A 52-week, multicenter, randomized, parallel-group, double-blind, double-dummy study to assess the efficacy of XXXX and @entity3413 in reaching low-density lipoprotein @entity165 and triglyceride targets: the treat-to-target (3T) study.

@entity1 @entity3413 @entity301 @entity2299 @entity1674 @entity2993 @entity11429 @entity65 @entity165
BACKGROUND: Guidelines for the prevention of @entity301 call for low-density lipoprotein @entity165 ( @entity11429 ) reduction as the primary target of treatment and reduction of @entity1674 (TG) as an additional target. OBJECTIVE: The purpose of this study was to investigate the ability of @entity2993 and @entity3413 to reduce @entity11429 and TG concentrations and to meet 3 target lipid levels: @entity11429 <or=2.6 mmol/L; TG <or=1.5 mmol/L; and both @entity11429 <or=2.6 mmol/L and TG <or=1.5 mmol/L. METHODS: The Treat-to-Target (3T) Study was a 52-week, multicenter, randomized, parallel-group study. Using the double-blind, double-dummy technique, adult @entity1 aged 35 to 75 years with @entity65 and @entity2299 , defined as @entity11429 concentration >or=4.0 mmol/L (>or=155 mg/dL), were randomized in a 1:1 ratio to receive once-daily oral treatment with 20 mg @entity2993 or 20 mg @entity3413 . Fasting (12-hour) blood samples for the estimation of lipid levels and clinical laboratory values were collected after 4, 8, 12, 26, and 52 weeks. The dose was doubled after 12 weeks if the target National @entity165 Education Program level of @entity11429 (<or=2.6 mmol/L [100 mg/dL]) was not reached at 8 weeks. RESULTS: The intent-to-treat analysis included 552 @entity1 (418 @entity1 , 134 @entity1 ) randomized to receive @entity2993 and 535 (404 @entity1 , 131 @entity1 ) randomized to receive @entity3413 . The number of @entity1 enrolled in the study allowed the evaluation fo the drugs' effects on TG. @entity1 demogrpahic characteristics were similar for the 2 treatment groups, and there were no differences in baseline lipid values. Compared with @entity3413 , @entity2993 produced significantly greater reductions in @entity11429 (8 weeks: -46% vs -40%, P < 0.001; 52 weeks: -49% vs -44%, P < 0.001) and in TG (8 weeks: -23% vs -14%, P < 0.001; 52 weeks: -24% vs -16%, P < 0.001). Compared with @entity3413 -treated @entity1 , a significantly greater number of @entity2993 -treated @entity1 reached the @entity11429 target after 8 weeks (45% vs 24%; P < 0.001). Fewer @entity2993 @entity1 needed to have their dose doubled; nevertheless more @entity2993 @entity1 reached the @entity11429 target after 52 weeks (61% vs 41%; P < 0.001). Both statins were well tolerated. Muscular symptoms occurred in 12 @entity1 (2.2%) in the @entity2993 group and in 13 @entity1 (2.4%) in the @entity3413 group. CONCLUSIONS: @entity2993 20 or 40 mg/d for up to 1 year of treatment was significantly more effective than @entity3413 20 or 40 mg/d in reducing @entity11429 and TG levels and at achieving recommended lipid targets in this selected @entity1 population with @entity65 and @entity2299 . Both statis were well tolerated.
