Relationship between coronary events and serum cholesterol during 10 years of low-dose simvastatin therapy: long-term efficacy and safety in Japanese patients with hypercholesterolemia in the Japan Lipid Intervention Trial (J-LIT) Extension 10 Study, a prospective large-scale observational cohort study.

Abstract

BACKGROUND:

Because many Japanese patients with hypercholesterolemia have received statin therapy for nearly a decade, there was a need to investigate the benefit of long-term treatment. The Japan Lipid Intervention Trial (J-LIT) Extension 10 study was planned to continue the original J-LIT study for a total of 10 years.

METHODS AND RESULTS:

All 51,321 patients (including 19,905 who agreed to continue the study) were analyzed. Low-dose treatment with simvastatin (mainly 5 mg/day) was continued throughout the study period and serum lipid levels were well controlled over 10 years. Incidence of adverse drug reactions during the 4-year extension period was lower than previously. Serum total cholesterol, low-density lipoprotein-cholesterol (LDL-C), and triglyceride levels showed a positive correlation with the risk of coronary events, whereas high-density lipoprotein-cholesterol showed an inverse correlation. Patients with an LDL-C level>or=140 mg/dl had a far higher risk of coronary events than those with a level<100 mg/dl.

CONCLUSIONS:

Long-term, low-dose simvastatin therapy was safe and effective in Japanese patients with hypercholesterolemia. Serum LDL-C levels should be <140 mg/dl to decrease coronary risk and a low cholesterol level should be maintained for as long as possible.

• Authors: Hiroshige Itakura, Toru Kita, Hiroshi Mabuchi, Masunori Matsuzaki, Yuji Matsuzawa, Noriaki Nakaya, Shinichi Oikawa, Yasushi Saito, Jun Sasaki, Kazuaki Shimamoto, J-LIT Study Group
• Journal: Circulation journal : official journal of the Japanese Circulation Society (Circ J) Vol. 72 Issue 8 Pg. 1218-24 (Aug 2008) ISSN: 1346-9843 [Print] Japan
• PMID: 18654003 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Cholesterol, LDL
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Triglycerides
• Cholesterol
• Simvastatin

Topics

• Adult
• Aged
• Asian People
• Cholesterol (blood)
• Cholesterol, LDL (blood)
• Coronary Disease (blood, etiology, mortality, prevention & control)
• Drug Administration Schedule
• Female
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (administration & dosage, adverse effects)
• Hypercholesterolemia (blood, complications, drug therapy, mortality)
• Japan (epidemiology)
• Male
• Middle Aged
• Prospective Studies
• Risk Assessment
• Risk Factors
• Simvastatin (administration & dosage, adverse effects)
• Time Factors
• Treatment Outcome
• Triglycerides (blood)