PMID- 20524719
OWN - NLM
STAT- MEDLINE
DCOM- 20100824
LR  - 20220321
IS  - 1175-3277 (Print)
IS  - 1175-3277 (Linking)
VI  - 10
IP  - 3
DP  - 2010
TI  - Efficacy and safety of rosuvastatin and fenofibric acid combination therapy 
      versus simvastatin monotherapy in patients with hypercholesterolemia and 
      hypertriglyceridemia: a randomized, double-blind study.
PG  - 175-86
LID - 10.2165/11533430-000000000-00000 [doi]
AB  - OBJECTIVES: To evaluate the efficacy and safety of fixed-dose combinations of 
      rosuvastatin and fenofibric acid (rosuvastatin/fenofibric acid) compared with 
      simvastatin in patients with high levels of low-density lipoprotein cholesterol 
      (LDL-C) and triglycerides (TG). BACKGROUND: Combination therapy with a statin and 
      a fibrate is one of the treatment options to manage multiple lipid abnormalities 
      in patients with hypercholesterolemia and elevated TGs. METHODS: In this 
      randomized, double-blind study, patients (n = 474) with LDL-C > or =160 mg/dL and 
      < or =240 mg/dL and TG > or =150 mg/dL and <400 mg/dL were treated for 8 weeks 
      with simvastatin 40 mg, rosuvastatin/fenofibric acid 5 mg/135 mg, 
      rosuvastatin/fenofibric acid 10 mg/135 mg, or rosuvastatin/fenofibric acid 20 
      mg/135 mg. Primary and secondary variables were mean percent changes in LDL-C 
      comparing rosuvastatin/fenofibric acid 20 mg/135 mg with simvastatin 40 mg and 
      rosuvastatin/fenofibric acid 10 mg/135 mg and rosuvastatin/fenofibric acid 5 
      mg/135 mg with simvastatin 40 mg, respectively. Additional efficacy variables 
      included non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein 
      (Apo) B, HDL-C, TG, and high-sensitivity C-reactive protein (hsCRP). Safety was 
      evaluated based on data collected for adverse events (AEs), physical and 
      electrocardiographic examinations, vital sign measurements, and clinical 
      laboratory tests. RESULTS: Significantly greater reductions in LDL-C levels from 
      baseline values were observed with the combination of rosuvastatin/fenofibric 
      acid 20 mg/135 mg (-47.2%, p < 0.001), rosuvastatin/fenofibric acid 10 mg/135 mg 
      (-46.0%, p < 0.001), and rosuvastatin/fenofibric acid 5 mg/135 mg (-38.9%, p = 
      0.007) than with simvastatin 40 mg (-32.8%). Significant (p < or = 0.04 for all 
      comparisons) improvements in non-HDL-C, ApoB, HDL-C, TG, and hsCRP levels were 
      also observed with each of the rosuvastatin/fenofibric acid doses as compared 
      with simvastatin 40 mg. Treatment-related AEs and discontinuations due to AEs 
      were similar across groups. The incidence of serious AEs was 0% with simvastatin 
      40 mg, 3.4% with rosuvastatin/fenofibric acid 5 mg/135 mg, 0.8% with 
      rosuvastatin/fenofibric acid 10 mg/135 mg, and 2.5% with rosuvastatin/fenofibric 
      acid 20 mg/135 mg. No cases of rhabdomyolysis or drug-related myopathy were 
      reported. CONCLUSION: In patients with high LDL-C and TG levels, combination 
      treatment with rosuvastatin/fenofibric acid was well tolerated, and each of the 
      rosuvastatin/fenofibric acid doses produced greater reductions in LDL-C and 
      improvements in other efficacy parameters, compared with simvastatin 40 mg. 
      [Clinical trial is registered at www.clinicaltrials.gov NCT00812955.].
FAU - Roth, Eli M
AU  - Roth EM
AD  - Sterling Research Group, Cincinnati, Ohio 45219, USA. eroth@sterlingresearch.org
FAU - McKenney, James M
AU  - McKenney JM
FAU - Kelly, Maureen T
AU  - Kelly MT
FAU - Setze, Carolyn M
AU  - Setze CM
FAU - Carlson, Dawn M
AU  - Carlson DM
FAU - Gold, Alex
AU  - Gold A
FAU - Stolzenbach, James C
AU  - Stolzenbach JC
FAU - Williams, Laura A
AU  - Williams LA
FAU - Jones, Peter H
AU  - Jones PH
LA  - eng
SI  - ClinicalTrials.gov/NCT00812955
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Am J Cardiovasc Drugs
JT  - American journal of cardiovascular drugs : drugs, devices, and other 
      interventions
JID - 100967755
RN  - 0 (Anticholesteremic Agents)
RN  - 0 (Cholesterol, HDL)
RN  - 0 (Cholesterol, LDL)
RN  - 0 (Fluorobenzenes)
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfonamides)
RN  - 83MVU38M7Q (Rosuvastatin Calcium)
RN  - AGG2FN16EV (Simvastatin)
RN  - BGF9MN2HU1 (fenofibric acid)
RN  - U202363UOS (Fenofibrate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anticholesteremic Agents/*therapeutic use
MH  - Cholesterol, HDL/blood
MH  - Cholesterol, LDL/blood
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Fenofibrate/administration & dosage/adverse effects/*analogs & derivatives
MH  - Fluorobenzenes/*administration & dosage/adverse effects
MH  - Humans
MH  - Hypercholesterolemia/*drug therapy
MH  - Hypertriglyceridemia/*drug therapy
MH  - Liver/drug effects
MH  - Male
MH  - Middle Aged
MH  - Pyrimidines/*administration & dosage/adverse effects
MH  - Rosuvastatin Calcium
MH  - Simvastatin/adverse effects/*therapeutic use
MH  - Sulfonamides/*administration & dosage/adverse effects
EDAT- 2010/06/09 06:00
MHDA- 2010/08/25 06:00
CRDT- 2010/06/08 06:00
PHST- 2010/06/08 06:00 [entrez]
PHST- 2010/06/09 06:00 [pubmed]
PHST- 2010/08/25 06:00 [medline]
AID - 4 [pii]
AID - 10.2165/11533430-000000000-00000 [doi]
PST - ppublish
SO  - Am J Cardiovasc Drugs. 2010;10(3):175-86. doi: 10.2165/11533430-000000000-00000.