Pharmacokinetics, pharmacodynamics, and safety of clevidipine after prolonged continuous infusion in subjects with mild to moderate essential hypertension.
Purpose: Clevidipine is a rapidly-acting intravenous dihydropyridine antihypertensive acting via calcium channel blockade. This was a randomized, single-blind, parallel-design study of a 72-h continuous clevidipine infusion. Method: Doses of 2, 4, 8, or 16.0 mg/h or placebo were evaluated in 61 subj...
| Publicado en: | European Journal of Clinical Pharmacology Vol. 68; no. 10; pp. 1385 - 1395 |
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| Autores principales: | , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Springer Nature
Oct2012
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=104505910&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 104505910 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00316970 NP9 jtl: European Journal of Clinical Pharmacology issn: 00316970 maglogo: N pubinfo: dt: Oct2012 vid: 68 iid: 10 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 104505910 79824360 10.1007/s00228-012-1260-3 NLM22457015 104505910 ppf: 1385 ppct: 10 formats: fmt: @attributes: type: P tig: atl: Pharmacokinetics, pharmacodynamics, and safety of clevidipine after prolonged continuous infusion in subjects with mild to moderate essential hypertension. aug: au: Smith, William Marbury, Thomas Komjathy, Steven Sumeray, Mark Williams, Gregory Hu, Ming-yi Mould, Diane affil: Volunteer Research Group, University of Tennessee Medical Center, Knoxville USA sug: subj: Clevidipine Butyrate Pharmacokinetics Clevidipine Butyrate Pharmacodynamics Clevidipine Butyrate Administration and Dosage Infusions, Intravenous Hypertension Drug Therapy Antihypertensive Agents Therapeutic Use Randomized Controlled Trials Clevidipine Butyrate Blood Safety Single-Blind Studies Human Random Assignment Male Female Placebos Dose-Response Relationship, Drug Regression Descriptive Statistics Chromatography, Liquid Methods Mass Spectrometry Methods Data Analysis Software Post Hoc Analysis Electrocardiography Methods Middle Age Clevidipine Butyrate Adverse Effects Clevidipine Butyrate Metabolism Funding Source Middle Aged: 45-64 years Male Female ab: Purpose: Clevidipine is a rapidly-acting intravenous dihydropyridine antihypertensive acting via calcium channel blockade. This was a randomized, single-blind, parallel-design study of a 72-h continuous clevidipine infusion. Method: Doses of 2, 4, 8, or 16.0 mg/h or placebo were evaluated in 61 subjects with mild to moderate essential hypertension. IV clevidipine or placebo was initiated at 2.0 mg/h and force-titrated in doubling increments every 3 min to target dose, then maintained for 72 h. Blood pressure and heart rate were measured during infusion, and for 4, 6 and 8 h after termination of infusion, although oral therapy could be restarted at 4 h. Clevidipine blood levels were obtained during infusion and for 1 hour after termination. Results: Rapid onset of drug effect occurred at all clevidipine dose levels, with consistent pharmacokinetics and rapid offset after 72-h infusion. No evidence of tolerance to the clevidipine drug effect was observed at any dose level over the 72-h infusion. No evidence of rebound hypertension was found for either 4 or 6 h after termination of the clevidipine infusion. At 8 h following cessation of clevidipine, blood pressure was not significantly higher than at baseline. Placebo-treated subjects had blood pressures lower than baseline at 8 h following infusion termination; hence, placebo-adjusted blood pressures tended to be slightly higher than baseline. Conclusion: This study supports the use of up to 72 h of IV clevidipine therapy for the management of blood pressure, with consistent pharmacokinetic/pharmacodynamic characteristics and context insensitive half-life across the dose ranges evaluated. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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