Abstract | BACKGROUND: A considerable number of patients with severely elevated LDL-C do not achieve recommended treatment targets, despite treatment with statins. Adults at high cardiovascular risk with hypercholesterolemia and LDL-C ≥ 2.59 and ≤ 4.14 mmol/L (N = 250), pretreated with atorvastatin 20 mg were randomized to ezetimibe/ simvastatin 10/40 mg or atorvastatin 40 mg for 6 weeks. The percent change in LDL-C and other lipids was assessed using a constrained longitudinal data analysis method with terms for treatment, time, time-by-treatment interaction, stratum, and time-by-stratum interaction. Percentage of subjects achieving LDL-C < 1.81 mmol/L, < 2.00 mmol/L, or < 2.59 mmol/L was assessed using a logistic regression model with terms for treatment and stratum. Tolerability was assessed. RESULTS: Switching to ezetimibe/ simvastatin resulted in significantly greater changes in LDL-C (-26.81% vs.-11.81%), total cholesterol (-15.97% vs.-7.73%), non-HDL-C (-22.50% vs.-10.88%), Apo B (-17.23% vs.-9.53%), and Apo A-I (2.56% vs.-2.69%) vs. doubling the atorvastatin dose (all p ≤ 0.002), but not HDL-C, triglycerides, or hs-CRP. Significantly more subjects achieved LDL-C < 1.81 mmol/L (29% vs. 5%), < 2.00 mmol/L (38% vs. 9%) or < 2.59 mmol/L (69% vs. 41%) after switching to ezetimibe/ simvastatin vs. doubling the atorvastatin dose (all p < 0.001). The overall safety profile appeared generally comparable between treatment groups. CONCLUSIONS: TRIAL REGISTRATION: Registered at clinicaltrials.gov: NCT00782184.
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Authors | Paul Kah Hing Ling, Fernando Civeira, Andrei Gheorghe Dan, Mary E Hanson, Rachid Massaad, Celine Le Bailly De Tilleghem, Christopher Milardo, Joseph Triscari |
Journal | Lipids in health and disease
(Lipids Health Dis)
Vol. 11
Pg. 18
(Jan 31 2012)
ISSN: 1476-511X [Electronic] England |
PMID | 22293030
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticholesteremic Agents
- Azetidines
- Drug Combinations
- Heptanoic Acids
- Lipids
- Pyrroles
- C-Reactive Protein
- Atorvastatin
- Simvastatin
- Ezetimibe
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Topics |
- Aged
- Anticholesteremic Agents
(therapeutic use)
- Atorvastatin
- Azetidines
(therapeutic use)
- C-Reactive Protein
(metabolism)
- Cardiovascular Diseases
(blood, etiology, prevention & control)
- Double-Blind Method
- Drug Combinations
- Ezetimibe
- Female
- Heptanoic Acids
(therapeutic use)
- Humans
- Hypercholesterolemia
(blood, complications, drug therapy)
- Lipids
(blood)
- Male
- Middle Aged
- Pyrroles
(therapeutic use)
- Simvastatin
(therapeutic use)
- Treatment Outcome
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