Korean Circ J.  2010 Dec;40(12):632-638. 10.4070/kcj.2010.40.12.632.

Effect of Lacidipine on Blood Pressure and Endothelial Function in Mild-to-Moderate Essential Hypertension Patients With Diabetes in Korea

• Kim DH
• Oh IY
• Lee HY
• Kim YJ
• Kim HS
• Kim CH
• Oh BH
• Kim KS
• Kim DI
• Kim YD
• Ryu KH
• Park SH
• Baek SH
• Shin DG
• Shim WJ
• Ahn TH
• Oh SK
• Lee SH
• Lee SY
• Jeong MH
• Chung WS
• Jeong JY
• Choi SY
• Choi SW
• Hyon MS

• KMID: 2225161
• DOI: http://doi.org/10.4070/kcj.2010.40.12.632

Abstract

BACKGROUND AND OBJECTIVES
The aim of this study was to evaluate the efficacy of lacidipine in reducing blood pressure (BP) and to determine its effect on endothelial function in mild-to-moderate hypertensive patients with type 2 diabetes mellitus (DM).
SUBJECTS AND METHODS
This was a prospective, multicenter, open-label, single-arm study, enrolling 290 patients with mild-to-moderate hypertension and type 2 DM. Patients were initially treated with 2 mg lacidipine orally once daily for 4 weeks, which was then increased as necessary every 4 weeks to a maximal dose of 6 mg daily. The primary endpoint was the mean change in systolic blood pressure (SBP) from baseline after 12 weeks of treatment. Secondary endpoints included mean changes in diastolic blood pressure (DBP), flow-mediated vasodilatation (FMD), and serum concentrations of biochemical markers such as high-sensitivity C-reactive protein (hs-CRP), monocyte chemo-attractant protein-1 (MCP-1), matrix metalloproteinase-9 (MMP-9), and plasminogen activator inhibitor-1 (PAI-1).
RESULTS
Lacidipine treatment significantly reduced SBP by -13.4+/-13.0 mmHg (p<0.001) and DBP by -6.2+/-9.3 mmHg (p<0.001). Lacidipine treatment did not improve endothelial-dependent vasodilatation, despite significantly improved nitroglycerin-induced, endothelial-independent vasodilatation. MCP-1 levels significantly decreased from 283.66+/-110.08 pg/mL to 257.83+/-100.23 pg/mL (p<0.001); whereas there were no significant changes in the levels of hs-CRP, MMP-9, or PAI-1.
CONCLUSION
Twelve weeks of treatment with lacidipine was effective and well tolerated in mild-to-moderate hypertensive patients with type 2 DM. In spite of inducing a significant reduction in MCP-1 levels, lacidipine did not improve endothelial function.

Keyword

Lacidipine; Diabetes mellitus; Hypertension; Endothelium

MeSH Terms

Biomarkers
Blood Pressure
C-Reactive Protein
Diabetes Mellitus
Diabetes Mellitus, Type 2
Dihydropyridines
Endothelium
Humans
Hypertension
Korea
Matrix Metalloproteinase 9
Monocytes
Plasminogen Activators
Prospective Studies
Vasodilation
C-Reactive Protein
Dihydropyridines
Matrix Metalloproteinase 9
Plasminogen Activators

Figure

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  Fig. 1 Flow diagram of study patients. ITT: intention to treat, FMD: flow-mediated dilatation, PP: per-protocol.

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  Fig. 2 Effect of lacidipine in mean sitting cuff- systolic blood pressure (SiSBP) in patients with mild-to-moderate hypertension after 4, 8, and 12 weeks of treatment. The mean change from baseline was significant in intention-to-treat (A) and per-protocol (B) groups (*p<0.001). LOCF: last observation carried forward.

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