Fluvastatin reduces the impact of diabetes on long-term outcome after coronary intervention--a Lescol Intervention Prevention Study (LIPS) substudy.
BACKGROUND
Diabetes increases the risk of developing cardiovascular disease. Patients with diabetes undergoing percutaneous coronary intervention (PCI) show poorer outcomes compared with nondiabetic patients. The aim of this study was to determine the clinical benefit of long-term fluvastatin in patients with diabetes who had undergone a successful PCI.


METHODS
This subanalysis of a prospective, multicenter, randomized, double-blind, placebo-controlled trial of patients who had undergone PCI and were treated with fluvastatin determined the impact of fluvastatin on the survival-free period of major adverse cardiac events (MACE) (defined as cardiac death, nonfatal myocardial infarction, and reintervention procedure [coronary artery bypass grafting, repeat PCI, PCI for a new lesion]). Patients with baseline total cholesterol levels of 135 to 270 mg/dL (3.5-7.0 mmol/L) and triglyceride levels of 400 mg/dL (4.5 mmol/L) were randomized at discharge either to fluvastatin (n = 844) or to placebo (n = 833); follow-up was 3 to 4 years. Among these patients, there were 202 with diabetes (120 on fluvastatin, 82 placebo) and 1475 without diabetes (724 on fluvastatin, 751 on placebo). The primary clinical outcome was survival time free of MACE and MACE excluding restenosis.


RESULTS
The presence of diabetes increased the risk of MACE by almost 2-fold in placebo-treated patients (RR 1.78, 95% CI 1.20-2,64, P = .0045). In contrast, in diabetic patients treated with fluvastatin, the risk of MACE was not significantly different from that in patients without diabetes. Fluvastatin reduced the risk of MACE in diabetic patients by 51% (P = .0088).


CONCLUSIONS
Diabetes is a consistent clinical predictor of cardiovascular complications and fluvastatin reduces the increased incidence of long-term adverse complications associated with the presence of diabetes.
Arampatzis
Chourmouzios A
CA
Department of Interventional Cardiology, Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
Goedhart
Dick
D
Serruys
Patrick W
PW
Saia
Francesco
F
Lemos
Pedro A
PA
de Feyter
Pim
P
D015906:Angioplasty, Balloon, Coronary; D000924:Anticholesteremic Agents / Q000627:therapeutic use; D003327:Coronary Disease / Q000150:complications / Q000401:mortality / Q000517:prevention & control* / Q000628:therapy; D048909:Diabetes Complications / Q000628:therapy*; D004311:Double-Blind Method; D005229:Fatty Acids, Monounsaturated / Q000627:therapeutic use*; D005260:Female; D000077340:Fluvastatin; D005500:Follow-Up Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D007211:Indoles / Q000627:therapeutic use*; D008074:Lipoproteins / Q000097:blood; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000517:prevention & control; D016019:Survival Analysis
D000924:Anticholesteremic Agents; D005229:Fatty Acids, Monounsaturated; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007211:Indoles; D008074:Lipoproteins; D000077340:Fluvastatin