Efficacy and safety of statins in the treatment of diabetic dyslipidemia


Olfa Berriche
Chiraz Amrouche
Henda Jamoussi
Samira Blouza


Background: The Adult Treatment Panel III recommends 3- hydroxy-3-methylglutaryl coenzyme A reductase inhibitors or statins as first-line-lipid-altering therapy for all adult patients with diabetes mellitus. This is based on the well-characterized efficacy and safety profiles of this class of agents as well as several clinical trials
demonstrating that statin treatment reduces the risk of cardiovascular events.
Aim : The objective of our study was to investigate the efficacy and safety of statin therapy in patients with diabetes type 2.
Methods: We analyzed data from 120 individuals with diabetes type 2. For all patients, the mean baseline LDL-cholesterol level was 4,26±0,82 mmol per liter, the total cholesterol level was 6,52±0,75 mmol/l, HDL-cholesterol level was 1,15±0,31 mmol/l and triglyceride level was 1,77±0,67 mmol/l.
Results: There was a significant reduction in total cholesterol (P = 2.10-3) and LDL-cholesterol (P = 5.10-4) with statins; the mean LDL-cholesterol level was reduced from 4,26±0,82 mmol/l at baseline to 2,8±0,59 mmol/l at 12 months. The percentage variation of LDL-cholesterol was between 24 and 35%; in addition, the percentage reduction of total cholesterol was between 22 and 28%, the mean reduction in TG levels was between 11 and 16%.There was a no significant increasing in HDL cholesterol. Among these 120 patients, 5,1% had a moderate CK elevation. Moreover 2% had a significant elevation of transaminase levels. Statins have also been associated with muscle-related adverse events; so milder complaints (myalgia) are reported by approximately 3,6% of patients who take statins.
Conclusion: Statins as highly efficacious agents for the lowering of low-density lipoprotein-cholesterol (LDL-C) revolutionized treatment of hypercholesterolemia, a long established risk factor for premature coronary heart disease and they are not only exhibit a remarkely high benefit to risk ration, but are equally characterized by a safety profile with excellent tolerance.


Statins, LDL-Cholestero, Total cholesterol, Triglycerides, Creatine kinase, Transaminases



  1. Bays H. Statin safety: an overview and assessment of the data-2005 Am J Cardiol. 2006; 97: 6C-26C.
  2. Low M, Rudnicka AR. Statin safety: a systemic review. Am J Cardiol. 2006; 97: 52 c-60C.
  3. Bruckert E, Haymen G, Djager S, Yau C, Begand B. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients. The PRIMO Study. Cardiovasc Drugs Ther. 2005; 19: 403-414.
  4. Colhoun HM, Betteridge DJ, Durrington PN, et al. On behalf of the CARDS investigators. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaboration Atorvastatin Diabetes Study (CARDS): multicentre randomized placebocontrolled trial. Lancet 2004; 364: 685-96.
  5. Amarenco P, Labrenche J, Lavallee P, Touboul PJ. Statins in stroke prevention and carotid atherosclerosis systemic review and up-todate meta-analysis. Stroke 2004; 35: 2902-2909.
  6. Christopher C, Bernstein L, Davis R, Rind D, Shmerling R. Screening for statin-related toxicity. Arch Intern Med. 2003; 163: 688-692.
  7. Heart Protection Study Collaborative Group. MRC/BHF. Heart Protection Study of cholesterol lowering with Simvastatin in 20536 high risk individuals: a randomized placebo controlled trial. Lancet 2002; 360: 7-22.
  8. Roglans N, Sanguino E, Peris C, Alegret M, Vazquez M, Adzert T, Diaz C, Hernandez G, Laguna JC, Sanchez RM. Atorvastatin treatment induced peroxisome proliferator-activated receptor · expression and decreased plasma nonesterified fatty acids and liver triglyceride in fructose-fed-rats. J Pharmacol Exp Ther 2002; 302: 232-239.
  9. Expert Panel on Detection Evaluation and Treatment of High blood cholesterol in Adults. Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA 2001; 285: 2486-2497.
  10. Martin G, Duez H, Blanquant C, Berezowski V, Poulain P, Fruchart JC, Najib-Fruchart J, Glineur C, Staels B. Statin-induced inhibition of the Rho-signaling pathway activated PPAR· and induces HDL apo-A-I. J Clin Invest 2001; 107: 1423-1432.
  11. Schwartz GC, Olssou AG, Ezekowitz MD, et al. For the Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators-Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes. JAMA 2001; 285: 1711-18.
  12. Bottorff M, Hamsten P. Long-term safety of hepatic hydroxymethyl glutaryl coenzyme A reductase inhibitors. Arch Intern Med. 2000; 150: 2273-2280.
  13. Marou DJ, Fazio S, Linton MF. Current perspective on statins. Circulation. 2000; 101:207-213.
  14. Farmer JA, Torre-Amione G. Comparative tolerability of the HMGCoA reductase inhibitors. Drug Saf. 2000; 197-213.
  15. Burnett JR, Wilcox LJ, Telforsd DE, Kleinstiver SJ, Barett PH, Newtou RS., Huff MW. Magnitude of decrease in hepatic very low density lipoprotein apolipoprotein B secretion is determined by the extent of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibition in miniature pigs. Endocrinology 1999; 140: 5293-5302.
  16. Long-term Intervention with Pravastatine Ischemic Disease (LIPID) study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and broad range of initial cholesterol levels. N Engl J Med 1998; 339: 1349-57.
  17. Downs JR, Clearfield M, Weis S, et al. For the AFCAPS/TEXCAPS Reseach Group. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TEXCAPS. JAMA 1998; 279: 1615-22.
  18. Sacks FM, Pfeffer MA, Moye LA, et al, for the Cholesterol Recurrent Events Trial Investigators. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. New Engl J Med 1996; 355: 1001-9.
  19. Thompson GR, Naoumova RP, Watts GF. Role of cholesterol in regulating apolipoprotein B secretion by the liver. J Lipid Res 1996; 37: 439-447.
  20. Shephered J, Cobbe SM, Ford I, et al, for the west of Scotland Coronary Prevention Study Group. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl Med 1995; 333: 1301-7.
  21. Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet 1994; 344: 1383-9.
  22. Gianfloue KM, Yasruel Z, Rodriguez MA, Vas D, Sniderman AD. Regulation of apoB secretion from Hep G2 cells: evidence for a critical role for cholesteryl ester synthesis in the response to a fatty acid challenge. J Lipid Res 1990; 31: 2045-2055.