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Efficacy and safety of the treatment： combination of benazepril/ lercanidipine vs. benazepril alone in patients with mild-to-moderate hypertension

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Chinese Medical Journal 2013年第12期126卷 2286-2290页

作者： CHEN Ting CHEN Guang-hui YANG Ting-shu ZHONG Zhen-yu AN Wei-shuai ZHANG Xiao-xia LI Jia-dan Department of Cardiology Chinese People's Liberation Army General Hospital Beijing 100853 China

Background Combination therapy is an effective method to reduce the blood pressure （BP） for patients with *** study was performed to evaluate the efficacy and safety of benazepril/lercanidipine compared with benazepril alone in patients with mild-to-moderate *** One hundred and eighty-one patients with mild-to-moderate primary hypertension were assigned in this randomized,single-blind,parallel-group study and were randomly divided into group A （benazepril 10 mg/lercanidipine 10 mg） and group B （benazepril 10 mg） for 8 *** 4 weeks,the dosage of Benazepril was titrated up to 20 mg if the diastolic blood pressure （DBP） remained ≥90 *** control and side effects were evaluated at the end of 1,4 and 8 *** The baseline characteristics of the two groups were *** BP in both groups decreased from the baseline （P 〈0.05）.At the end of 4 and 8 weeks,Benazepril/lercanidipine produced greater BP reduction than Benazepril alone （P 〈0.05）.The comparison of the rate of BP control for the benazepril/lercanidipine and benazepril groups at the end of 1,4,and 8 weeks were 41.2% vs.37.6% （P 〉0.05）,67.1% vs.44.7% （P 〈0.05）,and 71.8% vs.45.9% （P 〈0.05）.There was no significant difference of side effects between the two *** The benazepril/lercanidipine combination is more effective in reducing BP than benazepril alone,while it does not increase the incidence of side effects.

关键词： hypertension combination therapy benazepril lercanidipine

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Determination of lercanidipine in human plasma by an improved UPLC–MS/MS method for a bioequivalence study

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Journal of Pharmaceutical Analysis 2016年第2期6卷 87-94页

作者： Darshan V.Chaudhary Daxesh P.Patel Priyanka A.Shah Jaivik V.Shah Mallika Sanyal Pranav S.Shrivastav Department of Chemistry School of Sciences Gujarat University Navrangpura Ahmedabad Gujarat 380009 India Laboratory of Metabolism Center for Cancer Research National Cancer Institute National Institutes of Health Building 37 Room 3106 Bethesda MD 20892 USA Department of Chemistry St. Xavier's College Navrangpura Ahmedabad Gujarat 380009 India

An improved and reliable ultra-performance liquid chromatography/tandem mass spectrometry （UPLC- MS/MS） method has been developed and validated for the determination of lercanidipine in human plasma. Plasma samples with lercanidipine-d3 as an internal standard （IS） were prepared by solid phase extraction on Phenomenex Strata-X cartridges using 100 μL of human plasma. Chromatographic analysis was performed on UPLC BEH C18 （50 mm × 2.1 mm, 1.7 μm） column under isocratic conditions. Linear calibration curves were obtained over a wide dynamic concentration range of 0.010-20.0 ng/mL. Matrix effect was assessed by post-column infusion, post-extraction spiking and standard-line slope methods. The mean extraction recovery was 〉 94% for the analyte and IS. Inter-batch and intra-hatch precision （% CV） across five quality controls was 〈 5.8%. Bioequivalence study was performed with 36 healthy sub- jects after oral administration of 10 mg of lercanidipine and the assay reproducibility was evaluated by reanalysis of 133 incurred samples.

