Clevidipine: A review of its use for managing blood pressure in perioperative and intensive care settings

Drugs

Volumn 74, Issue 16, 2014, Pages 1947-1960

  Keating, Gillian M ^a  

^a Springer ^*  (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

CLEVIDIPINE; GLYCERYL TRINITRATE; NITROPRUSSIDE SODIUM; TRIACYLGLYCEROL; PYRIDINES;

AGED; ANTIHYPERTENSIVE THERAPY; BLOOD PRESSURE REGULATION; CAPACITANCE BLOOD VESSEL; CARDIOPULMONARY BYPASS; CLINICAL EFFECTIVENESS; CONTINUOUS INFUSION; CORONARY ARTERY BYPASS GRAFT; CORONARY ARTERY DILATATION; COST EFFECTIVENESS ANALYSIS; DRUG COST; DRUG EFFICACY; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; HEART RATE; HEART REPOLARIZATION; HEART SURGERY; HOSPITALIZATION; HUMAN; HYPERTENSION; INTENSIVE CARE UNIT; LENGTH OF STAY; LIPID METABOLISM; LUNG VASCULAR RESISTANCE; MEAN ARTERIAL PRESSURE; MULTICENTER STUDY (TOPIC); OPEN STUDY; PERIOPERATIVE PERIOD; PHASE 3 CLINICAL TRIAL (TOPIC); PLASMA CONCENTRATION-TIME CURVE; PLASMA PROTEIN BINDING; POSTOPERATIVE COMPLICATION; POSTOPERATIVE PERIOD; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SYSTEMIC VASCULAR RESISTANCE; TREATMENT FAILURE; TRIACYLGLYCEROL BLOOD LEVEL; VOLUME OF DISTRIBUTION AT STEADY-STATE; BLOOD PRESSURE; DRUG EFFECTS; HUMANS; INTENSIVE CARE; METHODS; PERIOPERATIVE CARE;

BLOOD PRESSURE; HUMANS; INTENSIVE CARE; PERIOPERATIVE CARE; PYRIDINES;

EID: 84922079806     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-014-0313-6     Document Type: Review

References (57)

