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Effects of low-dose simvastatin therapy on serum lipid levels in patients with moderate hypercholesterolemia: a 12-month study. The Simvastatin Study Group.

Abstract
The aim of this study was to investigate the safety and long-term effects on serum lipid levels of low-dose simvastatin, an inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase, in Japanese patients with moderate primary hypercholesterolemia. We assigned 201 patients (68 men and 133 women; mean +/- SD age, 61.3 +/- 10.2 years) with serum total cholesterol levels > or = 220 mg/dL to receive simvastatin 5 mg each evening; the treatment period was 1 year. Serum total cholesterol, triglycerides, and low-density lipoprotein (LDL) cholesterol levels decreased significantly in response to simvastatin therapy, and the changes were maintained throughout the treatment period. Mean total cholesterol decreased from 269.9 +/- 35.4 mg/dL to 215.2 +/- 34.5 mg/dL (20.3%), triglycerides decreased from 183.0 +/- 110.2 mg/dL to 155.5 +/- 88.5 mg/dL (15.0%), and LDL cholesterol decreased from 180.0 +/- 33.1 mg/dL to 130.1 +/- 35.1 mg/dL (27.7%). Total cholesterol, triglycerides, and LDL cholesterol tended to decline when the pretreatment values were higher; the critical values and the bidirectional changes of the serum lipid levels were 188.1, 109.5, and 91.6 mg/dL, respectively. Although the serum level of high-density lipoprotein cholesterol did not change significantly, it tended to increase more when the pretreatment values were lower; the "critical value" was 70 mg/dL. Nine patients experienced mild adverse events, but none discontinued simvastatin during the 12-month treatment period. We found that low-dose simvastatin therapy is effective in achieving long-term decreases in serum lipid levels and is well tolerated by patients with moderate hypercholesterolemia. Simvastatin therapy may result in normalization of serum lipid levels.
AuthorsT Itoh, M Matsumoto, H Hougaku, N Handa, Y Tsubakihara, Y Yamada, M Imaizumi, M Hoshi, Y Shimazu, M Hori, R Kawamori, N Ueda, H Fusamoto, T Kamada
JournalClinical therapeutics (Clin Ther) 1997 May-Jun Vol. 19 Issue 3 Pg. 487-97 ISSN: 0149-2918 [Print] United States
PMID9220213 (Publication Type: Clinical Trial, Journal Article)
Chemical References
  • Anticholesteremic Agents
  • Cholesterol, HDL
  • Cholesterol, LDL
  • Lipids
  • Triglycerides
  • Cholesterol
  • Lovastatin
  • Simvastatin
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Anticholesteremic Agents (adverse effects, therapeutic use)
  • Cholesterol (blood)
  • Cholesterol, HDL (blood)
  • Cholesterol, LDL (blood)
  • Female
  • Humans
  • Hypercholesterolemia (blood, drug therapy)
  • Japan
  • Lipids (blood)
  • Lovastatin (adverse effects, analogs & derivatives, therapeutic use)
  • Male
  • Middle Aged
  • Simvastatin
  • Triglycerides (blood)

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