PMID- 22925988
OWN - NLM
STAT- MEDLINE
DCOM- 20130205
LR  - 20151119
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 34
IP  - 9
DP  - 2012 Sep
TI  - Quantification of pedal edema during treatment with S(-)-amlodipine nicotinate 
      versus amlodipine besylate in female Korean patients with mild to moderate 
      hypertension: a 12-week, multicenter, randomized, double-blind, 
      active-controlled, phase IV clinical trial.
PG  - 1940-7
LID - S0149-2918(12)00484-5 [pii]
LID - 10.1016/j.clinthera.2012.08.003 [doi]
AB  - BACKGROUND: Amlodipine is a racemic mixture of (R)- and (S)-enantiomers. It has 
      been suggested that removing the therapeutically inactive (R)-enantiomer will 
      reduce adverse events while preserving the agent's efficacy. Women experience 
      more adverse effects from amlodipine. OBJECTIVE: This exploratory study compared 
      the amount of pedal edema experienced by female Korean patients with mild to 
      moderate hypertension when receiving S(-)-amlodipine nicotinate compared with 
      amlodipine besylate. METHODS: This study was a 12-week, multicenter, randomized, 
      double-blind, active-controlled, Phase IV clinical trial. Female patients with 
      mild to moderate hypertension were randomly assigned to receive either 
      S(-)-amlodipine nicotinate 2.5 to 5 mg once daily or amlodipine besylate 5 to 10 
      mg once daily for 12 weeks. The primary objective was to compare the change in 
      ankle-foot volume quantified by using a water displacement method after 12 weeks 
      of therapy. The secondary objectives were to compare the changes in mean sitting 
      systolic and diastolic blood pressures. Safety assessment included monitoring all 
      laboratory tests, adverse events (AEs), serious AEs, and possible relation to the 
      study medication. RESULTS: Of the 38 patients enrolled, 17 patients in each group 
      were eligible for final analysis. In the S(-)-amlodipine nicotinate group, the 
      mean ankle-foot volume at baseline was 1056.91 (98.15) mL, and volume after 12 
      weeks of treatment was 1016.68 (158.37) mL, a decrease of 40.24 (110.05) mL. In 
      the amlodipine besylate group, mean ankle-foot volume at baseline was 1037.56 
      (158.30) mL, and volume after treatment was 1067.59 (152.54) mL, an increase of 
      30.03 (69.59) mL. There was a significant difference in the change of ankle-foot 
      volume between the 2 groups (-70.26 mL [95% CI, -134.60 to -5.94], P = 0.028). 
      After 12 weeks, the mean changes in sitting systolic blood pressure from baseline 
      were not significantly different between the 2 groups (-21.82 [8.76] vs -26.82 
      [11.89] mm Hg; P = 0.172). Changes in mean sitting diastolic blood pressure also 
      were not significant (-14.71 [6.94] vs -10.88 [5.81] mm Hg; P = 0.091). One 
      patient in each group had facial edema, and another patient in the amlodipine 
      besylate group had facial flushing. Overall, there was no significant difference 
      in drug-related AEs between the 2 groups (P = 0.999). CONCLUSIONS: These female 
      Korean patients with hypertension taking S(-)-amlodipine nicotinate had less 
      ankle edema, with no significant difference in BP-lowering efficacy, compared 
      with those taking amlodipine besylate. S(-)-amlodipine nicotinate may be a 
      suitable alternative for patients intolerant to amlodipine besylate. (Clinical 
      Research Information Service: CRiS, KCT0000450).
CI  - Copyright (c) 2012 Elsevier HS Journals, Inc. All rights reserved.
FAU - Oh, Gyu-Chul
AU  - Oh GC
AD  - Department of Internal Medicine, Seoul National University Hospital, Seoul, 
      Korea.
FAU - Lee, Hae-Young
AU  - Lee HY
FAU - Kang, Hyun-Jae
AU  - Kang HJ
FAU - Zo, Joo-Hee
AU  - Zo JH
FAU - Choi, Dong-Ju
AU  - Choi DJ
FAU - Oh, Byung-Hee
AU  - Oh BH
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120825
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Calcium Channel Blockers)
RN  - 0 (amlodipine nicotinate)
RN  - 1J444QC288 (Amlodipine)
RN  - 2679MF687A (Niacin)
SB  - IM
MH  - Aged
MH  - Amlodipine/administration & dosage/*adverse effects/therapeutic use
MH  - Antihypertensive Agents/administration & dosage/*adverse effects/therapeutic use
MH  - Blood Pressure/drug effects
MH  - Calcium Channel Blockers/administration & dosage/adverse effects/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Edema/*chemically induced
MH  - Female
MH  - Follow-Up Studies
MH  - Foot
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Middle Aged
MH  - Niacin/administration & dosage/*adverse effects/therapeutic use
MH  - Republic of Korea
MH  - Stereoisomerism
EDAT- 2012/08/29 06:00
MHDA- 2013/02/06 06:00
CRDT- 2012/08/29 06:00
PHST- 2012/05/15 00:00 [received]
PHST- 2012/08/07 00:00 [revised]
PHST- 2012/08/08 00:00 [accepted]
PHST- 2012/08/29 06:00 [entrez]
PHST- 2012/08/29 06:00 [pubmed]
PHST- 2013/02/06 06:00 [medline]
AID - S0149-2918(12)00484-5 [pii]
AID - 10.1016/j.clinthera.2012.08.003 [doi]
PST - ppublish
SO  - Clin Ther. 2012 Sep;34(9):1940-7. doi: 10.1016/j.clinthera.2012.08.003. Epub 2012 
      Aug 25.