1. Haas CE, LeBlanc JM. Acute postoperative hypertension: a review of therapeutic options. Am J Health Syst Pharm. 2004;61(16):1661-73.
2. Feneck R. Drugs for the perioperative control of hypertension: current issues and future directions. Drugs. 2007;67(14):2023-44.
3. Weiss SJ, Longnecker DE. Perioperative hypertension: an overview. Coron Artery Dis. 1993;4(5):401-6.
4. Aronson S, Dyke CM, Levy JH, et al. Does perioperative systolic blood pressure variability predict mortality after cardiac surgery? An exploratory analysis of the ECLIPSE trials. Anesth Analg. 2011;113(1):19-30.
5. Awad AS, Goldberg ME. Role of clevidipine butyrate in the treatment of acute hypertension in the critical care setting: a review. Vasc Health Risk Manag. 2010;6:457-64.
6. Sarafidis PA, Georgianos PI, Malindretos P, et al. Pharmacological management of hypertensive emergencies and urgencies: focus on newer agents. Expert Opin Investig Drugs. 2012;21(8):1089-106.
7. Varon J. Treatment of acute severe hypertension: current and newer agents. Drugs. 2008;68(3):283-97.
8. Ericsson H, Fakt C, Jolin-Mellgård Å, et al. Clinical and pharmacokinetic results with a new ultrashort-acting calcium antagonist, clevidipine, following gradually increasing intravenous doses to healthy volunteers. Br J Clin Pharmacol. 1999;47(5):531-8.
9. The Medicines Company. Cleviprex (clevidipine) 0.5 mg/ml emulsion for injection: UK summary of product characteristics. 2013. http://www.medicines.org.uk/emc/medicine/28128/SPC/Cleviprex/. Accessed 25 Sep 2014.
10. The Medicines Company. The Medicines Company launches new formulation of Cleviprex® (clevidipine) injectable emulsion (media release). 2011. http://ir.themedicinescompany.com/phoenix.zhtml?c=122204&p=irol-newsArticle&ID=1612767&highlight=. Accessed 25 Sep 2014.
11. The Medicines Company. Cleviprex (clevidipine) injectable emulsion for intravenous use: US prescribing information. 2011. http://www.cleviprex.com/. Accessed 25 Sep 2014.
12. Deeks ED, Keating GM, Keam SJ. Clevidipine: a review of its use in the management of acute hypertension. Am J Cardiovasc Drugs. 2009;9(2):117-34.
13. Nordlander M, Sjöquist P-O, Ericsson H, et al. Pharmacodynamic, pharmacokinetic and clinical effects of clevidipine, an ultrashort-acting calcium antagonist for rapid blood pressure control. Cardiovasc Drug Rev. 2004;22(3):227-50.
14. Levy JH, Mancao MY, Gitter R, et al. Clevidipine effectively and rapidly controls blood pressure preoperatively in cardiac surgery patients: the results of the randomized, placebo-controlled Efficacy Study of Clevidipine Assessing its Preoperative Antihypertensive Effect in Cardiac Surgery-1. Anesth Analg. 2007;105(4):918-25.
15. Kieler-Jensen N, Jolin-Mellgård Å, Nordlander M, et al. Coronary and systemic hemodynamic effects of clevidipine, an ultra-short-acting calcium antagonist, for treatment of hypertension after coronary artery surgery. Acta Anaesthesiol Scand. 2000;44(2):186-93.
16. Singla N, Warltier DC, Gandhi SD, et al. Treatment of acute postoperative hypertension in cardiac surgery patients: an Efficacy Study of Clevidipine Assessing its Postoperative Antihypertensive Effect in Cardiac Surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial. Anesth Analg. 2008;107(1):59-67.
17. Ericsson H, Fakt C, Höglund L, et al. Pharmacokinetics and pharmacodynamics of clevidipine in healthy volunteers after intravenous infusion. Eur J Clin Pharmacol. 1999;55(1):61-7.
18. Bekker A, Didehvar S, Kim S, et al. Efficacy of clevidipine in controlling perioperative hypertension in neurosurgical patients: initial single-center experience. J Neurosurg Anesthesiol. 2010;22(4):330-5.
19. Smith WB, Marbury TC, Komjathy SF, et al. Pharmacokinetics, pharmacodynamics, and safety of clevidipine after prolonged continuous infusion in subjects with mild to moderate essential hypertension. Eur J Clin Pharmacol. 2012;68(10):1385-94.
20. Bailey JM, Lu W, Levy JH, et al. Clevidipine in adult cardiac surgical patients: a dose-finding study. Anesthesiology. 2002;96(5):1086-94.
21. Powroznyk AVV, Vuylsteke A, Naughton C, et al. Comparison of clevidipine with sodium nitroprusside in the control of blood pressure after coronary artery surgery. Eur J Anaesthesiol. 2003;20(9):697-703.
22. Schwieler JH, Ericsson H, Löfdahl P, et al. Circulatory effects and pharmacology of clevidipine, a novel ultra short acting and vascular selective calcium antagonist, in hypertensive humans. J Cardiovasc Pharmacol. 1999;34(2):268-74.
23. Ericsson H, Bredberg U, Eriksson U, et al. Pharmacokinetics and arteriovenous differences in clevidipine concentration following a short- and a long-term intravenous infusion in healthy volunteers. Anesthesiology. 2000;92(4):993-1001.
24. Ericsson H, Tholander B, Regårdh CG. In vitro hydrolysis rate and protein binding of clevidipine, a new ultrashort-acting calcium antagonist metabolised by esterases, in different animal species and man. Eur J Pharm Sci. 1999;8(1):29-37.
25. Vuylsteke A, Milner Q, Ericsson H, et al. Pharmacokinetics and pulmonary extraction of clevidipine, a new vasodilating ultrashort-acting dihydropyridine, during cardiopulmonary bypass. Br J Anaesth. 2000;85(5):683-9.
26. Zhang JG, Dehal SS, Ho T, et al. Human cytochrome p450 induction and inhibition potential of clevidipine and its primary metabolite H152/81. Drug Metab Dispos. 2006;34(5):734-7.
27. Aronson S, Dyke CM, Stierer KA, et al. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008;107(4):1110-21.
28. Merry AF, Avery EG, Nussmeier NA, et al. Clevidipine compared with nitroglycerin for blood pressure control in coronary artery bypass grafting: a randomized double-blind study. Can J Anaesth. 2014;61(5):398-406.
