoning People′s Hospital, Shenyang 110015, China
15. Department of Cardiology, Pingyi Branch of Qilu Hospital, Pingyi 273300, China
Publication Type:Clinical Trail
Keywords: Hypertension; Nifedipine; Treatment outcome
From: Chinese Journal of Cardiology 2019;47(5):374-380
CountryChina
Language:Chinese
Abstract: Objective:To evaluate the efficacy and safety of low dose sublingual nifedipine dripping pills (5 mg) in treating moderate and severe hypertension in comparison with normal dose (10 mg) of sublingual nifedipine dripping pills.
Methods:This study was designed as a randomized, double-blind, positive drug parallel controlled, multi-center, non-inferiority clinical trial. Patients with moderate and severe hypertension were enrolled by 14 clinical trial centers, randomly divided into the trial group (sublingual 5 mg nifedipine dripping pills) and the control group (sublingual 10 mg nifedipine dripping pills). The changes in blood pressure were monitored continuously within 2 hours after the initial administration, repeated the dose in 20 minutes interval after the initial administration for up to additional 3 doses (maximum 4 doses) if the antihypertensive efficacy was not satisfactory. The efficacy of antihypertensive therapy between the two groups was evaluated by repeated administration rates and blood pressure changes at 60 minutes post the initial administration, and the safety of treatment was evaluated by recording adverse event rate of the two groups.
Results:The anti-hypertensive effective rates at 60 minutes after sublingual administration were 83.5% (202/242) and 86.7% (208/240) respectively between the trial group and control group (χ²=1.307, P=0.253) . On the aspect of antihypertensive effectiveness at 60 minutes after single dose of sublingual administration, the anti-hypertension effective rates of the trial group and the control group were 85.6% (154/180) and 87.2% (164/188) respectively (χ²=0.221, P=0.639). Prevalence of the repeated administration was also similar between the two groups (25.6%(62/242) in the trial group and 21.7% (52/240) in the control group, χ²=1.043, P=0.307). On the safety aspect, there was no adverse events/reactions in the trial group, but there were 15 cases of adverse events/reactions occurred in control group (6.25%, χ²=15.611, P<0.001).
Conclusions:In the treatment of moderate to severe hypertension, the antihypertensive efficacy of low dose nifedipine dripping pills is similar to that of conventional dosage, and the safety profile of low dose nifedipine dripping pills is better than that of the conventional dose.