PMID- 20663203
OWN - NLM
STAT- MEDLINE
DCOM- 20101129
LR  - 20240502
IS  - 1476-511X (Electronic)
IS  - 1476-511X (Linking)
VI  - 9
DP  - 2010 Jul 27
TI  - Ezetimibe/simvastatin vs simvastatin in coronary heart disease patients with or 
      without diabetes.
PG  - 80
LID - 10.1186/1476-511X-9-80 [doi]
AB  - BACKGROUND: Treatment guidelines recommend LDL-C as the primary target of therapy 
      in patients with hypercholesterolemia. Moreover, combination therapies with 
      lipid-lowering drugs that have different mechanisms of action are recommended 
      when it is not possible to attain LDL-C targets with statin monotherapy. 
      Understanding which treatment or patient-related factors are associated with 
      attaining a target may be clinically relevant. METHODS: Data were pooled from two 
      multicenter, randomized, double-blind studies. After stabilization on simvastatin 
      20 mg, patients with coronary heart disease (CHD) alone and/or type 2 diabetes 
      mellitus (T2DM) were randomized to ezetimibe 10 mg/simvastatin 20 mg (EZ/Simva) 
      or simvastatin 40 mg. The change from baseline in low-density lipoprotein 
      cholesterol (LDL-C), total cholesterol (TC), high-density lipoprotein cholesterol 
      (HDL-C), TC/HDL-C ratio, triglycerides, and the proportion of patients achieving 
      LDL-C < 2.6 mmol/L (100 mg/dL) after 6 weeks of treatment were assessed, and 
      factors significantly correlated with the probability of achieving LDL-C < 2.6 
      mmol/L in a population of high cardiovascular risk Italian patients were 
      identified. A stepwise logistic regression model was conducted with LDL-C < 2.6 
      mmol/L at endpoint as the dependent variable and study, treatment, gender, age (> 
      or = 65 years or < 65 years), as independent variables and baseline LDL-C (both 
      as continuous and discrete variable). RESULTS: EZ/Simva treatment (N = 93) 
      resulted in significantly greater reductions in LDL-C, TC, and TC/HDL-C ratio and 
      higher attainment of LDL-C < 2.6 mmol/L vs doubling the simvastatin dose to 40 mg 
      (N = 106). Study [including diabetic patients (OR = 2.9, p = 0.003)], EZ/Simva 
      treatment (OR = 6.1, p < 0.001), and lower baseline LDL-C (OR = 0.9, p = 0.001) 
      were significant positive predictors of LDL-C target achievement. When baseline 
      LDL-C was expressed as a discrete variable, the odds of achieving LDL-C < 2.6 
      mmol/L was 4.8 in favor of EZ/Simva compared with Simva 40 mg (p < 0.001), 
      regardless of baseline LDL-C level. CONCLUSION: EZ/Simva is an effective 
      therapeutic option for patients who have not achieved recommended LDL-C treatment 
      targets with simvastatin 20 mg monotherapy. TRIAL REGISTRATION: Clinical trial 
      registration numbers: NCT00423488 and NCT00423579.
FAU - Rotella, Carlo M
AU  - Rotella CM
AD  - Dipartimenti Fisiopatologia Clinica, Universitad i Firenze, Viale Pieraccini 6, 
      50139, Florence, Italy.
FAU - Zaninelli, Augusto
AU  - Zaninelli A
FAU - Le Grazie, Cristina
AU  - Le Grazie C
FAU - Hanson, Mary E
AU  - Hanson ME
FAU - Gensini, Gian Franco
AU  - Gensini GF
LA  - eng
SI  - ClinicalTrials.gov/NCT00423488
SI  - ClinicalTrials.gov/NCT00423579
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100727
PL  - England
TA  - Lipids Health Dis
JT  - Lipids in health and disease
JID - 101147696
RN  - 0 (Anticholesteremic Agents)
RN  - 0 (Azetidines)
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Lipids)
RN  - AGG2FN16EV (Simvastatin)
RN  - EOR26LQQ24 (Ezetimibe)
SB  - IM
MH  - Aged
MH  - Anticholesteremic Agents/adverse effects/*therapeutic use
MH  - Azetidines/adverse effects/*therapeutic use
MH  - Cardiovascular Diseases/complications
MH  - Cholesterol, LDL/*blood
MH  - Coronary Disease/complications/*drug therapy
MH  - Diabetes Mellitus, Type 2/*complications
MH  - Double-Blind Method
MH  - Drug Therapy, Combination/adverse effects
MH  - Ezetimibe
MH  - Female
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects/*therapeutic use
MH  - Lipids/blood
MH  - Male
MH  - Middle Aged
MH  - Risk Factors
MH  - Simvastatin/adverse effects/*therapeutic use
MH  - Statistics as Topic
PMC - PMC2918617
EDAT- 2010/07/29 06:00
MHDA- 2010/12/14 06:00
PMCR- 2010/07/27
CRDT- 2010/07/29 06:00
PHST- 2010/06/17 00:00 [received]
PHST- 2010/07/27 00:00 [accepted]
PHST- 2010/07/29 06:00 [entrez]
PHST- 2010/07/29 06:00 [pubmed]
PHST- 2010/12/14 06:00 [medline]
PHST- 2010/07/27 00:00 [pmc-release]
AID - 1476-511X-9-80 [pii]
AID - 10.1186/1476-511X-9-80 [doi]
PST - epublish
SO  - Lipids Health Dis. 2010 Jul 27;9:80. doi: 10.1186/1476-511X-9-80.