29. Aronson S, Levy JH, Lumb PD, et al. Impact of perioperative blood pressure variability on health resource utilization after cardiac surgery: an analysis of the ECLIPSE trials. J Cardiothorac Vasc Anesth. 2014;28(3):579-85.
30. Aronson S, Dasta JF, Levy JH, et al. A cost analysis of the impact of a new intravenous antihypertensive in managing perioperative blood pressure during cardiac surgery. Hosp Pract. 2014;42(3):26-32.
31. Graffagnino C, Bergese S, Love J, et al. Clevidipine rapidly and safely reduces blood pressure in acute intracerebral hemorrhage: the ACCELERATE trial. Cerebrovasc Dis. 2013;36(3):173-80.
32. Polderman KH, Bajus D, Varon J. Use of clevidipine (Cleviprex®) to control blood pressure (BP) in patients with intracerebral hemorrhage (ICH) and subarachnoid hemorrhage (SAH) (abstract no. 323). In: 12th Annual Neurocritical Care Society Meeting; 11-14 Sep 2014; Seattle (WA).
33. Polderman KH, Bajus D, Varon J. IV clevidipine (Cleviprex®) rapidly controls blood pressure (BP) in acute ischemic stroke (AIS) (abstract no. 327). In: 12th Annual Neurocritical Care Society Meeting; 11-14 Sep 2014; Seattle (WA).
34. Polderman KH, Bajus D, Varon J. Clevidipine is safe and effective for blood pressure management in patients with acute neurological injuries (abstract). In: 27th Annual Congress of the European Society of Intensive Care Medicine; 27 Sep-1 Oct 2014; Barcelona.
35. Erickson AL, DeGrado JR, Fanikos JR. Clevidipine: a short-acting intravenous dihydropyridine calcium channel blocker for the management of hypertension. Pharmacotherapy. 2010;30(5):515-28.
36. van den Born BJH, Beutler JJ, Gaillard CAJM, et al. Dutch guideline for the management of hypertensive crisis: 2010 revision. Neth J Med. 2011;69(5):248-55.
37. Aronson S. Clevidipine in the treatment of perioperative hypertension: assessing safety events in the ECLIPSE trials. Expert Rev Cardiovasc Ther. 2009;7(5):465-72.
38. Ramos AP, Varon J. Current and newer agents for hypertensive emergencies. Curr Hypertens Rep. 2014;6(7):450.
39. Getsios D, Wang Y, Stolar M, et al. Improved perioperative blood pressure control leads to reduced hospital costs. Expert Opin Pharmacother. 2013;14(10):1285-93.
40. Mayer SA, Kurtz P, Wyman A, et al. Clinical practices, complications, and mortality in neurological patients with acute severe hypertension: the studying the treatment of acute hypertension registry. Crit Care Med. 2011;39(10):2330-6.
41. Manning L, Hirakawa Y, Arima H, et al. Blood pressure variability and outcome after acute intracerebral haemorrhage: a post-hoc analysis of INTERACT2, a randomised controlled trial. Lancet Neurol. 2014;13(4):364-73.
42. Rodríguez-Yáñez M, Castellanos M, Freijo MM, et al. Clinical practice guidelines in intracerebral haemorrhage. Neurologia. 2013;28(4):236-49.
43. Morgenstern LB, Hemphill JC 3rd, Anderson C, et al. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2010;41(9):2108-29.
44. Jauch EC, Saver JL, Adams HP Jr, et al. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44(3):870-947.
45. Bederson JB, Connolly ES Jr, Batjer HH, et al. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a statement for healthcare professionals from a special writing group of the Stroke Council American Heart Association. Stroke. 2009;40(3):994-1025.
46. Manning L, Robinson TG, Anderson CS. Control of blood pressure in hypertensive neurological emergencies. Curr Hypertens Rep. 2014;16(6):436.
47. Pollack CV, Varon J, Garrison NA, et al. Clevidipine, an intravenous dihydropyridine calcium channel blocker, is safe and effective for the treatment of patients with acute severe hypertension. Ann Emerg Med. 2009;53(3):329-38.
48. Peacock WF, Varon J, Ebrahimi R, et al. Clevidipine for severe hypertension in patients with renal dysfunction: a VELOCITY trial analysis. Blood Press. 2011;20(Suppl 1):20-5.
49. Peacock WF, Varon J, Ebrahimi R, et al. Clevidipine for severe hypertension in acute heart failure: a VELOCITY trial analysis. Congest Heart Fail. 2010;16(2):55-9.
50. Peacock WF, Chandra A, Char D, et al. Clevidipine in acute heart failure: results of the A Study of Blood Pressure Control in Acute Heart Failure - A Pilot Study (PRONTO). Am Heart J. 2014;167(4):529-36.
51. Tobias JD, Schechter WS, Phillips A, et al. Clevidipine for perioperative blood pressure control in infants and children undergoing cardiac surgery for congenital heart disease. J Pediatric Pharmacol Ther. 2011;16(1):55-60.
52. Tobias JD, Hoernschemeyer DG. Clevidipine for controlled hypotension during spinal surgery in adolescents. J Neurosurg Anesthesiol. 2011;23(4):347-51.
53. Tobias JD, Allee J, Ramachandran V, et al. Clevidipine controls intraoperative blood pressure in an adolescent with renal failure. J Pediatr Pharmacol Ther. 2009;14(3):144-7.
54. Bettesworth JG, Martin DP, Tobias JD. Intraoperative use of clevidipine in a patient with Von Hippel-Lindau disease with associated pheochromocytoma. J Cardiothorac Vasc Anesth. 2013;27(4):749-51.
55. Towe E, Tobias JD. Preliminary experience with clevidipine in the pediatric population. J Intensive Care Med. 2010;25(6):349-52.
56. Tobias JD, Tulman DB, Bergese SD. Clevidipine for perioperative blood pressure control in infants and children. Pharmaceuticals. 2013;6(1):70-84.
57. The Medicines Company. Assessment of efficacy, safety and dosing of clevidipine in pediatric patients undergoing surgery (PIONEER study) (ClinicalTrials.gov identifier NCT01938547) US National Institues of Health, ClinicalTrials.gov 2014. http://www.clinicaltrials.gov/ct2/show/NCT01938547. Accessed 25 Sep 2014.