Effects of Fluvastatin on Coronary Atherosclerosis in Patients With Mild to Moderate Cholesterol Elevations (Lipoprotein and Coronary Atherosclerosis Study [LCAS])
Section snippets
Trial Design
The design of the trial has been described in detail elsewhere.[3] In brief, LCAS was a randomized, double-blind, placebo-controlled trial of fluvastatin, 20 mg bid, conducted at a single center (Baylor College of Medicine) using 2 clinic sites. The trial comprised a 4-week screening and dietary lead-in period, 6-week diet stabilization and placebo washout period, and 2.5-year active treatment period that included diet as background therapy (Fig. 1). Open-label cholestyramine, up to 12 g/day as
Patient Group
Of the 909 patients entered into the dietary lead-in period, 429 were randomized. The major reasons for exclusion were lipid ineligibility (39.8%), lack of cooperation (21.0%), and transaminase elevation (13.5%). Selected baseline characteristics of the randomized patients are shown in Table 1; mean baseline lipid values are included in Table 2. The 2 randomized groups were comparable, although the placebo group included a higher proportion of men and lower proportions of patients with elevated
Discussion
Treatment with fluvastatin in LCAS yielded significant coronary lesion benefit; after 2.5 years, MLD decreased only 0.028 mm in all fluvastatin patients and 0.024 mm in fluvastatin monotherapy patients versus reductions of 0.100 and 0.094 mm in respective placebo patients (p <0.01 and <0.02, respectively). A unique feature of the LCAS population was that of the patients had relatively normal or only mildly elevated baseline LDL cholesterol concentration. One fourth of LCAS patients had
Acknowledgements
Funding for the Lipoprotein and Coronary Atherosclerosis Study was provided by Sandoz Pharmaceuticals Corporation Grant B351, East Hanover, New Jersey; and GCRC Grant 5M0IRR00350 from the National Institutes of Health, Bethesda, Maryland.
References (30)
- et al.
Effect on coronary atherosclerosis of decrease in plasma cholesterol concentrations in normocholesterolaemic patients
Lancet
(1994) - et al.
Benefits of lipid-lowering therapy in men with elevated apolipoprotein B are not confined to those with very high low density lipoprotein cholesterol
J Am Coll Cardiol
(1994) - et al.
Pravastatin Limitation of Atherosclerosis in the Coronary Arteries (PLAC I): reduction in atherosclerosis progression and clinical events
J Am Coll Cardiol
(1995) - et al.
Inhibitor of proliferation of arterial smooth-muscle cells by fluvastatin [letter]
Lancet
(1996) - et al.
Task Force 8. Organization of preventive cardiology service
J Am Coll Cardiol
(1996) Range of serum cholesterol values in the population developing coronary artery disease
Am J Cardiol
(1995)- et al.
The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels
N Engl J Med
(1996) - et al.
The Lipoprotein and Coronary Atherosclerosis Study (LCAS): design, methods, and baseline data of a trial of fluvastatin in patients without severe hypercholesterolemia
Control Clin Trials
(1996) Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults
Arch Intern Med
(1988)- et al.
Assessment of short-, medium-, and long-term variations in arterial dimensions from computer-assisted quantitation of coronary cineangiograms
Circulation
(1985)
Short-term cholesterol lowering decreases size and severity of perfusion abnormalities by positron emission tomography after dipyridamole in patients with coronary artery disease: a potential noninvasive marker of healing coronary endothelium
Circulation
Changes in myocardial perfusion abnormalities by positron emission tomography after long-term, intense risk factor modification
JAMA
Regression and ordered categorical variables
J Stat Soc
Second report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II)
Circulation
Beneficial effects of combined colestipol-niacin therapy on coronary atherosclerosis and coronary venous bypass grafts
JAMA
Cited by (320)
The pharmacokinetic characters of simvastatin after co-administration with Shexiang Baoxin Pill in healthy volunteers’ plasma
2016, Journal of Chromatography B: Analytical Technologies in the Biomedical and Life SciencesA systematic review of statin-induced muscle problems in clinical trials
2014, American Heart JournalCitation Excerpt :The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents. Fourteen studies examined pravastatin6–19; 6, lovastatin20–25; 6, atorvastatin26–31; 5, simvastatin32–36; 5, rosuvastatin37–41; 5, fluvastatin42–46; and 1, cerivastatin (Table I).47 The age (mean ± SD) of the statin and placebo groups was 60 ± 5.5 and 60 ± 5.6 years.
Statin-related inflammatory myopathy
2013, Revue de Medecine InterneStatins moderate coronary stenoses but not coronary calcification: Results from meta-analyses
2011, International Journal of CardiologyThe complex interplay between cholesterol and prostate malignancy
2011, Urologic Clinics of North AmericaThe association of statin therapy and cancer: a meta-analysis
2023, Lipids in Health and Disease
- 1
A list of the LCAS investigators and their affiliations appear in the Appendix.