Journal of the Chinese Medical Association
Volume 71, Issue 3 , Pages 113-118, March 2008

Efficacy and Safety of Rosuvastatin in Taiwanese Patients

  • Chern-En Chiang

      Affiliations

    • Corresponding Author InformationCorrespondence to: Dr Chern-En Chiang, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, 201, Section 2, Shih-Pai Road, Taipei 112, Taiwan, R.O.C.
    • ,
  • Shao-Sung Huang
    • ,
  • Shih-Hsien Sung

Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital and National Yang-Ming University School of Medicine, Taipei, Taiwan, R.O.C.

Received 11 December 2007; accepted 29 January 2008.

Article Outline

Background

Statins are effective in decreasing low-density lipoprotein cholesterol (LDL-C). The efficacy and safety of rosuvastatin, a newly launched statin, have not been determined in Taiwanese patients.

Methods

Patients with hypercholesterolemia receiving rosuvastatin 10 mg/d in this hospital were prospectively followed and retrospectively analyzed. Men and women with primary hypercholesterolemia were eligible for inclusion in the study if they were either lipid-lowering therapy (LTT)-naïve or had been receiving starting doses of other LLT that had proved ineffective in reaching goals. The primary measurement was the percentage of change in LDL-C from baseline at 12 weeks. Other measurements included: percentages of change from baseline in total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), TC/HDL ratio, percentage of patients reaching therapeutic goals, and any adverse effects at 12 weeks. Both intention-to-treat analysis and on-treatment analysis were used.

Results

A total of 447 patients, including 375 LTT-naïve and 72 switched patients were enrolled. In LLT-naïve patients, rosuvastatin 10 mg/d reduced LDL-C by a mean of 48.9% from baseline (p < 0.0001) by the on-treatment analysis and by a mean of 44.2% from baseline (p < 0.0001) by the intention-to-treat analysis. In switched patients, LDL-C was reduced by a mean of 26.2% from baseline (p < 0.0001) by both analyses. TC, TG, and TC/HDL ratio, but not HDL-C, were also significantly reduced. Overall, more than 75% patients reached their therapeutic goals. The safety profiles were excellent. Only 2.2% of patients complained of myalgia, 0.2% had elevation of creatine kinase > 3 ×upper limit of normal (ULN), and 0.6% had an elevation of ALT > 3 ×ULN. All the abnormal laboratory tests returned to pretreatment values after drug discontinuation. Only 2.7% of patients discontinued medication due to adverse effects.

Conclusion

Rosuvastatin 10 mg/d is safe and effective in Taiwanese patients.

Key Words:  hypercholesterolemia , low-density lipoprotein cholesterol , rosuvastatin , statin

No full text is available. To read the body of this article, please view the PDF online.

 

Back to Article Outline

References 

  1. Murray CJ , Lopez AD . Alternative projections of mortality and disability by cause 1990-2020: Global Burden of Disease Study . Lancet . 1997;349:1498–1504
  2. Mathers CD , Loncar D . Projections of global mortality and burden of disease from 2002 to 2030 . PLoS Med . 2006;3:e442
  3. Khot UN, Khot MB, Bajzer CT, Sapp SK, Ohman EM, Brener SJ, et al  Prevalence of conventional risk factors in patients with coronary heart disease . JAMA . 2003;290:898–904
  4. Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, et al  Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study . Lancet . 2004;364:937–952
  5. Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, Macfarlane PW, et al  Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group . N Engl J Med . 1995;333:1301–1307
  6. Downs JR, Clearfield M, Weis S, Whitney E, Shapiro DR, Beere PA, et al  Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS . JAMA . 1998;279:1615–1622
  7. Sever PS, Dahlof B, Poulter NR, Wedel H, Beevers G, Caulfield M, et al  Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial—Lipid Lowering Arm (ASCOT-LLA): a multicentre randomised controlled trial . Lancet . 2003;361:1149–1158
  8. Anon  . Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S) . Lancet . 1994;344:1383–1389
  9. Anon  . 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
  10. Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, et al  Intensive versus moderate lipid lowering with statins after acute coronary syndromes . N Engl J Med . 2004;350:1495–1504
  11. LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, et al  Intensive lipid lowering with atorvastatin in patients with stable coronary disease . N Engl J Med . 2005;352:1425–1435
  12. Pedersen TR, Faergeman O, Kastelein JJP, Olsson AG, Tikkanen MJ, Holme I, et al  High-dose atorvas-tatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL Study: a randomized controlled trial . JAMA . 2005;294:2437–2445
  13. Grundy SM, Cleeman JI, Merz CNB, Brewer HB, Clark LT, Hunninghake DB, et al  Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines . Circulation . 2004;110:227–239
  14. Jones PH, Davidson MH, Stein EA, Bays HE, McKenney JM, Miller E, et al  Comparison of the efficacy and safety of rosuvastatin versus atorvastatin, simvastatin, and pravastatin across doses (STELLAR* Trial) . Am J Cardiol . 2003;92:152–160
  15. Anon  . 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
  16. Lee E, Ryan S, Birmingham B, Zalikowski J, March R, Ambrose H, et al  Rosuvastatin pharmacokinetics and pharmacogenetics in white and Asian subjects residing in the same environment . Clin Pharmacol Ther . 2005;78:330–341
  17. Owan TE , Hodge DO , Herges RM , Jacobsen SJ , Roger VL , Redfield MM . Trends in prevalence and outcome of heart failure with preserved ejection fraction . N Engl J Med . 2006;355:251–259
  18. Bhatia RS, Tu JV, Lee DS, Austin PC, Fang J, Haouzi A, et al  Outcome of heart failure with preserved ejection fraction in a population-based study . N Engl J Med . 2006;355:260–269
  19. Deedwania PC , Gupta M , Stein M , Ycas J , Gold A , IRIS Study Group  . Comparison of rosuvastatin versus atorvastatin in South-Asian patients at risk of coronary heart disease (from the IRIS Trial) . Am J Cardiol . 2007;99:1538–1543
  20. Zhu J , Tomlinson B , Ro YM , Sim K-H , Lee Y-T , Sriratanasathavorn C . A randomised study comparing the efficacy and safety of rosuvastatin with atorvastatin for achieving lipid goals in clinical practice in Asian patients at high risk of cardiovascular disease (DISCOVERY-Asia study) . Curr Med Res Opin . 2007;23:3055–3068
  21. Gao R . The efficacy and safety of rosuvastatin on treating patients with hypercholesterolemia in Chinese: a randomized, double-blind, multi-center clinical trial . Chin J Cardiol . 2007;35:207–211
  22. Nissen SE, Nicholls SJ, Sipahi I, Libby P, Raichlen JS, Ballantyne CM, et al  Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: The ASTEROID Trial . JAMA . 2006;295:1556–1565
  23. Fang C . Comparison of the efficacy of 5 statins in Taiwan . Acta Cardiol Sinica . 2006;22(Suppl):187
  24. Shepherd J, Hunninghake DB, Stein EA, Kastelein JJ, Harris S, Pears J, et al. Safety of rosuvastatin . Am J Cardiol . 2004;94:882–888
  25. Shepherd J, Vidt DG, Miller E. Safety of rosuvastatin: update on 16,876 rosuvastatin-treated patients in a multinational clinical trial program. Cardiology 2008;(in press).

PII: S1726-4901(08)70001-7

doi:10.1016/S1726-4901(08)70001-7

Journal of the Chinese Medical Association
Volume 71, Issue 3 , Pages 113-118, March 2008

Article Tools