1. Levamlodipine Besylate New CCB half dose, save efficiency and safety
Dayi Hu, MD, FACC, FHRS, FESC
Medical school of Tongji University, Shanghai People’s Hospital of Peking University,Beijing

2. Amlodipine
A typical modern long acting Ca2+ channel blocker with significant antihypertensive effect.

3. The antihypertensive effect in different age groups

4. Significant antihypertensive effect

5. Outstanding antihypertensive effect
Amlodipine vs. Lasartan
n=93
n=97
P<0.001

6. Significant antihypertensive effect
Amlodipine vs. ACEI , ARB (The Aged Hypertension)
Amlodipine vs. ACEI, P=0.008
Amlodipine vs. ARB, P=NS

7. Valsartan / Amlodipine
VALUE Study:
Valsartan / Amlodipine
The major heart terminals
Incidence of heart disease
Death of heart diseases
All myocardial infarction
All congestive heart failure
All cerebral apoplexy
Death caused by all the reasons
New onset diabetes
0.5 1 2
Julius S et al. Lancet. June 2004;363.

8. Decrease of the risk of occurrence of cerebral apoplexy(%)
Amlodipine is remarkably superior in reducing the rate of cerebral apoplexy compared to other antihypertensive drugs
Franz H. Messerli et al. Hypertension. 2006;48:
VS.Placebo
VS.ACEI
VS.ARB
VS. Diuretic /β-Blocker
ALLHAT(n=24309)/ASCOT
(n=19257)
P=0.002
P=0.032
P=0.004
14%
16%
18%
Decrease of the risk of occurrence of cerebral apoplexy(%)
IDNT(n=1146)/VALUE(n=15245)
目前采用络活喜的临床研究似乎都显示络活喜在减少心脑事件尚处于优势地位，美国著名高血压专家Messerli在Hypertension杂志2006年9月发表最新文章，把所有采用氨氯地平的临床研究进行荟萃分析，结果显示：降低 脑卒中方面，络活喜显著优于包括ARB等在内的其他降压药物！并具有明显的统计学差异！
P=0.038
ALLHAT(n=18102)/CAMELOT(n=1336)
40%
PREVENT(n=825)/CAMELOT(n=1318)/IDNT(n=1136)

9. Amlodipine can effectively control early morning BP increase
Its consistent 24 hour antihypertension effect
It’s superior than other CCB in decreasing the rate of early morning BP increase.
The speed of early morning BP increase before and after treatment
Before treatment
After treatment
* P<0.05
SBP
DBP
mmHg/H *
不同的药物对于清晨血压的控制是不一样的！分子长效的CCB络活喜在这方面具有很大的优势！
这是一项关于不同CCB对于清晨血压速率影响的研究：
同其他长效CCB相比，如硝苯地平控释片，非洛地平缓释片，研究表明，只有络活喜®同时显著降低清晨收缩压、舒张压上升速度。
清晨血压升高是发生心脑血管事件的重要危险因素，清晨也是心脑血管事件高发时段。络活喜®通过控制清晨血压，可以更有效减少心脑血管事件发生。
络活喜之所以能有效的控制清晨血压，主要因为本身的分子长效，半衰期长达35－50小时！ *
Nifedipine
60mg QD
N=20
Amlodipine
10mg QD
N=20
Felodipine
10mg QD
N=15
Nifedipine
60mg QD
N=20
Amlodipine
10mg QD N=20
Felodipine
10mg QD
N=15
C. Macchiarulo et al. Cur Ther Res Clin Exp. 2001;62:

10. Levamlodipine (Shi Hui Da)
—— The New Generation Products of Amlodipine
Amlodipine is a racemic compound composed of levorotary and dextrorotary forms.
The Ca2+ antagonist activity of levorotary form is approxim-ately 1,000 times of the one of dextrorotary form and twice of the one of racemic compound..
Levamlodipine: half dose --the same effect of racemic amlodipine. Less side effects.

11. Levamlodipine besylate (Shi Hui Da)
Amlodipine besylate (Norvasc)
V.S.
Similar effectiveness in antihypertension?
Safer?
Equal organ protection effect?

12. One of the Clinical Studies: Levamlodipine vs Amlodipine
Chinese Journal of Medicine, 2002,37(5);46-47

13. Multi-center clinical study
The People’s Hospital of Beijing University (Hu Dayi, PI)
Capital Medical University Affiliated Beijing Tongren Hospital
Capital Medical University Affiliated Beijing Youyi Hospital
Capital Medical University Affiliated Beijing Xuanwu Hospital
Sino-Japan Friendship Hospital
Armed Police Contingent Hospital of Beijing
The No. 3 Hospital of Beijing University
Beijing Hospital
Capital Medical University Affiliated Beijing Fuxing Hospital
Beijing Willow Hospital

14. The trough / peak value of levamlodipine besylate (Shi Hui Da)

15. The changes of BP before treatment, after treatment and during drug holidays
CBP, n=80
Before Treatment
Eight weeks treatment
Drug holiday 1 for 24h
Drug holiday 2 for 48h
SBP
Levamlodipine
141.312.9
131.5 10.1*
135.3 11.5#
136.4 11.2#
Amlodipine
141.2 12.7
133.9 11.0*
136.9 11.5#
138.0 11.3#
DBP
91.5 7.2
84.6 7.9*
85.8 7.6#
87.4 8.2#
89.6 6.3
85.5 6.9*
86.8 6.9#
87.8 7.4#
*p<0.05: The value of SBP and DBP at the end of 8 weeks’ treatment
compared with those of no drug administered.
#p>0.05: The value of SBP and DBP after not administered for 24h or
48h compared with those at the end of 8 weeks’ treatment.

16. The reduction of SBP and DBP after eight weeks treatment in the two groups

17. The SBP and DBP Changes during drug holiday 1 after eight weeks treatment

18. The SBP and DBP Changes during drug holiday 2 after eight weeks treatment

19. Adverse Events (eight weeks treatment )

20. Conclusion
Both 2.5mg Levamlodipine besylate and 5mg Amlodipine besylate reduce BP effectively.
The incidence of Levamlodipine adverse effects is low.

21. Conclusion
CCB is the most common antihypertensive drug used in Chinese hypertensives.
Levamlodipine besylate (Shi Hui Da) is both save and effective.
Half dosage, Same effect and safety.

22. Thanks！