J Korean Diabetes Assoc.  2006 Jul;30(4):292-302. 10.4093/jkda.2006.30.4.292.

Efficacy Evaluation of Atorvastatin in Korean Hyperlipidemic Patients with Type 2 Diabetes Mellitus

• Choi DS
• Kim DK
• Kim DM
• Kim SY
• Nam MS
• Park YS
• Shon HS
• Ahn CW
• Lee KW
• Lee KU
• Lee MK
• Chung CH
• Cha BY
• 83 Investigators

• KMID: 2177601
• DOI: http://doi.org/10.4093/jkda.2006.30.4.292

Abstract

BACKGROUND: NCEP ATP III Guideline recommends aggressive treatments of diabetic dyslipidemia, recognizing diabetes mellitus as CHD risk equivalents. This study was conducted to evaluate the effectiveness and safety of atorvastatin in hyperlipidemic patients with Type 2 diabetes mellitus through post-marketing drug use investigation of atorvastatin.
METHODS
An open, multi-center, non-comparison, titrated dosage study was conducted in hyperlipidemic patients, who were treated with atorvastatin at first visiting hospitals from Mar. 2004 to Sep. 2004. 96 endocrinologists participated from 66 centers in this study. Total 2,182 hyperlipidemic patients were enrolled and 1,514 patients among them were accompanied by diabetes mellitus. Efficacy was evaluated at later than 4-week treatment by % change of total cholesterol, triglycerides, HDL-cholesterol and LDL-cholesterol from baseline. Percent of patients reaching LDL-cholesterol level less than 100 mg/dL was also analyzed. The adverse events incidence and abnormalities of clinical laboratory values were evaluated for safety monitoring.
RESULTS
Total cholesterol, triglycerides, and LDL-cholesterol level were reduced by 26.6%, 12.0%, and 34.8%, respectively, in diabetic hyperlipidemic patients after atorvastatin treatment. The patients with LDL-cholesterol level of less than 100 mg/dL were increased from 2.8% to 52.6%. Atorvastatin was considered to be safe because adverse drug reactions were reported in 32 patients (1.5%) of total 2,182 patients.
CONCLUSION
Atorvastatin was effective and safe in hyperlipidemic patients with type 2 diabetes mellitus.

Keyword

Atorvastatin; Hyperlipidemia; LDL-cholesterol; Total cholesterol; Type 2 diabetes mellitus

MeSH Terms

Adenosine Triphosphate
Cholesterol
Diabetes Mellitus
Diabetes Mellitus, Type 2*
Drug-Related Side Effects and Adverse Reactions
Dyslipidemias
Humans
Hyperlipidemias
Incidence
Triglycerides
Atorvastatin Calcium
Adenosine Triphosphate
Cholesterol
Triglycerides

Reference

1. Frick MH, Elo O, Haapa K, Heinonen OP, Heinsalmi P, Helo P, Huttunen JK, Kaitaniemi P, Koskinen P, Manninen V, Maenpaa H, Malkonen M, Manttari M, Norolae S, Pastrenack A, Pikkareinen J, Romo M, Sjoblom T, Nikkila EA. Helsinki heart study: primary prevention trial with gemfibrozil in middle-aged men with dyslipidemia. N Engl J Med. 1987. 317:1237–1245.

2. Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, MacFarlane PW, McKillop JH, Packard CJ. West of Scotland Coronary Prevention Study Group. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl J Med. 1995. 333:1301–1307.

3. Stamler J, Vaccaro O, Neaton JD, Wentworth D. Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care. 1993. 16:434–444.

4. Ho JE, Paultre F, Mosca L. Is diabetes mellitus a cardiovascular diseases risk equivalent for fatal stroke in women? Data from the Women's Pooling Project. Stroke. 2003. 34:2812–2816.

5. McCarron P, Greenwood R, Elwood P, Shlomo YB, Bayer I, Frankel S, Ebrahim S, Murray L, Smith GD. The incidence and aetiology of stroke in the Caerphilly and Speedwell Collaborative Studies II: risk factors for ischemic stroke. Public Health. 2001. 115:12–20.

6. American Diabetes Association. Position Statement: Management of dyslipidemia in adults with diabetes. Diabetes Care. 2002. 25:S74–S77.

7. American Diabetes Association. Position Statement: Management of dyslipidemia in adults with diabetes. Diabetes Care. 2001. 24:S58–S61.

8. National Cholesterol Education Program. Second Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). Circulation. 1994. 89:1333–1445.

9. 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. Waters D. Statins and Safety: Applying the results of randomized trials to clinical practice. Am J Cardiol. 2003. 92(6):692–695.

12. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL, Johns DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ. The National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. The JNC 7 report. JAMA. 2003. 289:2560–2572.

14. Jones PH, McKenney JM, Karalis DG, Downey J. Comparison of the efficacy and safety of atorvastatin initiated at different starting doses in patients with dyslipidemia. Am Heart J. 2005. 149:111e1–e111. e8

15. Grundy SM, Cleeman JI, Merz NB, Brewer HB Jr, Clark LT, Hunninghake DB, Pasternak RC, Smith SC Jr, Stone NJ. Coordinating Committee of the National Cholesterol Education Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines. Circulation. 2004. 110:227–239.

16. Olsson AG, Eriksson M, Johnson O, Kjellstrm T, Lanke J, Larsen ML, Pedersen T, Tikkanen MJ, Wiklund O. 3T study investigators. A 52-week, multicenter, randomized, parallel-group, double-blind, double-dummy study to assess the efficacy of atorvastatin and simvastatin in reaching low-density lipoprotein cholesterol and triglyceride targets: The treat-to-target study. Clin Ther. 2003. 25:119–138.