Effects of XXXX on vascular biomarkers and carotid atherosclerosis in lupus: a randomized, double-blind, placebo-controlled trial.

@entity1 @entity1255 @entity117 @entity8671 @entity1252 @entity8729 @entity4725 @entity731 @entity121 @entity165
OBJECTIVE: To study the effect of @entity8671 on vascular biomarkers and carotid @entity121 ( @entity121 ) in @entity1252 ( @entity1252 ). METHODS: @entity1252 @entity1 with inactive disease and subclinical @entity731 were randomized in a double-blinded manner to receive either @entity8671 (10 mg/day) or matching placebo (half in each group were also randomly allocated low-dose @entity117 ). After 12 months, treatment was unblinded. @entity1 treated with @entity8671 and @entity117 were continued on the same medications for another 12 months. Plasma levels of @entity1255 , high-sensitivity C-reactive protein (hsCRP), soluble @entity4725 , @entity8729 , and thrombomodulin were measured at baseline, 6 months, and 12 months. Measurement of carotid @entity121 was repeated at 24 months. RESULTS: Seventy-two @entity1 were studied (97% @entity1 , mean    SD age 50.8    9.7 years). Thirty-six @entity1 were randomly assigned to each of the study arms (18 @entity1 in each arm also received @entity117 ). Baseline clinical characteristics and medications were similar between the two groups. At 12 months, the mean low-density lipoprotein @entity165 (mean    SD 2.62    1.04 mmoles/liter to 1.69    0.72 mmoles/liter; P < 0.001) and median hsCRP levels (1.26 mg/liter, interquartile range [IQR] 2.3 to 0.88 mg/liter, IQR 1.1; P = 0.02) decreased significantly in the @entity8671 group. There was no significant change in @entity1255 , and @entity117 use did not influence the levels of the biomarkers studied. A subgroup analysis of @entity1 with a @entity1252 Activity Index score  <=2 revealed a significant decrease in hsCRP (1.20 mg/liter, IQR 2.3 to 0.92 mg/liter, IQR 1.1; P = 0.04) and thrombomodulin levels (0.76 ng/ml, IQR 1.2 to 0.67 ng/ml, IQR 1.0; P = 0.001) with @entity8671 treatment. At 24 months, the @entity121 of the internal carotid arteries appeared to be decreased in @entity1 treated with @entity8671 , which was well tolerated. CONCLUSION: In stable @entity1252 @entity1 , low-dose @entity8671 leads to a significant reduction in hsCRP and thrombomodulin levels, which may possibly help to reduce cardiovascular risk.
