Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1000 participants
INTERVENTIONAL
2002-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Interventions
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Simvastatin
40mg/day
Eligibility Criteria
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Inclusion Criteria
* Total Cholesterol between 160 to 400 mg/dl
* \> 3 grandparents of African-American descent or \> 3 grandparents of Caucasian descent
* serum triglycerides \< 400 mg/dl
* fasting glucose \< 126 mg/dl
Exclusion Criteria
* Use of over-the-counter products containing sterol or stanol esters or fish oil
* Recent or planned change in dietary intake or weight change of more than 4.5 kg
* Use of corticosteroids, immunosuppressive drugs or drugs affecting the CYP3A4 system
* Known liver disease or elevated transaminase levels
* Elevated creatine phosphokinase levels \> 10 times upper limits of normal
* Uncontrolled blood pressure, or diabetes mellitus
* Abnormal renal or thyroid function
* Current alcohol or drug abuse
* Major illness in the preceding three months
* Pregnancy
* Know intolerance to statins
* Racial ancestry other than African-American or Caucasian
30 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
San Francisco General Hospital
OTHER
University of California, Los Angeles
OTHER
Cedars-Sinai Medical Center
OTHER
University of Washington
OTHER
Duke University
OTHER
UCSF Benioff Children's Hospital Oakland
OTHER
Responsible Party
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Children's Hospital Oakland Research Institute
Principal Investigators
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Ronald M Krauss, M.D.
Role: PRINCIPAL_INVESTIGATOR
UCSF Benioff Children's Hospital Oakland
Locations
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San Francisco General Hospital
San Francisco, California, United States
Countries
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References
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Simon JA, Lin F, Hulley SB, Blanche PJ, Waters D, Shiboski S, Rotter JI, Nickerson DA, Yang H, Saad M, Krauss RM. Phenotypic predictors of response to simvastatin therapy among African-Americans and Caucasians: the Cholesterol and Pharmacogenetics (CAP) Study. Am J Cardiol. 2006 Mar 15;97(6):843-50. doi: 10.1016/j.amjcard.2005.09.134. Epub 2006 Jan 27.
Theusch E, Ting FY, Qin Y, Stevens K, Naidoo D, King SM, Yang NV, Orr J, Han BY, Cyster JG, Chen YI, Rotter JI, Krauss RM, Medina MW. Participant-derived cell line transcriptomic analyses and mouse studies reveal a role for ZNF335 in plasma cholesterol statin response. Genome Med. 2024 Jul 26;16(1):93. doi: 10.1186/s13073-024-01366-9.
Theusch E, Ting FY, Qin Y, Stevens K, Naidoo D, King SM, Yang N, Orr J, Han BY, Cyster JG, Chen YI, Rotter JI, Krauss RM, Medina MW. Participant-derived cell line transcriptomic analyses and mouse studies reveal a role for ZNF335 in plasma cholesterol statin response. bioRxiv [Preprint]. 2023 Jun 15:2023.06.14.544860. doi: 10.1101/2023.06.14.544860.
Trupp M, Zhu H, Wikoff WR, Baillie RA, Zeng ZB, Karp PD, Fiehn O, Krauss RM, Kaddurah-Daouk R. Metabolomics reveals amino acids contribute to variation in response to simvastatin treatment. PLoS One. 2012;7(7):e38386. doi: 10.1371/journal.pone.0038386. Epub 2012 Jul 9.
Mangravite LM, Medina MW, Cui J, Pressman S, Smith JD, Rieder MJ, Guo X, Nickerson DA, Rotter JI, Krauss RM. Combined influence of LDLR and HMGCR sequence variation on lipid-lowering response to simvastatin. Arterioscler Thromb Vasc Biol. 2010 Jul;30(7):1485-92. doi: 10.1161/ATVBAHA.110.203273. Epub 2010 Apr 22.
Barber MJ, Mangravite LM, Hyde CL, Chasman DI, Smith JD, McCarty CA, Li X, Wilke RA, Rieder MJ, Williams PT, Ridker PM, Chatterjee A, Rotter JI, Nickerson DA, Stephens M, Krauss RM. Genome-wide association of lipid-lowering response to statins in combined study populations. PLoS One. 2010 Mar 22;5(3):e9763. doi: 10.1371/journal.pone.0009763.
Medina MW, Gao F, Ruan W, Rotter JI, Krauss RM. Alternative splicing of 3-hydroxy-3-methylglutaryl coenzyme A reductase is associated with plasma low-density lipoprotein cholesterol response to simvastatin. Circulation. 2008 Jul 22;118(4):355-62. doi: 10.1161/CIRCULATIONAHA.108.773267. Epub 2008 Jun 16.
Krauss RM, Mangravite LM, Smith JD, Medina MW, Wang D, Guo X, Rieder MJ, Simon JA, Hulley SB, Waters D, Saad M, Williams PT, Taylor KD, Yang H, Nickerson DA, Rotter JI. Variation in the 3-hydroxyl-3-methylglutaryl coenzyme a reductase gene is associated with racial differences in low-density lipoprotein cholesterol response to simvastatin treatment. Circulation. 2008 Mar 25;117(12):1537-44. doi: 10.1161/CIRCULATIONAHA.107.708388. Epub 2008 Mar 10.
Other Identifiers
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MM2277
Identifier Type: -
Identifier Source: org_study_id