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.
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.


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.
Itakura
Hiroshige
H
Ibaraki Christian University, Hitachi, Japan.
Kita
Toru
T
Mabuchi
Hiroshi
H
Matsuzaki
Masunori
M
Matsuzawa
Yuji
Y
Nakaya
Noriaki
N
Oikawa
Shinichi
S
Saito
Yasushi
Y
Sasaki
Jun
J
Shimamoto
Kazuaki
K
D000328:Adult; D000368:Aged; D044466:Asian People; D002784:Cholesterol / Q000097:blood*; D008078:Cholesterol, LDL / Q000097:blood; D003327:Coronary Disease / Q000097:blood / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D006937:Hypercholesterolemia / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D019821:Simvastatin / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood
D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D014280:Triglycerides; D002784:Cholesterol; D019821:Simvastatin