Long-term event monitoring study of fluvastatin in Japanese patients with hypercholesterolemia: Efficacy and incidence of cardiac and other events in elderly patients (≥ 65 years old).

Abstract

OBJECTIVE:

This long-term event monitoring (LEM) study was designed to evaluate the long-term lipid-lowering efficacy and safety of fluvastatin (Lochol®, Novartis A.G.) along with the incidence of cardiac and other events, and safety of fluvastatin in Japanese patients with hypercholesterolemia.

METHODS:

Patients (n = 21,139) who started fluvastatin between April 1, 2000 and March 31, 2002, across 2563 centers in Japan were prospectively registered and followed up for 3 years (secondary prevention cohort) or 5 years (primary prevention cohort).

RESULTS:

Of the patients registered, 19,084 were included in this analysis. Levels of low-density lipoprotein-cholesterol (LDL-C) and total cholesterol (TC) decreased significantly in the primary (-27.1% and -18.8%) and secondary (-25.3% and -18.4%) prevention cohorts. Reductions in LDL-C (-22.1 vs. -18.2%, p < 0.0001) and TC (-16.1 vs. -13.1%, p < 0.0001) levels were significantly greater among patients aged ≥ 65 than < 65 years old. Overall, 1.7% (146/8563) and 1.1% (93/8563) of patients aged ≥ 65 years old experienced confirmed cardiac and cerebral events, compared with 1.1% (112/10,517) and 0.3% (28/10,517) of patients aged < 65 years old (p = 0.0002 and < 0.0001, respectively). Incidence of cardiac and cerebral events was lowest in patients aged < 65 years old in the primary prevention cohort and highest among patients aged ≥ 65 years old in the secondary prevention cohort. Adverse events were reported in 7.9% (1501/19,084) of patients.

CONCLUSION:

This large-scale, prospective, uncontrolled study confirmed the lipid-lowering efficacy and safety of long-term fluvastatin treatment for hypercholesterolemia in Japanese patients aged ≥ 65 years old. The higher incidence of cardiac and cerebral events in patients aged ≥ 65 years old in the secondary prevention cohort reflects a high-risk clinical profile with multiple classic risk factors warranting multifactorial interventions.

• Authors: Hiroshige Itakura, Noriaki Nakaya, Tadashi Kusunoki, Naokata Shimizu, Shunsaku Hirai, Seibu Mochizuki, Toshitsugu Ishikawa
• Journal: Journal of cardiology (J Cardiol) Vol. 57 Issue 1 Pg. 77-88 (Jan 2011) ISSN: 1876-4738 [Electronic] Netherlands
• PMID: 21067897 (Publication Type: Journal Article)
• Copyright: Copyright © 2011 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Chemical References

• Anticholesteremic Agents
• Cholesterol, LDL
• Fatty Acids, Monounsaturated
• Indoles
• Fluvastatin
• Cholesterol

Topics

• Age Factors
• Aged
• Anticholesteremic Agents (adverse effects, therapeutic use)
• Cardiovascular Diseases (etiology)
• Cerebrovascular Disorders (etiology)
• Cholesterol (blood)
• Cholesterol, LDL (blood)
• Drug Monitoring
• Fatty Acids, Monounsaturated (adverse effects, therapeutic use)
• Female
• Fluvastatin
• Humans
• Hypercholesterolemia (drug therapy)
• Indoles (adverse effects, therapeutic use)
• Male
• Middle Aged
• Prospective Studies