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Odkazy a zdroje - Studie - LIPS



LIPS

Lescol Intervention Prevention Study

Author(s)
(a) Serruys PW, De Feyter PJ, Benghozi R, Hugenholtz PG, Lesaffre E.
(b) Serruys PW, de Feyter P, Macaya C et al.
(c) Saia F, de Feyter P, Serruys PW et al.

Title(s)
(a) The Lescol(R) Intervention Prevention Study (LIPS): a double-blind, placebo-controlled, randomized trial of the long-term effects of fluvastatin after successful transcatheter therapy in patients with coronary heart disease.
(b) Fluvastatin for prevention of cardiac events following successful first percutaneous coronary intervention: a randomized controlled trial.
(c) Effect of fluvastatin on long-term outcome after coronary revascularization with stent implantation.

Reference(s)
(a) Int J Cardiovasc Intervent. 2001 Dec;4(4):165-172.
(b) JAMA. 2002;287:3215-22.
(c) Am J Cardiol. 2004 Jan 1;93(1):92-5.

Disease
Coronary heart disease

Purpose
To determine whether treatment with fluvastatin reduces major cardiac adverse events (MACE) in patients who have undergone PCI

Study design
Randomized, double-blind, placebo-controlled trial conducted at 77 referral centers in Europe, Canada, and Brazil

Follow-up
Median 3.9 years

Patients
A total of 1677 patients (aged 18-80 years) recruited between April 1996 and October 1998 with stable or unstable angina or silent ischemia following successful completion of their first PCI who had baseline total cholesterol levels between 135 and 270 mg/dL (3.5-7.0 mmol/L), with fasting triglyceride levels of less than 400 mg/dL (4.5 mmol/L)

Treatment regimen
Patients were randomly assigned to receive treatment with fluvastatin, 80 mg/d (n = 844), or matching placebo (n = 833) at hospital discharge for 3 to 4 years

Concomitant therapy
-

Results
MACE-free survival time was significantly longer in the fluvastatin group (P =.01). One hundred eighty-one (21.4%) of 844 patients in the fluvastatin group and 222 (26.7%) of 833 patients in the placebo group had at least 1 MACE (relative risk [RR], 0.78; 95% confidence interval [CI], 0.64-0.95; P =.01). This result was independent of baseline total cholesterol levels (above [RR, 0.76; 95% CI, 0.56-1.04] vs below [RR, 0.77; 95% CI, 0.57-1.02] the median). In subgroup analysis, the risk of MACE was reduced in patients with diabetes (n = 202; RR, 0.53; 95% CI, 0.29-0.97; P =.04) and in those with multivessel disease (n = 614; RR, 0.66; 95% CI, 0.48-0.91; P =.01) who received fluvastatin compared with those who received placebo. There were no instances of creatine phosphokinase elevations 10 or more times the upper limit of normal or rhabdomyolysis in the fluvastatin group.
In summary, fluvastatin treatment significantly reduced the risk of MACE by 22% compared with placebo in patients with average cholesterol levels undergoing their first successful PCI. Even more marked risk compared with placebo were seen in the subgroups of patients with diabetes (47% risk reduction) and multivessel disease (34% risk reduction)