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

Clinical Therapeutics

Volumn 34, Issue 9, 2012, Pages 1940-1947

  Oh, Gyu Chul ^a   Lee, Hae Young ^a   Kang, Hyun Jae ^a   Zo, Joo Hee ^b   Choi, Dong Ju ^c   Oh, Byung Hee ^a  

^a Seoul National University Hospital   (South Korea)

^b Seoul National University Boramae Hospital   (South Korea)

^c Seoul National University Bundang Hospital   (South Korea)

Author keywords

Amlodipine; Hypertension; Pedal edema

Indexed keywords

AMLODIPINE; AMLODIPINE BESYLATE; AMLODIPINE NICOTINATE; UNCLASSIFIED DRUG;

ABDOMINAL DISCOMFORT; ADULT; AGED; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; DERMATITIS; DIASTOLIC BLOOD PRESSURE; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EPISTAXIS; ESOPHAGITIS; FACE EDEMA; FEMALE; FLUSHING; FOOT EDEMA; HEADACHE; HUMAN; HYPERTENSION; HYPERTRANSAMINASEMIA; KOREA; MULTICENTER STUDY; OUTCOME ASSESSMENT; PERIPHERAL EDEMA; PHASE 4 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SPRAIN; SYSTOLIC BLOOD PRESSURE;

AGED; AMLODIPINE; ANTIHYPERTENSIVE AGENTS; BLOOD PRESSURE; CALCIUM CHANNEL BLOCKERS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; EDEMA; FEMALE; FOLLOW-UP STUDIES; FOOT; HUMANS; HYPERTENSION; MIDDLE AGED; NIACIN; REPUBLIC OF KOREA; STEREOISOMERISM;

EID: 84866151477     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2012.08.003     Document Type: Article

References (19)

1. Opie L.H., Yusuf S., Kubler W. Current status of safety and efficacy of calcium channel blockers in cardiovascular diseases: a critical analysis based on 100 studies. Prog Cardiovasc Dis 2000, 43:171-196.
2. Zhang X.P., Loke K.E., Mital S., et al. Paradoxical release of nitric oxide by an l-type calcium channel antagonist, the r+ enantiomer of amlodipine. J Cardiovasc Pharmacol 2002, 39:208-214.
3. Luksa J., Josic D., Kremser M., et al. Pharmacokinetic behaviour of r-(+)- and s-(-)-amlodipine after single enantiomer administration. J Chromatogr B Biomed Sci Appl 1997, 703:185-193.
4. Pathak L., Hiremath, Kerkar P.G., Manade V.G. Multicentric, clinical trial of s-amlodipine 2.5 mg versus amlodipine 5 mg in the treatment of mild to moderate hypertension-a randomized, double-blind clinical trial. J Assoc Physicians India 2004, 52:197-202.
5. Park J.Y., Kim K.A., Park P.W., et al. Pharmacokinetic and pharmacodynamic characteristics of a new S-amlodipine formulation in healthy Korean male subjects: a randomized, open-label, two-period, comparative, crossover study. Clin Ther 2006, 28:1837-1847.
6. Kim S.A., Park S., Chung N., et al. Efficacy and safety profiles of a new s(-)-amlodipine nicotinate formulation versus racemic amlodipine besylate in adult Korean patients with mild to moderate hypertension: an 8-week, multicenter, randomized, double-blind, double-dummy, parallel-group, Phase III, noninferiority clinical trial. Clin Ther 2008, 30:845-857.
7. Papavassiliou M.V., Vyssoulis G.P., Karpanou E.A., et al. P-256: Side effects of antihypertensive treatment with calcium channel antagonists. Am J Hypertens 2001, 14:114A.
8. Weir M.R. Incidence of pedal edema formation with dihydropyridine calcium channel blockers: issues and practical significance. J Clin Hypertens (Greenwich) 2003, 5:330-335.
9. Fogari R., Malamani G., Corradi L., et al. Effect of valsartan or olmesartan addition to amlodipine on ankle edema in hypertensive patients. Adv Ther 2010, 27:48-55.
10. Fogari R., Malamani G.D., Zoppi A., et al. Effect of benazepril addition to amlodipine on ankle oedema and subcutaneous tissue pressure in hypertensive patients. J Hum Hypertens 2003, 17:207-212.
11. Fogari R., Zoppi A., Derosa G., et al. Effect of valsartan addition to amlodipine on ankle oedema and subcutaneous tissue pressure in hypertensive patients. J Hum Hypertens 2007, 21:220-224.
12. Richy F.F., Laurent S. Efficacy and safety profiles of manidipine compared with amlodipine: a meta-analysis of head-to-head trials. Blood Press 2011, 20:54-59.
13. Fogari R., Zoppi A., Mugellini A., et al. Effect of aliskiren addition to amlodipine on ankle edema in hypertensive patients: a three-way crossover study. Expert Opin Pharmacother 2011, 12:1351-1358.
14. Bristol D.R. Designing clinical trials for two-sided multiple comparisons with a control. Control Clin Trials 1989, 10:142-152.
15. Beckey C., Lundy A., Lutfi N. Lercanidipine in the treatment of hypertension. Ann Pharmacother 2007, 41:465-473.
16. Pedrinelli R., Dell'Omo G., Nuti M., et al. Heterogeneous effect of calcium antagonists on leg oedema: a comparison of amlodipine versus lercanidipine in hypertensive patients. J Hypertens 2003, 21:1969-1973.
17. Weir M.R., Rosenberger C., Fink J.C. Pilot study to evaluate a water displacement technique to compare effects of diuretics and ACE inhibitors to alleviate lower extremity edema due to dihydropyridine calcium antagonists. Am J Hypertens 2001, 14:963-968.
18. Burnier M., Pruijm M., Wuerzner G. Treatment of essential hypertension with calcium channel blockers: what is the place of lercanidipine?. Expert Opin Drug Metab Toxicol 2009, 5:981-987.
19. Andresdottir M.B., van Hamersvelt H.W., van Helden M.J., et al. Ankle edema formation during treatment with the calcium channel blockers lacidipine and amlodipine: a single-centre study. J Cardiovasc Pharmacol 2000, 35:S25-S30.