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)

• Published in: Journal of cardiology Vol. 57; no. 1; pp. 77 - 88
• Main Authors: Itakura, Hiroshige, MD, Nakaya, Noriaki, MD, Kusunoki, Tadashi, MD, Shimizu, Naokata, MD, Hirai, Shunsaku, MD, Mochizuki, Seibu, MD, Ishikawa, Toshitsugu, MD
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 01.01.2011
• Subjects: Age Factors; Aged; Anticholesteremic Agents - adverse effects; Anticholesteremic Agents - therapeutic use; Cardiovascular; Cardiovascular Diseases - etiology; Cerebrovascular Disorders - etiology; Cholesterol - blood; Cholesterol, LDL - blood; Drug Monitoring; Elderly; Fatty Acids, Monounsaturated - adverse effects; Fatty Acids, Monounsaturated - therapeutic use; Female; Fluvastatin; Humans; Hypercholesterolemia; Hypercholesterolemia - drug therapy; Indoles - adverse effects; Indoles - therapeutic use; Local event monitoring; Male; Middle Aged; Prospective Studies; Safety; Fluvastatin; Hypercholesterolemia; Local event monitoring; Safety; Elderly
• ISSN: 0914-5087; 1876-4738
• DOI: 10.1016/j.jjcc.2010.09.003

Summary 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.