J Korean Soc Hypertens.  2011 Sep;17(3):103-113. 10.5646/jksh.2011.17.3.103.

The Phase 4 Randomized, Public, Parallel, Comparative, Clinical Trial to Compare Efficacy and Safety of S-(-)-Amlodipine Nicotinate with Ramipril in Hypertensive Patients

• Kim MS
• Jeong MH
• Lee MG
• Sim DS
• Park KH
• Yoon NS
• Yoon HJ
• Kim KH
• Hong YJ
• Kim JH
• Ahn YK
• Cho JG
• Park JC
• Kang JC

• KMID: 1750389
• DOI: http://doi.org/10.5646/jksh.2011.17.3.103

Abstract

BACKGROUND
The aim of this study was to compare the antihypertensive effect of S-(-)-amlodipine nicotinate with ramipril in patients with essential hypertension.
METHODS
Total 138 patients (54.5 +/- 10.5 years, 69 males) were enrolled in this study between 2008 and 2010. Amlodipine 2.5 mg or ramipril 2.5 mg was treated once in a day for 8 weeks. Epidemiologic analysis was performed in intend-to-treat (ITT) group. Efficacy analysis was performed in the differences of diastolic blood pressure in study groups. Abnormal reactions were divided with severities and drug-relationship.
RESULTS
The change of diastolic blood pressures were more prominent with -12.7 +/- 7.02 mm Hg in amlodipine group, and -9.6 +/- 7.38 mm Hg in ramipril group (p = 0.023). The change of systolic blood pressures was higher in amlodipine group with -18.1 +/- 7.91 mm Hg, and -14.3 +/- 11.96 mm Hg in ramipril group (p = 0.047). Blood pressure normalization rates were 81.3% (48 of 59 patients) in amlodipine group, and 61.4% (35 of 57 patients) in ramipril group (p = 0.017). Abnormal reaction occurred in 5.8% (4 of 68 patients) of amlodipine group and 14.2% (10 of 70 patients) of ramipril group (p = 0.102). The most frequent abnormal reaction was respiratory symptom.
CONCLUSIONS
S-Amlodipine-Nicotinate was more effective than ramipril in hypertensive patients without significant abnormal reaction.

Keyword

Hypertension; Calcium channel blocker; Angiotensin converting enzyme inhibitor

MeSH Terms

Amlodipine
Blood Pressure
Humans
Hypertension
Niacin
Ramipril
Amlodipine
Niacin
Ramipril

Figure

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  Fig. 1. Schedule from Screening to week 8.

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  Fig. 2. Efficacy evaluation with diastolic blood pressure decrement comparing Week 0 with Week 8 in per-protocol and intent-to-treat group.

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  Fig. 3. Efficacy evaluation with systolic blood pressure decrement comparing Week 0 with Week 8 in per-protocol and intent-to-treat group.

Reference

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