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Intensive lipid lowering with atorvastatin in patients with stable coronary disease.
N Engl J Med. 2005 Apr 07; 352(14):1425-35.NEJM

Abstract

BACKGROUND

Previous trials have demonstrated that lowering low-density lipoprotein (LDL) cholesterol levels below currently recommended levels is beneficial in patients with acute coronary syndromes. We prospectively assessed the efficacy and safety of lowering LDL cholesterol levels below 100 mg per deciliter (2.6 mmol per liter) in patients with stable coronary heart disease (CHD).

METHODS

A total of 10,001 patients with clinically evident CHD and LDL cholesterol levels of less than 130 mg per deciliter (3.4 mmol per liter) were randomly assigned to double-blind therapy and received either 10 mg or 80 mg of atorvastatin per day. Patients were followed for a median of 4.9 years. The primary end point was the occurrence of a first major cardiovascular event, defined as death from CHD, nonfatal non-procedure-related myocardial infarction, resuscitation after cardiac arrest, or fatal or nonfatal stroke.

RESULTS

The mean LDL cholesterol levels were 77 mg per deciliter (2.0 mmol per liter) during treatment with 80 mg of atorvastatin and 101 mg per deciliter (2.6 mmol per liter) during treatment with 10 mg of atorvastatin. The incidence of persistent elevations in liver aminotransferase levels was 0.2 percent in the group given 10 mg of atorvastatin and 1.2 percent in the group given 80 mg of atorvastatin (P<0.001). A primary event occurred in 434 patients (8.7 percent) receiving 80 mg of atorvastatin, as compared with 548 patients (10.9 percent) receiving 10 mg of atorvastatin, representing an absolute reduction in the rate of major cardiovascular events of 2.2 percent and a 22 percent relative reduction in risk (hazard ratio, 0.78; 95 percent confidence interval, 0.69 to 0.89; P<0.001). There was no difference between the two treatment groups in overall mortality.

CONCLUSIONS

Intensive lipid-lowering therapy with 80 mg of atorvastatin per day in patients with stable CHD provides significant clinical benefit beyond that afforded by treatment with 10 mg of atorvastatin per day. This occurred with a greater incidence of elevated aminotransferase levels.

Authors+Show Affiliations

State University of New York Health Science Center, Brooklyn, NY 11203, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15755765

Citation

LaRosa, John C., et al. "Intensive Lipid Lowering With Atorvastatin in Patients With Stable Coronary Disease." The New England Journal of Medicine, vol. 352, no. 14, 2005, pp. 1425-35.
LaRosa JC, Grundy SM, Waters DD, et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005;352(14):1425-35.
LaRosa, J. C., Grundy, S. M., Waters, D. D., Shear, C., Barter, P., Fruchart, J. C., Gotto, A. M., Greten, H., Kastelein, J. J., Shepherd, J., & Wenger, N. K. (2005). Intensive lipid lowering with atorvastatin in patients with stable coronary disease. The New England Journal of Medicine, 352(14), 1425-35.
LaRosa JC, et al. Intensive Lipid Lowering With Atorvastatin in Patients With Stable Coronary Disease. N Engl J Med. 2005 Apr 7;352(14):1425-35. PubMed PMID: 15755765.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intensive lipid lowering with atorvastatin in patients with stable coronary disease. AU - LaRosa,John C, AU - Grundy,Scott M, AU - Waters,David D, AU - Shear,Charles, AU - Barter,Philip, AU - Fruchart,Jean-Charles, AU - Gotto,Antonio M, AU - Greten,Heiner, AU - Kastelein,John J P, AU - Shepherd,James, AU - Wenger,Nanette K, AU - ,, Y1 - 2005/03/08/ PY - 2005/3/10/pubmed PY - 2005/4/13/medline PY - 2005/3/10/entrez SP - 1425 EP - 35 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 352 IS - 14 N2 - BACKGROUND: Previous trials have demonstrated that lowering low-density lipoprotein (LDL) cholesterol levels below currently recommended levels is beneficial in patients with acute coronary syndromes. We prospectively assessed the efficacy and safety of lowering LDL cholesterol levels below 100 mg per deciliter (2.6 mmol per liter) in patients with stable coronary heart disease (CHD). METHODS: A total of 10,001 patients with clinically evident CHD and LDL cholesterol levels of less than 130 mg per deciliter (3.4 mmol per liter) were randomly assigned to double-blind therapy and received either 10 mg or 80 mg of atorvastatin per day. Patients were followed for a median of 4.9 years. The primary end point was the occurrence of a first major cardiovascular event, defined as death from CHD, nonfatal non-procedure-related myocardial infarction, resuscitation after cardiac arrest, or fatal or nonfatal stroke. RESULTS: The mean LDL cholesterol levels were 77 mg per deciliter (2.0 mmol per liter) during treatment with 80 mg of atorvastatin and 101 mg per deciliter (2.6 mmol per liter) during treatment with 10 mg of atorvastatin. The incidence of persistent elevations in liver aminotransferase levels was 0.2 percent in the group given 10 mg of atorvastatin and 1.2 percent in the group given 80 mg of atorvastatin (P<0.001). A primary event occurred in 434 patients (8.7 percent) receiving 80 mg of atorvastatin, as compared with 548 patients (10.9 percent) receiving 10 mg of atorvastatin, representing an absolute reduction in the rate of major cardiovascular events of 2.2 percent and a 22 percent relative reduction in risk (hazard ratio, 0.78; 95 percent confidence interval, 0.69 to 0.89; P<0.001). There was no difference between the two treatment groups in overall mortality. CONCLUSIONS: Intensive lipid-lowering therapy with 80 mg of atorvastatin per day in patients with stable CHD provides significant clinical benefit beyond that afforded by treatment with 10 mg of atorvastatin per day. This occurred with a greater incidence of elevated aminotransferase levels. SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/15755765/Intensive_lipid_lowering_with_atorvastatin_in_patients_with_stable_coronary_disease_ L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa050461?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -