title: Effect of hypolipidemic treatment on emerging risk factors in mixed dyslipidemia: a randomized pilot trial.
abstract: BACKGROUND
  The effects of different hypolipidemic treatment strategies on emerging atherosclerosis risk factors remain unknown.
  
  
  METHODS
  This is a prespecified analysis of a prospective, randomized, open-label, blinded end point (PROBE) study (ClinicalTrials.gov identifier: NCT01010516). Patients (n = 100) with mixed dyslipidaemia on a standard statin dose who had not achieved lipid targets were randomized to switch to the highest dose of rosuvastatin (40 mg/day) or to add-on-statin extended release nicotinic acid (ER-NA)/laropiprant (LRPT) or to add-on-statin micronized fenofibrate for a total of 3 months.
  
  
  RESULTS
  Following 3 months of treatment, low-density lipoprotein (LDL) particle size increased equally in all groups. Similarly, all treatments were associated with comparable small dense LDL cholesterol reduction. Apolipoprotein B levels decreased by 15%, 7% and 4% in the rosuvastatin, add-on ER-NA/LRPT and add-on fenofibrate group, respectively (P < 0.01 for all compared with baseline, P < 0.01 for all comparisons between groups). Only add-on ER-NA/LRPT was associated with lipoprotein (a) reduction (26%, P < 0.01 compared with baseline). Rosuvastatin monotherapy and add-on ER-NA/LRPT groups were associated with 56% and 24% reduction in high-sensitivity C-reactive protein levels (hsCRP), respectively (P < 0.01 compared with baseline), while add-on fenofibrate was not associated with changes in hsCRP concentration. Lipoprotein-associated phospholipase A2 (Lp-PLA2) activity decreased similarly in both rosuvastatin and add-on fenofibrate groups, while add-on ER-NA/LRPT was associated with a more pronounced Lp-PLA2 activity reduction. ER-NA/LRPT was associated with more side effects compared with rosuvastatin and add-on fenofibrate.
  
  
  CONCLUSIONS
  Add-on ER-NA/LRPT followed by switch to the highest dose rosuvastatin were associated with more pronounced beneficial modifications in emerging cardiovascular risk factors compared with add-on fenofibrate in patients with mixed dyslipidaemia.
authors.affiliation: Department of Internal Medicine, University of Ioannina Medical School, Ioannina, Greece.
authors.forename: Anastazia
authors.initials: A
authors.lastname: Kei
authors.forename: Evangelos
authors.initials: E
authors.lastname: Liberopoulos
authors.forename: Kostantinos
authors.initials: K
authors.lastname: Tellis
authors.forename: Manfredi
authors.initials: M
authors.lastname: Rizzo
authors.forename: Moses
authors.initials: M
authors.lastname: Elisaf
authors.forename: Alexandros
authors.initials: A
authors.lastname: Tselepis
mesh_terms: D043203:1-Alkyl-2-acetylglycerophosphocholine Esterase / Q000097:blood; D000328:Adult; D000368:Aged; D001055:Apolipoproteins B / Q000097:blood; D050197:Atherosclerosis / Q000517:prevention & control; D002097:C-Reactive Protein / Q000378:metabolism; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D008078:Cholesterol, LDL / Q000097:blood; D004359:Drug Therapy, Combination; D050171:Dyslipidemias / Q000097:blood / Q000188:drug therapy*; D005260:Female; D011345:Fenofibrate / Q000627:therapeutic use; D005464:Fluorobenzenes / Q000627:therapeutic use; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D007211:Indoles / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000627:therapeutic use; D010865:Pilot Projects; D011446:Prospective Studies; D011743:Pyrimidines / Q000627:therapeutic use; D012307:Risk Factors; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D001055:Apolipoproteins B; D008078:Cholesterol, LDL; D005464:Fluorobenzenes; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D007211:Indoles; C518174:MK-0524; D011743:Pyrimidines; D013449:Sulfonamides; D009525:Niacin; D000068718:Rosuvastatin Calcium; D002097:C-Reactive Protein; D043203:1-Alkyl-2-acetylglycerophosphocholine Esterase; D011345:Fenofibrate