Erythrocyte-bound Apolipoprotein B After Withdrawal of Statin Therapy

NCT01634906 | Completed

• 1 other identifier: NL37698.101.11
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Background: preliminary data have shown that erythrocyte-bound apolipoprotein B (ery-apoB) may be protective against atherosclerosis. However, statins may have an effect on ery-apoB. Objective: to investigate the effect of statins on ery-apoB levels. Study design: a non-randomized intervention study. Ery-apoB will be measured twice in volunteers who are on statin therapy for medical reasons. After a baseline measurement of ery-apoB volunteers will discontinue their statin use for a period of six weeks followed by a second measurement of ery-apoB. Consecutively subjects will start with their original statin therapy again. Study population: patients on statin therapy aged 18 years or older. Intervention: temporary discontinuation of statin therapy for a period of six weeks. Main study endpoints: changes in ery-apoB levels. Risks, burden and benefits on participation: volunteers will visit the outpatient clinic twice, the second visit will be exactly six weeks after the first visit. The volunteers' general practitioner and medical specialist (internist or cardiologist) will be informed about their participation. Subjects have to fast for 10 hours before every visit and venous blood samples will be drawn on both visits (a total of 36ml of blood). Subjects will discontinue their usual statin therapy for a period of six weeks. No major risks are involved with temporary discontinuation of statin therapy in stable chronic cardiovascular disease. Volunteers will receive 25 euro's in total for participation. Participation serves to further investigate the relation of statins and potentially beneficial binding of apoB on erythrocytes.

Conditions

Hyperlipidemia; Atherosclerosis

Keywords

Apolipoprotein B, erythrocytes, statins

Outcome Measures

Primary Outcomes (1)

• Apolipoprotein B bound to erythrocytes

  Change in apollipoprotein B bound to erythrocytes six weeks after cessation of statin therapy

  6 weeks

Secondary Outcomes (2)

• Apolipoprotein B bound to leukocytes

  Six weeks

• Leukocyte activation

  six weeks

Study Arms (1)

Discontinuation of statin therapy

EXPERIMENTAL

Drug: Temporary discontinuation of statin therapy

Interventions

Temporary discontinuation of statin therapy DRUG

All statins, e.g. atorvastatin, simvastatin, fluvastatin, rosuvastatin, pravastatin

Also known as: e.g. Crestor, Lipitor

Discontinuation of statin therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• use of a statin

You may not qualify if:

• use of other lipid lowering drugs, other than statins
• a cardiovascular event in the past 6 months

Sponsors & Collaborators

• Sint Franciscus Gasthuis: lead

Study Sites (1)

Sint Franciscus Gasthuis

Rotterdam, South Holland, 3004 BA, Netherlands

Location

Related Publications (15)

• Bovenberg SA, Alipour A, Elte JW, Rietveld AP, Janssen JW, van de Geijn GJ, Njo TN, van Mechelen R, Hervas SM, Cabezas MC. Cell-mediated lipoprotein transport: a novel anti-atherogenic concept. Atheroscler Suppl. 2010 Jun;11(1):25-9. doi: 10.1016/j.atherosclerosissup.2010.04.003. Epub 2010 Apr 27.

  PMID: 20427243 BACKGROUND

• Hui DY, Harmony JA. Interaction of plasma lipoproteins with erythrocytes. I. Alteration of erythrocyte morphology. Biochim Biophys Acta. 1979 Feb 2;550(3):407-24. doi: 10.1016/0005-2736(79)90145-7.

  PMID: 217429 BACKGROUND

• Hui DY, Noel JG, Harmony JA. Binding of plasma low density lipoproteins to erythrocytes. Biochim Biophys Acta. 1981 Jun 23;664(3):513-26. doi: 10.1016/0005-2760(81)90129-6.

  PMID: 6791697 BACKGROUND

• Bovenberg SA, Klop B, Alipour A, Martinez-Hervas S, Westzaan A, van de Geijn GJ, Janssen HW, Njo T, Birnie E, van Mechelen R, Rietveld AP, Elte JW, Castro Cabezas M. Erythrocyte-associated apolipoprotein B and its relationship with clinical and subclinical atherosclerosis. Eur J Clin Invest. 2012 Apr;42(4):365-70. doi: 10.1111/j.1365-2362.2011.02591.x. Epub 2011 Sep 13.