关键词： lercanidipine UPLC-MS/MS Bioequivalence Solid phase extraction Human plasma

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lercanidipine对心肌病仓鼠心力衰竭过程中冠状反应和重构的作用(英文)

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Acta Pharmacologica Sinica 2003年第3期24卷 9-16页

作者： Julie MASSICOTTE, Antoine VIENS, Ming-Hui YAO~1, Amedeo LEONARDI~2,Giorgio SIRONI~2, Hongbo WANG, Louis DUMONT~3 Département de pharmacologie, faculté de médecine, Universitéde Montréal, Montréal, QC, Canada H3C 3J7 1~Department of Pharmacology, School of Medicine, Fudan University, Shanghai 200032, China 2~Pharmaceutical R&D Division, Recordati SpA, Milan, Italy Departement de pharmacologie faculte de medecine Universite de Montreal Montreal QC 加拿大 H3C 3J7 Department of Pharmacology School of Medicine Fudan University 上海 200032 Pharmaceutical R&D Division Recordati SpA Milan Italy

AIM: lercanidipine is a new vasoselective dihydropyridine calcium channel blocker with a short plasma half-life,long duration of action, and demonstrated cardioprotective properties. We hypothesized that it might be effective at attenuating the adverse impact observed on the coronary compartment and myocardium in the transition phase to heart failure in the UM-X7.1 cardiomyopathic (CM) hamster. METHODS: The effects of 4-month exposure to lercanidipine 3 and 10 mg/kg (daily oral administration) Were evaluated in 150-day-old CM hamsters and in agematched normal hamsters. Coronary reactivity (reactive hyperemia to 30-s coronary occlusion) and the response to the administration of acetylcholine (100 nmol/L) and sodium nitroprusside (1 μmol/L) were assessed monthly, using the isolated perfused heart model. The left ventricular chamber dilatation index and wall thickness, myocardial fibrosis and myocardial capillary density (papillary muscle) were estimated in selected subgroups at monthly intervals. RESULTS

关键词：钙通道阻滞药心肌病冠状血管心力衰竭 lercanidipine 心肌

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Thrapeutic equivalence in the treatment of hypertension:Can lercanidipine and nifedipine GITS be considered to be interchangeable?

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World Journal of Cardiology 2014年第6期6卷 507-513页

作者： Henry L Elliott Peter A Meredith Institute of Pharmaceutical and Biomedical Sciences University of StrathclydeGlasgow G4 0REUnited Kingdom Department of Medicine and Therapeutics University of GlasgowThe Western InfirmaryGlasgow G11 6NTUnited Kingdom

AIM: To undertake a review of the evidence that nifedipine GITS and lercanidipine are therapeutically equivalent in the management of essential ***: A systematic review of the published literature was prompted by the findings of two meta-analyses which indicated that there was a lower incidence of peripheral(ankle) oedema with lercanidipine. However,neither meta-analysis gave detailed attention to comparative antihypertensive efficacy or cardiovascular protection. Accordingly,a systematic,detailed and critical review was undertaken of individual published papers. The review started with those studies incorporated into the 2 meta-analyses and then all other salient and directly relevant papers identified through the following search criteria: all randomized controlled trials in which the therapeutic profile and antihypertensive effects of lercanidipine were directly compared with those of nifedipine GITS(in hypertensive patients). The searchstrategy was focused on the reports of clinical trials of lercanidipine vs nifedipine GITS,which were identified through a systematic search of PubMed(from 1966 to October 2012),Embase(from 1980 to October 2012) and the Cochrane library(from 1 October 2008 to end October 2013). The search combined terms related to lercanidipine vs nifedipine GITS(including MeSH search using calcium antagonists,calcium channel blockers and dihydropyridines).RESULTS: With regard to blood pressure(BP) control and the consistency of BP control throughout 24-h,there is limited published evidence. However,two studies using 24 h ambulatory blood pressure monitoring clearly identified the dose-dependency of BP lowering with lercanidipine and its variably sustained 24-h efficacy. In contrast,there is evidence of a consistent antihypertensive effect throughout 24 h with nifedipine GITS. The incidence of the most common "side effect",i.e.,peripheral(ankle) oedema can be estimated as follows. For every 100 patients treated with lercanidipine,

关键词： Nifedipine GITS lercanidipine 治疗学的等价

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