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Effect of ezetimibe coadministered with atorvastatin in 628 patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial.
- Source :
-
Circulation [Circulation] 2003 May 20; Vol. 107 (19), pp. 2409-15. Date of Electronic Publication: 2003 Apr 28. - Publication Year :
- 2003
-
Abstract
- Background: Despite the established efficacy of statins, many patients do not achieve recommended LDL cholesterol (LDL-C) goals. Contributing factors may be inadequate dosing, increased risk for adverse effects with high-dose monotherapy, and increased potential for intolerance and adverse effects with combinations of available agents.<br />Methods and Results: In a double-blind study, 628 patients with baseline LDL-C 145 to 250 mg/dL and triglycerides < or =350 mg/dL were randomly assigned to receive 1 of the following for 12 weeks: ezetimibe (10 mg/d); atorvastatin (10, 20, 40, or 80 mg/d); ezetimibe (10 mg) plus atorvastatin (10, 20, 40, or 80 mg/d); or placebo. The primary efficacy end point was percentage reduction in LDL-C for pooled ezetimibe plus atorvastatin versus pooled atorvastatin treatment groups. Ezetimibe plus atorvastatin significantly improved LDL-C, HDL cholesterol (HDL-C), triglycerides, total cholesterol:HDL-C, and high-sensitivity C-reactive protein (hs-CRP) compared with atorvastatin alone (P<0.01). Coadministration of ezetimibe provided a significant additional 12% LDL-C reduction, 3% HDL-C increase, 8% triglyceride reduction, and 10% hs-CRP reduction versus atorvastatin alone. Ezetimibe plus atorvastatin provided LDL-C reductions of 50% to 60%, triglyceride reductions of 30% to 40%, and HDL-C increases of 5% to 9%, depending on atorvastatin dose. LDL-C reductions with ezetimibe plus 10 mg atorvastatin (50%) and 80 mg atorvastatin alone (51%) were similar.<br />Conclusions: Ezetimibe plus atorvastatin was well tolerated, with a safety profile similar to atorvastatin alone and to placebo. When coadministered with atorvastatin, ezetimibe provided significant incremental reductions in LDL-C and triglycerides and increases in HDL-C. Coadministration of ezetimibe and atorvastatin offers a well-tolerated and highly efficacious new treatment option for patients with hypercholesterolemia.
- Subjects :
- Anticholesteremic Agents adverse effects
Atorvastatin
Azetidines adverse effects
C-Reactive Protein analysis
Cholesterol, HDL blood
Cholesterol, LDL blood
Digestive System drug effects
Double-Blind Method
Drug Synergism
Drug Therapy, Combination
Ezetimibe
Female
Heptanoic Acids adverse effects
Humans
Male
Middle Aged
Musculoskeletal Diseases chemically induced
Prospective Studies
Pyrroles adverse effects
Treatment Outcome
Triglycerides blood
Anticholesteremic Agents therapeutic use
Azetidines administration & dosage
Heptanoic Acids administration & dosage
Hypercholesterolemia drug therapy
Pyrroles administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1524-4539
- Volume :
- 107
- Issue :
- 19
- Database :
- MEDLINE
- Journal :
- Circulation
- Publication Type :
- Academic Journal
- Accession number :
- 12719279
- Full Text :
- https://doi.org/10.1161/01.CIR.0000068312.21969.C8