A randomized, double blind, placebo-controlled pilot trial of the safety and efficacy of atorvastatin in children with elevated low-density lipoprotein cholesterol (LDL-C) and type 1 diabetes

Pediatric Diabetes

Volumn 16, Issue 2, 2015, Pages 79-89

  Canas, Jose A ^a   Ross, Judith L ^b   Taboada, Martha V ^c   Sikes, Kaitlin M ^a   Damaso, Ligeia C ^c   Hossain, Jobayer ^d   Caulfield, Michael P ^e   Gidding, Samuel S ^d   Mauras, Nelly ^a  

^a NEMOURS CHILDREN S CLINIC   (United States)

^b THOMAS JEFFERSON UNIVERSITY   (United States)

^c NEMOURS CHILDREN S HOSPITAL   (United States)

^d NEMOURS ALFRED I DUPONT HOSPITAL FOR CHILDREN   (United States)

^e QUEST DIAGNOSTICS NICHOLS INSTITUTE   (United States)

Author keywords

Adolescents; Cardiovascular Disease; HMG CoA; Statins

Indexed keywords

APOLIPOPROTEIN B; ATORVASTATIN; CHOLESTEROL; CREATINE KINASE; GLUCOSE; HEMOGLOBIN A1C; LIPID; LOW DENSITY LIPOPROTEIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; VERY LOW DENSITY LIPOPROTEIN; ANTIDIABETIC AGENT; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; HEPTANOIC ACID DERIVATIVE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; INSULIN; PYRROLE DERIVATIVE;

ADOLESCENT; ARTICLE; CARDIOVASCULAR RISK; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DISEASE DURATION; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; FEMALE; GLYCEMIC CONTROL; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN RESISTANCE; INSULIN SENSITIVITY; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MUSCULOSKELETAL DISEASE; PILOT STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TREATMENT OUTCOME; ADVERSE EFFECTS; BLOOD; CHILD; CLINICAL TRIAL; COMPLICATION; DIABETES MELLITUS, TYPE 1; DIABETIC DIET; DIET THERAPY; DRUG MONITORING; EXERCISE; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; LOW FAT DIET; MULTICENTER STUDY; MULTIMODALITY CANCER THERAPY;

ADOLESCENT; CHILD; CHOLESTEROL, LDL; COMBINED MODALITY THERAPY; DIABETES MELLITUS, TYPE 1; DIABETIC DIET; DIET, FAT-RESTRICTED; DOUBLE-BLIND METHOD; DRUG MONITORING; EXERCISE; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HEPTANOIC ACIDS; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; INSULIN RESISTANCE; MALE; PILOT PROJECTS; PYRROLES;

EID: 84922792512     PISSN: 1399543X     EISSN: 13995448     Source Type: Journal    
DOI: 10.1111/pedi.12245     Document Type: Article

References (40)

1. McCrindle BW, Urbina EM, Dennison BA et al. Drug therapy of high-risk lipid abnormalities in children and adolescents: a scientific statement from the American Heart Association Atherosclerosis, Hypertension, and Obesity in Youth Committee, Council of Cardiovascular Disease in the Young, with the Council on Cardiovascular Nursing. Circulation 2007: 115: 1948-1967.
2. Mahoney LT, Burns TL, Stanford W et al. Coronary risk factors measured in childhood and young adult life are associated with coronary artery calcification in young adults: the Muscatine Study. J Am Coll Cardiol 1996: 27: 277-284.
3. Snell-Bergeon JK, Nadeau K. Cardiovascular disease risk in young people with type 1 diabetes. J Cardiovasc Transl Res 2012: 5: 446-462.
4. White NH, Cleary PA, Dahms W, Goldstein D, Malone J, Tamborlane WV. Beneficial effects of intensive therapy of diabetes during adolescence: outcomes after the conclusion of the Diabetes Control and Complications Trial (DCCT). J Pediatr 2001: 139: 804-812.
5. Kershnar AK, Daniels SR, Imperatore G et al. Lipid abnormalities are prevalent in youth with type 1 and type 2 diabetes: the SEARCH for Diabetes in Youth Study. J Pediatr 2006: 149: 314-319.
6. Specht BJ, Wadwa RP, Snell-Bergeon JK, Nadeau KJ, Bishop FK, Maahs DM. Estimated insulin sensitivity and cardiovascular disease risk factors in adolescents with and without type 1 diabetes. J Pediatr 2013: 162: 297-301.
7. Berneis KK, Krauss RM. Metabolic origins and clinical significance of LDL heterogeneity. J Lipid Res 2002: 43: 1363-1379.
8. Williams PT, Zhao XQ, Marcovina SM, Brown BG, Krauss RM. Levels of cholesterol in small LDL particles predict atherosclerosis progression and incident CHD in the HDL-Atherosclerosis Treatment Study (HATS). PLoS One 2013: 8: e56782.
9. Austin MA, Breslow JL, Hennekens CH, Buring JE, Willett WC, Krauss RM. Low-density lipoprotein subclass patterns and risk of myocardial infarction. JAMA 1988: 260: 1917-1921.
10. Schwab KO, Doerfer J, Hecker W et al. Spectrum and prevalence of atherogenic risk factors in 27, 358 children, adolescents, and young adults with type 1 diabetes. Diabetes Care 2006: 29: 218-225.
11. Sattar N, Preiss D, Murray HM et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet 2010: 375: 735-742.
12. Warnick GR, Nguyen T, Albers AA. Comparison of improved precipitation methods for quantification of high-density lipoprotein cholesterol. Clin Chem 1985: 31: 217-222.
13. Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem 1972: 18: 499-502.
14. Caulfield MP, Li S, Lee G et al. Direct determination of lipoprotein particle sizes and concentrations by ion mobility analysis. Clin Chem 2008: 54: 1307-1316.
15. Service FJ, Molnar GD, Rosevear JW, Ackerman E, Gatewood LC, Taylor WF. Mean amplitude of glycemic excursions, a measure of diabetic instability. Diabetes 1970: 19: 644-655.
16. Dabelea D, D'Agostino RB Jr, Mason CC et al. Development, validation and use of an insulin sensitivity score in youths with diabetes: the SEARCH for Diabetes in Youth study. Diabetologia 2011: 54: 78-86.
17. Libby P, Nathan DM, Abraham K et al. Report of the National Heart, Lung, and Blood Institute-National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Cardiovascular Complications of Type 1 Diabetes Mellitus. Circulation 2005: 111: 3489-3493.
18. Donaghue KC, Wadwa RP, Dimeglio LA et al. Microvascular and macrovascular complications in children and adolescents. Pediatr Diabetes 2014: 15 (Suppl 20): 257-269.
19. Zeitler P, Fu J, Tandon N et al. Type 2 diabetes in the child and adolescent. Pediatr Diabetes 2014: 15 (Suppl 20): 26-46.
20. Maahs DM, Wadwa RP, Bishop F, Daniels SR, Rewers M, Klingensmith GJ. Dyslipidemia in youth with diabetes: to treat or not to treat? J Pediatr 2008: 153: 458-465.
21. Lauer RM, Obarzanek E, Hunsberger SA et al. Efficacy and safety of lowering dietary intake of total fat, saturated fat, and cholesterol in children with elevated LDL cholesterol: the Dietary Intervention Study in Children. Am J Clin Nutr 2000: 72: 1332S-1342S.
22. Guy J, Ogden L, Wadwa RP et al. Lipid and lipoprotein profiles in youth with and without type 1 diabetes: the SEARCH for Diabetes in Youth case-control study. Diabetes Care 2009: 32: 416-420.
23. Jarvisalo MJ, Putto-Laurila A, Jartti L et al. Carotid artery intima-media thickness in children with type 1 diabetes. Diabetes 2002: 51: 493-498.
24. Nathan DM, Cleary PA, Backlund JY et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005: 353: 2643-2653.
25. Glaser NS, Geller DH, Haqq A, Gitelman S, Malloy M, Lawson Wilkins Pediatric Endocrine Society Committee on Drugs and Therapeutics. Detecting and treating hyperlipidemia in children with type 1 diabetes mellitus: are standard guidelines applicable to this special population? Pediatr Diabetes 2011: 12: 442-459.
26. Sninsky JJ, Rowland CM, Baca AM, Caulfield MP, Superko HR. Classification of LDL phenotypes by 4 methods of determining lipoprotein particle size. J Investig Med 2013: 61: 942-949.
27. Musunuru K, Orho-Melander M, Caulfield MP et al. Ion mobility analysis of lipoprotein subfractions identifies three independent axes of cardiovascular risk. Arterioscler Thromb Vasc Biol 2009: 29: 1975-1980.
28. Benson M, Hossain J, Caulfield MP, Damaso L, Gidding S, Mauras N. Lipoprotein subfractions by ion mobility in lean and obese children. J Pediatr 2012: 161: 997-1003.
29. Martin FI, Stocks AE. Insulin sensitivity and vascular disease in insulin-dependent diabetics. Br Med J 1968: 2: 81-82.
30. DeFronzo RA, Hendler R, Simonson D. Insulin resistance is a prominent feature of insulin-dependent diabetes. Diabetes 1982: 31: 795-801.
31. Nadeau KJ, Regensteiner JG, Bauer TA et al. Insulin resistance in adolescents with type 1 diabetes and its relationship to cardiovascular function. J Clin Endocrinol Metab 2010: 95: 513-521.
32. Schauer IE, Snell-Bergeon JK, Bergman BC et al. Insulin resistance, defective insulin-mediated fatty acid suppression, and coronary artery calcification in subjects with and without type 1 diabetes: The CACTI study. Diabetes 2011: 60: 306-314.
33. Colhoun HM, Betteridge DJ, Durrington PN et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 2004: 364: 685-696.
34. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20, 536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002: 360: 7-22.
35. Stone NJ, Robinson J, Lichtenstein AH et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol 2014: 63: 2889-2934.
36. Keaney JF Jr, Curfman GD, Jarcho JA. A pragmatic view of the new cholesterol treatment guidelines. N Engl J Med 2014: 370: 275-278.
37. Haller MJ, Stein JM, Shuster JJ et al. Pediatric Atorvastatin in Diabetes Trial (PADIT): a pilot study to determine the effect of atorvastatin on arterial stiffness and endothelial function in children with type 1 diabetes mellitus. J Pediatr Endocrinol Metab 2009: 22: 65-68.
38. Wiegman A, Hutten BA, de Groot E et al. Efficacy and safety of statin therapy in children with familial hypercholesterolemia: a randomized controlled trial. JAMA 2004: 292: 331-337.
39. Wierzbicki AS, Viljoen A. Hyperlipidaemia in paediatric patients: the role of lipid-lowering therapy in clinical practice. Drug saf 2010: 33: 115-125.
40. Pierce LR, Wysowski DK, Gross TP. Myopathy and rhabdomyolysis associated with lovastatin-gemfibrozil combination therapy. JAMA 1990: 264: 71-75.