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Effect of hypolipidemic treatment on emerging risk factors in mixed dyslipidemia: a randomized pilot trial
Author(s) -
Kei Anastazia,
Liberopoulos Evangelos,
Tellis Kostantinos,
Rizzo Manfredi,
Elisaf Moses,
Tselepis Alexandros
Publication year - 2013
Publication title -
european journal of clinical investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.164
H-Index - 107
eISSN - 1365-2362
pISSN - 0014-2972
DOI - 10.1111/eci.12095
Subject(s) - fenofibrate , rosuvastatin , dyslipidemia , medicine , statin , apolipoprotein b , rosuvastatin calcium , randomized controlled trial , endocrinology , lipid profile , pharmacology , cholesterol , gastroenterology , obesity
Background The effects of different hypolipidemic treatment strategies on emerging atherosclerosis risk factors remain unknown. Materials and 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 (hs CRP ), respectively ( P < 0·01 compared with baseline), while add‐on fenofibrate was not associated with changes in hs CRP concentration. Lipoprotein‐associated phospholipase A 2 (Lp‐ PLA 2 ) activity decreased similarly in both rosuvastatin and add‐on fenofibrate groups, while add‐on ER ‐ NA / LRPT was associated with a more pronounced Lp‐ PLA 2 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.