PMID- 22269152
OWN - NLM
STAT- MEDLINE
DCOM- 20120612
LR  - 20221207
IS  - 1879-1484 (Electronic)
IS  - 0021-9150 (Linking)
VI  - 221
IP  - 1
DP  - 2012 Mar
TI  - Non-lipid effects of rosuvastatin-fenofibrate combination therapy in high-risk 
      Asian patients with mixed hyperlipidemia.
PG  - 169-75
LID - 10.1016/j.atherosclerosis.2011.12.042 [doi]
AB  - OBJECTIVE: The aim of this study is to compare the non-lipid effects of 
      rosuvastatin-fenofibrate combination therapy with rosuvastatin monotherapy in 
      high-risk Asian patients with mixed hyperlipidemia. METHODS: A total of 236 
      patients were initially screened. After six weeks of diet and life style changes, 
      180 of these patients were randomly assigned to receive one of two regimens: 
      rosuvastatin 10 mg plus fenofibrate 160 mg or rosuvastatin 10 mg. The primary 
      outcome variables were the incidences of muscle or liver enzyme elevation. The 
      patients were followed for 24 weeks during drug treatment and for an additional 
      four weeks after drug discontinuation. RESULTS: The rates of the primary outcome 
      variables were similar between the two groups (2.8% and 3.9% in the combination 
      and the rosuvastatin groups, respectively, p=1.00). The combination group had 
      more, but not significantly, common treatment-related adverse events (AEs) (13.3% 
      and 5.6%, respectively) and drug discontinuation due to AEs (10.0% and 3.3%, 
      respectively) than the rosouvastatin group. Combination therapy was associated 
      with higher elevations in homocysteine, blood urea nitrogen, and serum 
      creatinine, whereas elevation in alanine aminotransferase was greater in the 
      rosuvastatin group. Leukocyte count and hemoglobin level decreased to a greater 
      extent in the combination group. The combination group showed greater reductions 
      in TG and elevation in HDL-cholesterol. CONCLUSION: In our study population, the 
      rosuvastatin-fenofibrate combination resulted in comparable incidences of myo- or 
      hepatotoxicity as rosuvastatin monotherapy. However, this combination may need to 
      be used with caution in individuals with underlying pathologies such as renal 
      dysfunction (NCT01414803).
CI  - Copyright A(c) 2012 Elsevier Ireland Ltd. All rights reserved.
FAU - Lee, Sang-Hak
AU  - Lee SH
AD  - Cardiology Division, Department of Internal Medicine, Yonsei University College 
      of Medicine, Seoul, Republic of Korea.
FAU - Cho, Kyoung-Im
AU  - Cho KI
FAU - Kim, Jang-Young
AU  - Kim JY
FAU - Ahn, Young Keun
AU  - Ahn YK
FAU - Rha, Seung-Woon
AU  - Rha SW
FAU - Kim, Yong-Jin
AU  - Kim YJ
FAU - Choi, Yun-Seok
AU  - Choi YS
FAU - Choi, Si Wan
AU  - Choi SW
FAU - Jeon, Dong Woon
AU  - Jeon DW
FAU - Min, Pil-Ki
AU  - Min PK
FAU - Choi, Dong-Ju
AU  - Choi DJ
FAU - Baek, Sang Hong
AU  - Baek SH
FAU - Kim, Kwon Sam
AU  - Kim KS
FAU - Byun, Young Sup
AU  - Byun YS
FAU - Jang, Yangsoo
AU  - Jang Y
LA  - eng
SI  - ClinicalTrials.gov/NCT01414803
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120105
PL  - Ireland
TA  - Atherosclerosis
JT  - Atherosclerosis
JID - 0242543
RN  - 0 (Biomarkers)
RN  - 0 (Blood Glucose)
RN  - 0 (Drug Combinations)
RN  - 0 (Enzymes)
RN  - 0 (Fluorobenzenes)
RN  - 0 (Hemoglobins)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Hypolipidemic Agents)
RN  - 0 (Lipids)
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfonamides)
RN  - 0LVT1QZ0BA (Homocysteine)
RN  - 83MVU38M7Q (Rosuvastatin Calcium)
RN  - AYI8EX34EU (Creatinine)
RN  - U202363UOS (Fenofibrate)
SB  - IM
MH  - Aged
MH  - *Asian People
MH  - Biomarkers/blood
MH  - Blood Glucose/metabolism
MH  - Blood Urea Nitrogen
MH  - Cardiovascular Diseases/blood/ethnology/etiology/*prevention & control
MH  - Chemical and Drug Induced Liver Injury/blood/etiology
MH  - Creatinine/blood
MH  - Drug Combinations
MH  - Enzymes/blood
MH  - Female
MH  - Fenofibrate/adverse effects/*therapeutic use
MH  - Fluorobenzenes/adverse effects/*therapeutic use
MH  - Hemoglobins/metabolism
MH  - Homocysteine/blood
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects/*therapeutic use
MH  - Hyperlipidemias/blood/complications/*drug therapy/ethnology
MH  - Hypolipidemic Agents/adverse effects/*therapeutic use
MH  - Lipids/blood
MH  - Liver/drug effects/enzymology
MH  - Male
MH  - Middle Aged
MH  - Muscle, Skeletal/drug effects/enzymology
MH  - Patient Selection
MH  - Pyrimidines/adverse effects/*therapeutic use
MH  - Republic of Korea/epidemiology
MH  - Rhabdomyolysis/blood/chemically induced
MH  - Risk Assessment
MH  - Risk Factors
MH  - Rosuvastatin Calcium
MH  - Sulfonamides/adverse effects/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2012/01/25 06:00
MHDA- 2012/06/13 06:00
CRDT- 2012/01/25 06:00
PHST- 2011/10/24 00:00 [received]
PHST- 2011/12/03 00:00 [revised]
PHST- 2011/12/22 00:00 [accepted]
PHST- 2012/01/25 06:00 [entrez]
PHST- 2012/01/25 06:00 [pubmed]
PHST- 2012/06/13 06:00 [medline]
AID - S0021-9150(12)00002-0 [pii]
AID - 10.1016/j.atherosclerosis.2011.12.042 [doi]
PST - ppublish
SO  - Atherosclerosis. 2012 Mar;221(1):169-75. doi: 
      10.1016/j.atherosclerosis.2011.12.042. Epub 2012 Jan 5.