  PMID: 21913916 BACKGROUND

• Molgaard J, von Schenck H, Olsson AG. Effects of simvastatin on plasma lipid, lipoprotein and apolipoprotein concentrations in hypercholesterolaemia. Eur Heart J. 1988 May;9(5):541-51. doi: 10.1093/oxfordjournals.eurheartj.a062541.

  PMID: 3402470 BACKGROUND

• Bard JM, Luc G, Douste-Blazy P, Drouin P, Ziegler O, Jacotot B, Dachet C, De Gennes JL, Fruchart JC. Effect of simvastatin on plasma lipids, apolipoproteins and lipoprotein particles in patients with primary hypercholesterolaemia. Eur J Clin Pharmacol. 1989;37(6):545-50. doi: 10.1007/BF00562541.

  PMID: 2693115 BACKGROUND

• Klop B, Elte JW, Cabezas MC. [Cholesterol homeostasis and enterohepatic connection: new insights in cholesterol absorption]. Ned Tijdschr Geneeskd. 2011;155:A2503. Dutch.

  PMID: 21262010 BACKGROUND

• Poli A. Atorvastatin: pharmacological characteristics and lipid-lowering effects. Drugs. 2007;67 Suppl 1:3-15. doi: 10.2165/00003495-200767001-00002.

  PMID: 17910517 BACKGROUND

• Alipour A, van Oostrom AJ, Izraeljan A, Verseyden C, Collins JM, Frayn KN, Plokker TW, Elte JW, Castro Cabezas M. Leukocyte activation by triglyceride-rich lipoproteins. Arterioscler Thromb Vasc Biol. 2008 Apr;28(4):792-7. doi: 10.1161/ATVBAHA.107.159749. Epub 2008 Jan 24.

  PMID: 18218988 BACKGROUND

• Jukema JW. [The availability of only one statin is inadequate]. Ned Tijdschr Geneeskd. 2005 Dec 10;149(50):2773-4. Dutch.

  PMID: 16385828 BACKGROUND

• Garcia MJ, Reinoso RF, Sanchez Navarro A, Prous JR. Clinical pharmacokinetics of statins. Methods Find Exp Clin Pharmacol. 2003 Jul-Aug;25(6):457-81.

  PMID: 12949632 BACKGROUND

• Pineda A, Cubeddu LX. Statin rebound or withdrawal syndrome: does it exist? Curr Atheroscler Rep. 2011 Feb;13(1):23-30. doi: 10.1007/s11883-010-0148-x.

  PMID: 21104165 BACKGROUND

• Janssen SP, Smulders YM, Gerdes VE, Visseren FL. [Muscle problems due to statins: underestimated]. Ned Tijdschr Geneeskd. 2010;154:A1684. Dutch.

  PMID: 21435278 BACKGROUND

• Taylor F, Ward K, Moore TH, Burke M, Davey Smith G, Casas JP, Ebrahim S. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2011 Jan 19;(1):CD004816. doi: 10.1002/14651858.CD004816.pub4.

  PMID: 21249663 BACKGROUND

• de Vries MA, Alipour A, Klop B, van de Geijn GJ, Janssen HW, Njo TL, van der Meulen N, Rietveld AP, Liem AH, Westerman EM, de Herder WW, Cabezas MC. Glucose-dependent leukocyte activation in patients with type 2 diabetes mellitus, familial combined hyperlipidemia and healthy controls. Metabolism. 2015 Feb;64(2):213-7. doi: 10.1016/j.metabol.2014.10.011. Epub 2014 Oct 16.

  PMID: 25456098 DERIVED

MeSH Terms

Conditions

Hyperlipidemias; Atherosclerosis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Manuel Castro Cabezas, MD, PhD

  Sint Franciscus Gasthuis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 22, 2013

Record last verified: 2013-03

Locations

NL (1)